| Buxin capsule is developed based on Buxin tablet as dosage changing. It is comprised of Rehmannia, ophiopogonis tuber, tuckahoe, Raidix Scrophulariae, Radix Codonopsis, Fructus Schisandrae, Radix Angelicae Sinensis, Radix Polygalae, Radix Platycodi, Semen Ziziphi Spinosae, Semen Platycladi, Radix Salviae Miltiorrhiae, Radix Glycytthizae, Rhizoma Acori Talarinowii, Radix Asparagi, Cinnabaris. It has the effect of nourishing yin, enriching blood, calming the nerve in the terms of Chinese medical theory. Buxin capsule can be mainly used to treat symptoms of cardiopalmus, fatigue, insomnia, forgetful as well as dry and hard stool, bore ulcer on month and tougue, red tougue and few moss, and micro and fast pulses.The specification of original BuXin tablet is issued by the Ministry of public health, Very simple method of preparation technology was regulated in the original specification, there is no any specified criteria on the aspect of quality control. The research on technological data that is missed in original specification was carried out in this study. The technological validation test and middle sized amplificatory production was implemented, It was indicated through the study that the preparation procedure of the production is reasonable and feasibleTechnology research:On the basis of original manufacture process of Buxin tablet, The quantity of water added was tested, The optimum condition is that 10 times water may be added in the first extraction and 7 times water may be added in second extraction based on the result of extraction ratio and n-butyl alcohol extraction ratio. The orthogonal experiment was conducted concerning three factors which is collective percolate volume, the rate of percolate, marinating duration. The optimum condition is 6 time of raw materials volume to be collected during percolate, the rate of percolate is 1.0～2.0 ml/min and marinating duration is 24 hours. And this technology procedure is stable that is proved by technology validation and middle-sized amplificatory production, The study also showed that the manufacture procedure is stable, reasonable and feasible.Quality control research:A TLC method was set up for the examination of Rehmannia, Fructus Schisandrae, Raidix Ophiopogonis, Radix Salviae Miltiorrhiae. A systematic study on the methodology of the HPLC method on schisandrin; wuweizi alcohol A was implemented, and the content limit of schisandrin;wuweizi alcohol A was established; A systematic study on the methodology of the titration method on mercuric sulfide was carried out and the content range was set up. These qualitation and quantitation method are simple, specific, practical as well as good reproducibility. Based on the experimental results, The draft quality control standard of Buxin capsule was set up.Investigation on stability:According to "New Medicine Examination and approval Means", the stability test of the preparation was conducted. The "acceleration test" with the high humidity, high temperature condition was carried out, The physical character, distinction aspect and the content examination of the capsule is qualified. At the same time, a long time normal condition stability test was also carried on. During the inspection time, the physical character and chemical character of BuXin capsule were observed, The result is qualified. The study result indicated that BuXin capsule is stable, the preparation procedure and the quality control standard is reasonable and feasible. |
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