CN108159300B

CN108159300B - Traditional Chinese medicine compound composition with function of treating hypertension complicated with diabetes and preparation method and application thereof

Info

Publication number: CN108159300B
Application number: CN201810076372.0A
Authority: CN
Inventors: 严士海; 严冬; 张舒; 刘福明; 刘顺; 李婕; 耿志荣
Original assignee: Individual
Current assignee: Individual
Priority date: 2018-01-26
Filing date: 2018-01-26
Publication date: 2020-06-09
Anticipated expiration: 2038-01-26
Also published as: CN108159300A

Abstract

The invention discloses a Chinese medicinal compound composition for treating hypertension complicated with diabetes, its preparation method and application, wherein the composition is prepared from pilose asiabell root 15-45 parts, dried rehmannia root 15-45 parts, root of red rooted saliva 10-30 parts, sophora flower bud 10-30 parts, bamboo leaf 10-30 parts, reed rhizome 10-30 parts, kudzu vine root 10-30 parts, and perilla fruit 10-30 parts. The traditional Chinese medicine compound composition provided by the invention is prepared by adopting the theory of treatment based on syndrome differentiation, and clinical experiment results show that the traditional Chinese medicine compound composition provided by the invention has the comprehensive effects of multiple links and multiple targets, can improve the clinical symptoms of patients with hypertension complicated with diabetes, has the effects of reducing blood pressure and blood sugar and improving insulin resistance, can be used for preventing and treating hypertension complicated with diabetes, and has no adverse reaction and safer medication in long-term use.

Description

Traditional Chinese medicine compound composition with function of treating hypertension complicated with diabetes and preparation method and application thereof

Technical Field

The invention relates to a traditional Chinese medicine compound, in particular to a traditional Chinese medicine compound composition with the function of treating hypertension complicated with diabetes, a preparation method and application thereof.

Background

The incidence of Essential Hypertension (EH) combined with Type 2diabetes mellitus (T2 DM) is increasing year by year, and the incidence of hypertension combined with diabetes mellitus accounts for up to 20-40% of the population with hypertension. The common morbidity of EH and T2DM greatly increases the incidence rate of cardiovascular and cerebrovascular events and kidney damage of patients, and seriously affects the physical and mental health of the patients.

At present, most of the traditional Chinese medicines for treating hypertension complicated with diabetes are different in prescription and proved by a long term, and most of the traditional Chinese medicines are not obvious in toxic or side effect, but have unique advantages in the aspect of treating hypertension complicated with diabetes. Therefore, based on the pathogenesis of hypertension complicated with diabetes, the traditional Chinese medicine actively searches and strives to explore the medicine which is efficient, nontoxic and convenient to carry and has important significance for treating the hypertension complicated with diabetes.

Disclosure of Invention

The purpose of the invention is as follows: the invention aims to solve the defects of the prior art and provides the traditional Chinese medicine compound which is scientific and reasonable in proportion, can obviously improve the insulin resistance, the blood sugar and the blood pressure of patients suffering from hypertension complicated with diabetes and can improve the clinical symptoms of the patients; the invention also aims to provide a preparation method and application of the traditional Chinese medicine compound composition.

The technical scheme is as follows: in order to achieve the above purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine compound composition with an effect of treating hypertension complicated with diabetes is prepared from the following raw material medicines in parts by weight: 15-45 parts of codonopsis pilosula, 15-45 parts of radix rehmanniae, 10-30 parts of salvia miltiorrhiza, 10-30 parts of sophora flower bud, 10-30 parts of lophatherum gracile, 10-30 parts of reed rhizome, 10-30 parts of kudzu root and 10-30 parts of perilla fruit.

As a preferred scheme, the traditional Chinese medicine compound composition with the effect of treating hypertension complicated with diabetes is prepared from the following raw material medicines in parts by weight: 15-30 parts of codonopsis pilosula, 15-30 parts of radix rehmanniae, 10-20 parts of salvia miltiorrhiza, 10-20 parts of sophora flower bud, 10-20 parts of lophatherum gracile, 10-20 parts of reed rhizome, 10-20 parts of kudzu root and 10-20 parts of perilla fruit.

