Systematic Study Of A-Wei Capsule, Chinese Medicine Prescription, On The Basis Of Modern Theory And Technology

Objective: Investigate the rule of distribution of the Chinese medicine syndromes of hyperlipidemia and the biochemistry pathogenesis of defferent Chinese medicine syndromes of hyperlipidemia, research and develop modern Chinese medicine--A-Wei capsule which has the distinctive function, also exploring the its lipid-adjusting mechanism on the Basis of modern theory and technology. Methods: Clinical epidemiology research on syndrome distribution was carried on in 171 patients with hyperlipidemia. The rules of syndrome distribution and development in different age, course of illness of the patients were investigated by Factor analysis, TCM theory and expert's experiences. The pharmaceutical pre-clinical studies of A-Wei capsule was accomplished including literature study, manufacture research, quality control standard study, pharmacological study and toxicology experiment, according to the criteria for notification of Chinese herbal medicine. The pharmacological mechanism of A-Wei capsuled was clarified on hyperlipidemia rat model. Results: 1) The syndrome of hyperlipidemia in Xinjiang were classified spleen-kidney and Jing deficiency syndrome, Qi and blood deficiency syndrome, lung-defense dryness syndrome, liver–kidney yin deficiency and blood stasis syndrome, phlegm-dampness obstructing lung syndrome and dampness-heat accumulation syndrome. The main syndrome of hyperlipidemia was Qi and blood deficiency syndrome (60 patients 35.09%), lung-defense dryness syndrome was 51 patients (29.82%), spleen-kidney and Jing deficiency syndrome is 23 patients (13.45%). Based on comparison among different TCM syndrome types of hyperlipidemia, it was found that the patient's condition was the gravest with spleen-kidney and Jing deficiency syndrome, secondly, was liver–kidney yin deficiency and blood stasis syndrome. There was statistical difference in the age of each of syndrome types in patients with hyperlipidemia (P<0.05, P<0.01). The correlation analysis indicated that age has a positive correlation with Qi and blood deficiency syndrome (r=0.27, P<0.01), also found that age has a negative correlation with HDL-C (r=-0.21, P<0.01) and weight (r=-0.16, P<0.01). The lung-defense dryness syndrome has a negative correlation with with HDL-C (r=-0.21, P<0.01). We found that the age has positive correlation with spleen-kidney and Jing deficiency syndrome (r=0.57, P<0.01), with weight are negative correlation (r=-0.34, P<0.05). The phlegm-dampness obstructing lung syndrome has positive correlation with age (r=0.22, P<0.01). Among of the 171 hyperlipidemia patients, 116 (67.84%) patients was turned up at least one symptoms of blood stasis syndrome and 130 (76.02%) patients turned up at least one symptoms of phlegm and wet. The main diseases accompanied with hyperlipidemia was hypertension, 90 (52.63%). Secondly, is coronary heart disease 42 (24.56%). A Study on Risk Factors of hyperlipidemia found that main risk factor was non-sports lifestyle 107 (62.57%), secondly is cooking fat dietary habits 83 (48.54%). 2) The main biochemistry changes was TG level elevated in serum of hyperlipidemia 97 patients (56.73%), secondly was the TC and TG level increasing 48 patients (28.07%). 3) We accomplished the on pre-clinical A-Wei Capsule study according to the criteria for notification of Chinese herbal medicine:①TCM theory of A-Wei Capsule was verificated .②The function of A-Wei Capsule was invigorating spleen and resolving dampness, removing blood stasis and descending turbid.③Study preparation procedure of A-Wei capsule by water extraction, ethanol extraction. Through the pilot experiment ,we determined that the preparation process of A-Wei capsule was scientific and reasonable, also established quality control system of A-Wei Capsule by Thin Layer Chromatography (TLC) analysis on Rhizoma Bistortae, Cortex Magnoliae Officinalis and Rhizoma Imperatae, and the contents of Gallic Acid were determined by High Performance Liquid Chromatograph (HPLC). We investigated the stability of A-Wei capsule. Escherichia coli and Coliform can be tested by standard methods. Validation method was used for microbial limits of A-Wei Capsule.④Pharmacological Study:the result showed that A-Wei Capsule can decrease the levels of TC, TG, LDL-C level in serum and increase the ratio of HDL-C/TC in hyperlipoidemia animal, (P<0.05, P<0.01). Compared to the model group, A-Wei Capsule could reduce high, middle, low blood viscosity and Hematocrit (HCT) level in hyperlipoidemia rat (P<0.05, P<0.01). A-Wei Capsule could decrease contract ratio of the diameter of artery and vein and decrease reduce ratio of micrangium crossing net (P<0.05, P<0.01). 4) Study the pharmacological mechanism of A-Wei capsuled:results showed that compared to the model group, A-Wei Capsule could increase LPL and HL activity in serum,Apo-A4 genetic transcription and inhibit HMG-CoA activity in rat,(P<0.05, P<0.01). Conclusions: 1) The hyperlipidemia patients in Xinjiang Uighur Autonomus Region has its own characteristics--common syndrome type was Qi and blood deficiency. The patient's condition was the gravest with spleen-kidney and Jing deficiency syndrome. We can conclude, Phlegm and stasis was a pathogenic factors, also a new pathological factors. 2) The research result showed that the biochemistry foundation of hyperlipidemia is TG elevated. The result was coincide with the survey about Chinese nutrition and health in 2002. Chinese hyperlipidemia patients was mostly with high TG in serum, but there was high TC level in western country patients. 3) Hypertension and coronary heart disease are mainly accompanying disease in hyperlipidemia patients, and these diseases were mainly caused by resting life-style and high-fat diet style. 4) The animal experiment results showed that A-Wei Capsule has preventing and theraputical effect on high blood lipid in rats and rabbits, can reduce obviously the TG, can increase the ratio of HDL-C/TC. Meanwhile A-Wei Capsule can improved auricle microcirculation and hemorheology of the blood-stasis model rats, but A-Wei Capsule didn't influence hemorheology indexes of normal animal. 5) The main mechanism of A-Wei Capsule is increase LPL, HL activity, accelerating dismiss TG and TC, inhibite HMG-CoA reductase activity, and improve or stable Apo-A4 genetic transcription. 6) Now, we developed A-Wei Capsule VI class of new Chinese drugs according to the State Act for Drug Registration. We had already got clinical trail approval of A-Wei Capsule by Xinjiang Food and Drug Administration.