CN1754546A - A kind of traditional Chinese medicine preparation for treating and preventing diabetes and its vascular disease - Google Patents

Abstract

A Chinese medicine for preventing and treating diabetes and its angiopathy is prepared from 9 Chinese-medicinal materials (by weight portions): 2-15 parts of dogwood, 1-12 parts of radix rehmanniae, 5-30 parts of astragalus, 4-20 parts of motherwort, 2-10 parts of winged euonymus twig, 3-15 parts of scutellaria, 2-8 parts of sophora flower, 2-10 parts of stiff silkworm and 1-4 parts of emblic leafflower fruit. The Chinese medicinal preparation is in the form of capsule. Clinical application proves that the medicine is safe, effective and free from toxic and side effects. The total effective rate for treating diabetic nephropathy is 86.53%, and the total effective rate for treating traditional Chinese medicine symptoms is 90%. The Chinese medicinal preparation has effects of reducing blood sugar, urine sugar, blood pressure, and blood lipid, improving blood circulation, and effectively treating and preventing diabetes and its complicated vascular diseases such as nephropathy, retinopathy, cardiomyopathy, cerebrovascular disease, hypertension, and hyperlipemia. The Chinese medicinal preparation provides an effective new medicament for the market.

Description

A kind of traditional Chinese medicine preparation for treating and preventing diabetes and its vascular disease

Technical field:

The invention relates to a traditional Chinese medicine preparation, in particular to a traditional Chinese medicine preparation for treating and preventing diabetes and its vascular lesions.

Background technique:

The prevalence of diabetes is increasing year by year in the world. According to the World Health Organization (WHO) estimate in 1995, the total number of diabetic patients in the world has exceeded 120 million. By 2050, the number of diabetic patients in the world will reach 300 million. The adult prevalence rate in my country is about 2.5%, which is more than three times higher than the prevalence rate 15 years ago. It is estimated that there are more than 20 million diabetic patients in the country. Diabetes is prone to a variety of complications, especially the chronic complications of diabetes with microvascular and macrovascular lesions as the main pathological basis, which can affect almost all organs and tissues and become the main cause of seriously affecting the quality of life of patients and causing disability and death. Large vessel lesions mainly cause coronary atherosclerotic heart disease, cardiomyopathy, cardiac autonomic neuropathy, hypertension and hyperlipidemia, and can also cause cerebrovascular lesions, peripheral arterial lesions such as gangrene, and infectious skin diseases, pruritus , pellagra, etc. Microangiopathy mainly includes diabetic nephropathy, diabetic retinopathy, cataract, etc. Diabetic microangiopathy is more common, and diabetic nephropathy is a typical manifestation of microangiopathy. It is now known that in patients with diabetic nephropathy, telangiectasia, red blood cell aggregation often occurs in capillaries, capillary basement membrane thickens, and vascular endothelial cells are damaged. Moreover, patients with diabetic nephropathy have hyperplatelet function. Diabetic state leads to abnormal blood rheology and microcirculation disturbance. Microthrombosis and microembolism can also lead to microcirculation stasis and increased venous pressure, which jointly promote glomerular filtration. Increased blood pressure and increased urinary albumin excretion. At present, the clinical and research in this area is still in the early stage in China, and there are very few effective drugs on the market, which cannot meet the needs of clinical medication. In view of this point, a Chinese medicine preparation for the treatment and prevention of diabetes and its vascular diseases is developed to provide The demand for medicines in the market is of great significance.

Contents of the invention

The invention provides a kind of Chinese medicine preparation (trade name is Gandhi Capsules, formerly known as Jinchang Capsules) for treating and preventing diabetes and its vascular lesions. The theory of treatment is based on ancient prescriptions, combined with clinical experience, and processed by modern pharmaceutical technology, it is a new drug for treating diabetic vascular disease with the functions of nourishing yin and activating blood, clearing heat and eliminating phlegm, dispelling blood stasis and relieving depression, replenishing qi and dredging collaterals. The traditional Chinese medicine preparation can be used for treating and preventing diabetes and its vascular lesions, as well as preventing and treating coronary heart disease, angina pectoris, atherosclerosis, hyperlipidemia and antithrombosis.

