Pulse Capsule Preparation And Quality Control

Maishu Capsule is a TCM preparation made from the extracts of the peanut hulls,which contains the flavonoids andβ-sitosterol,and possesses the activities of reducing blood lipids and blood pressure. Maishu Capsule was embodied in the medicine standards collection of the health ministry,but the product quality control and guarantee were influenced because of no item of assay. This was carried on to investigate the total flavonoids and luteolin content of Maishu Capsules both from the market and the self-made products to determine the assay methods and their limits; To investigate the total flavonoids content of the peanut hulls of different sources; To optimize the extraction technology by single factor method,orthogonal experimental design and validatory experiments;To research the granules forming techniques with the hygroscopy and fluidity serving as indices.The results and conclusions were as follows:1.The total flavonoids content of Maishu Capsules was determined by spectrophotometry detecting absorbances at 510 nm with aluminum nitrate as the colour-developing agent and Rutin as the reference substance, the mean recovery was 99.68%,the relative standard deviation(RSD) was less than 2%,and the assay limit was ascertained as 25.0 mg per capsule caculating based on Rutin;The luteolin content was determined by RP-HPLC method.the best mensuration was on ODS-C₁₈ column with MeOH-0.4% phosphatic acid(50:50) as a mobile phase, luteolin as the reference substance and detecting at 350 nm, the mean recovery of luteolin was 99.49%,the relative standard deviation(RSD) was less than 2%,and the assay limit was ascertained as 4.0 mg per capsule.The two assay methods complied with the requirements validated by methodology.2.The total flavonoids content of peanut hulls of different sources were evidently different,those peanut hulls contained more total flavonoids from Shandong province,higher maturity and raw. This suggested that attention should be paid to the choice of peanut hulls as medicine materials.3.The optimized extraction technology conditions considering the two indices of total flavonoids andβ-sitosterol were: the peanut hulls were extracted by 95% acohole 6 times of the hulls weight refluxing for 2 hours first,and extracted by 70% acohole 4 times of the hulls weight refluxing for 2 hours at the temperature below 80℃successionally,then the concentrate was dried vacuumizedly with the additament of starch 2% of the concentrate weight after the extracts were fitrated,united and concentrated.4.The dried extract powder possessed high hygroscopy and low fluidity,but the weight variation of capsule contents could comply with the requirement of CP if it was mixed with dextrin and granulated by sieving 40 meshes using 95% ethanol as the wetting agent,and filled into capsules after dried below 60℃.The critical relative humidity of the granules was about 63%.The Maishu capsules prepared according to the optimized technology complied with the drafted quality criterion,and the primary stability test showed it was stable.The production technology was optimized and the quality standard was improved in this study, making the products quality controllable and assurable,and reducing the production cost meanwile.The study was significative to make the most of peanut hulls resource and promote the people's health cause.