| Qilan Tangzhining capsule is a Chinese patent medicine designed by Prof. Gao Xuemin based on his experiences and the scientific statement that DM is often accompanied with hyperlipoidemia. This study is conducted in a systematic and comprehensive way on the laboratory effects of Qilan Tangzhining capsule on DM with hyperlipoidemia from the following aspects: literature review,theoretical analysis and laboratory experiments. This study is aimed to develop a new Chinese patent medicine and provide a good foundation for the future development of safe and effective Chinese patent medicine for DM with hyperlipoidemia. 1.Literature Review: We have reviewed DM-related literature in the past 10 years home and abroad, having a good hand of the present study of DM, hyperlipoidemia in Traditional Chinese Medicine (TCM) and western medicine. 2.Theoretical Analysis: Under the guide of TCM fundamental theories, combining the current clinical treatment of DM with hyperlipoidemia, we for the first time provide a fair systematic account of the theory 'Treating DM with hyperlipoidemia in the light of Deficiency, Phlegm, Stasis and Toxin'. We state that DM with hyperlipoidemia is mainly caused by long time accumulation of phlegm, turbid and blood stasis due to Qi-yin deficiency leading to formation of toxin. Qi-yin deficiency is the root (ben), while stagnation of phlegm, stasis and toxin is the branch (biao). So the principle is to support right and expel evil. The method is to supplement qi and nourish yin, transform phlegm and turbid, remove stasis and expel toxin. It is significant to elucidate TCM pathogenisis of DM with hyperlipoidemia and explore effective treatments as well. 3.Laboratory experiments 3.1 Fundamental Drug Efficacy Study:Experimental diabetic with hyperlipoidemia model was successfully established in rats. The effects of Qilan Tangzhining capsule on glycometabolism, lipid metabolism, and pathomorphological changes of liver and pancreas were observed among model rats. Serum biochemics tests of glycometabolism indicate that medium-dose and low-dose Qilan Tangzhining groups significantly lower down the blood-fasting sugar level of model rats. It takes longer time to take effect yet the decline shows more stability with the prolonging of medication period compared with metformin group. In addition, Qilan Tangzhining groups do better at maintaining rats' weight and active state. Serum biochemics tests of lipid metabolism show that Qilan Tangzhining groups of all doses have the significant effect of cutting down serum level of cholesterol, triglyceride, LDL-cholesterol, and increasing HDL-cholesterol, which is of no significant difference compared with control group (Zhibituo group). HE stain of pancreas and liver tissues of rats indicates that Qilan Tangzhining capsule can improve pathological impairment of pancreas and liver. Primary pharmacodynamics proves that Qilan Tangzhining capsule is well-formulated and effective in treating DM with hyperlipoidemia. 3.2 Mechanism exploration 3.2.1 Use of chromatometry in studying effect of Qilan Tangzhining capsule on GHb in experimental DM rats with hyperlipoidemia. The result shows that Qilan Tangzhining groups of high, medium and low dosage significantly decrease GHb level in model rats. There is a positive relation between GHb and Blood-fasting sugar in each group, which indicates that the higher blood-fasting sugar is, the more hemoglobin saccharify. 3.2.2 Use of radio-immunity method in studying the effects of Qilan Tangzhining capsule on serum insulin,C-peptide and glucogan in experimental DM rats with hyperlipoidemia. The result shows that Qilan Tangzhining capsule significantly decreases the level of insulin and protein C in serum, which indicates that it may take effect by improving glycometabolism rather than promoting the secretion of insulin. This mechanism needs to be further researched and proved. On the other hand, this study shows that glucagon levels in low-dose and medium-dose Qilan Tangzhining capsule groups are significantly lower than that of...
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