A Study On Preparation Of Bi Doujing Reduced Granule

Objective: A scientific researching proposal to develop a new traditional Chinese Medicine dosage form—Bi Doujing Reduced Granule, which is used to cure chronic nasoinusitis. Methods: Orthogonal Design is adopted to optimize the best conditions of the weater extraction from such materials as Ligusticum Chuanxiong Hort,Asarum sieboldii Miq,Magnolia biondii Pamp,Angelica dahurica Benth et Hook f,Chrysanthemum indicum L,Angelica sinensis(oliv)Diels,Xanthium sibiricum Patr in terms of the volatile oil extraction ratio, and at the same time the optimal parameter of including volatile oil with ?-cyclodextrin (?-CD) is determined.The technological process of the ethanol extraction from the materials such as P.villosa (Thunb.) Juss, Platycodongrandiflorum, Radix Puerariae, Salvia rniltiorrhiza Bge, Gleditsiasinensis Lam according to the content of Platycodon grandiflorum(Jacq )A.DC, Salvia miltiorrhiza BgeKetone-IIA and Dry extract.of n-BuOH content and the optimized weater extraction from Scutellaria baicalensis Georgi A.membranaceus(Fisch) Bge according to the content of baicalin are also obtained through the orthogonal design. The proper excipient and its ratio in the whole Granule are optimized in terms of its formation, solution and taste.The quality control of Baicalin and Salvia rnilti-orrhiza Bgeketone IIA in the Granule is carried out according to high efficiency liquid chromatography, and the ingredients of Scutellaria baicalensis Georgi Platycodongrandiflorum Ligusticum Chuanxiong Hort Salvia rnilti-orrhiza Bge are all TLC-appraised.Result: Tthe extract process parameters of volatile oil is with 8 times water, soaked for 2 hours and extracted for 6 hours in the steam, the optimal parameter of including volatile oil is with ?-cyclodextrin at the ratio of 10:1, mixed for one hour at 40℃; the ethanol extract technological process is carried out with eight times of 90% ethonol for one hour and with eight times of 70% ethanol for one hour; the weater extract process is boiled three times with 8 times of water and each time for one hour. The excipient is common cyclodextrin and minor fibrin at the ratio of 1:1:0.2, and 80% ethanol is taken as moisture. The average content retrieving ratio of Baicalin is 96.4 % , RSB=1.66%.Conclusion: The technological process and quality control are easy and practical. This granule is of highly reliable quality.