The Preparation Technology And Quality Standard Of Shenrong Soft Capsule

Objective: According to the requirements to file for approval of new drug，studies of extraction， preparation techniques and quality standards of Shenrong softcapsule were conducted. The project may further improve the quality of the softcapsule products， therefore ensure the safety and efficacy of drug therapy.Methods: Extraction techniques of ginseng and pilose antler were orthogonallyinvestigated， and the extraction conditions were optimized. Furthermore，preparation techniques studied according to the characteristics of pharmaceuticaldosage of the soft capsule. Physicochemical and dosage form of product requirementsfor research， using thin layer chromatography to control medicine and reference as acontrol， the other in ginseng， pilose antler research conducted qualitativeidentification TLC; according medicinal characteristics， using atomic absorption，atomic fluorescence study of some elements; using high performance liquidchromatography in which the main active ingredient of ginsenoside Rg1，ginsenosideRe，ginsenoside Rb1were chromatographic determination and identification ofresearch， combined with the UV determination of total amino acid content.Meanwhile， according to the draft study formulated long-term preparation，accelerated stability study.Results: The optimized preparation procedure of herbs extraction，reasonable，effective and established a quality control method of herbs.Conclusion: Shenrong soft capsule prescription is reasonable， science andadvanced technology to extract preparation， in line with the workshop massproduction， strict quality control standards.