| 1BackgroundWhen women come into menopause, the function of ovary gradually declined, in response the number of follicle and the secretion of estradiol(E2) cut back, the negative feedback to the Hypothalamic-Pituitary axis weakened, making Hypothalamic’s function to secrete Gonadotropin and release hormone hyperthyroidism, pituitary secreting follicle stimulating hormone (FSH) and luteinizing hormone (LH) increased, thus cause series of changes in psychological and physiological and so on, even affect the normal life. Currently, it’s more likely to use the estrogen replacement therapy (ERT) to treat menopausal syndrome in and abroad, pure estrogen therapy can relieve the symptoms of perimenopause, but since it doesn’t have progesterone antagonist, it can cause endometrial hyperplasia if used for a long time, even lead to endometrial cancer. There are studies show that, exogenous E2can act directly on the castrated animals reproductive system, increase in uterine weight significantly, but it can not improve its endocrine and immune function. That prompts though exogenous estrogen replacement therapy can improve the clinical symptoms of menopausal patients, it can not regulate their endocrine disorders fundamentally. However, using Chinese medicine to treat women’s menopausal syndrome is started from the etiology and pathogenesis of this disease, recuperated both yin and yang, took both exterior and interior into account, consistented both the symptoms and root cause, treated after discriminating patterns, recuperated the whole and is effective in reducing adverse drug reactions and potentially dangerous. With the rapidly development of the traditional Chinese medicine and pharmacy career and yearly increasing of patient groups, the advantages of using traditional Chinese medicine to treat this disease attracts more and more people’s attention, however, Chinese medicine treatment of menopausal syndrome that has been listed now can not meet the needs of the market, therefore, the development of Chinese patent medicines that is efficient, non-toxic (or low toxicity) and has broad market prospects for the treatment of menopausal syndrome is very necessary.Kun geng xin capsule’s prescription is a well-made effective experienced formula which is based on Song Dynasty’s gynecological master Suan Chen’s Bushen Decoction of Radix Rehmanniae,which is for treating the weakness of the kidney, body fluid exhausted and the menstrual blocked up, and is combined with modern technology in accordance with long-term clinical practice.This research is on the basis of a large number of relevant literature,accrding to the active ingredients and physical and chemical properties each herbal medicine contained, divided the11medicine contained in this prescription into three parts, ethanol refluxed abstract, extracting volatile oil and boiling water, alcohol precipitation, and through a number of orthogonal tests, preferred the optimum conditions for each part of the drug extraction process, carried out three batches of test sample preparation process validation test and strict quality control,on the basis of fully kepted each drugs’ effective composition, developed this pure Chinese medicine formulation.2PurposeIn this study, natural aging "menopause" rat as research object, the purpose is through observing effectively Kankunxin Capsule’s influence on the level、frequency of locomotor activity、plantar sweat glands、ink propulsion rate in small intestine of rat models’ serum E2、FSH、LH、LPO、SOD、MDA、5-HT、NE etc., using the method of "test the syndromes by prescription" to study drug’s regulatory role to menopausal syndrome patients’nervous, reproductive, endocrine and other systems, to explore its pharmacological effect and mechanism of treating FCS, Provide prophase work foundation for the next step into clinical trials.3Research Methods3.1Grouping and processingDivide the50natural aging "Menopause" rats randomized into menopause control group、Gengnianan group and Kungengxin group which including high、 medium and low dose group each contains10rats, set another10young rats into the control group for youth (Rats number of independent activities, the sweat gland secretion of rats and rats length of small intestine propulsion experiment without the youth in the control group)Force-feed Gengnianan capsule group Gengnianan capsules0.729g/kg; the three dose groups of Kungengxin capsule are administered separately Kun geng xin capsules as0.648g/kg,1.296g/kg,1.944g/kg.Young control group、menopause control group are given an equal volume of saline. Feed by gavage once daily, after15consecutive days, observe the indicators.3.2Determination of observed indices(1) Detection of level of vaginal epithelial cell Cornification.(2) Determination of serum E2,FSH,LH.(3) Determination of the uterus,adrenal gland index.