As a preferred scheme, the traditional Chinese medicine compound composition with the effect of treating hypertension complicated with diabetes is prepared from the following raw material medicines in parts by weight: 15 parts of codonopsis pilosula, 15 parts of radix rehmanniae, 10 parts of salvia miltiorrhiza, 10 parts of sophora flower bud, 10 parts of lophatherum gracile, 10 parts of reed rhizome, 10 parts of kudzu root and 10 parts of perilla fruit.

The invention is based on the traditional Chinese medicine theory and the clinical manifestations of hypertension complicated with diabetes: headache, dizziness, shortness of breath, lassitude, abdominal fullness and distention, chest distress, irritability, thirst with desire for drink, dark tongue with ecchymosis, wiry or deep and unsmooth pulse. The group of items is summarized as the syndrome of both qi and yin deficiency with intermingled stagnant heat according to the symptoms. Adopts the method of supplementing qi, nourishing yin, removing blood stasis and relieving fever to treat. Through a large number of experimental screens, the Chinese herbal compound preferentially obtained by the invention is codonopsis pilosula, radix rehmanniae, salvia miltiorrhiza, sophora japonica, lophatherum gracile, reed rhizome, kudzu root and perilla fruit. Radix Codonopsis, sweet and neutral, has effects of invigorating spleen, invigorating qi, and promoting fluid production. Radix rehmanniae, sweet and cold, has the effects of nourishing yin, promoting the production of body fluid, clearing heat and cooling blood. The codonopsis pilosula and the rehmannia root are used as monarch drugs together, so that qi and yin are supplemented. Salvia miltiorrhiza, bitter in taste and slightly pungent in flavor, slightly cold in nature, activates blood and removes stasis, nourishes blood and tranquilizes mind, cools blood and reduces swelling. Flos Sophorae Immaturus is cold in nature, sweet and mild in taste, and has effects of clearing liver-fire, cooling blood and stopping bleeding. Lophatherum gracile, sweet and light in nature and taste, has the effects of clearing heat, relieving restlessness, inducing diuresis and treating stranguria. Rhizoma phragmitis, sweet and cold in nature, can clear heat and promote fluid production, relieve restlessness, stop vomiting and promote urination. Kudzuvine root, sweet and pungent in flavor, cool in nature, defervesce heat, promote the production of body fluid to quench thirst. The salvia miltiorrhiza, the sophora flower bud, the lophatherum gracile, the reed rhizome and the radix puerariae are used as ministerial drugs for removing blood stasis, relieving fever and promoting the production of body fluid. The perilla fruit is warm and slightly pungent, can lower qi, clear phlegm, moisten lung, widen intestines, lower blood pressure and blood sugar, improve symptoms of abdominal fullness and the like of patients, promote drug absorption and is an adjuvant and guiding drug.

A medicine for treating hypertension complicated with diabetes is prepared from extract of Chinese medicinal compound composition and pharmaceutically acceptable vehicle by making into oral liquid, granule, capsule, tablet, powder for injection, dripping pill, soft capsule or injection.

Or the extract of the Chinese medicinal compound composition and a food acceptable carrier are prepared into effervescent tablets, tea bags or functional beverages according to a conventional method.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into oral liquid, the extracts of the raw materials are dissolved in distilled water, filtered, and the pH value is adjusted to prepare the oral liquid.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into tablets, the raw materials, lactose or corn starch and lubricant magnesium stearate are added if necessary, mixed uniformly, granulated and then tabletted to prepare the tablets.

When the extract of the traditional Chinese medicine compound provided by the invention is prepared into capsules, the extract of each raw material and carrier lactose or corn starch are uniformly mixed, granulated and then encapsulated to prepare the capsules.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into granules, the extracts of the raw materials and diluent lactose or corn starch are uniformly mixed, granulated, dried and prepared into the granules.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into powder injection, the extracts of the raw materials are frozen, dried and sterilized to prepare the powder injection.

When the extracts of the raw materials of the traditional Chinese medicine compound provided by the invention are prepared into injection, the extracts of the raw materials are taken and added with normal saline to be dissolved, then activated carbon is added, the mixture is uniformly stirred, heated at 80 ℃ for 30 minutes, filtered, adjusted in pH value, filtered by a sintered glass funnel or other filters until the mixture is clear, filled and sterilized at 100-142 ℃ for 30 minutes to prepare the injection.

Wherein the effervescent tablet, tea bag and functional beverage can be prepared by conventional method in pharmacy or food industry.

