| IBS capsule is comprised by such as Huanglian, rutaecarpa and so on ,have the efficacy of Shagan Jieyu,Liqi Zhitong,Jianpi Hewei and Zaoshi Zhixie,and is used for the treatment of IBS.Now In accordance with the requirements of Chinese medicine new drug , according to the study of prescription drugs in the flavor of the active ingredient and its efficacy, pharmacokinetics and pharmacology, applicate the modern extraction, separation technology to study the drug separation and purification and Preparation Process, then to study the quality standards and stability ,finally is made to the new Chinese Compound drug . Specific studies include the following:1 Literature study: Chinese medical theory as a guide, to expose comprehensively the legislation and significance of title,at the same time to summarize and summe the chemical constituents in the medicinal herbs .2 Preparation technology study: First, orthogonal test method was used to study the best extraction of Huanglian and rutaecarpa group. Then, optimize the extract process of Baicalin group and volatile oil ’ s extraction and inclusion . After the extraction process was determined, inspected the enrichment method, optimizd of the spray-drying conditions, finally study the molding process, a small-scale test, pilot study.3 Quality standards study: First of all, using thin-layer chromatography to identify the Huanglian, rutaecarpa, Costas, baicalin; and then proceed to the Huanglian Determination of berberine in methodological research; And inspected the capsule under the Pharmacopoeia capsule inspection.4 Stability study: Investigated samples at room temperature in 0 month, 3 months, 6 months, 9 months and accelerated stability in 0 month, 1 month. 2 months, 3 months and 6 months. |
PDF Full Text Request