Clinical application and new drug development of powdered Chinese patent medicine

As a traditional dosage form of traditional Chinese medicine, powder is different from modern Chinese patent medicine. It extracts the "effective components" of traditional Chinese medicine by various means, without changing the physical and chemical properties of medicinal materials, and completely retains the original prescription of traditional Chinese medicine. The author discusses the clinical application of Chinese medicine powder with unique advantages in dosage form and curative effect, and thinks that Chinese medicine powder will show a good development prospect in the innovation of Chinese patent medicine.

Keywords: powder Chinese patent medicine new drug development

Decoction and Gaodan Pill Powder are traditional Chinese medicine formulations. Except for Dan medicine, which is rarely used now, other dosage forms are commonly used. With the country's attention to the cause of traditional Chinese medicine and the promotion of "modernization of traditional Chinese medicine", the quality of traditional Chinese medicine has been greatly improved, which has basically changed the image of "rough black" of traditional Chinese medicine in the past, thus making it possible to develop powder Chinese patent medicine with high-quality traditional Chinese medicine.

As a powder, only the traditional Chinese medicine in the widely used decoction prescription is roughly processed into powder, which becomes another convenient form to take. Because it only changed the physical properties of traditional Chinese medicine, did not extract it, and did not change the chemical properties of traditional Chinese medicine, it completely retained the "original flavor" of clinical prescriptions of traditional Chinese medicine, which is essentially different from traditional Chinese medicine produced by physical and chemical means.

The application of 1 Chinese medicinal powder has great advantages.

The advantages of traditional Chinese medicine powder are: (1) powder is easy to take, and it can be taken directly with water or soaked in boiling water, which is suitable for the pace of life in modern society. The processed powder has reached a certain fineness, and patients will not find it difficult to take it with water. If you drink boiled water, it is very comfortable to drink, just like the taste of tea, and it is easily accepted by many patients who are afraid of the bitter taste of traditional Chinese medicine decoction. (2) The powder can be prepared in advance for emergency use (it can also be prepared in real time according to the patient's condition during clinical treatment), which saves the time for patients to wait for drug selection and decoction. (3) After the powder is packaged separately, the dosage is accurate and easy to carry, which is convenient for users to better control the dosage. (4) Compared with the decoction with the same formula, the single dosage of patients is reduced, the utilization degree of medicinal materials is higher, and the medicinal materials are more "economical". (5) The decoction mainly contains soluble components, while the powder taken contains all the contents of the medicinal materials, including all kinds of crude fibers and components insoluble in water or alcohol, which completely retains the medicinal properties of the medicinal materials. (6) Compared with decoction, it is more suitable for patients with chronic diseases to take for a long time. Compared with decoction, it has little influence on gastrointestinal tract and is not easy to affect the appetite and digestive function of users. (7) The powder is easy to be further processed into other dosage forms, such as ointment, pill, capsule, tablet, etc. (8) The medicinal materials are sealed and stored after subpackaging, thus prolonging the storage period. If it is sterilized by radiation, the storage period can be greatly extended.

Technical points of powder preparation and processing II

There are also many technical requirements for the crushing and processing of Chinese herbal medicines, including the following aspects.

2. 1 quality requirements of medicinal materials

Because when using powder, users are often required to take all medicinal materials, including dregs. Compared with decoction, the processed medicinal materials must be of high quality and must not contain too many impurities, including metals, stones, soil, plastics and so on. , and can not be moth-eaten, mildew, pesticides and fertilizers exceed the standard.

2.2 Requirements for the nature of medicinal materials themselves

Due to the differences in the nature, hardness, viscosity and wettability of medicinal materials and the proportion of fiber components, general drugs should be kept dry as much as possible before processing to ensure certain brittleness and facilitate processing. At present, the water content of Chinese herbal pieces produced by regular Chinese herbal pieces factory is low, which can meet the processing requirements. Generally, it is difficult to process single medicine, and the mixed prescription is easy to crush. Drugs such as Radix Rehmanniae and Radix Rehmanniae are too wet and sticky. If they are roasted, their medicinal properties will change again. Another example is towel gourd, a kind of medicinal fiber with many components and sufficient toughness. It cannot be broken into fine powder when processed alone, but it is easier to be broken into fine powder when used in compound prescription through compatibility.

2.3 Requirements for fineness of medicinal materials processing

According to the needs of practical application, the fineness of medicinal materials is different, and it is generally 80 ~ 120 mesh for oral administration. If the particles processed by powder are too coarse, the solubility of the drug is relatively low and there are too many residues, which irritates the throat and makes it difficult to swallow. If the processing is too fine, the solubility of the drug will be high, and it will be bitter when cooked, and the taste will be bad, which will affect the appetite. So at present, the powder we use in clinic is generally 50 ~ 80 mesh, which is enough to meet the clinical needs and has achieved good curative effect, which not only ensures the taste but also ensures sufficient dosage.