(4) Determination of brain tissue5-HT,NE.(5) Determination of serum LPO,SOD,MDA.(6)Determination of the independent activity times.(7)Determination of foots weat points.(8) Determination of advance the length of ink in the small intestine.4. Result4.1Kungengxin capsule’s influence to the "menopause" rats’weight By drug treatment15days later on, weight of Kun geng xin capsule group and geng nian an capsule group was significantly lower than menopausal rat group(P<0.05), and compared with before treatment,it was significantly lower (P<0.05)。 4.2Kungengxin capsule’s influence to the "menopause" rats’drinking water Bydrug treatment15days later on, drinking water of Kun geng xin capsule group and geng nian an capsule group was significantly lower than menopausal rat group (P<0.05), and compared with before treatment,it was significantly lower (P<0.05)o4.3Kungengxin capsule’s influence to the "menopause" rats’rectal temperatureBy drug treatment15days later on, rectal temperature of Kun geng xin capsule group and geng nian an capsule group was significantly lower than menopausal rat group(P<0.05), and compared with before treatment,it was significantly lower (P<0.05)。4.4Kungengxin capsule’s influence to the "menopause" rats’level of vaginal epithelial cells keratinBy drug treatment15days later on, level of vaginal epithelial cells keratin of each Kun geng xin capsule group and geng nian an capsule group was significantly rises than menopausal rat group(P<0.05), and compared with young control group,it was significantly lower (P<0.05)。4.5Kungengxin capsule’s influence to the "menopause" rats’level of serum sex hormoneBy drug treatment15days later on,level of E2of Kun geng xin capsule high dose group and geng nian an capsule group was significantly rises than menopausal rat group(P<0.05);level of FSH of Kun geng xin capsule high dose group was significantly lower than menopausal rat group(P<0.05);level of LH of Kun geng xin capsule three dose group was significantly lower than menopausal rat group(P<0.05)。4.6Kungengxin capsule’s influence to the "menopause" rats’uterine and adrenal indexBy drug treatment15days later on,uterine and adrenal index of Kun geng xin capsule three dose group and geng nian an capsule group was significantly rises than menopausal rat group (P<0.01, P<0.05)。4.7Kungengxin capsule’s influence to the "menopause" rats’5-HT and NEBy drug treatment15days later on, NE of Kun geng xin capsule three dose group and geng nian an capsule group was significantly rises than menopausal rat group (P <0.01);5-HT and5-HT/NE of Kun geng xin capsule high dose group and geng nian an capsule group was significantly lower than menopausal rat group(P<0.05).4.8Kungengxin capsule’s influence to the "menopause" rats’ACTHBy drug treatment15days later on,ACTH of Kun geng xin capsule three dose group and geng nian an capsule group was significantly lower than menopausal rat group (P<0.01)。4.9Kungengxin capsule’s influence to the "menopause" rats’ LPO,SOD and MDABy drug treatment15days later on, activity of SOD of Kun geng xin capsule three dose group and geng nian an capsule group was significantly riser than menopausal rat group (P<0.01) and level of LPO、MDA was significantly lower (P<0.05,P <0.01).4.10Kungengxin capsule’s influence to the "menopause" rats’independent activity timesBy drug treatment15days later on, independent activity times of Kun geng xin capsule medium and high dose group was significantly riser than menopausal rat group (P<0.05).4.11Kungengxin capsule’s influence to the "menopause" rats’ sweat gland secretionBy drug treatment15days later on, khan points of Kun geng xin capsule medium and high dose group was significantly lower than menopausal rat group (P<0.05)4.12Kungengxin capsule’s influence to the "menopause" rats’ small intestinal propulsion ratesBy drug treatment15days later on, small intestinal propulsion rates of Kun geng xin capsule three dose group was significantly lower than menopausal rat group (P<0.05).5ConclusionKungengxin capsules may have the following effect:(1) reduce the body weight of the "menopause" rats.(2) reduce water quantity of "menopause" rats.(3) reduce body temperature of the "menopause" rats.(4) promote keratosis of vaginal epithelial cells of the "menopause" rats.(5) to improve the secretion of hormones of the "menopause" rats.(6) increase index of the uterus and adrenal of the "menopause" rats.(7) higher NE content of brain tissue of the "menopause" rats, reduce content of5-HT.(8) reduce content of ACTH.(9) enhance activity of SOD of the "menopause" rats.(10) reduce Independent activity times of the "menopause" rats, have a calming except vexed.(11) reduce the secretion of sweat glands of the "menopause" rats.(12) promote the intestinal movement of the "menopause" rats, Have a run chang purge function. |
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