Study On Extraction Process And Quality Standard For Shugan Hewei Jiangni Particle

Gastroesophageal reflux disease (GERD) refers to one of common and frequent diseases. In recent years there is an increasing trend in the incidence of the GERD. Antacids and prokinetic drugs are used mainly in the treatment of GERD. These drugs have a certain effect, but easy to relapse. Shugan hewei jiangni particle, which is self-maded by Institute of Integrated Traditional and Western Medicine of Lanzhou University, is extremely effective through clinical observation. To provide basic information of new drugs, the thesis conducted a study on extractable process and quality standards for Shugan hewei jiangni particle. The content is as follows:1. The optimum extractable process by Orthogonal DesignThe content of extraction, Paeoniflorin and baicalin extracted were regarded as the assessing index, the extraction was determined by weight, Paeoniflorin and Baicalin were determined by HPLC. Water multiple, times of extraction, hours of extraction and times of infiltration were selected as influencing factors and table L9 (3⁴)was used to do by orthogonal experimental design. The optimum process was 8 times volume water of herb material immersed 1h, extracted 3 times, 1hour for each time. The optimal extractable process was steady, reasonable and feasible.2.TLC identificated bupleurum, radix paeoniae alba and chenpi of Shugan hewei jiangni particle.Identificated bupleurum to use silica G thin layer plate, chloroform -methanol-water (30:10:1) as developing agent, bupleurum saponin d and Chaihu herbs for the reference substance. Identificated paeony to use silica G thin layer plate, chloroform-methanol (5:1) as developing agent, paeoniflorin and paeony herbs for the reference substance. Identificated Chenpi to use silica G thin layer plate, Chloroform - methanol - formic acid (10:2:2) as developing agent, Chenpi medicine for the reference substance, in the UV-lamp view. The above Identification has been made more satisfactory results.3.The content of Paeoniflorin and Baicalin is determined in Shugan hewei jiangni particles by HPLC.The determination of Paeoniflorin was developed by HPLC on a C₁₈ column, acetonitrile-0.1% Phosphoric acid (20:80) as mobile phase. The detection wavelength was 230 nm with column temperature 30℃and flow rate 1.0ml/min.The results showed that Paeoniflorin had a good linearity within the range 0.3984～1.992μg(r=0.9999). The average recovery was 100.21% with RSD of 1.30%. The average content of Paeoniflorin in three batches of samples was 3.17mg/g.The determination of Baicalin was developed by HPLC on a C₁₈ column with Methanol-0.1% Phosphoric acid (47:53) as mobile phase. The detection wavelength was 280 nm with column temperature 30℃and flow rate 1.0ml/min. The results showed that Baicalin had a good linearity within the range 23.376～163.632μg(r=0.9996). The average recovery was 100.04% with RSD of 1.42%. The average content of Baicalin in three batches of samples was 9.34mg/g.The method of this paper can control the quality of Shugan hewei Jiangni particle.