Diabetes belongs to the category of "diabetes thirst" in traditional Chinese medicine. Its main pathogenesis lies in the loss of yin fluid and endogenous dryness and heat. What's more, if the heat is strong, it will damage the yin and make the yin more deficient, thus forming a vicious circle, which will definitely affect the physiological functions of the five internal organs. The main lesions of diabetes are in the lung, spleen, kidney, liver and other organs. According to the five elements theory, the kidney belongs to water, and the liver belongs to wood. Physiologically, water and wood are the mother-child relationship. Kidney water is the mother, liver and wood are the children, and kidney Yin nourishes the liver wood, and the liver can be healthy and comfortable. Pathologically, "the mother's disease affects the child" and "the child's disease invades the mother". Kidney yin deficiency causes liver wood to lose its nourishment, causing liver yin deficiency, yin deficiency leads to hyperactivity of yang, and It leads to the hyperactivity of liver yang; the liver loses its nourishment, and the function of catharsis and excretion is abnormal, so that the solidification of the kidney is abnormal, the body fluid goes straight to the bladder, and a large amount of water and grain essence leaks down, resulting in insufficient kidney water. Therefore, diabetes complicated by hypertension or kidney disease is very common in clinical practice. "Prolonged illness enters the collaterals and becomes blood stasis". Diabetes patients with long-term yin damage qi consumption, kidney qi is not solid, meridians lose nourishment, blood stasis occurs from deficiency, blood vessels are blocked, collaterals are stagnant, and even phlegm and blood stasis are seen. Inclusions such as knots. "Yin deficiency and blood stasis" are the main causes of diabetic macrovascular and microvascular lesions. Therefore, the present invention uses traditional Chinese medicine preparations with the functions of nourishing kidney and nourishing yin, promoting blood circulation and removing blood stasis, and replenishing qi and dredging collaterals to treat diabetes and its vascular complications.

The active ingredient of the Chinese medicine preparation of the present invention is prepared from 9 kinds of Chinese medicinal materials in the following ratio (parts by weight):

2-15 parts of dogwood, 1-12 parts of raw land, 5-30 parts of astragalus, 4-20 parts of motherwort, 2-10 parts of ghost arrow feather, 3-15 parts of skullcap, 2-8 parts of Sophora japonica, 2-10 parts of silkworm part, 1-4 parts of emblica.

The active ingredient of traditional Chinese medicine and the pharmaceutical carrier are composed in any proportion, wherein the active ingredient can account for 0.1-99.9% by weight, the pharmaceutical carrier can account for 99.9-0.1% by weight, and the pharmaceutical carrier can be starch, dextrin, protein Sugar, sucrose, micronized silica gel, condensed honey or other commonly used carriers.

The traditional Chinese medicine preparation used for treating and preventing diabetes and its vascular lesions of the present invention contains 9 kinds of active ingredients of Chinese medicinal materials. Due to suitable compatibility, a good synergistic effect is produced, so that the Chinese medicinal preparation of the present invention has a good curative effect. The therapeutic effect of these components As described below:

Dogwood, Habitat, Astragalus

The root of the pathogenesis of diabetes complicated with vascular disease lies in the loss of liver and kidney caused by prolonged thirst. Therefore, in the treatment, cornus officinalis is used to invigorate the liver and kidney, astringent essence and solidification. Use rehmannia to clear away heat and cool blood, nourish yin, promote body fluid and moisten dryness, and lower blood sugar. Use Astragalus to invigorate qi and generate yang, diuretic and reduce swelling. Astragalus is combined with Shengdi and Cornus officinalis, and Astragalus tends to restrain the spleen essence, while Shengdi and Cornus officinalis tend to strengthen the kidney essence. The combination of these medicines promotes each other, strengthens the power of lowering urine sugar and blood sugar, nourishing yin, nourishing qi and lowering blood sugar.

Motherwort, ghost arrow feather

"Yin deficiency and blood stasis" in diabetes complicated with vascular disease almost run through the whole process of complications. Therefore, motherwort is used in treatment to promote blood circulation and detoxify. And motherwort also has the effect of diuresis and swelling, and can treat edema caused by water channel disorders. Ghost Arrow Feather is used to break blood stasis and promote blood circulation. Its function of activating collaterals and dredging meridians has been clinically proven. It can quench thirst, clear fire, lower blood sugar and urine sugar, and has good curative effect on diabetes complicated with heart, cerebrovascular, kidney, fundus and other lesions.