2.4 Processing technology requirements

There are many ways to crush drugs, such as cell wall breaking technology and freezing crushing technology, which are widely used in food processing industry. At present, the fineness of micro-powder traditional Chinese medicine is generally in the micron range, reaching the degree of wall breaking [3]. However, due to the release of various enzymes in the cytoplasm, the medicinal properties of the whole compound drug may change with different compatible drugs, which is not in line with the original intention of our current powder application. Therefore, we use a simple mechanical pulverizer to pulverize in clinic. On the one hand, the processing cost is low and the operation is simple. On the other hand, it can keep the original physical and chemical characteristics of medicinal materials unchanged. The pulverizer adopts all stainless steel structure, which has good sealing performance and can meet the hardware requirements of GMP standard for drug production.

3 market acceptance of powder use

3. 1 patient identification

Due to the unique advantages of powder medicine, especially the convenience of use, this dosage form is basically the same as western medicine after sub-packaging, and it is easy to be recognized by patients.

3.2 Price recognition

If you take traditional decoction, you have to take 250g of Chinese medicine every day, but with powder, 250g of Chinese medicine can be processed into 40 bags of about 6g/ bag. According to the calculation of taking 3 bags a day, the taking time of traditional Chinese medicine will exceed 13 days, so the taking time of powder with the same dose will be more than 10 times of that of decoction. Although the cost of powder medicine will increase a lot after processing, it is still relatively economical compared with the cost of decocting medicine in the same course of treatment.

3.3 Recognition of curative effect

Many people may be worried that the clinical effect is not good because the dose is not enough. It used to take only one or two days for a dose of Chinese medicine, but now it takes ten days. In fact, the most important thing in treating diseases in traditional Chinese medicine is not the weight of dose. The first is whether the method is correct, and then whether the drugs are compatible. If the patient's condition can be accurately judged and the drug is used reasonably, the clinical effect of the powder is very high.

4. Application of powdered Chinese patent medicine

We have achieved good curative effect and accumulated rich experience by using Chinese medicine powder in clinical treatment. How to promote the development of traditional Chinese medicine powder, benefit more patients, and better develop and carry forward traditional Chinese medicine is worthy of in-depth discussion and research.

4. 1 powder use history

Traditional Chinese medicine powder has a very long history of clinical application. Since ancient times, there are countless prescriptions, and powders (including boiled powders [4]) account for a very high proportion, and the types of clinical diseases involved in treatment are also very extensive, among which there are many famous prescriptions. Such as Shengyang Yiwei Decoction, Gentiana Biejia Powder, Fangfeng Tongsheng Powder, Wuji Powder, Shen Ling Baizhu Powder, Perilla Jiang Qi Decoction, Siwu Decoction, Shiquan Dabu Decoction, Guipi Decoction, Yangxin Decoction, Hemoptysis Formula, Huaihua Powder, Xiaoji Yinzi Decoction, Fuyuan Huoxue Decoction, Daqi Gentiana Decoction, Duhuo Decoction, Chuanxiong Tea Powder, etc. There are many pastes and pills that need to be ground into powder, such as Huanshaodan, Jinkui Shenqi Pill, Qian Hu Pill, Baohe Pill, Xiaohuoluo Pill and so on.

4.2 The key to using powder

For the use of powder, the most critical part should be the prescription. Generally speaking, patients have higher requirements for the clinical efficacy of powder than decoction. There are two ways to use powder. First, the doctor makes a prescription temporarily according to the patient's condition, and then grinds it into powder for the patient to take. Second, doctors choose the right prescription according to their own experience, prepare it in advance, smash it and save it, and use it in the treatment of a large class of related diseases according to the patient's condition in clinical work. There is a difference in the choice of prescription between the two. For the latter, doctors need to have comprehensive medical and medical knowledge, be able to deeply understand the theory of traditional Chinese medicine, take into account the characteristics of common clinical diseases and frequently-occurring diseases, consider the characteristics of one kind of disease and the personality of the same disease in different patients, and make appropriate prescription compatibility. Therefore, compared with the use of decoction, it is necessary to use powder well in clinic, which puts forward higher requirements for doctors.

4.3 Clinical application experience of powder

If we expect to achieve good clinical therapeutic effect, we should deeply think and analyze the compatibility thinking and medication methods of some famous prescriptions, and integrate them with each other to become our own use. For example, the original method of taking Shengyang Yiwei Decoction in Li Dongyuan is to grind the medicine into coarse powder, add ginger and jujube and add water to decoct, and 3 yuan each time. However, if the doctor just makes a prescription and asks the patient to take a big bag of medicine together with water, the effect will often be discounted. The composition of powder also needs to be carried out according to the characteristics of compatible drugs. For example, drugs with high volatile oil content, easy failure after heating, insoluble and toxic are all suitable for making powder. Some precious medicinal materials, such as Panax notoginseng, Fritillaria, Moschus, Cordyceps, etc. , processed into powder, taken directly with water, has good effect and avoids wasting medicinal materials.

