Study On Preparation And Quality Standards Control Of Quban Gels

Objective:Considering the prescription from the dermatology department, we tried to prepare Quban hydrogel using carbomer, a polymer material, as the gel matrix in order to develop a novel preparation for melisma treatment. This article discussed all the following aspects of the Quban gels, including formulation extraction process, preparation technology and quality standards.Methods:1. Study on the optimized extraction process of the Quban gelsOrthogonal test was employed inselection of optimal conditions for the extraction procedure. The content of ferulic acid,the major active ingredient of Radix Angelicae Sinensis, was taken as indicator and evaluated the influence of the factors such as ethanol concentration, ethanol volume and extraction time.2. Study on the preparation technology of Quban gelsThe uniform design was adopted to optimize gel formulation, including the amounts of carbomer940and glycerin, the pH value, with rheological parameters as the index, such as viscosity and yield value in room temperature, viscosity and yield value in average temperature of skin, thixlotropy. Then using the SPSS2.0analysed the functional relation between the gel quality and rheological parameters.3. Study on the quality standards control of Quban gelsRadix Angelicae Sinensis, Radix et Rhizoma Ginseng and Poria were identified by thin layer chromatography (TLC). The content of Ferulic acid was determined by high performance liquid chromatography with mobile phase consisted of acetonitrile-0.085%phosphoric acid (17:83), column temperature was set at35℃and detection wavelength was326nm.Results:1.The optimum conditions of formulation extraction was as follows:the Angelicae sinensis Radix and Ginseng Radix and Rhizoma were extracted by8volumes of ethanol for3times, and each extraction lasting for2hours, then the dregs mixed with the other herbs were extracted by water for3times,each time lasting for2hours.2. The results indicated that the optimum proportion of matrix was made of1.Og carbomer940,5mL glycerin and pH value5-6.3. The study on the quality standards:Radix Angelicae Sinensis, Radix et Rhizoma Ginseng and Poria were identified by thin layer chromatography(TLC). The characteristic identification was distinct and highly specific. The HPLC indicated that the retention time of ferulic acid was13.6min, and the measured peak was well separated with other peaks. The content of ferulic acid showed a good linear relationship in the range of0.024-0.144ug (R2=0.9999).the precision RSD was0.86%; The Stability RSD was1.94%, sample solution was stable within10h; The reduplicate RSD were1.57%;The average recovery of ferulic acid was100.2%(RSD2.93%). the content of ferulic acid of3batches were0.0230mg/g、0.0229mg/g、0.0226mg/g.Conclusion:The Quban gels exhibited desirable transparency and bioadhension. The base of Quban gel was elementarily investigated and evaluated in this article, it provided a reference for development of traditional Chinese medicine applications.