Generally speaking, how are tablets made?

After tabletting, the hardness is not enough, and there are pits on the surface, which will be broken by gently pressing with your fingers. Cause analysis and solutions:

① The fineness of drugs is not enough, and there are many fibrous or elastic drugs or oils, which are not evenly mixed. It can be overcome by crushing the drug through 100 mesh sieve, selecting strong adhesive, increasing the pressure of tablet press appropriately, and adding oil drug absorbent to make it fully mixed.

② Inadequate dosage or improper selection of binder or wetting agent leads to loose grain texture or uneven distribution of grain thickness, resulting in delamination of coarse and fine grains. It can be overcome by selecting suitable binder or increasing dosage, improving granulation process, stirring more soft materials and mixing particles evenly.

③ The moisture content of particles is too small, and the elasticity of over-dried particles is high. Drugs containing crystal water lose more crystal water during the drying process of granules, which makes the granules brittle and easy to loose leaves. Therefore, the water content of granules should be controlled according to different varieties during granulation. If the granules are too dry, a proper amount of dilute ethanol (50%-60%) can be sprayed, mixed evenly and tabletted.

④ The nature of the drug itself. Although the high-density flat plate has a certain hardness, it can't stand collision and vibration. Such as bismuth subnitrate tablets and soda tablets. It is often prone to loose tablets; Low density, poor fluidity, poor compressibility, and then granulation.

⑤ The fluidity of particles is poor, and the particles filled in the die holes are uneven.

⑥ Blocks or particles and fragments block the scraper and the discharge port, which affects the filling amount.

⑦ Mechanical factors of tablet press. The pressure is too small, the punch length of the multi-punch tablet press is uneven, the vehicle speed is too fast, or there are more or less particles in the hopper. It can be overcome by adjusting the pressure, checking whether the mold is complete, adjusting the speed and adding particles frequently to keep a certain stock in the hopper.

2. earlobe

When the flat plate is shaken or placed, it splits from the waist, which is called lumbar fissure; Cracking from the top is called top crack, and waist crack and top crack are always called lobes. Cause analysis and solutions:

① The drug itself has strong elasticity, and there are many fibrous drugs or oily components. Sugar powder can be added to reduce the elasticity of fiber, strengthen adhesion or increase the absorbability of oil drugs, and then the mixture is fully mixed and tabletted.

② The adhesive or wetting agent is not suitable or the dosage is not enough, and the particle adhesion is poor when tabletting.

③ The particles are too dry, and too much medicine containing crystal water is lost, leading to fragmentation. The solution is the same as pine chips.

④ Some crystallized drugs have not been completely crushed. These drugs can be fully crushed and made into granules.

⑤ Fragmentation caused by too much fine powder and lubricant, part of the air in the powder can't escape in time and is trapped in the tablet. When the pressure is released, the air inside the tablet expands and causes fragmentation, which can be overcome by sieving some fine powder and reducing the amount of lubricant appropriately.

⑥ The pressure of the tablet press is too large, and the resilience is large and cracked; If the vehicle speed is too fast or the die does not meet the requirements, the length of the punch is uneven, the middle part is worn, the middle part is larger than the upper and lower parts, or the punch is curled inward, which may cause the tablets to crack when ejected. Adjust the pressure and speed, improve the matching of stamping dies, and check and replace them in time.

⑦ The room temperature humidity of tabletting room is low, which is easy to cause cracking, especially for drugs with poor viscosity. Adjusting the air conditioning system can solve this problem.

Step 3 stick and hang

When tabletting, the fine powder on the tablet surface is adhered by the punch and the die, resulting in one-sided unevenness and depression, and the lettering punch is more likely to adhere. Rough and textured hanging edge, causes and solutions;

① There is too much water in the granules, which leads to damp drugs. The operating room has high temperature and humidity, which is easy to cause adhesion. Pay attention to proper drying, reduce the temperature and humidity of the operating room, and avoid wetting drugs from getting wet.

