Study On The Preparation And Quality Standards Of Compound Danshen Orally Disintegrating Tablets

Orally disintegrating tablets are prepared on behalf of Compound Danshen for the reseach of Chinese patent medicine, and the methods are developed for the determination of the main index to control its quality by modern analytical instrument.Compound Danshen orally disintegrating tablets(CD-ODT)are prepared by direct compression, used Compound Danshen extract as the material medica, in which Borneol is included by β -cyclodextrin.The including technology is optimized by the orthogonal-designed method to get the optimum including conditions, used the including rate and recovery as criteria in the test. The results show that the including rate and recovery of inclusion complex are high under the optimum including conditions.To get the formula prescription, at first the single factor experiment is used to select the type and proportion of disintegrants and the type of lubricant, then the orthogonal-designed method is used to optimize the amount of drug and excipients, such as disintegrants, lubricant and so on, used the disintegrating time in vitro and vivo , the fluidity of power and the appearance of tablet as criteria in the test. At last the amount of glidants and spicery and hardness are get by single factor experiment. CD-ODT are prepared under the optimum formulation. The appearance of CD-ODT is grey ,uniform and lubrical. It can disintegrate in mouth only in 1 minute and taste good. The technology of direct compression is simple and feasible in factories.The quality standards are establish according to the 2000 edition of Chinese Pharmacopoeia and the speciality of orally disintegrating tablets. In the quality standards, the modified dissolution method of Japanese Pharmacopoeia is used as the methods for the determination of disintegrating time and the determination of hardness is added. The amount of the main active ingredients of CD-ODT:Salvianolic acid B, Notoginsenoside R1, Ginsenoside Rg1, Ginsenoside Rb1 are determinated by HPLC with ODS Column. The experimental conditions of salvianolic acid B: mobile phase, acetonitrile-water(containing 0.5% formic acid)(23:77); flow rate, 1mL/min; temperature 25°C; detection wavelength, 281nm. The experimental conditions of Notoginsenoside R1 and Ginsenoside Rg1: mobile phase, acetonitrile-water(containing 0.05% phosphoric acid)(20.5:79.5); flow rate, lmL/min; temperature 25°C; detection wavelength, 203nm. The experimental conditions of Ginsenoside Rb1: mobile phase, acetonitrile-water(31.5:68.5); flow rate, lmL/min; temperature 25 °C ; detection wavelength, 203nm. The results of determination to many batches of CD-ODT show that the methods for the determination of disintegrating time and amount are simple, accurate, stable and efficient; the qulity standards can be used to effectively control to the qulity of CD-ODT.The method of observation for reserved-sample under ambient conditions is used to test the preliminary stability of CD-ODT. The result show that it is stabile according to the data of 3 months.