Qingkailing frozen-dry-powder injecta and preparing method

Abstract

The present invention discloses a Qingkailing freeze-dried powder injection and its preparation method. Said method includes the following steps: extracting the medicinal materials in the Qingkailing prescription and purifying them to obtain high-purity extract, mixing the obtained extract with medicinal auxiliary material, and making them into the invented Qingkailing freeze-dried powder injection.

Description

Technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a Qingkailing freeze-dried powder injection and a preparation method thereof. Background technique [0002] Qingkailing Injection is obtained from Angong Niuhuang Pills, which is a modern Chinese medicine compound preparation. It is mainly composed of cholic acid, hyodeoxycholic acid, mother-of-pearl, buffalo horn, baicalin, mast, Radix isatidis, and honeysuckle, which are extracted, refined, and mixed. Enlightenment effect. It is used for coma due to febrile disease, hemiplegia due to stroke, and confusion. It can also be used for acute and chronic hepatitis, hepatitis B, upper respiratory tract infection, pneumonia, high fever, and cerebral thrombosis and cerebral hemorrhage with the above syndromes. [0003] Qingkailing Injection is one of the essential Chinese patent medicines in the emergency department of TCM hospitals across the ...

AI Technical Summary

Problems solved by technology

[0003] Qingkailing Injection is one of the essential Chinese patent medicines in the emergency department of TCM hospitals across the country. It has a remarkable clinical effect, but with the wide application in clinic, its adverse reactions are reported from time to time, among which the most serious anaphylaxis occupies a certain proportion. The reason is that we believe that the preparation process of water injection is relatively traditional, and its preparation process basically adopts the conventional process of injection, that is, liquid preparation, filtration, potting, and sterilization, while the filtration method is to use filter paper, ceramic sand core or sand Rods, etc., and then filtered through a microporous membrane of 0.22-0.45 μm. After such a filtration process, the liquid medicine is filled and sterilized. It is tested according to the national pharmacopoeia standard. Pyrogen is often unqualified and there is a problem after medication. allergic reaction

The qualification rate of the product due to unqualified pyrogens is only 70%-80%, the safety of the preparation is not high, and it cannot meet the technical requirements of modern Chinese medicine injections, and its preparation process is complicated and the production cycle is long, resulting in high production costs. The quality of preparations is not easy to control. Therefore, it is necessary to solve the phenomenon of unqualified pyrogens from the production process of Qingkailing injection, and improve the pass rate of products and the safety of medication.

Due to the complex composition of the Qingkailing preparation prepared by the prior art, which includes both animal medicine and herbal medicine, the stability during storage is relatively poor, which also limits the application of Qingkailing preparation

[0004] The patent with the application number 200310111036 uses two alcohol precipitation methods to extract and purify the medicinal flavors of Qingkailing prescription. Although this method improves the safety of the preparation and greatly reduces the intolerant particles, with the second alcohol precipitation The production of the Chinese medicine coerces the precipitation of a part of the active ingredients, which reduces the utilization rate of traditional Chinese medicine and causes waste of resources; the patent application number is 03126699, which uses a three-stage filtration method to process the liquid medicine. Positive charge pressure filtration makes the charged active ingredients in traditional Chinese medicine such as amino acids be filtered out, resulting in waste of resources; the patent application number 03109422 uses high-speed centrifugation and 0.22μm filtration to process the liquid medicine, which cannot solve the problem of liquid medicine well. The problem of medium heat source can only achieve the problem of removing insoluble particles and bacteria; the patent application number 96103347 adopts the filtration method of 0.65 μm filter element, which cannot meet the requirements of removing bacteria and heat source; the patent application number 95116716 only briefly introduces Sterilization and filtration, no specific process is introduced