Bombyx mori, Scutellaria baicalensis, Sophora japonica

Diabetes disease for a long time, yin deficiency and heat knots can cause blood stasis and arthralgia, and heat knots can also cause phlegm and blood stasis. Disease dispelling stagnation, dredging collaterals to relieve pain. Scutellaria baicalensis clears away heat and dampness, purifies fire and detoxifies, and is especially used for clearing heat and toxin from upper burns. Sophorae japonica cools blood to stop bleeding, clears liver and reduces fire. Above-mentioned three medicines are used in combination, heat-clearing, expectorant-drying and damp-drying.

Scutellaria baicalensis is mainly used for purging fire and lowering blood pressure, and Sophora japonica is mainly used for cooling blood and lowering blood pressure. The combination of the two medicines has a remarkable effect on treating hypertension and arteriosclerosis. In addition, the two are used together with habitat, motherwort, etc., and can also treat intraocular hemorrhage.

Amla

Diabetes for a long time, yin deficiency, blood stasis, qi stagnation, stagnation of liver qi, the upper part is easy to melt fire, the upper part is to smoke the eye orifices, and the lower part is easy to make the meridians and collaterals congested.

In addition, in view of the complications of diabetes, its root lies in the disorder of glucose metabolism. Controlling blood sugar and urine sugar is the core of treating diabetic complications. Therefore, the content of the drug with hypoglycemic function selected in the prescription process of the traditional Chinese medicine preparation of the present invention accounts for about two-thirds of the whole preparation.

In summary, this traditional Chinese medicine preparation has the functions of nourishing yin and activating blood circulation, clearing heat and eliminating phlegm, dispelling blood stasis and dredging collaterals, resuscitating depression and other effects, and can treat diabetic vascular disease with deficiency of both qi and yin and blood stasis in blood collaterals.

The preparation method of Chinese medicine preparation of the present invention

Weigh the traditional Chinese medicinal materials according to the above formula, add water to decoct twice, the first time for 2 hours, the second time for 1 hour, filter, combine the filtrates, settle for 18 hours, take the supernatant and shrink to a clear liquid with a relative density of 1.35 (90°C). Paste, add appropriate amount of medicinal carrier, dry under reduced pressure at 60°C, pulverize, pass through a 40-mesh sieve, dry, mix in appropriate amount of lubricant, pack into capsules, and obtain.

The modern pharmacology of Chinese medicine preparation of the present invention:

dogwood

It can significantly reduce blood sugar, urine sugar, drinking water and urination, inhibit platelet aggregation in hyperglycemic rats, and reduce whole blood viscosity in hyperglycemic rats. Experiments have found that it also has insulin-like effects.

habitat

It can resist aging, reduce the damage of free radicals to body tissues, achieve the purpose of delaying tissue aging, and lower blood sugar.

Astragalus

It has the effects of dilating blood vessels and coronary arteries, lowering blood pressure, anti-aging and lowering blood sugar.

Astragaloside can improve myocardial contractility, increase coronary flow, and protect heart function.

It can also protect myocardial cells, reduce the degree of cell damage, and have a protective effect on the myocardium.

Scutellaria baicalensis

It has the effects of lowering blood pressure, lowering blood fat, increasing serum high-density lipoprotein content, lowering serum cholesterol and triglyceride and inhibiting the synthesis of fat from glucose. It has a therapeutic effect on diabetes and can inhibit the action of alsidase in the body. It can delay cataract, has antibacterial, anti-inflammatory, and antiviral effects.

Sophora japonica

It has blood coagulation and hemostasis effects, can improve the permeability of capillaries, can effectively reduce the amount of cholesterol in the liver, aorta and blood, and increase the stability of cholesterol-protein complexes. It can prevent and treat experimental arteriosclerosis Effect. It has the effect of lowering blood fat, and has the effect of removing fat on fatty infiltrated liver.

Silkworm

It has hypoglycemic and anticonvulsant effects.

ghost arrow feather

Sodium oxaloacetate contained in it can stimulate insulin cells, adjust abnormal metabolic process, strengthen insulin secretion, thereby lowering blood sugar.

Motherwort

It can lower blood pressure and have a protective effect on cardiovascular. It has a certain preventive effect on myocardial infarction. Can increase coronary flow and reduce coronary resistance. It can directly expand peripheral blood vessels, increase blood flow, and reduce vascular resistance. It has the effect of improving microcirculation and promoting the recovery of local blood flow caused by adrenaline. It has the effect of promoting blood circulation and removing blood stasis.

