CN101606999B - Traditional Chinese medicine preparation for treating type diabetes B lower limb atherosclerosis - Google Patents
Traditional Chinese medicine preparation for treating type diabetes B lower limb atherosclerosis Download PDFInfo
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Abstract
本发明公开了一种治疗2型糖尿病下肢动脉粥样硬化的中药制剂，是由以下重量份的组分制成的：肉桂10～15份，黄芪40～60份，桂枝10～20份，仙灵脾30～50份，鬼箭羽30～50份，三七5～10份，红花10～20份，川芎6～10份，黄连10～15份，川牛膝10～20份。实验研究研究结果表明本发明的中药制剂具有改善动脉内膜增生，减少斑块厚度及稳定斑块的作用，其机制可能是通过抗炎症反应及降低MMP-9的表达来实现的。本发明在延缓糖尿病下血管病变的进展、预防急性大血管事件及治疗糖尿病早期LEAD病变、改善糖尿病大血管病变预后提供了新的治疗思路。The invention discloses a traditional Chinese medicine preparation for treating type 2 diabetic lower extremity atherosclerosis. 30-50 parts of fairy spleen, 30-50 parts of ghost arrow feather, 5-10 parts of panax notoginseng, 10-20 parts of safflower, 6-10 parts of Chuanxiong, 10-15 parts of coptis, and 10-20 parts of Sichuan achyranthes bidentata. Experimental research results show that the traditional Chinese medicine preparation of the present invention has the effect of improving arterial intima hyperplasia, reducing plaque thickness and stabilizing plaque, and its mechanism may be realized by anti-inflammatory response and reducing the expression of MMP-9. The present invention provides new treatment ideas for delaying the progression of diabetic vascular lesions, preventing acute macrovascular events, treating early-stage LEAD lesions in diabetes, and improving the prognosis of diabetic macrovascular lesions.
Description
Technical field
The present invention relates to a kind of atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity that is used for the treatment of, belong to biomedicine field.
Background technology
Type 2 diabetes mellitus is a kind of with insulin resistant (insulin resistance, IR) be main, companion's insulin secretion relative deficiency and what cause is chronic, the systemic disease of feature with the hyperglycemia, prevalence rises year by year in China, the incidence rate of its chronic complicating diseases also is continuous rising, and wherein macroangiopathic becomes common complication.More than 40 years old, the course of disease surpasses among the patient in 5 years, and 90% suffers from peripheral angiopathy, and wherein 43% merges serious vascular lesion.Macroangiopathy is that diabetes disable, the key factor of fatality rate, and the treatment research of carrying out Chinese medicine is necessary.Type 2 diabetes mellitus and the main pathological change of giving the branch vessel pathological changes are atherosclerosis (AS), therefore seek a kind of atherosclerosis to be had the medicine of therapeutical effect, and be one of effective measures of treatment type 2 diabetes mellitus.
Summary of the invention
At above-mentioned prior art, the invention provides a kind of atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity that is used for the treatment of.
The present invention is achieved by the following technical solutions:
A kind of atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity for the treatment of, be to make: 10～15 parts of Cortex Cinnamomis by the component of following weight portion, 40～60 parts of the Radixs Astragali, 10～20 parts of Ramulus Cinnamomi, 30～50 parts of Herba Epimedii, 30～50 parts of Ramulus Euonymis, 5～10 parts of Radix Notoginseng, 10～20 parts on Flos Carthami, 6～10 parts of Rhizoma Chuanxiongs, 10～15 parts of Rhizoma Coptidis, 10～20 parts of Radix Cyathulaes.
Preferred following component: Cortex Cinnamomi 15g, Radix Astragali 60g, Ramulus Cinnamomi 20g, Herba Epimedii 50g, Ramulus Euonymi 50g, Radix Notoginseng 8g, Flos Carthami 20g, Rhizoma Chuanxiong 10g, Rhizoma Coptidis 15g, Radix Cyathulae 20g.
