The Bugan Qiangshen Cream Pharmaceutical Research

Buganqiangshen Gao is a modern compound preparation of traditional Chinese medicine which was prepared on the basis of traditional empirical prescription. Because of its actions in tonifying liver and kidney, strengthening the bones and muscles and anti-aging, it is mostly used to treat some frequent disease such as dizziness, tinnitus, sore waist and numb limbs, white hair, etc. The clinical observations showed good results of Buganqianghsen Gao in treating of above symptoms. In order to make the drug have the characteristics of high performance and immediate effect, reliability and safety, controllable quality, convenient usage, we carried out the pharmoceutical research on the preparation according to the requirements of Drug Registration Administration of SFDA under the traditional theory.Through the systematic analysis of chemical compositions contained in each ingredient in the prescription and combining the findings of modern pharmacology, we researched the extraction technology by orthogonal design, compared the membrane separation with traditional purification, investigated the concentration technology parameter, studied the forming technology by applying traditional processing method and superfine comminution technology, and finally we obtained the feasible producing technology conditions, and formulated comparative detailed technology flowsheet with stong maneuverability.It has been found the preparation has good effects by preliminary pharmacology.At the same time, quality standard has been researched systematically, and the methods of identification and determination has been founded, which can control the overall quality of the preparation. In addition, we carried out room temperature stability test and accelerated stability test. The finding indicated that production quality had little change and each index remained stable in present during the test.Through the profound analysis of chemical composition and correlative pharmacologic action of each ingredients in the prescription, we researched the preparation process systematically, screened out the preparation technology conditions, formulated quality standard items, determined the preparation's expiration date, accomplished the preparation's pharmaceutical research, and created a new Chinese medicine preparation, which not offers helpful suggestion for the application of traditional processing craft and new technology in traditional Chinese medicine preparation, and pours new vigour to the old dosage form.