Study On The Preparing Process And Quality Control Of Shengmai Formula Granules

Objective To examine the necessity of Schisandra volatile oil extraction process, exploring the possibility of a simplified extracting process, and screening a optimum extraction condition; To research the preparation forming process of Shengmai extracts, and forming feasibility and related conditions were to be found out; To study and control the quality of prepared Shengmai formula particles, to provide a theoretical reference for the development of quality standards.Method According to optimum extract conditions on the literature related to the trial groups, trial extracts were made to investigated the efficacy differences by mice reflection in the anti-stress efficacy trials; Selecting dry extract yield and ginsenosides Rg1, ginsenoside Re content as the evaluation index, factors affecting the extraction route was studied by orthogonal test, then a preferably optimum extraction route for Shengmai preparations was chosen; Investigate preparation molding process conditions: conducted small scale test to study the preparation process route and relevant conditions, as well as semi-finished granules process control study on absorbent, bulk density and angle of repose. with the preferred process route, the engagement and the rationality with the actual production was studied by pilot scale test in order to improve the process; Conduct quality control study for Shengmai formula granules, to establish a appropriate HPLC analytical method for main drug assay, and proposed regulation for related inspection items.Results Anti-stress response in mice behavior efficacy trials revealed that volatile oil extracted preparation and no volatile oil extracted preparation had no obvious behavior efficacy differences in mice; the orthogonal experiment results for medicinal herbs extract route showed that the best extraction condition for Shengmai preparation was 8 times 65% ethanol reflux extraction 3 times, each time for 1.5 h. Repeated verification test of the optimal conditions showed a certain repeatability and stability; Preparation process study for Shengmai formula granule showed a satisfactory moldability, with an average bulk density of 0.3987 g·mL-1, an average tap density of 0.4343 g·mL-1, an angle repose of 35.2 °, and critical relative humidity(CRH) of 58%, pilot process was stable and feasible, which can provide support for further research; Quality control study for Shengmai Formula Granules: in the TLC identification, Shengmai Granules showed the same spots in the same position as the reference drug, with a similar chromatographic behavior, the main drug ginsenosides Rg1 and Re content was determined by HPLC method, the linear regression result showed that ginsenosides Rg1 within the range of 0.392 μg~2.352 μg, equation was y = 105 x + 4 257.7, the correlation coefficient R was 0.9 997; ginsenosides Re at 0.4 μg~2.4 μg with peak area, the linear equation was y = 69 403x-5 748.6, the correlation coefficient R was 0.9 99, the total content of two saponins was above 1.8 mg·g-1, other granules examinations iterms were within relevant regulations.Conclusion Shengmai preparation process of fructus schisandrae naphtha can be omitted according to practical and clinical needs to simplify the process steps, which can provide a reference for solving the actual manufactory problem in extraction; The selected optimal conditions in repeated verification testhad a certain repeatability, indicating that screened extracting route was stable; Granule preparation process and quality of semi-finished products inspection for the preparation provided a reference basis for the follow-up production condition selection and quality control. Pilot scale test showed stability and repeatability, Shengmai Formula Granules has certain economic effect and social benefit, can provide more preparation option for patients; The established HPLC method was stable and reliable, and can be well used for quality control, study on other related inspection items for granules can also provide theoretical reference for the quality standard development.