The preparation method of Chinese medicine preparation of the present invention may further comprise the steps:
1) each component being pulverized mixing, is that 50～75% ethanol extracted 1～3 hour down at 60～80 ℃ with volumetric concentration;
2) centrifuging and taking supernatant, 60～70 ℃ are reclaimed ethanol, get medicinal liquid;
3) in medicinal liquid, add suitable quantity of water, make mixture; Or 4) in medicinal liquid, add appropriate amount of starch or dextrin, heating concentrate or spray drying after add an amount of starch and granulate, make granule or capsule.
When taking, every day twice, each dose is: mixture 50ml, granule 10g, 2～3 of capsules.
Chinese medicine thinks that vasculopathy of the lower extremity in diabetes becomes and belongs to the deficiency in origin and excess in superficiality card, and its pathology key is a little less than the yang deficiency gas, and treatment answers that warming YANG and invigorating QI is invigorated blood circulation, the regulating qi to disperse stagnation collateral dredging is method.Chinese medicine preparation of the present invention is monarch's benefit kidney-replenishing with the Cortex Cinnamomi, YANG invigorating QI invigorating, Zhi Qiben; Herba Epimedii and Ramulus Cinnamomi are auxilliary Yiyang warming the meridian and promoting blood circulation; The sweet temperature QI invigorating of the assistant Radix Astragali, Radix Notoginseng, Flos Carthami, Ramulus Euonymi, the circulation of qi promoting of Rhizoma Chuanxiong warming the meridian, promoting blood circulation to remove obstruction in the collateral; The property of all warm-dryness syndrome of assistant Rhizoma Coptidis system; With the Radix Cyathulae is guiding drug, and the merit of the descending our blood circulation promoting and blood stasis dispelling that can gain again of priming.Make a general survey of full side, have that warming YANG and invigorating QI is invigorated blood circulation, the merit of regulating qi to disperse stagnation collateral dredging.Modern clinical and pharmacological research confirms that the Radix Astragali, Radix Notoginseng etc. can reduce the expression of type 2 diabetes mellitus macroangiopathy patient MMP-9.
The present inventor has done a large amount of experimentatioies, result of study shows that Chinese medicine preparation of the present invention has its intimal hyperplasia of improvement, reduce the effect of plaque thickness and stabilize plaque, its mechanism may be to realize by anti-inflammatory response and the expression that reduces MMP-9.
The present invention is in the progress that delays vascular lesion under the diabetes, prophylaxis of acute trunk incident and treat the early stage LEAD pathological changes of diabetes, improve the diabetictrunk angiopathy prognosis provides new treatment thinking.
The specific embodiment
The present invention is further illustrated below in conjunction with embodiment and clinical data:
Embodiment 1: preparation is used for the treatment of the atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity
Needed raw material is as follows: Cortex Cinnamomi 15g, Radix Astragali 60g, Ramulus Cinnamomi 20g, Herba Epimedii 50g, Ramulus Euonymi 50g, Radix Notoginseng 8g, Flos Carthami 20g, Rhizoma Chuanxiong 10g, Rhizoma Coptidis 15g, Radix Cyathulae 20g.
Preparation technology is:
1) each component being pulverized mixing, is that 50% ethanol extracted 3 hours down at 70 ℃ with volumetric concentration;
2) centrifuging and taking supernatant, 70 ℃ are reclaimed ethanol, get medicinal liquid;
3) in medicinal liquid, add suitable quantity of water, make mixture.
Embodiment 2: preparation is used for the treatment of the atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity
Needed raw material is as follows: Cortex Cinnamomi 10g, Radix Astragali 40g, Ramulus Cinnamomi 10g, Herba Epimedii 30g, Ramulus Euonymi 30g, Radix Notoginseng 5g, Flos Carthami 10g, Rhizoma Chuanxiong 6g, Rhizoma Coptidis 10g, Radix Cyathulae 10g.
Preparation technology is:
1) each component being pulverized mixing, is that 75% ethanol extracted 1 hour down at 60 ℃ with volumetric concentration;
2) centrifuging and taking supernatant, 60 ℃ are reclaimed ethanol, get medicinal liquid;
3) add appropriate amount of starch or dextrin in medicinal liquid, heating concentrates back adding starch and granulates, and makes granule.
