Study On The Preparation And Quality Standard Of Bushen Jiangu Tablets

Osteoporosis (osteoporosis, OP) is a reduction in bone mass caused by increased bone fragility, high incidence of fracture of a systemic disease. Primary osteoporosis is most prevalent, the clinical manifestation of low back, limb pain, spinal deformities and even fractures. At present, the clinical treatment of the disease is most commonly used estrogen, calcium, activated vitamin D, calcitonin and fluoride and other substances, and achieved certain efficacy, side effects, but larger and more expensive. Many scholars have increasingly turned to Chinese medicine, internal medicine in recent years, osteoporosis prevention and treatment of experimental study made great progress.This topic for the treatment of pharmacy are studied for drug development and clinical batch reporting basis. Bushen Jiangu tblets medicine is from icariin, astragalus, Poria, etc.6 Chinese medicine compound consisting of tablets, the subject first of all from the perspective of medicine discusses the kidney in treatment of bone health osteoporosis theory. Technology used in the preparation of orthogonal experimental method to determine the water extract and ethanol extract of the best technology, and preparation of molding process has been studied to establish a consistent production process of large-scale industrial production. In the study, quality standards, according to "Chinese Pharmacopoeia" in 2005 edition of a tablet under Appendix ID requirements, preparation of on-chip weight difference, Disintegration, heavy metals, arsenic, salt, and microbiological limits of detection, the results were in line with the provisions of. Pairs of Astragalus, Poria TLC tests carried out, as a method of qualitative identification. and using high performance liquid chromatography, developed a preparation in the method for determination of icariin, which requires the product to each and contains Epimedium icariin (C33H40O15) dollars, shall not be less than 0.2mg. In the stability test study, the use of samples left at room temperature (6 months) observation and accelerated test (6 months) observation, right Bushen Jiangu Tablets stability of 3 batches of samples were investigated, the results of the indicators are compliance. The research projects in the declaration of new drugs for the drug provides a complete pharmacy data.