Jiechangan Suppository Production Process And Quality Standard

Purpose:Jiechangan suppositories for modern Chinese herbal medicine compound preparations,drug composition of rhizoma bletillae,radix ampelopsis,radix angelicae dahuricae,radix angelicae sinensis,radix saposhnikovlae, For my school anorectal Professor Zhou Jianhua, director of clinical experience side .Has the effect of treatment of ulcerative colitis. This experiment identified the production process jiechangan suppository and quality standards lay the foundation for the further development of new drugs.Method: Optimized by orthogonal test method prescribed in the extraction process of the herbs, purified by centrifugation extract, in this based on research carried out molding process, and the quality standard.Result: rhizoma bletillae boiling alone for the best extraction 8 times the amount of water, boiling 3 times, each time 2 hours; radix angelicae dahuricae optimum extraction of ethanol extraction was 80% plus 4 times the amount of ethanol extracted 3 times 2 hours; radix angelicae sinensis,radix saposhnikovlae optimum extraction of volatile oil was 8 times the amount of water, distillation 5 hours; radix ampelopsis,radix angelicae sinensis,radix saposhnikovlae Boiling water for the best extraction with 10 times the amount of water, extracted 2 times extraction for 2 hours; Three drugs for the relative density centrifugation optimum is 1.05, the centrifugal rotation of 8,000 rpm; Molding process selected for the semi-synthetic fatty acid glyceride suppository matrix,Choose the best drugs and the ratio of 9:10 matrix, drug molding temperature is 60℃, add essential oil temperature 50℃, with water as lubricant suppository mold coated system,Replacement value: f = 1.4786; Quality standards. Tentative The product quality standards to imperatorin per gram of dollars, not less than 0.13mg.Conclusion: The production process used to make reasonable and preparation of finished product quality is stable and controllable.