Embodiment 3: preparation is used for the treatment of the atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity
Needed raw material is as follows: Cortex Cinnamomi 13g, Radix Astragali 50g, Ramulus Cinnamomi 15g, Herba Epimedii 40g, Ramulus Euonymi 40g, Radix Notoginseng 10g, Flos Carthami 15g, Rhizoma Chuanxiong 8g, Rhizoma Coptidis 13g, Radix Cyathulae 15g.
Preparation technology is:
1) each component being pulverized mixing, is that 60% ethanol extracted 2 hours down at 80 ℃ with volumetric concentration;
2) centrifuging and taking supernatant, 70 ℃ are reclaimed ethanol, get medicinal liquid;
3) in medicinal liquid, add appropriate amount of starch or dextrin, add starch after the spray drying and granulate, incapsulate, make capsule.
Embodiment 4: preparation is used for the treatment of the atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity
Needed raw material is as follows: Cortex Cinnamomi 12g, Radix Astragali 45g, Ramulus Cinnamomi 18g, Herba Epimedii 45g, Ramulus Euonymi 35g, Radix Notoginseng 7g, Flos Carthami 18g, Rhizoma Chuanxiong 7g, Rhizoma Coptidis 12g, Radix Cyathulae 17g.
Preparation method is with embodiment 1.
Clinical data:
One, data and method
1, diagnostic criteria:
(1) the diabetes diagnosis standard of diagnosis of diabetes standard reference 1999WH0 announcement;
(2) diagnostic criteria of lower limb vascular pathological changes diagnosis standard reference Fontaine artery of lower extremity vascular lesion.
2, include standard in:
(1) 45～70 years old age;
(2) be diagnosed as T2DM patient;
(3) the blood vessel color doppler ultrasonography confirms that dorsal artery of foot, anterior tibial artery and posterior tibial artery have the above arteriosclerosis plaque projection in a place, calcified plaque, tube chamber irregular narrow.
3, exclusion standard:
(1) age is less than 45 years old or greater than 70 years old;
(2) hemorrhage and bleeding tendency are arranged;
(3) the serious heart, brain, liver, kidney, hemorrhage and merging malignant tumor and psychosis are arranged;
(4) in nearly 3 months ketoacidosis took place;
(5) skin diabrosis even gangrene appear in lower limb;
(6) patient of artery of lower extremity obturation or Fontaine IV phase patient.
4, physical data: 45 routine patients participate in test, adopt table of random number to be divided into two groups, and 26 examples are organized in treatment, male 14 examples, women 12 examples; Year mean age (58.24 ± 28.46); Individual month of the course of disease (62.41 ± 6.13); Carry out by stages I phases 14 example, II phases 10 example, III phases 2 example by the conditions of patients severity by the Fontaine standard; Matched group 24 examples, male 13 examples, women 11 examples, year mean age (57.16 ± 9.23); Individual month of the course of disease (61.63 ± 27.31); By stages: I phases 15 example, II phases 8 example, III phase 1 example.Two groups of patient's sexes, age, the course of disease, wait to learn by statistics and handle the difference not statistically significant by stages.
5, Therapeutic Method: the treatment group gives the Chinese medicine preparation of preparation among the embodiment 1, and every side makes 400ml, and every bag of 100ml, divides morning, late twice oral meal, 12 week of logotype at 2 bags of every days; Matched group gives cilostazol (the trade name training reaches, by the big tomb pharmacy development of Japan big tomb Co., Ltd.), every 50mg, and each 50mg, took for 12 week at every day twice.Inactive other antiplatelets and anticoagulant during the treatment.
