Study On Preparation Process And Quality Standard Of Yimu Gengniankang Capsules

Yimu Gengniankang Capsules is a new compound preparation of pure Traditional Chinese Medicine, which consists of Epimedium brevicornu Maxim,Radix Rehmanniae Praeparata, Radix Polygoni Multiflori,Schisandra Chinensis,et al.The prescription from the First Hospital of Wuxue is an empirical anagraph and it has been used clinically for many years. Yimu Gengniankang Capsules has the function of nourishing yin and yang,regulating chong and ren. It is used to treat for the women’s climacteric syndrome in clinic,the symptoms are showed as follows, dizziness and tinnitus, forgetfulness, alternative chillness fever, facial heating, soreness and weakness of waist and knees, pale tongue, moss thin, thready pulse. This subject is under the guidance of traditional Chinese theory and base on requirements of the 6.1 classification of traditional Chinese medicine, natural medicine new drug registration and combined with modern research technology to study the preparation process and quality standard of Yimu Gengniankang Capsules which is to ensure the preparation process is scientific and rational, the quality is stable and controllable. 1. Study on preparation process.The extraction process: Using the transfer rate of icariinand and schisandrin as the evaluation index, applying the beginning expriment and orthogonal design expriment, then combined with the pharmacodynamic test results, ultimately we determined the extraction process of Yimu Gengniankang Capsules as follows: To take the seven herbs in the prescription using 8 times amount of 70% ethanol, extracting 3 times, 1.5 hours every time, filtering, merging filtrate, contentration and drying.Contentration and drying process:Using the transfer of icariin as index, studying on thick paste concentration degree and drying temperature. Alcohol extract after the merger was decompression concentrated to a relative density of 1.32(60℃) thick cream after vacuum drying(80℃,-0.09Mpa) into dry extract.Prepation Process: In order to research the influence of excipients which consist by different ratio of starch and silica on the granulation, it was combinied with the ten batch of pilot test, and ultimately determine the forming process of Yimu Gengniankang capsules for the dry paste powder(80 mesh) and starch, silicon dioxide(35:4:6) mixing evenly, with 80% ethanol made of soft material, 20 mesh sieve granulation, drying at 60℃, 18 mesh sieving grain, filling the capsules, plastic packaging, namely2. Study on quality standardTLC method was used to qualitatively identify Yimu Gengniankang capsules of Epimedium brevicornu Maxim,Radix Rehmanniae Praeparata, Radix Polygoni Multiflori,Schisandra Chinensis.Results in chromatography for the test, the control herbs or contrast product corresponding to the position of the same color fluorescent spots, and has no negative interference.Study oncontent of HPLC determination: The HPLC method was used to determine the contains of icariin in Epimedium brevicornu Maxim of Yimu Gengniankang capsules, the chromatography conditions as fllows: with eighteen alkyl silane bonded silica as filler; using acetonitrile and water(30:70) as mobile phase; the detection wavelength was 270nm; the column temperature of 30℃; flow velocity 1.0mL·min-1. Through the ten batch of pilot study, to determine the content of icariin in the product is not less than 0.50 mg in each capsule...