The preparation method of the medicine with the effect of treating hypertension complicated with diabetic nephropathy comprises the following steps:

(1) taking radix codonopsitis, radix rehmanniae, salvia miltiorrhiza, sophora flower bud, reed rhizome and radix puerariae according to the weight part of any one of claims 1 to 3, adding water with the weight of 8-10 times of the weight of the medicinal materials, decocting or reflux-extracting for 2-3 times, each time for 1-2 hours, combining the extracting solutions, and concentrating to obtain an extract for later use;

(2) taking the lophatherum gracile and the perilla seeds according to the weight part of any one of claims 1 to 3, carrying out reflux extraction for 2 to 3 times by using ethanol with the weight of 8 to 10 times of that of the medicinal materials, combining extracting solutions for 1 to 2 hours each time, carrying out reduced pressure concentration, recovering the ethanol, and concentrating to obtain an extract for later use;

(3) and (3) mixing the extract obtained in the step (1) and the extract obtained in the step (2) with a pharmaceutically acceptable carrier, and preparing the mixture into the medicaments in the dosage forms of oral liquid, granules, capsules, tablets, effervescent tablets, tea bags, functional beverages, powder injections, dropping pills, soft capsules or injections.

The invention relates to application of a traditional Chinese medicine compound composition with the function of treating hypertension complicated with diabetes in preparation of a medicine for treating hypertension complicated with diabetes.

Has the advantages that: according to the traditional Chinese medicine theory of treatment based on syndrome differentiation, the traditional Chinese medicine formula is screened according to the pathogenesis of hypertension complicated with diabetes, the provided traditional Chinese medicine compound is scientific and reasonable in proportion and rigorous in medication, and experimental results show that the traditional Chinese medicine compound composition provided by the invention has good effects of reducing blood pressure and blood sugar. The traditional Chinese medicine compound composition provided by the invention has small toxic and side effects after long-term use and is safe and reliable to use.

Detailed Description

The present invention is further illustrated by the following examples, which are intended to be purely exemplary and are not intended to limit the scope of the invention, as various equivalent modifications of the invention will occur to those skilled in the art upon reading the present disclosure and fall within the scope of the appended claims.

Example 1

1. A traditional Chinese medicine compound composition with an effect of treating hypertension complicated with diabetes is prepared from the following raw material medicines in parts by weight: 15g of codonopsis pilosula, 15g of radix rehmanniae, 10g of salvia miltiorrhiza, 10g of sophora flower bud, 10 parts of lophatherum gracile, 10g of reed rhizome, 10g of kudzu root and 10g of perilla seed.

2. The preparation method of the traditional Chinese medicine compound composition with the effect of treating hypertension complicated with diabetes comprises the following steps:

(1) taking 15g of codonopsis pilosula, 15g of radix rehmanniae, 10g of salvia miltiorrhiza, 10g of sophora flower bud, 10g of reed rhizome and 10g of radix puerariae according to the weight parts, adding water with the weight being 10 times of that of the medicinal materials, decocting and extracting for 3 times, each time for 1 hour, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) taking 10g of lophatherum gracile and 10g of perilla seeds according to the weight parts, carrying out reflux extraction for 2 times by using 8 times of ethanol in weight of the medicinal materials, each time for 2 hours, combining extracting solutions, concentrating under reduced pressure, recovering ethanol, and concentrating to obtain an extract for later use;

(3) and (3) uniformly mixing the extract obtained in the step (1) and the extract obtained in the step (2) with a carrier lactose or corn starch, granulating, drying, preparing into granules, and packaging by 10 g/bag. (batch number: 001)

Example 2

1. A traditional Chinese medicine compound composition with an effect of treating hypertension complicated with diabetes is prepared from the following raw material medicines in parts by weight: 45g of codonopsis pilosula, 45g of radix rehmanniae, 30g of salvia miltiorrhiza, 30g of sophora flower bud, 30g of lophatherum gracile, 30g of reed rhizome, 30g of kudzu root and 30g of perilla seed.