6, observation index and method: two groups of patients all promptly do the artery of lower extremity color doppler ultrasonography before treatment and after the treatment, media thickness (MT) in record biped back of the body tremulous pulse, anterior tibial artery, the posterior tibial artery, plaque thickness (adopts the Course method to measure each speckle maximum ga(u)ge, calculating mean value etc., the artery of lower extremity B ultrasonic adopts the Acuson SEQUO IA512 of company computer colorful Doppler ultrasound diagnostic apparatus, 15L 8W high frequency probe, frequency range 8～13MHz is by the skilled technician special messenger's operation of professional technique.And blood sampling checks that 1/2 patient have a blood test matrix metalloproteinase-9 (MMP-9), interleukin (L-6) are clearly all arranged after blood fat (TC, TG, HDL-C, LDL-C), the two groups of treatments.Sandwich enzyme-linked immunosorbent assay method is adopted in the detection of MMP-9, L-6, and the MMP-9 test kit is available from U.S. R﹠amp; DSystems company, L-6 reagent is available from French Diaclone company, the strict by specification operation of operating procedure.
7, statistical method: all interpretation of result is finished with the SPSS statistical software, and the result represents with .x ± s, relatively adopts the t check between the measurement data group, and own control adopts paired t-test.There is statistical significance P＜0.05 for difference.
Two, result
1, ordinary circumstance: matched group 1 example that comes off, be nonlocal patient, treat 8 Zhou Houwei further diagnosis and treatment again, lose and visit.The treatment group is rejected 1 routine patient, and this patient does not take medicine in accordance with regulations, and takes other drug without authorization.
2, the comparison of two groups of treatment front and back plaque thickness: as shown in table 1, treatment group and matched group are relatively treated preceding plaque thickness no significant difference, treatment back plaque thickness obvious difference, and the treatment group is starkly lower than matched group; Two groups of treatment back plaque thickness reduce treatment group (P＜0.01), matched group (P＜0.05) before the treatment.
Plaque thickness comparison before and after the table 1 liang group treatment (mm, x ± s)
Annotate:
*P＜0.05
*P＜0.01
3, the comparison of two groups of each tremulous pulse IMTc of treatment front and back: as shown in table 2, through paired t-test, after the treatment, the right dorsal artery of foot of treatment group patient, left and right sides posterior tibial artery IMTc improve significantly (P＜0.05) before the treatment, and matched group everywhere the intra-arterial media thickness all do not have obvious change (P＞0.05).
Each tremulous pulse IMTc comparison before and after the table 2 liang group treatment (mm .x ± s)
Annotate:
*P＜0.05
4, two groups of treatment front and back lipid metabolism indexs: TC, TG, HDL-C, LDL-C treat the equal not statistically significants of front and back Blood Lipid for two groups through paired t-test.
5, the comparison of MMP-9 and L-6 before and after two groups of patient treatments: as shown in table 3, treatment back two groups of MMP-9, L-6 obviously reduce (P＜0.05) before the treatment.
The comparison of MMP-9 and L-6 before and after table 3 treatment (.x ± s)
Annotate: relatively preceding with treatment,
*P＜0.05
7, adverse events: matched group 1 routine patient is because of dizziness appears in the back of taking medicine, headache requires drug withdrawal; Treatment group patient does not see that in drug administration process adverse events takes place.
