Study On Preparation Technology And Quality Standard

Object:Based on the main effective components and prescription principle of Xinlikang Granule, orthogonal test was used to select the best preparation process. And based on its prescription principles and the medicines’ different physical and chemical properties, a scientific and controllable quality standard was established. Meanwhile, the preliminary stability study of this granule proceeded simultaneously. In order to develop a new type of cardiac drugs with clear curative effect, little side effect, and convenient administration of patients.Methods:1. Study of preparation technologyThrough L9(34) orthogonal test, and with the comprehensive score of the contents of five components, ginsenoside Rgi, Re, Rb1, tanshinone Ⅱ A and salvianolic acid B, as the index, to optimize the ethanol extraction process of Red ginseng, Salvia miltiorrhiza, Rhodiola rosea, Ligusticum wallichii, Rhizoma corydalis. Through L9(34) orthogonal test, and with the content of epimedium glucoside as the index, to optimize the water extraction process of Herba epimedii, Semen lepidii, and Radix aconiti lateralis preparata, and to investigate the impurity removal technology. To establish the preparation of the Borneol-β-Cyclodextrin Inclusion Complexes by the literature research, and select the best inclusion conditions by verifying the inclusion rate. Verifying the best concentration, drying process and formulation process.2. Study of quality standardTLC was used for qualitative analysis of every medicinal materials and content determination of diester-alkaloids in finished product, HPLC was used for content determination of ginsenoside and epimedium glucoside in finished product. And according to Chinese Pharmacopeia to finish the examination of Characteristics, moisture, heavy metals, microbial limit, etc.Results:1. Preparation technologyWith 6 times amount of 70% ethanol, red ginseng, salvia miltiorrhiza, rhodiola rosea, ligusticum wallichii, rhizoma corydalis were reflux extracted for 3 times, and every time with 2 hours, combined with ethanol extract, recovery ethanol, dry and spare. With 12 times amount of water, herba epimedii, semen lepidii, and radix aconiti lateralis preparata were extracted for 2 times, and every time with 2 hours, combined extract, dry and spare. Borneol was dissolved by 2 times amount of anhydrous ethanol, included by 8 times amount of β-cyclodextrins and 32 times amount of water (adduction time was 1 hour). After refrigeration and suction filtration, the sediment was dried for 24 hours at 50℃, and then was crushed into fine powder. Mix the ginseng extract powder and epimedium extract powder and dextrin amount, granulation. Adding borneol inclusion compound, mixing, which was 1000g granules.2. Quality standardIdentification methods of salvia miltiorrhiza, rhodiola rosea, etc, limit test method of aconitine, and content determination methods of epimedium glucoside, salvianolic acid B were established. All the checks of pharmaceutics met the needs of general rules on preparations of Chinese Pgarmacopoeia.Conclusion:Based on the prescription principle and the medicines’ different physical and chemical properties of Xinlikang Granule, combine with characteristics of granules this topic systematically studied preparation technology, the established technology was feasible. Moreover, rationality and safety of the preparation technology were further validated by pilot-production. With the study of the pilot-production the preliminary quality standard was established, which was easy and repeatble.