Motherwort has inhibitory effects on platelet aggregation, microthrombus formation, fibrin thrombus formation and red blood cell aggregation, prolongs the time of thrombus formation and shortens the length of thrombus.

Leonurine can significantly reduce blood viscosity, resist platelet aggregation, have varying degrees of resistance to experimental myocardial ischemia, myocardial infarction or arrhythmia, improve coronary circulation, and significantly reduce the scope of myocardial infarction , reduce the degree of disease and the amount of myocardial necrosis, and also have a certain effect on arrhythmia.

Amla

Anti-aging, scavenging free radicals, anti-cytotoxicity, anti-mutagenic effects. It has the effect of lowering fat and blood pressure, and can cure simple obesity.

The toxicity test of Chinese medicine preparation of the present invention

Acute toxicity test in mice

Get 20 healthy Kunming mice (half and half male and female), respectively orally administer the medicinal liquid prepared by Chinese medicine preparation capsules of the present invention (make every milliliter containing 0.15g crude drug with 0.5% CMC), press 0.8ml/20g, orally give The drug was observed for 7 days, and the result: after the mice were orally administered the prepared medicinal solution, the animal activities were normal, and no obvious toxic reaction or death was found. After the test, the anatomical examination showed no obvious changes in the main organs. The mouse LD50 has been determined to be greater than 6g/kg, which is equivalent to more than 100 times the clinical dosage of humans (calculated on the basis of 50kg body weight for humans). Show that the traditional Chinese medicine preparation of the present invention is safe and nontoxic.

Drug effect of Chinese medicine preparation animal test of the present invention

1. Hypoglycemic effect of Gandhi capsules

Test results: Compared with the model group, Gandhi Capsules had a significant hypoglycemic effect, both in low and high doses, indicating that Gandhi Capsules had the effect of lowering blood sugar.

2. Gandhi Capsules Effect on Glucose Tolerance in Mice

Test results: Compared with the control group, the Gandhi Capsule high-dose group has significant differences at each time point, and the low-dose group also has an effect at 2 hours. It shows that Gandhi Capsule has obvious regulating effect on the glucose metabolism of normal mice.

3. The effect of Gandhi Capsules on lowering blood fat

Test results: Gandhi Capsule high and medium dose groups can significantly reduce the TC and TG values of rats with hyperlipidemia caused by feeding high-fat diet. It also shows that the drug has a certain effect of lowering blood fat.

4. Effect of Gandhi Capsules on Hemorheology in Rats

Test results: Gandhi Capsule has the following effects on the hemorheology of the rat "blood stasis" model: reduce the high-shear viscosity, low-shear viscosity and plasma specific viscosity of whole blood; reduce the fibrinogen content; reduce erythrocyte sedimentation rate and hematocrit.

The following conclusions can be drawn from the above test results: Gandhi Capsule has the effect of promoting blood circulation and improving many clinical symptoms caused by "blood stasis".

5. The protective effect of Gandhi capsule on the cardiovascular system of rats

Test results: Under the microscope, compared with the control group, the endocardial myocardium cells in the model group had fatty degeneration and cloudy swelling, thickened muscle fibers, unclear striations, occasional small focal necrosis, and a small amount of neutrophils and lymphocytes around them. infiltration. Coronary endothelial cells shed, the intima thickened and bulged, the subendothelial space widened, and foam cells could be seen, while in the Gandhi capsule group, no obvious myocardial necrosis was seen, subendocardial fatty degeneration was slight, coronary endothelial edema was not shed, and the intima Thinning, no bulge, neatly arranged medial smooth muscle, no obvious foam phenomenon. This shows that Gandhi Capsule can repair the arterial intima and significantly reduce myocardial fibrosis and necrosis. Cardiovascular protection.

The clinical therapeutic effect of Chinese medicine preparation of the present invention:

The effective dose used by the traditional Chinese medicine preparation of the present invention is three times a day, 3-4 capsules each time, and each capsule contains about 3g of crude drug.

