A freeze-dried excipient containing volatile components of traditional Chinese medicine

Abstract

The invention discloses a freeze-dried excipient preparation, which is composed of an inner core and an outer layer, the inner core contains effective doses of non-volatile pharmaceutical active ingredients and auxiliary materials, and is characterized in that the outer layer can partially or completely cover the The inner core of the freeze-dried excipient preparation and the outer layer contain volatile components of traditional Chinese medicine and pharmaceutically acceptable materials with a melting point of 30-70°C, and the number of layers of the outer layer is 1-5. The invention also discloses a preparation method of the freeze-dried excipient preparation containing the volatile components of the traditional Chinese medicine. The advantage of the freeze-dried excipient preparation of the present invention is that it can not only achieve the quick-dissolving and quick-release effect of the freeze-dry excipient preparation, but also accurately preserve the volatile components and reduce the risk of drug safety; in addition, the content uniformity of the volatile components can reach Guaranteed.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, and furthermore, the invention relates to combining the volatile components of traditional Chinese medicines into freeze-dried excipient preparations. Background technique [0002] At present, traditional Chinese medicine, as an integral part of China's therapeutic drug system, plays an important role in maintaining people's lives and health. It is especially worth mentioning that the quick-release preparations of traditional Chinese medicines, such as Angong Niuhuang Pills, although prescribed as pills, have special effects for first aid for stroke. The Qingkailing injection developed from this has special protection against high fever and coma. effect; Houttuynia cordata injection and Bupleurum injection are also exerting first-aid effects that many chemical drugs are difficult to achieve; but in recent years, as the safety problems of traditional Chinese medicine inject...

AI Technical Summary

Problems solved by technology

[0006] 3. The drug content of the dropping pills is relatively low (generally, the ratio of drug and excipients is more than 1:1.5), and most of them weigh less than 70mg. , it is bound to increase the number of single doses

[0007] 4. Polyethylene glycol and liquid paraffin need to be used in the manufacturing process. Paraffin will cause the aging of polyethylene glycol and affect the long-term stability of the preparation

Since the volatile oil or volatile components are easy to volatilize at room temperature and are sensitive to air, sunlight and temperature, it is difficult to effectively control them with general preparation methods

At present, in the prior art, the methods for stabilizing the preparation and quality control of the volatile oil or volatile components contained in the traditional Chinese medicine preparation mainly include cyclodextrin inclusion complex technology, microencapsulation technology, liposome technology, microemulsion technology, etc. But these technologies all have such and such shortcomings. First, the use of inclusion technology greatly increases the amount of excipients, which greatly increases the dosage of the preparation and increases the difficulty of taking it; secondly, the stability of the inclusion technology is relatively poor, resulting in the preparation Decreased stability of the drug affects the shelf life of the drug; it is difficult to apply on a large scale in the pharmaceutical industry