| The Sangjuganmao granule is consist of eight kinds of herbs,which are Mori Folium, Chrysanthemi Flos, Platycodonis Radix, Glycyrrhizae Radix Et Rhizoma, Phragmitis Rhizoma, Armeniacae Semen Amarum, Menthae Haplocalycis Herba, Forsythiae Fructus. Designed as the granules is to accommodate to the need of the clinical. At the same time, having a comprehensive and systematic study with the extracting technology, the manufacture technology and the standard of quality control, making the medicament become the modern Chinese medical prescription with lower cost, much more stable and controllable.According to each individual component contained in each herbal medicine in its pharmacological action, pharmadynamics, physical&chemical property, as well as the main action of the whole recipe, a reasonable and effective plan of extracting technology has been made. Making an L9(34) orthogonal design of the Menthae Haplocalycis Herba' and the Forsythiae Fructus's naphtha extraction, with the oil yield efficiency as the evaluation index, and with the multiple water, the extraction times and the extraction time as the facors. Finding out a Optimization of the naphtha extraction process:added8times of water, extraction4hours for each time; with the dry-ointment rate and the content of Forsythin as the evaluation index, making a orthogonal design, to select the best process of the water extraction, there are Mori Folium, Chrysanthemi Flos, Platycodonis Radix, Glycyrrhizae Radix Et Rhizoma, Phragmitis Rhizoma, Armeniacae Semen Amarum:adding12times water, extracting3times and each time for2hours.Making an Lg(34) orthogonal design of the preparation procedure of the β-CD clathration, with the encapsulation rate and the entrapment efficiency as the evaluation index, and with the β-CD:naphtha, the temperature and time as the factors. Finding out a Optimization of the preparation procedure of the β-CD clathration: β-CD:naphtha=6-1, the temperature is70℃,2hours.According to the Chinese pharmacopoeia (2010edition) requiring the provisions of the granules and prescription content. Making an Lg(34) orthogonal design of the granules spraying and drying granulation preparation procedure, with the pellet formation conditions as the evaluation index, and with the the speed of spraying, the pressure of the atomization and the temperature of the material as the factors. Finding out a Optimization of the preparation procedure:concentrating the water extraction liquid until the relative density of the liquid become1.20(60℃), a portion of concentration and2portions of sucrose, the speed of spraying is60g/min, the pressure of the atomization is2.1kg, the temperature of the material is80℃; adding the inclusion complex into the granule, mixing and repacking.The study of the quality standards control includes of the examination of the granule's character, TLC and content analysis of Forsythin. We have a qualitative identification on Sangjuganmao gradule with Mori Folium, Glycyrrhizae Radix Et. Rhizoma, Forsythin and Menthae Haplocalycis Herba, as the comparison products, the negative control has no interference. a methodological survey has been conducted on the content analysis of Forsythin, and the conclusion is as followed:good linear indications has been shown as a result of the injection for HPLC being controlled within0.02204~1.102ug, Y=30.041X-0.0547, r=0.99997; the sample solution remains in a stable condiction within24hrs, RSD%at1.18%; the RSD of reproducibility is1.40%(n=6); samples recovery rate at99.40%, RSD%is1.31%(n=6); Concentration designed for the survey range meets the demand. The results of the experiments has demonstrated that above-mentioned method is easy for manipulation, the result is accurate and there is no interference from the negative samples, therefore it can be used as the Sangjuganmao granule's quality control. In accordance with Chinese Parmacopoeia (2010edition) Grain Diameter, Moisture Content, the size, the arsenic, the heavy metal, content uniformity, and some other things have been researched, the results are up to the mustard. |
PDF Full Text Request