② Too little lubricant or uneven mixing, too much fine powder. The amount of lubricant should be appropriately increased or fully mixed to solve the sticking problem.

(3) The surface of the punch is not clean, with antirust oil or lubricating oil, and the surface of the new die is rough or the lettering is too deep and angular. You can wipe the punch clean and replace the unqualified mold, or you can apply a small amount of liquid paraffin to the surface of the lettering punch to make it literally lubricated. In addition, if it is caused by mechanical fever, check the cause and repair the equipment.

(4) The male die and the female die are too tightly matched to cause die hanging. The matching inspection of stamping die should be strengthened to prevent die hanging and punching.

4. The paper weight difference exceeds the limit.

Reasons and solutions for the weight difference of finger pieces exceeding the limit specified in Pharmacopoeia;

① The particle thickness distribution is uneven, and the particle velocity is different when tabletting, which leads to the uneven particle thickness filling the die hole. If there are many coarse particles, the tablets are light; if there are many fine particles, the tablets are heavy. Particles should be evenly mixed or sieved to remove excessive fine powder. If it can't be solved, it will be re-granulated.

(2) If the fine powder adheres to the punch and causes the punch to hang, the weight difference of the chip is large. At this time, the lower punch does not rotate flexibly, so it should be checked in time, the mold should be removed, and the lower punch and the die hole should be wiped clean.

(3) The fluidity of particles is not good, and the amount of particles flowing into the die hole is sometimes very small, resulting in a large difference in sheet weight and exceeding the standard. Therefore, it is necessary to re-granulate or add appropriate glidants such as micro-powder silica gel to improve the fluidity of particles.

④ The hopper is blocked, which is common in drugs with strong viscosity or moisture absorption. The hopper should be dredged, the tabletting environment should be kept dry, and the flow aid should be added appropriately to solve the problem.

⑤ The punch does not match the die hole. For example, there is more powder leakage between the periphery of the lower punch and the wall of the die hole, which causes the phenomenon of "poor punching" of the lower punch and insufficient material filling. Therefore, the punch and die ring should be replaced.

⑥ The vehicle speed is too fast and the filling quantity is insufficient.

⑦ The length of the first punch is different, which leads to different fillers.

⑧ The distributor is not installed properly, resulting in different fillers.

5. Delayed disintegration

It means that tablets cannot disintegrate within a specified time limit, which affects the dissolution, absorption and curative effect of drugs. The reasons and solutions are as follows:

(1) Influence of pore state of tablets Water infiltration is the primary condition for tablet disintegration, and the speed of water infiltration is related to many pore states in tablets. Although the tablet is a compact thin sheet on the outside, it is actually a porous body with many small holes in it, which are connected with each other to form a capillary network, which is zigzag and closed and open. It is through these small holes that water enters the tablet, and its law can be explained by the following capillary theory:

L2=Rγcosθ/2η？ t

The above formula is the law of liquid flowing in capillary, where L is the distance of liquid penetrating into capillary, θ is the contact angle between liquid and capillary wall, R is the aperture of capillary, γ is the surface tension of liquid, η is the viscosity of liquid, and t is time. Because the general disintegration medium is water or artificial gastric juice, its viscosity does not change much, so the four main factors affecting the disintegration medium (water) to penetrate into tablets are the number of capillaries (porosity), the pore size of capillaries (pore size R), the surface tension γ of liquid and the contact angle θ. The conditions that affect these four factors are:

① Compressibility of raw and auxiliary materials. Raw and auxiliary materials with strong compressibility are prone to plastic deformation during pressing, and the porosity and pore size R of tablets are small, so the amount and distance L of water penetration are relatively small, and the disintegration of tablets is slow. Experiments show that adding starch to some tablets can often increase their porosity and significantly enhance the water absorption of tablets, which is beneficial to the rapid disintegration of tablets. However, it cannot be inferred that the more starch, the better, because there is too much starch, poor compressibility, and it is difficult to form tablets.

