Brain Health Soft Capsule Pharmaceutical Research

The formula of Nao De Sheng (NDS) which is composed of Panax notoginseng (Burk.) F.H.Chen, Radix Puerariae, Carthamus tinctorius L, Crataegus pinnatifida Bge. and Ligusticum Chuanxiong Hort. comes from Chinese Pharmacopoeia 2005(part one). The major effects of this medicine include reducing stasis and improving blood circulation, mediating main and collateral channels, and regaining consciousness. It is a remedy for cerebral arteriosclerosis, stoke and sequel of cerebral hemorrhage. It has a longer use time and leads to more accurate effects. The thesis adopt modern common character key technology to research the compound Naodesheng,including the extraction and purification process, preparation formulation reform,qulity standard,stability,etc,aim at providing bases of the secondary development about the Naodesheng preparation.The method of solvent and the technology of macroporous adsorption resin purification were used to study the extraction and purification process about the main effective part of compound Naodesheng,optimize the best extraction and purification process,obtain the reliable technical parameters and proved by pilot test, these can make transition to industrialization; the total content of effective part in the extracts is over 50%,which is accord with relevant regulations of SFDA.On the basis of the study on the extraction and purification process about the main effective part of compound Naodesheng, we did research into the preparation technology about the new formulation "Naodesheng soft capsule", determined the preparation of the contents, mixture and suspension of the drugs and excipients,the preparation of the capsule materials, compatibility of contents and rubber,etc, and proved by pilot test. The qualified rate of the soft capsule is 94.3%.The modern analysis methods were carried out to study on the characters,TLC, gross deviation, disintegration and determination of the Naodesheng soft capsule systematically,set the perfect quality standard.Adopted the accelerated test to study the preliminary stability about three batches samples in pilot test of the Naodesheng soft capsule in three months. According to the detection of each index in quality standard,the results are accord with relevant regulations .It shows that this herb species has a good stability.