For some chronic diseases, patients need to take medicine for a long time. If you take decoction, it will affect the appetite and gastrointestinal digestive function of patients, but it is not conducive to recovery, while the use of powder is mild and often can receive good results. The drugs used to treat chronic diseases in general powder are mild and safe, basically non-toxic or highly toxic, otherwise they cannot be taken for a long time. For diseases such as colds, it is usually necessary to take decoction in acute attack, but in the later recovery stage, you can often take some powder to consolidate the curative effect. In the empirical aspect, decoction is widely used, and in the aspect of deficiency, powder and pill have their own unique advantages. Generally speaking, decoction has strong medicinal properties and has great influence on the local environment of the stomach. If there is something wrong with the gastric mucosa, it is not conducive to the absorption of drugs. At the same time, strong bitterness often affects the whole digestive function. On the contrary, for some gastrointestinal diseases, such as gastritis and gastric ulcer, powder can often receive much higher curative effect than decoction. In addition to chronic diseases, powder is often used to treat many acute diseases. Li Dongyuan pointed out: "Generally speaking, people who make soup will be shaken and seriously ill;" Scattered, scattered, and used in emergency; Taking medicine is slow, and you can't walk fast. They use drugs slowly and the meaning of treatment is also. " How to use powder flexibly and skillfully in clinic needs doctors to constantly sum up and improve in practice. Some mature and effective powder prescriptions are suitable for developing into Chinese patent medicines. Yunnan Baiyao is an effective and very successful powder medicine, which can be used both externally and orally.

Powder research and new drug development

The theory of traditional Chinese medicine provides us with very scientific principles and prescription basis. With the development of modern medicine, the development of Chinese patent medicine has become a hot spot in the research and development of new drugs. The development of powdered Chinese patent medicine has extraordinary market potential, which can be produced on a large scale, and its convenience and efficiency are incomparable to the dosage forms of soup and medicine.

5. 1 Looking at the application of powder from a modern perspective

According to the theory of traditional Chinese medicine, there are many kinds of medicinal materials that can be processed into powder, mainly natural animals and plants. Metals and minerals, such as gold, gypsum, cinnabar and magnets, are also used in some prescriptions, such as Zixuedan, but they are not commonly used. Why do the original usage of many prescriptions require that the medicinal materials in the prescriptions be crushed? After the medicinal materials are processed into powder, the surface area of the drug particles increases, and it is easy to be digested and absorbed by the human body when taken directly. In addition, the medicinal materials processed into powder can also be decocted in water, and the effective components are easier to precipitate and the curative effect is better. Natural plant medicines mainly include bark, roots, stems, leaves, grasses, flowers, fruits and seeds. , which contains more plant fiber, protein, mucopolysaccharide, vitamins and trace elements, while animal medicine includes some insects, animal organs, crustaceans and so on. , which contains more protein, etc. In fact, in essence, they all belong to something that can become human food, just because their partial eclipse is too big.

The main components of decoction and various extracted Chinese patent medicines developed at present are soluble components (soluble in water or alcohol). Generally speaking, the stomach is one of the main absorption parts of the medicinal components in the decoction, so the decoction is irritating to the gastrointestinal tract, and long-term administration (depending on the medicine used) is easy to affect appetite and digestive function. For powder, the whole digestive tract is the absorption site of drugs, and the amount of drugs taken each time is relatively small, and the effect is relatively mild and lasting. In the treatment of some chronic diseases or serious diseases, such as tumors, powder can often achieve better curative effect, because on the one hand, it avoids the influence of decoction on appetite; On the other hand, the drugs in the powder can not only play a therapeutic role, but also provide certain nutrition for patients, such as protein and lipids in insect drugs, sugars and trace elements in plant drugs. And a large amount of crude fiber can promote gastrointestinal peristalsis and help patients solve constipation without laxatives.

5.2 powder Chinese patent medicine and new drug development environment

At present, according to the national new drug approval method, it is still difficult for compound Chinese patent medicines such as traditional Chinese medicine powder to pass the new drug approval. The main reason is that the complexity of natural medicine components and the complex chemical changes after compatibility cannot be analyzed clearly. Western countries have very strict procedures for the research and development of new drugs, which are suitable for the characteristics of western medicine. At the same time, they take a very flexible attitude towards the development of natural medicines. As a new drug research and development, the most important thing is to evaluate the curative effect, side effects and quality stability of the drug without fully analyzing its composition and mechanism of action. Therefore, the development of Chinese patent medicine should not only seriously study and follow the theory of Chinese medicine, but also face up to the characteristics of Chinese medicine with a realistic, objective and scientific attitude, rather than mechanically copy it according to the development model of western medicine, otherwise it will be impossible to develop truly excellent varieties of Chinese patent medicine. With the progress of modern pharmaceutical engineering technology, the research on the processing methods of Chinese herbal pieces, the relationship between fineness and drug component precipitation, and the influence of micro-powder processing on the changes of Chinese herbal properties are also deepening. In the innovation of Chinese patent medicine, the development of new drugs mainly in powder dosage form will surely show good development prospects.