② particle hardness. When the hardness of particles (or materials) is small, they are easy to be broken by pressure, so the pores and aperture R of tabletting are small, so the amount and distance L of water penetration are also small, and the disintegration of tablets is also slow; On the contrary, it just breaks down faster.

③ tabletting force. Generally speaking, the greater the pressure, the smaller the porosity and pore size R of tablets, the smaller the amount and distance L of water penetration, and the slower the disintegration of tablets. Therefore, the pressure should be moderate when tabletting, otherwise the tablet will be too hard and disintegrate. However, the disintegration time of some tablets decreases with the increase of pressure. For example, when the pressure is low, the porosity of phenacetin tablets is large, and the disintegrant has enough expansion space after absorbing water, so it is difficult to disintegrate. But when the pressure is high, the porosity is small, the disintegrant has enough expansion space after absorbing water, and the tablet expands and disintegrates faster.

Lubricants and surfactants. When the contact angle θ is greater than 90, cosθ is negative, and water cannot penetrate into the pores of the tablet, that is, the tablet cannot be wetted by water, so it is difficult to disintegrate. This requires that the contact angle θ between drugs and excipients is very small. If θ is large, for example, the contact angle θ of hydrophobic drug aspirin is large, a proper amount of surfactant should be added to improve its wettability, reduce the contact angle θ and increase the cosθ value, thus accelerating the disintegration of tablets. Hydrophobic lubricants commonly used in tablets may also seriously affect the wettability of tablets, increase the contact angle θ, make water difficult to penetrate, and cause slow disintegration. For example, the contact angle of magnesium stearate is 12 1. When mixed with granules, it will be adsorbed on the surface of granules, which will significantly enhance the hydrophobicity of tablets, make it difficult for water to penetrate and slow down disintegration, especially when the dosage of magnesium stearate is large, as shown in Figure 4- 14. Similarly, when the hydrophobic lubricant is mixed with the particles for a long time and the mixing intensity is high, the surface of the particles is completely covered by the hydrophobic lubricant. Therefore, the pore wall of tablets is hydrophobic, which obviously prolongs the disintegration time. Therefore, in production practice, the variety, dosage, stirring intensity and stirring time of lubricant should be strictly controlled to avoid a lot of waste.

(2) the influence of other auxiliary materials

(1) adhesive. The greater the adhesion, the longer the disintegration time of tablets. Generally speaking, the viscosity order of adhesives is: animal glue (such as gelatin) >; Gum (such as Arabic gum) > syrup > starch slurry. In the specific production practice, it is necessary to comprehensively consider the forming and disintegration of tablets, and select the appropriate binder and appropriate dosage.

② Crusher. As far as the varieties of disintegrants in China are concerned, it is generally believed that the disintegration degrees of low-substituted hydroxypropyl cellulose (L-HPC) and sodium carboxymethyl starch CMS-Na can meet the requirements of the Pharmacopoeia, but the fact that dry starch is widely used as a disintegrant is not contradictory, because dry starch is still a good disintegrant when the disintegration degree can meet the requirements of the Pharmacopoeia, because it is cheap and easy to obtain. In addition, different methods of adding disintegrants will also produce different disintegration effects.

(3) Influence of storage conditions of tablets After storage, the disintegration time of tablets is often prolonged, which is mainly related to the temperature and humidity of the environment, that is, the tablets absorb moisture slowly, so that the disintegrant can not play its disintegration role, and the disintegration of tablets becomes relatively slow.

