Introduction of Chinese Medicine Injection

Table of Contents 1 Pinyin 2 English reference 3 Advantages of Chinese medicine injections 4 Brief introduction to the development of Chinese medicine injections 5 Production and storage of Chinese medicine injections 6 Loading of Chinese medicine injections 7 Clarity of Chinese medicine injections 8 Aseptic requirements of Chinese medicine Attachment: 1 Chinese medicine injections in ancient Chinese literature 1 Pinyin

zhōng yào zhù shè jì

2 English reference

Injection

Chinese medicine injection refers to the active ingredients extracted from Chinese herbal medicines, and made by modern science and technology and methods, which can be injected into the body, including intramuscular, acupoint, intravenous injection and intravenous drip use of sterile solutions, suspensions, or sterile powder before use to liquid injection into the human body preparations.

3 Advantages of Chinese medicine injections

The advantages of Chinese medicine injections are:

(1) rapid and reliable effects.

(2) Applicable to drugs that should not be taken orally.

(3) For patients who can not be administered orally, such as patients who can not swallow or are unconscious.

(4) Can produce local localization effect. Such as Compound Yin Chen Injection, Compound Da Qing Ye Injection, Chai Hu Injection, Ginseng Injection and so on.

4 Chinese medicine injection development

In the traditional dosage form of traditional Chinese medicine, there is no such dosage form as injection, due to the injection has many unique advantages, so a few decades ago, some people have begun to develop Chinese medicine injection. As early as in the 30's, "Chaihu injection" was successfully developed for the treatment of colds, fever and other diseases and received good results. After the founding of the country from the mid-50s again carries on the Chinese medicine injection development, to the home 60s early development "protests 601 injection", "the Yin gardenia yellow injection", "2012 (Panlangen) injection and so on twenty several Variety ", most apply to the clinic, some have formally put into production, still in widely use. Due to the continuous improvement of quality and stable efficacy, it opened the way for the development of Chinese medicine injection. The 70s was a period of great development for Chinese medicine injection, not only scientific research, teaching and production units carried out research, but also many urban and rural medical units carried out trial production. According to statistics, Chinese medicine injections were clinically tested during this period. There are more than 700 kinds of reported data, and the Chinese People's Pharmacopoeia of 1977 (a) contains 23 kinds. Among them, there are dozens of good quality and reliable efficacy, such as the single injection of Ding Gongteng, Seven-leaf Lotus, Ginseng, Rhubarb, Sanguisorba alkaloids, smallpox pollen crystals, Salvia miltiorrhiza, Maodongqing, total alkaloid of Hansenbergia, Dijinzhao, Angelica sinensis, Luying, Fritillariae chinensis, Andrographis paniculata, Xiawu, Curcuma longa oil, antler antler essence, etc.; the compound injections of Shengxin, Angelica sinensis and safflower, Compound Chaihu, Compound Panax notoginseng, Anti-Hemorrhoidal Ling, Qingkailing, etc. have all received good clinical results. In the clinic have received a better therapeutic effect. Some of them have remarkable therapeutic effects and have been produced in batches with stable quality to meet the requirements of Chinese medicine clinics, especially for the treatment of acute diseases. The quality control of Chinese medicine injection is a key issue, because injection is the route of drug delivery by injection, which is not absorbed through the digestive tube but directly into the body, so the quality control must be strict. But most of the Chinese medicine injection is based on herbs or tablets as raw materials by extracting and refining formulated, objectively there are impurities, the active substance content varies greatly, easy to bring into the pyrogens and other issues in these areas in recent years at home and abroad to do a lot of in-depth research work, to the specific varieties of the attack one by one. Such as smallpox pollen has been purified protein crystals, pulse injection, Qingkailing injection, etc. Provide content determination standard strict pyrogen check; rhubarb, white head, yellow lingin injections such as stability experiments. In addition, for the characteristics of traditional Chinese medicine injection, a series of conventional quality inspection projects and standards, so that the quality of some traditional Chinese medicine injection has passed. It shows that as a dosage form of Chinese medicine, Chinese medicine injection has been basically finalized and shows its unique advantages, which is a promising dosage form of Chinese medicine. Especially in the development of Chinese medicine, to solve the Chinese medicine emergency treatment, will be indispensable to a major form. Not only "small needle" varieties to increase, and infusion will gradually pass, and then put into production to meet the requirements of Chinese medicine clinical use of drugs.

