Study On Chinese Medicine Biyuanshu Soft Capsule Treating Chronic Nasosinusitis

In this paper, traditional Chinese compound preparation Biyuanshu Soft Capsule was studied which was used to treat chronic nasosinusitis. Extracting methods of Chinese materia medica in Biyuanshu Soft Capsule were optimized. Then mixtures of volatile oil and dry powder were used to optimize. Eventually the quality control methods of Chinese materia medica and active component in Biyuanshu Soft Capsule were established and the suitable results were obtained.The extracting methods of volatile oil, gruffs, and Radix Scutellariae were carried out, respectively. Taking yield as index, volatile oil in prescription was distilled with water vapourand optimized by single factor and orthogonal test. The gruffs were further extracted with water optimized by orthogonal test with jasminoidin yield as index. The extracting solutions in above tests were collected, and purified with alcohol, and optimized by orthogonal test with jasminoidin yield as index. The fined extracting solution was dealt with spray drying method. The powder yied was as index, parameters of spray drying method were optimized by orthogonal test. Considering baicalin was unstable in cold water, the extracting method of Radix Scutellariae with hot water was optimized by orthogonal test with baicalin yield as index. Volatile oil, fined extracting powder, and Radix Scutellariae extract were collected as Biyuanshu Soft Capsule dry extract.The proportions between Biyuanshu Soft Capsule dry extract and dispersion material, suspending agent, and wetting agent were studied with stability as index. The results indicated that the optimized prescription was polyethylene glycol 400(PEG 400)as dispersion material including 2% Tween 80 as suspending agent . The prescriptions of capsule shell were studied with property and disintegration time as index, and the best prescription was gelatin: glycerol: sorbitol with proportion 1:0.25:0.4. The soft capsule was prepared by pressing method with gelatin temperature 70℃and holding temperature 60℃. The preparation results of test, semi-works production, and manufacture were coherent in production yield, disintegration time, and active component concentration.Biyuanshu Soft Capsule prescription included several Chinese material medica, so TLC methods of Radix Astragali, Fructus Gardeniae, Radix Scutellariae, Rhizoma Chuanxion, and Radix Angelicae Dahuricae were established. Results indicated the evident difference in TLC chromatograms of samples, and no difference in TLC chromatograms of negative samples. HPLC method was established, and jasminoidin, one of active components in Fructus Gardeniae, was determinated by HPLC. There was a good linear correlation in 0.0869—1.7376μg between jasminoidin and peak area, and the average recovery was 99.78%,RSD was 0.81%.