6. Dissolution exceeds the limit

If the tablet fails to dissolve the prescription drug within the specified time, it is called dissolution exceeding the limit or dissolution unqualified. After the tablet is taken orally, it will produce drug effect after disintegration, dissolution and absorption. Any problem in any link will affect the actual curative effect of the drug. The surface area of the intact tablet without disintegration is very small, so the dissolution rate is slow. After disintegration, there are many small particles, the surface area is greatly increased, the dissolution process is also maximized, and the drug dissolution rate is also the fastest. So the factors that can accelerate disintegration can generally accelerate dissolution. However, tablets of many drugs can disintegrate rapidly, but their dissolution rate is very slow. Therefore, qualified disintegration does not necessarily guarantee the rapid and complete dissolution of drugs, so it cannot guarantee reliable curative effect. For many drugs with poor solubility, the dissolution rate will not be great, and some other methods need to be taken to improve the dissolution rate.

When the hydrophobic drugs in (1) grinding mixture are crushed alone, the surface free energy increases with the decrease of particle size, and the particles tend to re-aggregate, so the actual crushing efficiency is not high. At the same time, the particle size of this hydrophobic drug decreases and the specific surface area increases, which will enhance the hydrophobicity of the tablet and is not conducive to the disintegration and dissolution of the tablet. If this hydrophobic drug and a large number of water-soluble excipients are ground and crushed into a mixture, the particle sizes of the drug and excipient can be reduced to a very small size. In addition, due to a large number of excipients, a large number of water-soluble excipient particles are adsorbed around the drug particles, so that the drug particles can be prevented from being aggregated with each other and stably existing in the mixture. When the water-soluble excipient is dissolved, the drug particles are directly exposed to the dissolution medium, so the dissolution (dissolution) speed is greatly accelerated. For example, hydrophobic drugs such as digoxin and hydrocortisone are mixed with 20 times lactose by ball milling, and the dissolution rate is greatly accelerated.

(2) Making solid dispersion It is an effective method to improve the dissolution rate to make insoluble drugs into solid dispersion. For example, the solid dispersion of indomethacin and PEG6000 in a ratio of 1: 9, the dissolution rate is greatly improved after crushing, and suitable excipients are added for tabletting.

(3) Carrier adsorption Dissolve insoluble drugs in a small amount of non-toxic solvent (such as PEG400), and then adsorb with porous carriers such as silica gel, and finally make tablets. Because the drug is adsorbed on silica gel in molecular state, it is easy to dissolve when it comes into contact with dissolution medium or gastrointestinal fluid, which greatly speeds up the dissolution of the drug.

7. Uneven tablet content

All the factors that cause too large difference in tablet weight will cause uneven drug content in tablets. In addition, for small doses of drugs, uneven mixing and migration of soluble components are the two main reasons for the unqualified content uniformity of tablets.

(1) Uneven mixing Uneven mixing leads to uneven tablet content in the following ways. (1) When the main dose is far from the auxiliary dose, it is generally not easy to mix evenly. At this time, the gradual dilution method should be used to mix or dissolve a small amount of drugs in a suitable solvent, and then spray them evenly into a large number of auxiliary materials or particles (generally called solvent dispersion method) to ensure uniform mixing; (2) When the particle sizes of the main drug and the auxiliary materials are quite different, it is easy to cause uneven mixing, so the main drug and the auxiliary materials should be crushed to make the particles of each component smaller and as consistent as possible, so as to mix evenly; (3) If the morphology of particles is complex or the surface is rough, the friction between particles is small, so it is difficult to separate them once they are mixed evenly, while the surfaces of particles are smooth, so they are easy to separate from each other during processing after mixing, and it is difficult to keep their uniform state; (4) When a small dose of drug is dispersed in blank particles by solvent dispersion method, the amount of drug solution absorbed varies greatly due to the high porosity of large particles and the low porosity of small particles. In the subsequent processing, due to vibration and other reasons, large and small particles delaminate and small particles sink to the bottom, which leads to too large difference in chip weight and unqualified content uniformity.

