The New Medicine Research Of Compound Ligu Capsule On Anti-osteoporosis

Osteoporosis (OP) is a kind of metabolic disease that arouses from many factors such as heredity, immunity, endocrine, and nutrition. The incidence of osteoporosis increases with the advancing age, particularly those old postmenopausal women. It ranks seventh in the current common diseases and seriously threats the health of the elderly. The subject was based on the traditional Chinese medicine theory "The kidney is in charge of the bones", carried out research into disassembled prescriptions of new Yougui Yin (YGY) prescription, and then screened out effective parts of three medicinal materials which have obvious anti-osteoporosis effect (F3. H1, B2). Based on the pharmacodynamics results, we intended to further develop an innovative Chinese herbal compound preparation which had the character of safe, effective, and controllable quality.The new prescription of Yougui Yin (YGY) was composed of eight medicinal materials, and they were extracted and separated by systemic separating method to get the different extracted parts.The effective parts of three medicinal materials were screened out from eight medicines by in vitro experiments. The effective parts and its optimum ratio were determined through the whole animal models.In terms of preparation process, the product was decided as capsule, and filled after the wet legal system grain, by investigating the effects of sample loading, flowability, and dissolution rate, the most desirable formulation and preparation process were determined. Then, the pilot-scale study was carried out and the results showed that the preparation process was reasonably practicable.In terms of quality standards, the qualitative and quantitative determination of effective parts and product were determined by TLC and HPLC methods, and the organic solvent residues were also tested. Finally, the quality standards (Draft) of the three effective parts and the finished capsules were worked out. In terms of stability studies, the three effective parts and the finished capsules were eligible in character, identification, and content determination within for6-9months at a long-term stability test condition.In terms of pharmacodynamics evaluation, The experimental study of pharmacodynamics and dose-effect relationship had been carried out, results show that the pharmacological effects of drugs was in a dose-effect manner, there had a drug accumulation and pharmacological growth falters with the increased usage of drugs.