Clearance Soothing Release Capsules Of Pharmaceutical Research

Tongguanshu sustained release capsule is a modern Chinese herbal drug for the therapy of Rheumatoid Arthritis.It consists of two kinds of Chinese herbs, one comes from Liliaceae, the other is a plant of Menispermaceae. According to correlative regulations of patent traditional Chinese medicine, the primary researches were done as follows.To research the extraction process of effective parts, single factor and orthogonal experiments were used. By single factor experiment, the purifying process of Tujingan total saponins extraction was researched by means of Macroporous resin; and Yefurong total alkaloids extraction was puried by Ion exchange resin. By these experiments, the practicable process was choosed.The qualities of intermediate of Tujingantang total saponins extraction and Yefurong total alkaloids extraction were stable and controllable.As the material of preparation, the intermediates were mixed with starch both inside and ouside. The pellets were prepared by means of layering in coating pan. Then the pellets were coated by Surelease. The characters of coated pellets were also studied.According to correlative regulations of "pharmacopoeia of the People's Republic of China" 2000's edition, the character, identifying methods, and general checks of Bitong sustained release capsule were studied; Selecting total saponins as technological marker, the method of determining the cumulate release rate was established, and the release percentage of different time was ascertained; The releasing characteristic parameter was explored by different mathematical model to explain the mechanism of drugs release. The methods of determining the content of M saponin and N alkaloid by HPLC were studied, and the limits of content were also established.Through the research of the thesis, we made the herbs into sustainedrelease capsules. It's hopeful that we can offer a preparation made of compound modern Chinese herbs for clinic, which can sustainedly release and have few side effects. It is convenient for taking and earring. At the same time, through the research of process characters of compound Chinese herbs preparation, some beneficial experience and data for preparing preparation of compound Chinese herbs was accumulated.