(2) the migration of soluble components between particles, which is one of the important reasons for the uneven content of tablets. In order to make it easier to understand, this paper takes the migration of soluble components in particles as an example to introduce the migration process: before drying, water is evenly distributed in wet particles, and during drying, water on the surface of particles is vaporized, resulting in the temperature difference between inside and outside particles. Therefore, when the water inside the particle diffuses to the outer surface, this water-soluble component also transfers to the outer surface of the particle, which is the so-called migration process. After drying, water-soluble components are concentrated on the outer surface of the particles, resulting in uneven content inside and outside the particles. This phenomenon is most intuitive when tablets contain soluble pigments. Although the pigment and other ingredients have been mixed evenly during wet mixing, most of the pigment has migrated to the outside of the particles after drying, and the color inside is very light. After pressing into tablets, many "spots" are formed on the surface of tablets. In order to prevent "color spots", the most fundamental way is to choose insoluble pigments, such as using color lakes (that is, adsorbing pigments on adsorbents and then adding them to tablets). In the usual drying method, it is difficult to avoid the migration of soluble components in the above particles, but when microwave heating is used for drying, this migration can be minimized because the inside and outside of the particles are uniformly heated.

The main problem caused by the migration of soluble components in granules is that the tablets are mottled or mottled, which has little effect on the uniformity of tablet content. However, the migration of soluble components between particles will greatly affect the content uniformity of tablets, especially when box drying is used. When the particles spread out into a thin layer in the tray, the water in the bottom particles will spread upward to the surface of the upper particles for gasification, and the soluble components in the bottom particles will be transferred to the upper particles to increase the content of soluble components in the upper particles. When using this kind of pellet tablets with high drug content in the upper layer and low drug content in the lower layer, it will inevitably cause uneven tablet content. Therefore, when box drying is used, the particles should be turned frequently to reduce the migration between particles, but it still cannot prevent the migration inside particles.

When fluidized (bed) drying method is used, because wet particles are in fluidized motion and are not in close contact with each other, the migration of soluble components between particles generally does not occur, which is beneficial to improve the content uniformity of tablets, but spots or spots may still appear because migration within particles is still inevitable. In addition, when using the fluidized drying method, we should also pay attention to the fact that because the particles are in constant motion, there is great friction and impact between the particles, which will increase the fine powder, and the surface of the particles often has high water-soluble components, so the content of drug (water-soluble) components in these ground fine powders is also high and cannot be easily discarded. This loss can also be considered when adding materials to prevent the drug content in tablets from being low.

8. Spots and marks

Causes and solutions of unqualified appearance caused by spots with different shades on the surface of tablets.

① Too much adhesive, too hard particles, uneven melting or coloring of sugary varieties of powdered sugar, uneven drying and wetting, uneven tightness or insufficient mixing of lubricants may all cause printing spots. The granulation process can be improved to make the granules loose, and the colored tablets can be granulated by appropriate methods to make the prepared granules uniform in thickness and appropriate in elasticity. The lubricant should be screened first as required, and then fully mixed with the granules.

② There are different shades of raw and auxiliary materials in compound tablets. If the raw and auxiliary materials are not finely ground or fully mixed, it is easy to cause mottling. Before granulating, the raw materials should be finely ground, and the granules should be mixed before tabletting. If mottling is found during tabletting, it should be reworked.

(3) Oil stains will be generated when oil stains fall into particles from the upper punch during tabletting, so it is necessary to remove the oil stains and affix a rubber stamp on the upper punch to prevent the oil stains from falling.

(4) The colored varieties are not thoroughly cleaned and polluted.

9. Other issues

(1) Lamination means that two pieces are stacked into one piece, and the tablets stick to the upper punch due to the sticking or curling of the upper punch, and then the particles are filled into the die hole and pressed into a laminate again, or the lower punch cannot be ejected in time when the rising position is too low, and at the same time, the particles are added into the die hole and pressed again. Pressing the lamination makes the tablet press easy to be damaged, so it is necessary to solve the problems of sticking and punching, improve the accuracy of mold loading and eliminate the faults of the tablet press.

