Chinese medicinal dispersible tablet, its preparation process and ingredient detection method

Abstract

The invention discloses a dispersible tablet of Phlomis rotata Benth, which is prepared from Phlomis rotata Benth extract, cross bonding polyvinylpyrrolidone, low substituted methylcellulose propylene glycol ether, crystalline cellulose and micro powder silica gel. The invention also discloses the process for preparing the dispersing tablet and the quality control method.

Description

technical field [0001] The invention relates to a raw material composition of a dispersible tablet of traditional Chinese medicine, and also relates to a preparation method of the dispersible tablet and a detection method of active ingredients, belonging to the field of traditional Chinese medicine. Background technique [0002] A Supplement to the 2000 Edition of the Pharmacopoeia of the People's Republic of China announced a unique traditional Chinese medicine unique tablet, which has been proved to be effective in hemostasis, analgesia, bacteriostasis, acute and subacute toxicity tests, immune function tests and anti-tumor tests. It has better hemostatic, analgesic and antibacterial effects, less toxicity, fewer side effects, and can also improve specific and non-specific immune functions. Its modified formulation, Duyiwei Capsules, can significantly prolong the appearance time of pain response, significantly shorten the bleeding time of mice, increase the phagocytosis ra...

AI Technical Summary

Problems solved by technology

[0003] Aiming at the shortcomings of existing Duyiwei preparations, it has become an important content of Duyiwei research in recent years to develop Duyiwei oral preparations with fast disintegration, fast absorption, high bioavailability, and good stability, such as Duyiwei capsules, Duyiwei soft capsules, etc. The contents of Duyiwei soft capsules are liquid or semi-solid, and they are quickly dispersed or dissolved in gastrointestinal fluids after oral administration, which is conducive to absorption. The rate-limiting process that affects the absorption of soft capsules is the disintegration speed of the capsule shell , The disintegration time limit of soft capsules is generally 4? minutes. If the soft capsule can completely disintegrate within the specified disintegration time limit, the bioavailability of the drug is very high. However, at present, the soft capsules developed in my country generally have disintegration problems. It increases with the increase of the aging degree of the capsule shell, and some do not even disintegrate. Therefore, the soft capsule preparation still has a large defect in the stability problem. The capsule, like the ordinary tablet, is a traditional process. Compared with tablets, there is no qualitative improvement in utilization, so the existing unique oral preparations have the above obvious deficiencies, and there is an urgent need to develop new oral preparations with better effects

[0004] Dispersible tablets are a soft and good way to solve the above problems, but since dispersible tablets have been used in chemical drugs mainly composed of monomers, it is still difficult to apply them to traditional Chinese medicines with complex components. Stability, disintegration time and other related technical issues