Three, discuss
The main pathological change of the concurrent lower limb vascular pathological changes of type 2 diabetes mellitus is atherosclerosis (AS), research is thought, AS is a chronic inflammatory disease process from developing into the overall process that lapses to, AS is a kind of chronic inflammation disease, plays key effect on the breaking of inflammation unstable and speckle fibrous cap at speckle.L-6 is the cytokine relevant with inflammatory reaction, phase albumen when it can promote the liver cell synthesized acute, can also cause the generation of AS by other approach, the erosion of CRP, the L-6 of the medium-term and long-term high concentration of blood is to cause one of reason of the generation of diabetic angiopathy, inflammatory reaction can increase the expression of MMP-9, clinical research finds that MMP-9 obviously increases in T2DM macroangiopathy patients serum and the speckle, and MMP-9mRNA expresses and inflammatory factor also obviously increases.Animal Experimental Study also shows in the mass concentration of the AS speckle visible MMP-9 in place and active obviously increase, accumulative MM-29 passes through degraded cells of vascular wall epimatrix (ECM) on the one hand in the part for these, help vascular smooth muscle cell VSMC) the fine and close mesh breaking through the surrounding tissue barrier and constitute by proteoglycan and collagen, therefrom film moves to inner membrance, and breed, secrete a large amount of ECM, form the AS speckle; Secondly MMP-9 can destroy the fibrous cap that is covered in plaque surface, weakens the effect of its opposing stress, makes speckle be easy to break, and secondary thrombus forms and machineization, causes AS damage progress and speckle to enlarge; In addition, MMP-9 also can destroy the interaction between cell and substrate, promotes that VSMC discharges solvable Fas part and film conjunction type tumor necrosis factor 2 α (TNF2 α), induces VSMC that apoptosis takes place, thereby quickens the progress of AS.Therefore, serum MMP-9 level raises can increase the atherosclerotic generation of patient, development, also can cause acute trunk incident by decomposing speckle, and it may be one of circulation mark of diabetic angiopathy that the MMP-9 level increases.If can rationally control the expression of MMP-9 and suppress its activity, then can prevent and alleviate developing of atherosis, vascular conditions, particularly MMP-9 and AS plaques stabilize have substantial connection, therefore, MMP-9 the research aspect the diagnosis of AS plaques stabilize and MMP-9 stablizing in the treatment of AS speckle research can both to future numerous cardiovascular patients beneficial.
Result of study shows that Chinese medicine preparation of the present invention has its intimal hyperplasia of improvement, reduce the effect of plaque thickness and stabilize plaque, its mechanism may be to realize by anti-inflammatory response and the expression that reduces MMP-9, for we in the progress that delays vascular lesion under the diabetes, prophylaxis of acute trunk incident and the early stage LEAD pathological changes of treatment diabetes, improve the diabetictrunk angiopathy prognosis new treatment thinking be provided.
Claims (3)
1. treat the atherosis Chinese medicine preparation of type 2 diabetes mellitus artery of lower extremity for one kind, it is characterized in that, be to be made by the component of following weight portion: 10～15 parts of Cortex Cinnamomis, 40～60 parts of the Radixs Astragali, 10～20 parts of Ramulus Cinnamomi, 30～50 parts of Herba Epimedii, 30～50 parts of Ramulus Euonymis, 5～10 parts of Radix Notoginseng, 10～20 parts on Flos Carthami, 6～10 parts of Rhizoma Chuanxiongs, 10～15 parts of Rhizoma Coptidis, 10～20 parts of Radix Cyathulaes.
2. the atherosis Chinese medicine preparation of treatment type 2 diabetes mellitus artery of lower extremity according to claim 1 is characterized in that, is made by following component: Cortex Cinnamomi 15g, Radix Astragali 60g, Ramulus Cinnamomi 20g, Herba Epimedii 50g, Ramulus Euonymi 50g, Radix Notoginseng 8g, Flos Carthami 20g, Rhizoma Chuanxiong 10g, Rhizoma Coptidis 15g, Radix Cyathulae 20g.
3. the preparation method of the Chinese medicine preparation that treatment type 2 diabetes mellitus artery of lower extremity according to claim 1 is atherosis is characterized in that, may further comprise the steps:
1) each component being pulverized mixing, is that 50～75% ethanol extracted 1～3 hour down at 60～80 ℃ with volumetric concentration;
2) centrifuging and taking supernatant, 60～70 ℃ are reclaimed ethanol, get medicinal liquid;
3) in medicinal liquid, add water, make mixture; Or 4) in medicinal liquid, add starch or dextrin, heating concentrate or spray drying after add starch and granulate, make granule or capsule.
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| CN104257839B (en) * | 2014-10-17 | 2016-08-24 | 山东省中医药研究院 | A kind of Chinese medicine composition with hypoglycemic protection blood vessel endothelium effect and preparation method thereof |
| CN104784602A (en) * | 2015-04-23 | 2015-07-22 | 冯立顺 | Traditional Chinese medicine preparation for treating type 2 diabetes mellitus combined atherosclerosis |
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