Promote Progesterone Tablets Preparation Process And Quality Standards

Objectives: to process fertilization-promoting tablets, to investigate labile ingredients in the preparation, to provide base for optimization of process technology and selection of packaging materials, to formulate quality standard draft, and to estimate expiration date of the patent medicine.Methods: (1)On the basis of Chinese medical theory of formulae, and contemporary pharmacological and chemical pharmacy achievements, active ingredients of the prescription were identified, which in combination with rate of extracta sicca served as indices in orthogonal experiment through which water and ethanol extraction technology were selected respectively.(2)Condensation and drying technology were established by investigating content variation of such labile ingredients as Icariin and Salvianolic Acid B through manufacturing process and fitting a degradation kinetic equation for Salvianolic Acid B.(3) Tablet process technology was optimized followed by semi-works production. Evaluate the quality under the provisions of Tablet as stipulated in the Chinese Pharmacopoeia. In addition, qualitative methods were established for major herbs; quantitative assay of Icariin, Peoniflorin and Salvianolic Acid B were founded on methodology investigation.(4) Packaging materials for the tablets were selected by accelerated stability test using content of Salvianolic Acid B as the index. Expiration date for the patent medicine was estimated by comparing results of the method of classic constant temperature, method of t0.9, method of temperature coefficient and method of temperature index.Results: Optimum ethanol extraction technology is to twice reflux with 10-fold 80% (v/v) ethanol, 1.5h for each. Optimum water extraction technology is to reflux with 6-fold water for three times, 1h for each. Decoctions are mixed, condensed under low atmospheric pressure, and spray dried. The powdered extract were mixed with pulverized crude drug powder and quantum satis adjuvants, moistened with 80% (v/v) ethanol, wet granulated, pressed, film coated, packaged with alu-plastic compound membrane by turns to obtain patent medicine. Quality standard draft is composed on the basis of qualitative identification and quantitative assay. Expiration date is estimated to be 2 years.Conclusion: Evaluation of Semi-works products and results from accelerated stability test showed process technology for the fertilization-promoting tablets is stable and capable of restraining the content variation of labile ingredients within reasonable area. Quality evaluation showed each item was up to the scratch as stipulated under the provisions of Tablet in the Chinese Pharmacopoeia. In addition, packaging materials of choice ensured comparatively long term of validity.