Studies On New Traditional Chinese Medicine-Semen Hoveniae Tablet For Anti-altitude Hypoxia

The research subject of this thesis is the study of high altitude anoxia-resistant HoveniaDulcis Thunb tablets. Previous research has proved the activity of the water extracts fromSemen Hoveniae in resisting fatigue, anoxia, coldness and heat. The following job is mainlyabout exploring the foundation of the mice model simulating the high altitude anoxiaenvironment and investigating the protection in the high altitude anoxia environment fromseries of treatment drugs.After seeking out an optimized prescription for ethanol immersedextract on water extraction process, the quality standards for the tablets are established andstability test experiment is carried out at the same time,and meanwhile the experiments of thedrug dynamics metabolism study with beagle dogs is followed.The success of the foundation of high altitude anoxia model depends on the determinationof a numble of selected biochemistry indexes that are fluctuating along with the altitude、duriation of the altitude、hoisting rate of the altitude and the frequency of thehoisting.Differences of these biochemical indexes including GPT、GOT、BUN、LDH and CPKbetween groups are detected which indicates the protestion of the treatment drugs from the3modeling environments.The results show that the models are available for evaluation of thedrugs for high altitude anti-anoxia.Hperbaric-hypobaric chamber provides the simulated high altitude environment with anproper air exhausting system and thanks to the O2and CO2detecting and adjusting system thesimulated environment is highly similar to actual high altitude and anxia environment.Thesimulated high altitude environment helps to evaluate the high altitude reaction in staticsituation,to distinguish the previous model that simulated the motive situation, with miceswimming model.There are two problems, the composition of prescription and moisture absorption, in theprocess of study of the formulation. Through the preliminary experiment, the starch, dextrin,sucrose, medicinal calcium carbonate, polyvinylpyrrolidone, microcrystalline cellulose,sodium carboxymethyl starch and other accessories are tested, and in the end, polyethylenepyrrolidone, microcrystalline cellulose and sodium carboxymethyl starch are applied in theprescription. A three-factors-and-three-levels orthogonal experiment was applied to optimizethe formulation. Determine the water content of granula，weight variation, disintigrate andhardness value, and after Mathematical transformation,the adducts of these indexes are used as parameters utilized in synthetical scored method to find out the optimal prescription. Theprescription that gets the highest score will be regarded as the optimal prescription. The threefactors in the orthogonal experiment are A for dosage of PVP、B for dosage of MCC、C forconcentration of ethanol solution. The combination of A2B2C2gets the highest score inassessment process, so the formulation in the prescription is chosen to be the optimalprescription.Traditional Chinese medicine preparations usually prove high in water absorbability, andthe three adjuvants chosen in the prescription are hygroscopic. To maintain the stability of thetablets in the process of storage, so a coating protection is needed. The preliminary tablets arebrown cylinder-shaped pill, and after the coating process are yellow membrane-coated tablet,using the ethanol solution opadry coating liquid, curcumin as colorant.As the result of the Synthetical Scored Method, the optimal prescription is as follows,extract powder150mg, PVP3.0%, MCC20%wetting agent being70%Ethanol solution,drying for120min at50℃, substrate tablets are coated with12%Opadry-ethanol solution ascoating solution and3%curcumin as coloring agent. The tablets are coated with yellowmembranes and total weight of the tablets is320mg.Quality standard basically includes both qualitative identification and quantitativedetermination, and in accordance with the "Chinese Pharmacopoeia"(2010Edition), essentialchecks such as friability and tablet weight variation, and the disintegration should beproceeded. Stability test including influencing factors test、accelerated stability test、long-termstability test is executed and the results show that requirement from the quality standards arefulfilled with all the quality indexes qualified.Dihydromyricetin, Dihydroquercetin, Myricetin and Quercetin, the four kinds offlavones of high content, are separated with TLC method. HPLC method proves both accurateand effective, and hardness value, breakage complies with Chinese Pharmacopoeia (2010version).The standard specification is practicable.