(2) The punch is missing, and the metal sheet may be embedded in the tablet. Due to improper heat treatment of the punch, its own damage and cracks are not carefully checked, and it can't stand the pressure or the pressure of the tablet press is too high, which will cause an explosion when pressing crystalline drugs. We should improve the heat treatment method of punch, strengthen the inspection of mold quality, adjust the pressure and pay attention to the appearance inspection of tablets. If an explosion is found, find the debris immediately and find the reason to overcome it.

(2) Possible problems and solutions in the process of tablet coating.

The coating process of sugar-coated tablets is complex, time-consuming and prone to many problems, such as cracking, edge exposure, pockmarked surface and mottling. The answers to these questions can be found in pharmacy. Sugar coating has been gradually replaced by film coating, and only the film coating is introduced below.

The reason of (1) foaming is improper curing conditions and too fast drying speed, so we should master the film-forming conditions and suitable drying speed.

(2) The adhesion between the wrinkled tablet surface and the coating material is affected by the chemical properties, and the feeding interval between two coatings is too short, and the amount of liquid sprayed is too much. The characteristics of coating materials should be mastered, the interval time should be adjusted, the concentration of coating solution should be appropriately reduced, and the spraying amount should be reduced.

(3) The pigment with uneven color is not fully mixed with the film coating material, or the dosage of additives such as plasticizer and pigment in the coating formula is improper, and the solvent brings soluble substances to the film surface during drying. The coating material can be mixed into a dilute solution and sprayed several times, or the pigment and the coating material can be evenly finely ground in a colloid mill or a ball mill before being added. Adjust the air and temperature to slow down the drying speed.

(4) The strength of coating film is not enough, the proportion of coating material is not suitable, the adhesion strength between coating layer and drug is low, and the thickness of coating layer is not enough. Change the coating formula and increase the coating thickness.

In addition to the above problems, the enteric film coating has disintegrated in the stomach. The reasons are improper selection or proportion of enteric coating materials, low adhesion strength between coating and drugs, and insufficient or uneven coating layer. Appropriate materials should be selected to master the appropriate proportion, and the coating layer should be added and coated evenly, and then further coating should be carried out after disintegration is qualified. It does not disintegrate in the intestine, but it is "discharged from tablets" due to improper selection of enteric coating materials, too thick coating and changes during storage, which is related to the penetration of gastric juice. When gastric juice penetrates into the tablet core, the tablet core expands, and when it enters the intestinal juice, the enteric coating dissolves, but the tablet core only expands slightly and does not completely disintegrate. You can choose enteric coating materials to adjust the proportion, master the coating level, choose appropriate disintegrants such as carboxymethyl starch instead of starch or add a small amount of microcrystalline cellulose for granulation.

(3) capsules

The unqualified dissolution rate of (1) is mainly due to the process variation of raw materials or auxiliary materials manufacturers, and the dissolution rate of the original prescription was affected after changing the suppliers of raw materials or auxiliary materials. Suppliers of raw and auxiliary materials should be stable. After changing the raw and auxiliary materials, process verification should be carried out.

(2) The reason why the loading difference exceeds the limit leads to the unqualified loading difference is poor particle fluidity and uneven particle fineness. The particle thickness should be kept uniform, the fine powder should be reduced and the fluidity should be increased. In the process of particle filling, the weighing inspection should be strengthened, and it can be weighed once every 15 minutes.

(3) Moisture absorption leads to unqualified moisture. Reduce the humidity between capsule filling and storage. Some varieties with strong hygroscopicity, after using aluminum-plastic packaging, are easy to cause unqualified moisture in humid environment. Aluminum-aluminum packaging can be changed to improve air tightness.

(4) The titer of antibiotics decreased. Antibiotics are granulated by wet method, and heating in the drying process is easy to cause the drug titer to decrease, so dry granulation should be adopted.

(4) Causes and solutions of possible problems in injection production.