Curative effect of Chinese medicine preparation of the present invention in treating diabetic nephropathy (deficiency of both qi and yin combined with blood stasis type)

In the clinical application, 120 patients with diabetic nephropathy were randomly selected, and the 1:1 control principle was selected, with 60 cases in the test group and 60 cases in the control group. The gender distribution, age distribution, course of disease and complications of the two groups are as follows, see Table 1-Table 4

Table 1 Comparison of general conditions between the two groups group Number of cases male female age course of disease number of people % number of people % ^x2 P (X+S) years old t P (X+S) years t P test group control group 6060 2826 46.7433 3234 53356.7 1.25 >0.05 56.21±0.8855.84±9.72 0.238 >0.05 9.33±4.659.40±4.81 0.451 >0.05

Table 1 shows that before treatment, there was no statistically significant difference between the two groups in terms of gender composition, age, and course of disease, and they were comparable.

Table 2 Comparison of fasting blood glucose, urine protein, and renal function between the two groups before treatment project Test group (X+S) Control group (X+S) t P Fasting blood glucose (mmol/L) 24h urine albumin (mg/24h) 24h urine microglobulin (mg/24h) BUNCr 8.87±2.34242±133326±1587.38±1.87114±29.4 8.79±2.33233±136317±1497.32±1.90112±30.5 1.0451.4321.4690.6650.583 >0.05>0.05>0.05>0.05>0.05

Table 2 shows that there was no significant difference in fasting blood glucose, 24h urine albumin, 24h urine microglobulin, BUN, and Cr between the two groups before treatment, and they were comparable.

Table 3 Comparison of TXB ₂ and 6-K-PGF ₂ between the two groups of subjects before treatment project Test group (X+S) Control group (X+S) t P TXB ₂ (ng/L)6-K-PGF ₂ (ng/L) 209±68.82.3±7.2 198±71.221.8±6.9 1.3621.084 ＞0.05＞0.05

Note: TXB ₂ is thromboxane B ₂ , 6-K-PGF ₂ is 6-keto-prostaglandin F ₂

Table 3 shows that before treatment, there was no significant difference in TXB ₂ and 6-K-PGF ₂ between the two groups of subjects, and they were comparable.

Table 4 Comparison of scores of TCM syndromes between the two groups of subjects before treatment project test group control group t P Thirsty, good drink, eat more, easy to hunger, fatigue, weakness, fear of heat, upset, polyuria, back pain, edema 4.02±1.133.87±0.963.81±1.013.55±0.743.62±0.823.26±0.602.99±0.51 3.99±1.063.91±0.983.77±0.963.51±0.753.58±0.773.30±0.662.86±0.48 0.3650.4010.3290.5510.4350.5070.685 >0.05>0.05>0.05>0.05>0.05>0.05>0.05

Table 4 shows that before treatment, there was no statistically significant difference in the scores of TCM syndromes between the two groups, and they were comparable.

Use the following treatments

Method of administration: The patients in the test group and the control group had the same diet as the general treatment during the treatment period, and the protein intake was kept constant (0.6-0.8g/kg per day), mainly high-quality protein from meat and eggs, and the amount of staple food was controlled, and sweets were forbidden Unlimited fruits and vegetables. Oral mepidar, 5mg each time, 2-3 times a day.

Treatment group: add Chinese medicine preparation capsule of the present invention on the above-mentioned treatment basis, each 3, every day 3 times, one month is a course for the treatment of, treat two courses for the treatment of.

Control group: on the basis of the above treatment, additionally take Shenyan Siwei Tablets, 8 tablets each, 3 times a day, one month as one course of treatment, two courses of treatment.

Treatment results:

1. Comprehensive curative effect of diabetic nephropathy The comparison of curative effect of diabetic nephropathy between the test group and the control group is shown in Table 5.

Table 5 Comparison of curative effect of diabetic nephropathy in two groups group Number of cases markedly effective efficient invalid total effective rate number of people % number of people % number of people % number of people % Treatment group Control group 6060 206 33.310 3226 53.343.33 828 13.346.67 5232 86.6353.33

U＝2.60 P＜0.05

Table 5 shows that there is a statistically significant difference in the curative effect of diabetic nephropathy between the two groups, and the curative effect of the treatment group is significantly better than that of the control group.

2. Efficacy of TCM syndromes The efficacy of TCM syndromes of diabetic nephropathy in the two groups is compared in Table 6.

Table 6 Comparison of curative effects of TCM syndromes in patients with diabetic nephropathy between the two groups group Number of cases markedly effective efficient invalid total effective rate number of people % number of people % number of people % number of people % Treatment group Control group 6060 226 36.6726 3228 53.3346.7 620 1041.2 5440 9066.7

U＝1.98 P＜0.05

Table 6 shows that the difference in curative effect of diabetic nephropathy symptoms between the two groups is statistically significant, and the curative effect of symptom improvement in the treatment group is better than that in the control group.

