| Diabetes have become a major hazard to human health disease,professor Xie Chunguang to improve the symptoms of diabetes and its vascular complications prevention perspective, under the guidance of TCM theory, after 20 years of clinical practice, summed up the prescription for treatment of diabetes mellitus——Shenqi Fufang, which is a compound preparation of traditional Chinese medicine consisting by panax ginseng, astragalus membranaceus, radix rehmanniae, trichosanthin, Chinese yam, salvia, processed radixet Rhizoma rhei. It has the efficacy of diabetes and its vascular complications of diabetes. Under the guidance of traditional Chinese medicine theories, using the modern pharmaceutical technology to study on the preparation process,the quality standard and stability of Shenqi Fufang Granular, to ensure clinical application safely and effectively.1.Preparation technology researchAccording to the physicochemical properties of drugs and prescription in the pre test results,the alcohol extraction of panax ginseng was established with Rg1, Re, Rb1 content and dry paste yield comprehensive score by orthogonality test, and the optimal technological parameters were:with 70% ethanol,the solid/liquid ratio (m/V) 1:8, extracted two times with 1 hour each time;The water extraction of astragalus membranaceus and other herbs were established with astragaloside IV, total polysaccharide content and dry extract yield comprehensive score by single factor and response surface experimental design method, and the optimal technological parameters were:8 times the amount of water extracted 3 times,1 hour each time. The concentration of aqueous extract was studied by using the content of astragalus IV as the index, and the water extract was concentrated directly. The purification process was established with astragaloside IV, total polysaccharide content and dry extract yield comprehensive score by filtration, centrifugation and ethanol precipitation, the water extract was concentrated to a crude drug:liquid (1:2) centrifuged,and the centrifugate was concentrated to a relative density of 1.20～1.30(60℃).Adding ginseng extract and proper amount of dextrin,vacuum drying temperature50 70℃,the vacuum degree:0.06～0.1 MPa), Crushing, fine powder, and mix to 85% ethanol by the particles,60℃ dried, whole, packaging,ie.2. Study on the quality standardSet up the feasible TLC methods for the identification of panax ginseng, astragalus membranaceus, Chinese yam, salvia, processed radixet Rhizoma rhei. Establish an HPLC-ELSD method for determining four kinds of saponins in Shenqi Fufang Granular. According to the test results of sample determination, make the content limit, to develop the product per bag containing total ginsenoside Rg1 and ginsenoside Re shall not be less than3.91mg, ginsenoside Rbi shall not be less than 1.31 mg, astragaloside IV shall not be less than0.51 mg.3. Stability studyThe quality was stable according to the results of 6 months stability test. Studies have shown that the preparation process is reasonable and feasible, quality standard is controllable. |
