Studies On The Pharmaceutic Of The Xihuang Soft Capsules

The formula of Xihuang Wan comes from the NO.9 of the Ministry-issued standard of Chinese.The major effects of this medicine include heat- clearing and detoxicating drugs,They are chiefly used in the treatment of the carbuncles and boils,scrofula, ulcers,cancer,etc.It has a longer use time and leads to more accuraet effects.The purpose of this project is to develop the Xihuang pill by technological process,quality standards,and results in new form of Traditional Chinese Medicine—Soft Capsule.During the course of the research on extraction process,based on our analysis of each individual component contained in each herbal medicine in its pharmacological action,pharmadynamics, physical &chemical property,Cow-bezoare and musk are directly crushed little particles,Volatile oil in Olibanum and Myrrha are extracted by stream distillation,then Dregs were extracted by ethanol.According to L9(3⁴) orthogonal survey conducted with the extraction rate of volatile oil & the content of octyl acetate as the index for the evaluation,we concluded that the optimum process for extraction of Volatile oil would be:Milled into granules; 7-fold water added,not soaking,extraction for 7 hours.In the same way,using the ether oozes as indicator,we decided the best process for extraction of Dregs:7-fold 85%ethanol added,1 times of extraction,2 h for extraction process. In our study on its granules-forming,using Disintegration time limit and accelerated test(40℃±2℃,relative humidity 75%±5%,placed 28 days) under the conditions of Disintegration time limit as indicators,L9(3⁴) orthogonal test was adopted to optimum the ratio of gelatin and glycerin,the ratio of waiter and gelatin, plastic melting temperature,the best capsule shell composed of Soft Capsule was:gelatin:glycerol:water = 2:1:2,plastic melting temperature of 70℃.we decided a final forming process based on our research on concentration of different types contents,and different proportions of the molding material,the amount of suspending agent:The best soft capsules formatting ratio of soya bean oil,beeswax and drug was 60:5:35.On this way,the contents have good fluidity,suitable viscosity,and the settlement ratio of 98%.In its quality control study,the research conducted has included the TLC of Olibanum and Myrrha,content analysis of Cholic Acid and Muscone.We have a qualitative identification on Xihuang Soft Capsule with Olibanum herb,Myrrha herb as comparative samples, it came out to be negative.The quality of Cholic Acid was determined by HPLC-ELSD.In accordance with Chinese Parmacopoeia(2005 Rev.), a methodological survey has been conducted and it concluded:good linear indications has been shown as a result of the injection for HPLC being controlled within 45.2 ng - 904 ng,r=0.9999;the sample solution remains in a stable condiction within 24hrs,RSD was 1.25%;samples recovery rate was 99.12%,RSD was 1.53%; Concentration designed for a survey ranges from Minimum of -50%to Max.of 200%,its accuracy(from Min to Max.):1.84%,1.53%,1.82%. The quality of Muscone was determined by GC.The linear range of Muscone was 0.05 mg·mL^-1- 0.5 mg·mL^-1,r = 0.9999.The average recovery was 99.33%,RSD was 1.26%.Our experiments has demonstrated that above-mentioned method is easy for manipulation and correct identification,therefore can be adopted for its quality control.