(1) taking 45g of codonopsis pilosula, 45g of radix rehmanniae, 30g of salvia miltiorrhiza, 30g of sophora flower bud, 30g of reed rhizome and 30g of radix puerariae according to the weight parts, adding water with the weight being 8 times of that of the medicinal materials, carrying out reflux extraction for 2 times, each time for 2 hours, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) taking 30g of lophatherum gracile and 30g of perilla seeds according to the weight parts, carrying out reflux extraction for 3 times by using ethanol with the weight of 10 times of that of the medicinal materials, each time for 1 hour, combining extracting solutions, carrying out reduced pressure concentration, recovering the ethanol, and concentrating to obtain an extract for later use;

(3) dissolving the extract obtained in step (1) and the extract obtained in step (2) with distilled water, filtering, adjusting pH, and making into oral liquid. (batch No. 002)

Example 3

1. A traditional Chinese medicine compound composition with an effect of treating hypertension complicated with diabetes is prepared from the following raw material medicines in parts by weight: 30g of codonopsis pilosula, 30g of radix rehmanniae, 20g of salvia miltiorrhiza, 20g of sophora flower bud, 20g of lophatherum gracile, 20g of reed rhizome, 20g of kudzu root and 20g of perilla fruit.

(1) taking 30g of codonopsis pilosula, 30g of radix rehmanniae, 20g of salvia miltiorrhiza, 20g of sophora flower bud, 20g of reed rhizome and 20g of radix puerariae according to the weight parts, adding water with the weight being 12 times of that of the medicinal materials, carrying out reflux extraction for 2 times, each time for 1 hour, combining extracting solutions, and concentrating to obtain an extract for later use;

(2) taking 20g of lophatherum gracile and 20g of perilla seeds according to the weight parts, carrying out reflux extraction for 2 times by using 8 times of ethanol in weight of the medicinal materials, each time for 2 hours, combining extracting solutions, recovering ethanol, and concentrating to obtain an extract for later use;

(3) and (3) taking the extract obtained in the step (1) and the extract obtained in the step (2), adding a diluent cyclodextrin or corn starch, uniformly mixing, granulating, drying, and then encapsulating to prepare capsules. (batch No. 003)

Example 4

And (3) freeze-drying the extract obtained in the step (1) in the embodiment 1 and the dry extract obtained in the step (2), sterilizing and preparing the powder injection. (batch number: 004)

EXAMPLE 5 clinical study

The incidence rate of Essential Hypertension (EH) combined Type 2diabetes mellitus (T2 DM) is increasing year by year, and the incidence rate of hypertension combined diabetes mellitus accounts for up to 20% >, up to four hundred percent of the population with hypertension

40 percent. The co-morbidity of EH and T2DM greatly increases the incidence of cardiovascular and cerebrovascular events and renal damage in patients. The traditional Chinese medicine has unique advantages in the aspect of treating EH and T2DM, has lasting curative effect and mostly has no obvious toxic or side effect. The traditional Chinese medicine composition is a hospital agreement prescription for treating hypertension complicated with diabetes in traditional Chinese medicine hospital in Jiangsu province, and the clinical application of the traditional Chinese medicine composition is subjected to standardized research, and the result is reported as follows.

1 clinical data

1.1 diagnostic criteria:

western diagnostic criteria: hypertension diagnosis standard: the systolic blood pressure (SBD) is more than or equal to 140mmHg and/or the Diastolic Blood Pressure (DBP) is more than or equal to 90mmHg for 3 different times.

The T2DM diagnostic standard is determined according to the WHO diagnostic standard T2DM in 1999, wherein the venous plasma measured value of Fasting Blood Glucose (FBG) is more than or equal to 7.0mmol/L, and the blood glucose (2hBG) is more than or equal to 11.1 mmol/L2 h after sugar load; and the patient with the type 2diabetes can be diagnosed as the patient with the type 2diabetes due to the main insulin resistance accompanied by relative insulin deficiency or the obvious insulin deficiency accompanied by insulin resistance.

The traditional Chinese medicine diagnosis standard is as follows: referring to the "clinical research guidelines for new Chinese medicine", the syndrome of both qi and yin deficiency and heat-stagnation is: the main symptoms are: shortness of breath, fatigue, dry mouth and throat, and obesity. The secondary symptoms are as follows: dysphoria with feverish sensation in the chest, palms and soles, tidal fever, night sweat, constipation, dizziness, tinnitus, palpitation, insomnia, thirst, polydipsia, soreness and weakness of waist and knees. Tongue pulse: a pale and dark tongue with ecchymosis or a red tongue with little body fluid, a thin or peeled coating, a thready, rapid and weak pulse, or a thready and wiry pulse. The above main symptoms are 3 items, and the secondary symptoms are 2 items, and the diagnosis can be confirmed by referring to the tongue pulse. Symptom grading and quantifying standard: the score criteria for the chief complaints were: no-0 min, light-2 min, medium-4 min and heavy-6 min. The secondary symptoms scoring standard is as follows: no-0 min, light-1 min, medium-2 min and heavy-3 min.