(1) Insoluble particulate fiber mainly comes from working environment and work clothes of workers. Work clothes should use long fiber fabrics, and clean tools and other auxiliary appliances should use long fiber fabrics without fiber shedding, such as silk and mercerized towels. White spots or other particles are caused by many reasons, which may come from water, air or materials. The bottle was not cleaned because the water for injection was polluted and unqualified; The amount of water for injection used to wash bottles is not enough; The high efficiency filter in the cooling section of tunnel kiln is damaged. The plug is not cleaned; The quality of rubber stopper is not good, and some particles fall off. Ampoule potting produces broken glass. The high-efficiency filter in the 10,000-class clean area is damaged, which makes the clean area fail to meet the clean requirements.

(2) Reasons for unqualified pyrogen inspection ① The sterilization temperature or time of bottles and stoppers is not enough, and the sterilization equipment should be verified regularly, usually once a year. If any abnormality is found, it should be checked and verified immediately. ② Water for injection has been left for too long. The storage time of water for injection shall not exceed 65438±02h, and it shall be kept above 80℃ or circulated above 65℃. ③ The production environment can't meet the production requirements. The dust particles and settling bacteria in the sterile room should be monitored regularly.

(3) The causes and solutions of unqualified sterility test are basically the same as pyrogen.

(4) The loading quantity is unqualified

① Powder spraying. Spiral packer is the most widely used in China, which is stable in use and high in output. The main reasons for unqualified loading are: powder sticks to the metering screw and needs to be removed; The spring controlling the load has reached the fatigue limit and should be replaced. In addition, the packaging heads of the two screws are not synchronized, and the amount of powder in the two hoppers is different. The powder is too fine or too thick, and the fluidity is poor.

② Water injection. The main reasons for the inaccurate filling quantity of LSAG wire drawing are that the push rod nut and fulcrum clamping nut are loose, the pump sleeve spring cannot be reset, and the one-way glass valve and glass pump in the liquid filling pipeline system leak. The solution to the problem is to loosen it, tighten it, and replace it when it is no longer used. Peristaltic pump is more accurate than piston filling.

③ infusion. The main reasons for inaccurate loading are the change of liquid level in the high tank, unstable rotating speed and the leakage of liquid medicine from the bottle. The corresponding treatment methods are to keep the liquid level stable, stabilize the voltage, correct the funnel mouth and adjust the thumbwheel.

(5) The paste-head liquid medicine splashed on the inner wall of the ampoule neck silk, which was carbonized at high temperature when it was melted and sealed, mainly because the needle was discharged too fast or too slowly and the needle contracted seriously. Solution: The former is to adjust the filling cam, and the latter is to adjust the volume of the air bag used to buffer the air bubbles in the filling pipeline. Uneven thread thickness of ampoule neck and poor matching between liquid pressing action and needle stroke can also cause focal head, which can be overcome by taking corresponding measures.

Second, the equipment failure

Equipment failure is inevitable, but it not only affects normal production, but also may affect product quality.

Quantity brings risks, so try to reduce the occurrence of equipment failures. If there is any fault, it should be repaired in time. See table 4- 14 for the common faults and treatment methods of several equipments.

Table 4- 14 Treatment Methods of Several Common Faults of Equipment

Method of dealing with the original reason of equipment fault record

When high-speed tablet press presses tablets with the same specifications, the pressure display value suddenly becomes very large, and the machine cannot work normally. ① The connecting cable between the main pressure sensor and the computer may be broken.

② The amplifier zero point of the main pressure sensor has a serious drift ① Disconnect the cable connected to the computer and measure the resistance of the bridge. If there is an open circuit or short circuit, please check the cable in sections to eliminate the fault.

② Adjust the amplifier of the main pressure sensor.

There is too much powder in the machine. ① The gap between the distributor and the template is too large.

② The gap between scraper and turntable is too large.

③ The middle die is higher than the turntable ① Check the parallelism between the platform and the template, and control the gap at 0.04-0.06mm..

② Check, adjust and clamp.

③ Check the leveling.

Press the on clutch button, and the turntable cannot rotate ① The electromagnetic clutch is disconnected or powered off.

