Pharmaceutical Research Of Tongjiang Granules

This topic by the ministry of science and technology"natural medicine major national drug discovery projects:bashu international cooperation platform" support, based on the theory of traditional Chinese medicine.combined with modern research. according to the laws and regulations of traditional Chinese medicine health food and the research method.in view of the intestinal constipation and high blood fat crowd, developed with cassia seed,hawthorn,fleece-flower root,salvia miltiorrhiza acidin soluble, ash.turmeric as the main raw material with runchang purge auxiliary, help hypolipidemic functions of traditional Chinese medicine health food-TongJiang granules.Extraction process part,according to the related literature combined with pharmacological efficacy determination results,determine the backflow extraction with 70% ethanol.By orthogonal design.the extraction time, extraction times, amount of solvent screening process optimization, the final process parameters as follows:70% ethanol reflux extraction twice, first add 12 times.1 hour to extract:0.5 hours 2 times and 8 times, extraction.filtration.the filtrate to merge.60℃ decompression recover,’of ethanol to the relative density of 1.20-1.25 (60℃ test)of thick paste, thick paste 60℃ decompression drying, eventually have to extract dry paste.According to the optimization result of prescription medicine extraction technology, the prescription extract extract rate of 31.0%on average, prescription, 22.6 g content reduced dry paste amount is 7.0 g, daily doses is larger, at the same time, according to dry paste powder powder research results and the demand of clinical application, determine the granules for the prescription of the dosage form.Preparation in the molding process, according to the survey of extract powder property, comprehensive weighted scoring method is used to optimize the excipients. to determine the final preparation for:dry paste powder research, adding 50.75% mannitol and 5.0% citric acid,0.5% aspartame. always mixed with 90% alcohol as the wetting agent, after granulating.60℃ oven drying, granulation.into the bag.Quality standard study, the thin layer chromatography (TLC) of compound medicines:hawthorn, fleece-flower root, salvia miltiorrhiza. acid-insoluble ash has carried on the qualitative identification, the chromatographic spots were clear, negative without interference, strong characteristic, good reproducibility;According to "Chinese pharmacopoeia" 2010 version of the appendix IC granules under the corresponding requirements, inspection on through drop granule;Each other plays a main role in the determination of content of flavone and orange tree element in semen cassiae method has carried on the system methodology, and tentatively the content limit. Stability test, accelerated test and long-term test of through drop granule appearance, identification, moisture, melt, the difference of filling quantity and content of examination, inspection, according to the results of three groups of samples within 6 months stability is good, the indicators are qualified.