Table 7 compares the curative effects of each single symptom of diabetic nephropathy in the two groups.

Table 7 Comparison of curative effects of individual symptoms of diabetic nephropathy in two groups symptom group Number of cases markedly effective efficient invalid total effective rate Thirsty, good drink, eat more, easy to hunger, fatigue, weakness, fear of heat, upset, polyuria, back pain, edema treatment group control group treatment group treatment group treatment group treatment group treatment group treatment group treatment group treatment group treatment group treatment group treatment group 5654444648484244484436323028 301226162410201420161810128 22261414182016122214148148 416416618618614414412 92.9% 70.4% 90.9% 65.2% 87.5% 62.5% 85.7% 59.1% 87.5% 68.2% 88.9% 56.3% 86.7% 57.1%

Table 7 shows that after treatment, the symptoms of diabetic nephropathy in the two groups of patients improved to varying degrees, and the improvement in the treatment group was more obvious, especially in the improvement of symptoms such as thirsty and drinking, fatigue and weakness.

3. Efficacy of lowering fasting blood sugar

Table 8 Comparison of curative effect on reducing fasting blood sugar between the two groups (X±S)mmol/L group Number of cases Before treatment After treatment Treatment group Control group 6060 8.87±2.348.79±2.33 6.53±1.59 ^△* 7.41±1.48 ^△

Note: ^△ Compared with before treatment, P<0.05; ^* Compared with two groups after treatment, P<0.05;

Table 8 shows that the fasting blood glucose levels of the two groups were similar before treatment, and the fasting blood glucose levels of the two groups decreased after treatment (P < 0.05), and there were differences in the fasting blood glucose levels of the two groups after treatment (P < 0.05), indicating that the test group lowered blood sugar. The curative effect was better than that of the control group.

4. The improvement of urinary albumin and microglobulin in the two groups is shown in Table 9

Table 9 Comparison of urinary albumin and microglobulin reduction in the two groups group Number of cases Urinary albumin (X±S)mg/24h Urinary microglobulin (X±S)mg/24h Before treatment After treatment Before treatment After treatment Treatment group Control group 6060 242±133233±136 96±48 ^△△** 188±67 ^△ 326±158317±149 118±68 ^△△** 204±58 ^△

Note: ^△ P<0.05 compared with before treatment; ^△△ P<0.01 compared with before treatment; ^** P<0.01 compared with control group

Before treatment, the levels of urinary albumin in the two groups were similar (P>0.05), but after treatment there was a statistically significant difference in urinary albumin between the two groups (P<0.01).

The levels of urinary microglobulin in the two groups were similar before treatment (P>0.05), and the difference was statistically significant after treatment (P<0.01).

Table 9 shows that the improvement of urinary albumin and urinary microglobulin in the treatment group is better than that in the control group.

5. The improvement of renal function in the two groups before and after treatment is compared in Table 10

Table 10 Changes of renal function in the two groups before and after treatment project Before treatment (X+S) Control group (X+S) t P BUN test group control group 7.38±1.877.32±1.90 6.23±1.626.99±1.93 2.031.42 <0.05>0.05 Cr test group control group 114±29.4112±30.5 90±21.6103±28.7 2.121.69 <0.05>0.05

Table 10 shows that after treatment, BUN and Cr in the test group were lower than before (P<0.05), and there was no statistically significant difference in the control group before and after treatment, indicating that the renal function of the test group had improved, while the change in the control group was not obvious.

6. The changes of TXB ₂ and 6-K-PGF ₂ in the two groups are compared in Table 11

Table 11 Comparison of changes in blood TXB ₂ and 6-K-PGF ₂ between the two groups group Number of cases TXB ₂ (X+S)ng/L 6-K-PGF ₂ (X+S)ng/L Before treatment After treatment Before treatment After treatment Treatment group Control group 6060 209±68.8198±71.2 115±45 ^*△△ 172±69.3 22.3±7.221.8±6.9 27.5±6.1 ^*△ 23.6±7.0

Note: ^* P<0.05 compared with before treatment; ^△ P<0.05 compared with control group; ^△△ P<0.01 compared with before treatment;