② The gap between clutch friction plates is too large.

③ The tablet press is overloaded.

④ Bad button and plug-in ① Measure clutch resistance and working voltage.

② Inspection and adjustment

③ check

④ Check the control circuit with reference to the electrical schematic diagram.

The automatic hard capsule filling machine cannot discharge capsules into the holes of the capsule plate. The opening and closing time of the capsule spring is not appropriate, and the positions of the capsule pushing claw and the capsule pressing claw are not appropriate. Adjust the limit block to a proper position, and adjust the positions of the capsule pushing claw and the capsule pressing claw.

Poor separation between capsule body and bottle cap ① There are foreign bodies on the surface of vacuum separator, which leads to poor adhesion with the lower capsule plate.

② Improper position of bottom ejector pin, dislocation of upper and lower capsule plates.

③ There are foreign bodies in the hole of capsule plate.

(4) the vacuum pipeline is not tightly sealed, and the vacuum degree can not meet the requirements. ① Take out the garbage bag. Remove foreign bodies

② Adjust the position of the ejector pin. Fastening capsule plate

③ Clean with a brush.

④ Clean the filter, check the vacuum system and adjust the gauge pressure.

Clutch overload ① Due to the wrong movement of the metering template, the filling rod and the metering hole are misaligned, resulting in increased friction and even jamming.

② The friction between the metering template and the sealed environment increases due to the viscous moisture of the powder.

③ The gap between the metering disc and the sealing ring is inappropriate.

④ The clutch torque becomes smaller ① Loosen the fastening screw of the lecturer's template, and tighten the fastening screw after adjustment with the debugging lever.

② Adjust the viscosity and dryness of powder.

③ Adjust the gap between the metering template and the sealing ring.

④ Turn the clutch nut to increase the friction.

Wire drawing and filling machine ① Electrical control circuit is open.

② The electromagnet has weak suction.

③ Loosen the mandril nut ① Replace the wire or open the connection.

(2) Clean the inner cavity of the iron absorption device or adjust the gap of the electric absorption core.

③ Tighten the nut.

There is no liquid medicine in the bottle ① The ejector pin is polluted and blocked, and the spring cannot be reset.

② Short circuit of electrical control circuit ① Remove, clean or replace the spring.

② Troubleshooting electrical faults

Method of dealing with the original reason of equipment fault record

The screw powder needle dispensing machine suddenly stops or can't start during operation. ① The dosage screw jumps too much.

② The metering screw contacts with the powder nozzle, resulting in automatic power failure of the control appliance ① Remove the funnel and adjust the metering screw.

② Adjust the funnel so that the powder nozzle does not touch the metering screw.

The rubber stopper cap does not reach the bottle mouth or the capsule falls continuously ① The rubber stopper bayonet is misaligned with the bottle.

② Loosen the rubber stopper bayonet ① Adjust the alignment between the bayonet and the bottle.

② Adjust the rubber plug bayonet.

Automatic ointment filling and sealing machine tube cup alignment is not accurate ① The pin and key of the transmission rod (chain) of Markov mechanism are loose.

(2) The martensite groove and roller are seriously worn and the gap is too large.

③ A pair of bevel gears of the continuous Markov mechanism and the cup and plate are seriously worn, and the gap is too large. ① Fasten or replace the pin and key.

② Replace Markov mechanism.

③ Replace the bevel gear.

The tail of the hose is bent, uneven and inappropriate ① The tail of the packaging material is curled and has different lengths.

(2) The height of the three-fold tail is not properly adjusted.

③ The turnover folding knife and its shaft sleeve are seriously worn, which leads to a large gap between the turnover folding knife and the shovel.

(4) The suture line between the turning folding knife and the shovel blade deviates from the axis of the cup.

⑤ The connecting rod hole and pin shaft are badly worn. ① The tail of the hose is required to be round and unfolded, and the tolerance of pipe length is+0.5 mm..

(2) according to the hose tail is reasonable