1.2 inclusion criteria: voluntarily attending, understanding and signing an informed consent; 45-70 years old with unlimited nature; it meets the diagnosis standard of Western medicine and Chinese medicine syndrome differentiation standard.

Exclusion criteria: pregnant or lactating women; patients with severe center of gravity, cerebrovascular diseases, primary kidney diseases, liver diseases, and blood system diseases; severe center of gravity, liver and renal insufficiency.

The traditional Chinese medicine curative effect judgment standard is as follows: the evaluation standard of the traditional Chinese medicine curative effect refers to the guidance principle of clinical research of new traditional Chinese medicines, and a nimodipine method is adopted. The efficacy was determined as the reduction rate of integration. The reduction rate of integration is (pre-treatment integration-post-treatment integration)/pre-treatment integration x 100%. The effect is shown: the clinical symptoms or physical signs are obviously improved, and the total integral of the symptoms is reduced by more than or equal to 70 percent; the method has the following advantages: the clinical symptoms or physical signs are improved, and the total integral of the symptoms is reduced by more than or equal to 30 percent; and (4) invalidation: in the case of no significant improvement or aggravation of clinical symptoms or signs, the total integral of symptoms is reduced by < 30%.

1.3 general data: according to the standard, collect the patients meeting the conditions in the affiliated Hospital of the traditional Chinese medicine university in 2015, 7 months to 2017, 12 months Nanjing. The treatment groups were divided into 142 cases and 140 cases according to the random number table method. 70 men and 72 women in the treatment group are in the age range of 42-70 years, the average age is 56.06 +/-7.88, the disease course range is 9 months-12 years, and the average disease course is 5.06 +/-3.12; 66 men and 74 women in the control group had age range of 40-67 years, mean age of 55.45 + -6.93, disease course range of 10 months-14 years, and mean disease course of 4.78 + -3.06. The study was approved by the ethical committee of my hospital and informed consent was obtained from each patient. The difference between the two groups of patients in terms of sex, age, course of disease, fasting blood sugar, blood pressure, blood fat and the like has no statistical significance (P is more than 0.05), and the two groups of patients have comparability.

2 method

2.1 methods of treatment: and (4) health education: two groups of patients were asked to control diet and appropriate exercise. Both groups of patients maintained the basic western medicine treatment before group, orally administered valsartan capsules (80 mg/tablet, manufactured by Beijing Nowa pharmacy Co., Ltd.) 80mg each time; pioglitazone hydrochloride capsules (15 mg/capsule, manufactured by Guangdong Rott pharmaceuticals Co., Ltd.) 15mg each time; is administered orally 1 time per day. In addition, the granules prepared in example 1 of the present invention were administered to the treatment groups 2 times a day, 1 bag per time; the control group received placebo granules 2 times daily, 1 bag/time. The treatment period was observed to be 8 weeks.

2.2 observation indexes: systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), waist circumference, fasting plasma glucose, fasting insulin, insulin resistance index, glycated hemoglobin, cytokines including plasma tumor necrosis factor a (TNFa), and interleukin-6 (IL-6). The safety of hematuria routine and liver and kidney function index evaluation.

2.3 statistical methods: all data were analyzed using SPSS12.0 software. Data are all represented as X + -S. Observation indicators for pre-and post-treatment comparisons within groups paired sample t-tests were used, for inter-group comparisons independent sample t-tests were used, and for count data X2 was used. The difference is statistically significant when P is less than 0.05.

3. Results of the experiment

3.1 the effect on the curative effect of the traditional Chinese medicine syndrome of the patient is shown in the table 1:

table 1: the ratio of the traditional Chinese medicine syndrome curative effect (%) (before and after two groups of treatment)

Group of	Number of examples	Show effect	Is effective	Invalidation	Total effective
						Treatment group	142	68(47.89％)	60(42.25％)	14(9.86％)	128(90.14％*)
Control group	140	40(28.57％)	45(32.14％)	55(39.29％)	85(60.71％)

P < 0.05, compared to control group

After 8 weeks of treatment, the total effective rate of the treatment group is 90.14%, the total effective rate of the control group is 60.71%, and the curative effect of the traditional Chinese medicine syndrome of the treatment group is better than that of the control group (p is less than 0.05), which indicates that the traditional Chinese medicine composition has good improvement effect on the traditional Chinese medicine syndrome of the patient.