Before treatment, the levels of TXB ₂ in the two groups were similar (P>0.05), but after treatment there was a statistically significant difference in TXB ₂ between the two groups (P<0.05). Before treatment, the levels of 6-K-PGF ₂ in the two groups were similar, and after treatment, there was a statistically significant difference in 6-K-PGF ₂ between the two groups (P<0.05). Table 11 shows _that the levels of TXB ₂ and 6- _K -PGF ₂ in the two groups were similar before treatment. The level of 6-K-PGF ₂ in the treatment group was significantly increased, while that in the control group was not significantly increased, and the increase in 6-K-PGF ₂ in the treatment group was significantly better than that in the control group.

Clinical application proves that the drug is safe, effective and has no toxic and side effects. For the treatment of diabetic nephropathy (qi and yin deficiency combined with blood stasis type), the clinical marked rate is 33.3%, the effective rate is 53.3%, the ineffective rate is 13.3%, and the total effective rate is 86.53%, which is obviously better than that of Shenyan Siwei tablet. group; the marked rate of TCM syndrome was 36.67%, the effective rate was 53.35%, the invalid rate was 10%, and the total effective rate was 90%, which was obviously better than that of the Shenyan Siwei tablet matched group; The 8.87 ± 2.34mmol/L of the present invention is reduced to 6.53 ± 1.59mmol/L (P＜0.05), compared with the fasting blood glucose level after the treatment of the control group is low (P＜0.05), the hypoglycemic effect of the capsules of the present invention is better than that of Shenyan Siwei Tablets; After treatment, the 24h urinary albumin and microglobulin in the test group were lower than those in the control group (P<0.01), and the improvement of renal function (Bun, Cr) was also more obvious than that in the control group; TX B ₂ was lower than that in the control group (P<0.05 ); while 6-K-PGF ₂ was higher than that in the control group (P<0.05). The above results show that because the capsule of the present invention has comprehensive functions of nourishing qi, nourishing yin and promoting blood circulation, it helps to improve glucose metabolism and enhance the cell function of the body, so the drop in blood sugar is more obvious. Improve microcirculation, reduce blood TXB ₂ level, increase 6-K-PGF ₂ level, adjust T/K ratio, thereby improving microcirculation, reducing blood viscosity, helping to reduce urinary protein excretion of diabetic nephropathy, and delaying the progression of diabetic nephropathy Develop, protect and improve kidney function.

In summary, the traditional Chinese medicine preparation capsule of the present invention is mainly used for treating and preventing diabetes and its vascular diseases, as well as preventing and treating coronary heart disease, angina pectoris, atherosclerosis, hyperlipidemia and antithrombosis. Clinical practice has proved that it can safely and effectively lower blood sugar, urine sugar, blood pressure, blood lipids, improve blood circulation, effectively treat and prevent diabetes and its concurrent vascular diseases such as nephropathy, retinopathy, cardiomyopathy, cerebrovascular disease, hypertension , hyperlipidemia, etc., the drug is safe, effective and has no side effects. The total clinical effective rate for the treatment of diabetic nephropathy (qi and yin deficiency and blood stasis type) is 86.53%, and the total effective rate for TCM syndrome improvement is 90%. Symptoms such as fear of heat, upset, polyuria, and edema are all significantly improved. The medicine can lower blood sugar, effectively prevent and treat diabetes and its complications, and at the same time, the capsule of the present invention has the function of protecting and improving the renal function of diabetic nephropathy patients. The traditional Chinese medicine preparation of the invention has definite curative effect, is safe and has no side effects, makes up for the shortage of therapeutic drugs on the market, provides an effective new drug, and has great economic and social benefits.

Detailed ways:

Embodiment 1 The preparation method of capsule of the present invention

Weigh 560 grams of habitat, 316 grams of dogwood, 380 grams of astragalus, 333 grams of baicalin, 312 grams of Sophora japonica, 252 grams of silkworm, 500 grams of motherwort, 226 grams of ghost arrow feather, and 166 grams of emblica. The total amount of crude drug is about 3000g, add water to decoct twice, add 8 times the amount of water to decoct for 2 hours for the first time, add 6 times the amount of water for the second time to decoct for 1 hour, combine the decoction, filter, and let the filtrate stand for 18 hours, take Concentrate the supernatant to a clear paste with a relative density of 1.35 (90°C), add 20% by weight starch, stir well, dry under reduced pressure at 60°C for 24 hours, pulverize, pass through a 40-mesh sieve, and dry at 60°C-80°C until the water content is low Add an appropriate amount of magnesium stearate at 3%, pack into capsules, and make 1000 capsules, 0.3g per capsule, containing about 3g of crude drug.

