Studies On Preparation Technology And Quality Control Standard Of DanShenTiaoGan Gran Les

DanShenTiaoGan Granules is a kind of traditional Chinese medicine compounds which consists of12herbs. With the guidance of Traditional Chinese Medicine and Pharmacy, we are intended to finalize the does form, finding out the optimal manufacture and establishing final product quality standard.1. Preparation technology was as follows:it was prepared by the method of water extraction, the best extraction parameters were determined by the extraction yield, single factor experiments and orthogonal experiments. The prescription was boiled with water for twice. Ten times the water of its own weight was added at the first time, then eight times was added. Each decoction lasted2hours. The fried liquid was gathered, then filtered.2. In order to evaluate the forming technology of DanShenTiaoGan Granules, the effects of the temperature, the pressure, the dried method, granulation conditions, the particles’angle of repose and hygroscopicity were also investigated. The filtrate was concentrated with vacuum distillation (80℃,-0.06～-0.08MPa) until the relative density of the thick cream was1.30(60℃). The resulting concretes were dried in vacuum (75℃,0.0～60.08MPa) and crushed into fine powder. Then the powders passed through a100-mesh sieve. Appropriate amount of accessories were added and mixed, soft material was obtained. The soft material was passed through a10-mesh sieve. The granulation was dried and passed through a12-mesh sieve. The final preparations were made into granules.3.Materials such as salvia miltiorrhiza, giant knotweed, white paeony root and white atractylodes rhizome wolfberry fruit, citrus aurantium, licorice were identificated by TLC. The samples had the same colors in the same locations with the reference substance, except for the liquorice, which was affected by the negative samples. This method was simple and feasible that can be used as the quality standards.4. The amount of Tanshinone IIA and Salvianolic acid B were detected by HPLC. The chromatogram conditions of the Tanshinone IIA were as follows:the analytical column was a C18-MS-Ⅱ column (250mm×4.6mmi.d.) and the temperature was35℃. The mobile phase was the mixture of methanol and water solution (25:75; v:v) and the flow-rate was set at1.0mL·min-1.The UV detection of Tanshinone IIA was performed at270nm. The linear range of calibration curve for Tanshinone IIA was2μg～12μg. The calibration equation was y=13561616.8x+310425.8, R2=0.9992. The precision, spiked recovery, stability and repeatability about the method were studied. The amount of Tanshinone IIA were above0.02%among5batches of samples. As a results, the amount of Tanshinone IIA in DanShenTiaoGan Granules were measured to be not less than0.02%as the quality standards.The chromatogram conditions of the Salvianolic acid B were as follows:The analytical column was a C18-MS-Ⅱ column (250mm×4.6mmi.d.) and the temperature was35℃.The mobile phase was the mixture of methanol, acetonitrile, formic acid and water solution (30:10:1:59; v:v:v:v) and the flow-rate was set at1.0mL-min’.The UV detection of Salvianolic acid B was performed at286nm. The linear range of calibration curve for Salvianolic acid B was0.05μg-3μg, while the calibration equation was y=24656x+145.61, R2=0.9998. The precision, spiked recovery, stability and repeatability about the method were also studied. Among5batches of samples, the amounts of Salvianolic acid B were above0.80%. As a results, the amounts of Salvianolic acid B in DanShenTiaoGan Granules was measured to be not less than0.80%as the quality standards.5. Many inspections of DanShenTiaoGan Granules were investigated. According to the rules of China Pharmacopoeia(2005), DanShenTiaoGan Granules were detected by the limits of heavy metals Arsenic salt, microorganisms and any other items. The granules showed good abilities.In this work, we optimized the preparation technology of DanShenTiaoGan Granules. Not only the preparation process of DanShenTiaoGan Granules is feasible and reasonable, but also the quality standard is advanced and reliable. The preparation process determined according to the method can be used for follow-up efficacy, toxicology and clinical trials.