Drop pills of Chinese traditional medicine, and preparation method

Abstract

A dripping pill for treating vasculitis, cerebral thrombus, and their sequelae features high natural level and safety and low toxic by-effect. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to an orally administered traditional Chinese medicine compound medicine and a preparation method thereof. More specifically, the present invention relates to a kind of traditional Chinese medicine dripping pill and its preparation method. Background technique [0002] Mailuoning Injection is a traditional Chinese medicine compound intravenous injection for the treatment of vasculitis, cerebral thrombosis and its sequelae and other thrombotic occlusive diseases. The method is extracted and refined. It has the effects of nourishing yin and clearing heat, nourishing liver and kidney, promoting blood circulation and removing blood stasis. Its mechanism of action is related to anticoagulation, thrombolysis, spasmolysis, pain relief, blood vessel expansion, improving circulation, regulating immunity, and anti-free radicals. After more than ten years of clinical application practice, the drug has a ra...

AI Technical Summary

Problems solved by technology

This may be related to its medicine directly entering the vein. At present, someone makes it into a dripping pill preparation to overcome the defects of the injection itself. The application number is 03131739.1. It overcomes the shortcomings of slow tablet absorption, slow effect, inconvenient carrying of injections, and many adverse reactions. However, most of the excipients used in the drop pills made by this method are chemically synthesized. At present, people are more eager to return to nature. High drug treatment and prevention of problems that cannot be solved by some chemically synthesized drugs, so the application of natural herbal medicine is beyond the background of its original national traditional culture

Seeking high-quality and low-cost drugs with low side effects from natural medicines has become the goal pursued by pharmaceutical companies all over the world. However, many products produced by traditional Chinese medicine in my country are rejected because they cannot meet the standards and requirements of the international pharmaceutical market.

[0003] With the global expansion of the market and the requirement of human beings to return to nature, the use of drugs with low toxicity and side effects, especially pure natural drugs, has become the first choice of people. The dropping pill preparation is a new type of Chinese medicine preparation with high efficiency and quick effect. The shortcomings and deficiencies of traditional Chinese medicine preparations in the past, but the current drop pill preparations generally face the following problems: 1. The drop pill auxiliary materials are not purely natural: at present, most of the drop pill base auxiliary materials are chemically synthesized, and the natural degree is low. New alternatives The search for matrix excipients, especially the search for alternative matrix excipients with a high degree of naturalness and the determination of their preparation process, is also very difficult, because the preparation conditions required for common and possible substitutes for natural matrix excipients are very harsh. And its dripping pill dripping conditions are the key to affect the preparation of dripping pills

If the melting temperature of the excipient is too high, the viscosity will be low and the plasticity will be poor. If the melting temperature of the excipient is too low, although the plasticity is strong, the dropping pills have disadvantages such as easy sticking and deformation. The accessories are very hard work

2. Problems encountered in the export of dripping pills: With the development of the economy, the market is becoming more and more internationalized, and China is also trying to adapt to this trend. Currently, Chinese medicine dripping pills, which are used as health food, have been successfully exported to many countries, but There are also many problems at present, because different countries have different approvals for the excipients selected for the preparation of Chinese medicine dripping pills, especially in Europe with developed industries, which have stricter regulations on food excipients and pharmaceutical excipients, and the drops exported as health food The chemically synthesized auxiliary materials (such as polyethylene glycol) selected for pill preparations are not listed in the food additive catalogs of some countries, which is very unfavorable for Chinese medicine dripping pill preparations to enter the international market, and has become a stumbling block for Chinese medicine to enter the international market. Therefore, looking for One or more new matrix excipients that can be accepted by the international market are particularly important and urgent

3. Disadvantages of mouthfeel and speed of onset of action: Poor taste of traditional Chinese medicine and its preparations is one of its major characteristics. When people take certain medicines, they are far more afraid of the bad taste of the medicine than they are of the disease. What's more, some patients give up the treatment of traditional Chinese medicine because they can't overcome the bad taste or smell of traditional Chinese medicine or its preparations. For example, making the medicine into capsules or sugar-coated tablets can improve the taste and reduce stimulation, but the disintegration speed is prolonged. , which is not conducive to the rapid onset of the drug, and is not suitable for some diseases, especially those that require the rapid onset of the drug

4. Difficult preparation process for industrial production of dripping pills: In the replacement process of dripping pill preparation auxiliary materials, it is very difficult to determine the preparation process for industrial production, such as the melting temperature of matrix auxiliary materials, dripping temperature, auxiliary materials and The ratio of the drug, the ratio of the caliber of the dropper, and the condensing agent are all factors that affect the drop pills. Therefore, it is time-consuming and expensive to replace the matrix and be suitable for industrial production.

[0004] In order to change the long-term situation that the base excipients of drop pills are mainly chemically synthesized excipients, and solve the problem that the base of drop pills is currently facing a low level of naturalness, it is increasingly unable to meet people's requirements for returning to nature, taking pure natural medicines with low toxicity and no side effects It can also solve some problems encountered in the export process of Chinese medicine preparations, especially dripping pill preparations, and enhance the competitiveness of the international market; the present invention has invented a toxic and side effect through a large number of experiments and research on preparation technology. Pure Chinese medicine dripping pill preparation with low cost, significant curative effect, moderate price, and suitable for industrialized large-scale production