5 Chinese medicine injection production and storage

Injections in the production and storage period should be in line with the following relevant provisions: First, the solvents used in injections, including aqueous solvents, vegetable oils and other non-aqueous solvents, etc. The most commonly used aqueous solvents are injection solvents. The most commonly used aqueous solvent is water for injection, or sodium chloride injection or other suitable aqueous solution. Commonly used oil solvents for hemp oil, tea oil, etc., in addition to the oil should be consistent with the provisions of the item, and should be refined to meet the following requirements. (1) There should be no strange odor, no rancid taste; in addition to other provisions, the color shall not be darker than yellow No. 6 standard colorimetric solution, at 10 ℃ should remain clear. (2) Iodine value of 79-128; saponification value of 185-200; acid value of not more than 0.56. Other solvents must be safe and harmless, the dosage should not affect the efficacy. When preparing injections, suitable additives can be added according to the nature of the drug. Additional agents such as bacteriostatic agents, the dosage should be able to inhibit the growth of microorganisms in the injection. Commonly used bacteriostatic agents and dosage (g/ml) for 0.5% phenol, 0.3% cresol, 0.5% tert-butyl trichloride and so on. Injections with bacteriostatic agents should still be sterilized by appropriate methods. Injection volume more than 5 ml of injection solution, added bacteriostatic agent must be especially carefully selected. For intravenous (unless otherwise specified) or vertebral injection injection, are not allowed to add bacteriostatic agent. Unless otherwise specified, the containers shall comply with the provisions of the national standards for pharmaceutical glass containers. Container plug should be in line with the relevant provisions. Fourth, the preparation of injectable solutions, filling the liquid must be clear, the container should be clean and dry after use. Preparation of oil solution for injection, the first refined oil should be sterilized at 150 ℃ dry heat 1 ~ 2 hours, and cooled to the appropriate temperature. Unless otherwise specified, the fineness of the drug in the suspension for injection should be controlled below 15μm, 15-20μm (occasionally 20-50μm) shall not exceed 10%. For direct partition into sterile powder for injection of raw materials should be sterile, where the use of freeze-drying method, the liquid should be sterile, filling fashion differences should be controlled within ± 4%. V. Injections in the preparation process, should be strictly prevented from deterioration and contamination of microorganisms, pyrogens and so on. The liquid should be filled and sterilized within the same day, if it can not be completed within the same day, the liquid must be preserved under the condition of not deteriorating and not easy to propagate microorganisms; for intravenous and spinal injection of injections, it should be strictly controlled. Sixth, exposure to air perishable drugs, in the filling process, the container should be excluded from the air, filled with carbon dioxide or nitrogen and other gases after melt-sealing. Seventh, melt sealing or tightly sealed, according to the nature of the drug to choose the appropriate method of sterilization, must ensure that the finished product is sterile. Eight, melt-sealed injections in the sterilization or sterilization, should be used to decompression method or other appropriate methods for container leakage detection. Nine, the injection should be in accordance with the specified conditions of shade storage.

6 Chinese medicine injection filling

Filling injection, should be in accordance with the following table to appropriately increase the amount of filling to ensure that the amount of injection is not less than the labeled amount. Unless otherwise specified, for multiple dosage of injection, each container shall not be filled more than 10 times the amount of injection, the increase in the amount should be able to ensure that the amount of each injection.

? Labeled volume? Increased volume? Easy to flow liquid viscous liquid ?0.5ml ?0.10ml ?0.12ml ?1.0ml ?0.10ml ?0.15ml ?2.0ml ?0.15ml ?0.25ml ?5.0ml ?0.30ml ?0.50ml ?10.0ml ?0.50ml ?0.70ml ?20.0ml ?0.60ml ?0.90ml ?50.0ml ?1.0ml ?1.0ml ?2.0ml ?1.5ml ?2.5ml ?1.5ml ?2.5ml ?2.5ml ?3ml ?2.5ml ?2.5ml ?3ml ?3ml ? 50.0ml ?1.0ml ?1.5ml Inspection method The labeled volume of injection solution is 2ml or less, take 5 pieces of test material, more than 2ml to 10ml, take 3 pieces of test material, more than 10ml, take 2 pieces of test material; when opening to avoid loss, the contents of the corresponding volume of dry syringe (pre-labeled) were drawn out, at room temperature inspection; determination of oil solutions or suspensions should be determined by When determining the amount of oil solution or suspension, it should be warmed and shaken well first, then pumped out with a dry syringe and cooled to room temperature for inspection. The quantity of each injection shall not be less than the labeled quantity. Unless otherwise specified, the limit of loading difference of sterile powder for injection should be in accordance with the following table. ? Average loading amount ? Load variance limit ?0.05g or less or 0.0g ? ±15% ?0.05g or more to 0.15g ? ±10% ?0.15g or more to 0.5g ? ±7% Check method take 5 bottles (sticks) of test material, remove the label, aluminum cap, the outer wall of the container washed with ethanol, drying, open the attention to avoid glass shavings and other foreign objects falling into the container, respectively, quickly and precisely weighed, poured out the contents of the container can be washed with water, ethanol, dry under suitable conditions, and then precisely weighed each container, to find out the amount of each bottle (stick) of the loading and the average amount of loading. Each bottle (branch) of the volume and the average volume of comparison, should be consistent with the provisions of the above table. If 1 bottle (branch) does not meet, should take another 10 bottles (branch) retest, should meet the requirements. 7 Chinese medicine injection clarity

According to the Ministry of Health on the injection clarity check the provisions of the inspection, should be in line with the provisions.

8 Chinese medicine asepsis requirements

According to the aseptic inspection method under the method of inspection, should comply with the provisions.

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