Research On Shenhuangjiangtang Capsules Preparation Process And Quality Standard

Objective: Shenhuangjiangtang Capsule is made of American ginseng,radix astragali, polygonatum, radix trichosanthis, rhizoma coptidis, radix puerariae, salvia miltiorrhiza, yam, radix rehmanniae, radix achyranthis bidentatae, has the effect of clearing heat and promoting fluid, boosting qi and nourishing yin, has good curative effect caused by a variety of type 2 DM and deficiency of both qi and yin of Xiaoke disease. From the perspective of the traditional Chinese medicine treatment, this study takes the traditional Chinese medicine theory as a research basis, and through the modern pharmaceutical technology, this study discuss the preparation process analysis and quality standardization of this preparation.Methods:According to the needs of drug use, and the characteristics of the drug, this product is determined as a capsule formulation. At the same time,according to the function of the preparation and the prescription compatibility,take the yield of dry extract as the evaluation index, the orthogonal test method was used to prepare the process route the best process. Take the repose(α) as the evaluation index to prepare the size of capsule content, the radix astragalus and American ginseng of the two Chinese herbal medicines in the Shenhuangjiangtang Capsule was identified by using thin-layer chromatography; The content determination of Saponins was carried out by using gravimetric method, and its methodology was investigated systematically. According to the stipulations of the Chinese Pharmacopoeia appendix IL capsules, the moisture content, disintegration time and the amount of difference of preparation of samples were inspected. The stability of Shenhuangjiangtang capsules was inspected through the accelerated testing and long-term test, and the accelerated tests were at 60 ℃high temperature, RH 90 ± 5% high humidity, 4500 ± 500 Lx lightillumination conditions, long-term test was carried out as follows, taking three batches of the samples of the Shen Huang Hypoglycemic Capsule, except for1 sampling inspection of the production month, and the sampling inspection is also done one time in 0, 1st, 2nd, 3rd, 6th months, the inspection for their traits,identification, inspection, content determination is a total of 6 months.Results: According to the pilot scale experiment results, take radix astragali, polygonatum, radix trichosanthis, radix puerariae, salvia miltiorrhiza,yam, radix rehmanniae, radix achyranthis bidentatae according to the prescription,2/3prescription coptis, soak with 8 times of water, decocting2 times and 2 hours every time, make filtration, then merge the solution,concentrate the solution to the relative density of 1.20 ~ 1.25(60 to 65℃),adding American ginseng with prescription amount and 1 / 3 prescription coptis powder, and sifting with sieve of 60 mesh, drying at(80℃), crushing,then sifting with sieve of 60 mesh, and put into the No.0 capsules, this is the best preparation process. Using thin-layer chromatography method for identification, the Radix astragalus and American ginseng in the sample was positive. Using gravimetric method for the determination of content, the measured recovery rate is 102.7%, the content is more than 1.20%. In the stability analysis, the results and data showed that the characteristics,identification, examination and content determination of the three batches of the samples of the groups were consistent with the requirements.Conclusion: the process is scientific, reliable, easy to implement, the quality of the medicine is stable, and the quality standard can be controlled.