Embodiment 2 The preparation method of capsule of the present invention

Weigh 562 grams of Cornus officinalis, 150 grams of raw land, 750 grams of astragalus, 115 grams of scutellaria baicalensis, 188 grams of Sophora japonica, 375 grams of silkworm, 712 grams of motherwort, 75 grams of ghost arrow feather, and 80 grams of emblica. The total amount of crude drug is about 3000g, add water to decoct twice, add 8 times the amount of water to decoct for 2 hours for the first time, add 6 times the amount of water to decoct for 1 hour for the second time, filter, combine the filtrates, settle for 18 hours, and take the supernatant Concentrated to a clear paste with a relative density of 1.35 (90°C), add 20% by weight starch, stir well, dry under reduced pressure at 60°C for 24 hours, pulverize, pass through a 40-mesh sieve, and dry at 60°C-80°C until the water content is less than 3% , add an appropriate amount of magnesium stearate, pack into capsules, and make 1000 capsules, 0.3g per capsule, containing about 3g of crude drug.

Embodiment 3 treatment case

A 62-year-old male patient had intermittent edema for 5 years, general fatigue for 1 month, abdominal distension, nausea and vomiting, decreased urine output (about 500-800ml per day), and increased urine foam. He had hypertension for 20 years and his blood pressure was as high as 230/100mmHg, diabetes history for 10 years, examination: urine protein++, 24-hour urine protein quantification 15.18g/24 hours, blood urea nitrogen 11.9mmoL/L, creatinine 342umoL/L, fasting blood sugar 11.6mmol/L, 2 hours after meal Blood sugar 18.9mmol/L. Orally take this traditional Chinese medicine capsule preparation three times a day, 4 capsules each time. After 3 months of treatment, the blood pressure of the patient tends to be normal, the symptoms of general edema and general fatigue disappear, and the spirit, appetite, and sleep are all OK. The test results show: Urinary protein ±, creatinine 135.5μmol/L, blood urea nitrogen 7.2mmol/L, fasting blood glucose 5.6mmol/L, and 2-hour postprandial blood glucose 7.8mmol/L.

Embodiment 4 treatment case

A 55-year-old female patient has suffered from diabetes for more than ten years. She took Xiaoke Wan, Tangshiping, and metformin by mouth, and had intermittent high blood pressure for 10 years. After being diagnosed and treated by many hospitals, the effect was not good. Recently, edema of the face and lower limbs and oliguria appeared. . Urine protein +++, urine sugar +++, granular casts 1-2/HP, red blood cells 2-3/HP, white blood cells 10-15/HP, blood sugar 16mmol/L, creatinine 275umol/L. The diagnosis was: "diabetic nephropathy, early renal insufficiency". The condition is serious. After taking this traditional Chinese medicine capsule preparation, three times a day, 4 capsules each time, after taking it for two weeks, her urine output increased from 500 ml per day to more than 1500 ml per day, the edema gradually subsided, and her blood pressure was controlled stably. One month later, the edema gradually disappeared, urine protein (-), urine sugar (-), fasting blood glucose 5.1mmol/L, two-hour postprandial blood glucose 8.9mmol/L, creatinine 130μmol/L, blood urea nitrogen 6.3mmol/L, and then Consolidate and take for two months, and each index is all in normal range through reexamination.

Claims (2)

1, a kind of Chinese medicine preparation that is used for the treatment of with prevent diabetes and vascular lesion thereof, the active component that it is characterized in that described Chinese medicine preparation is that 9 kinds of Chinese medicine medical materials of following row weight portion proportioning are prepared from: Fructus Corni 2-15 part, Radix Rehmanniae 1-12 part, Radix Astragali 5-30 part, Herba Leonuri 4-20 part, Ramulus Euonymi 2-10 part, Radix Scutellariae 3-15 part, Flos Sophorae 2-8 part, Bombyx Batryticatus 2-10 part and Fructus Phyllanthi 1-4 part.

2, by the described Chinese medicine preparation of claim 1, it is characterized in that described Chinese medicine preparation is a capsule formulation.