3.2 the Effect of the Chinese medicinal composition of the invention on the blood pressure and waist circumference of patients

Table 2: the influence of the traditional Chinese medicine composition on blood pressure and waistline

Group of		Number of examples	SBP(mmHg)	DBP(mmHg)	Waist circumference (cm)
						Treatment group	Before treatment	142	150.50±7.04	89.83±5.49	93.03±5.57
	After treatment	142	125.52±4.18#*	78.10±3.58#*	90.75±5.68#*
						Control group	Before treatment	140	149.91±8.38	88.98±4.68	93.44±5.63
	After treatment	140	131.20±6.39#	82.97±4.32#	93.23±5.81

# p < 0.05, compared to the group before treatment, # p < 0.05, compared to the control group at the same time

The SBP, DBP and waist circumference of the two groups before treatment have no significant difference (P is more than 0.05); after treatment, SBP and DBP in the two groups are obviously reduced; SBP and DBP of the traditional Chinese medicine composition after treatment are lower than those of a control group; the waistline of the traditional Chinese medicine composition is reduced to a certain extent after treatment, and the value of the traditional Chinese medicine composition has statistical significance after treatment with a control group. The result shows that the traditional Chinese medicine composition has good effect on blood pressure and waist circumference.

3.3 Effect of the Chinese medicinal composition of the present invention on blood glucose of patients

Table 3: the influence of the traditional Chinese medicine composition on blood sugar

As can be seen from Table 3 above, there was no significant difference (P > 0.05) between fasting plasma glucose, fasting insulin, insulin resistance index, and glycated hemoglobin in the first two groups; after treatment, the fasting blood sugar, the fasting insulin, the insulin resistance index and the glycosylated hemoglobin of the two groups are all obviously reduced; wherein the fasting blood sugar, the fasting insulin, the insulin resistance index and the glycosylated hemoglobin after the treatment of the traditional Chinese medicine composition are lower than the numerical values after the treatment of a control group. The results show that the traditional Chinese medicine composition has good effects of reducing blood sugar and inhibiting insulin resistance.

3.4 Effect of the Chinese medicinal composition of the present invention on the cytokines TNFa and IL-6 of patients

Table 4: effect of the Chinese medicinal composition of the present invention on cytokines

Group of		Number of examples	TNFa(ng/L)	IL-6(ng/L)
					Treatment group	Before treatment	142	25.69±3.16	67.24±6.26
	After treatment	142	13.30±1.24#*	28.75±3.11#*
					Control group	Before treatment	140	25.98±2.42	67.86±6.00
	After treatment	140	17.27±1.52#	42.40±1.65#

The TNFa and IL-6 in the two groups before treatment have no significant difference (P is more than 0.05); after treatment, TNFa and IL-6 in two groups are obviously reduced; TNFa and IL-6 after the treatment of the traditional Chinese medicine composition are lower than the values after the treatment of a control group. The result shows that the traditional Chinese medicine composition has good anti-inflammatory factor effect and good prevention and treatment effect on the inflammatory reaction of hypertension complicated with diabetes.

3.5 safety assay

The examinations of hematuria routine, liver and kidney functions and the like are carried out before and after the treatment of two groups of patients, and no adverse effect of taking test medicines on the hematuria routine, the liver and kidney functions is seen. 4 cases of rash and 5 cases of digestive tract reaction appear in the control group, and the incidence rate of adverse reactions is 8.18 percent; the treatment groups had 2 cases of rash and 6 cases of digestive tract reaction, the incidence rate of adverse reactions was 7.02%, and the difference between the two groups had no statistical significance (p > 0.05).

The invention is based on the traditional Chinese medicine theory and the clinical manifestations of hypertension complicated with diabetes: headache, dizziness, shortness of breath, lassitude, abdominal fullness and distention, chest distress, irritability, thirst with desire for drink, dark tongue with ecchymosis, wiry or deep and unsmooth pulse. The groups of items were classified into qi and yin deficiency and syndrome of intermingled stagnant heat (yin deficiency with blood stasis) according to their symptoms. Adopts the method of supplementing qi, nourishing yin, removing blood stasis and relieving fever to treat. Through a large number of experimental screens, the Chinese herbal compound preferentially obtained by the invention is codonopsis pilosula, radix rehmanniae, salvia miltiorrhiza, sophora japonica, lophatherum gracile, reed rhizome, kudzu root and perilla fruit. Radix Codonopsis, sweet and neutral, has effects of invigorating spleen, invigorating qi, and promoting fluid production. Radix rehmanniae, sweet and cold, has the effects of nourishing yin, promoting the production of body fluid, clearing heat and cooling blood. The codonopsis pilosula and the rehmannia root are used as monarch drugs together, so that qi and yin are supplemented. Salvia miltiorrhiza, bitter in taste and slightly pungent in flavor, slightly cold in nature, activates blood and removes stasis, nourishes blood and tranquilizes mind, cools blood and reduces swelling. Flos Sophorae Immaturus is cold in nature, sweet and mild in taste, and has effects of clearing liver-fire, cooling blood and stopping bleeding. Lophatherum gracile, sweet and light in nature and taste, has the effects of clearing heat, relieving restlessness, inducing diuresis and treating stranguria. Rhizoma phragmitis, sweet and cold in nature, can clear heat and promote fluid production, relieve restlessness, stop vomiting and promote urination. Kudzuvine root, sweet and pungent in flavor, cool in nature, defervesce heat, promote the production of body fluid to quench thirst. The salvia miltiorrhiza, the sophora flower bud, the lophatherum gracile, the reed rhizome and the radix puerariae are used as ministerial drugs for removing blood stasis, clearing heat and promoting the production of body fluid. Perilla fruit, fructus Perillae, being warm and slightly pungent, descending qi, clearing phlegm, moistening lung, widening intestine, improving abdominal fullness symptoms of patients, promoting drug absorption, is an adjuvant drug.

The traditional Chinese medicine compound provided by the invention is prepared according to the traditional Chinese medicine theory and by adopting the theory of syndrome differentiation and treatment, and the experimental results show that the traditional Chinese medicine compound provided by the invention has the comprehensive effects of multiple links and multiple targets, can correct hypertension complicated with diabetes syndrome and improve insulin resistance, and the clinical experimental results show that the traditional Chinese medicine compound provided by the invention has no adverse reaction after long-term use and is safer to use.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. A traditional Chinese medicine compound composition with an effect of treating hypertension complicated with diabetes is characterized by being prepared from the following raw material medicines in parts by weight: 15-45 parts of codonopsis pilosula, 15-45 parts of radix rehmanniae, 10-30 parts of salvia miltiorrhiza, 10-30 parts of sophora flower bud, 10-30 parts of lophatherum gracile, 10-30 parts of reed rhizome, 10-30 parts of kudzu root and 10-30 parts of perilla fruit.

2. The traditional Chinese medicine compound composition with the effect of treating hypertension complicated with diabetes as claimed in claim 1, is characterized by being prepared from the following raw material medicines in parts by weight: 15-30 parts of codonopsis pilosula, 15-30 parts of radix rehmanniae, 10-20 parts of salvia miltiorrhiza, 10-20 parts of sophora flower bud, 10-20 parts of lophatherum gracile, 10-20 parts of reed rhizome, 10-20 parts of kudzu root and 10-20 parts of perilla fruit.

3. The traditional Chinese medicine compound composition with the effect of treating hypertension complicated with diabetes as claimed in claim 2, is characterized by being prepared from the following raw material medicines in parts by weight: 15 parts of codonopsis pilosula, 15 parts of radix rehmanniae, 10 parts of salvia miltiorrhiza, 10 parts of sophora flower bud, 10 parts of lophatherum gracile, 10 parts of reed rhizome, 10 parts of kudzu root and 10 parts of perilla fruit.

4. A medicine with the effect of treating hypertension complicated with diabetes is characterized in that the extract of the traditional Chinese medicine compound composition of any one of claims 1 to 3 and a pharmaceutically acceptable carrier are prepared into the medicine in the dosage forms of oral liquid, granules, capsules, tablets, powder injection, dropping pills or injection.

5. A preparation method of a medicine with the effect of treating hypertension complicated with diabetes is characterized by comprising the following steps:

(1) taking radix codonopsitis, radix rehmanniae, salvia miltiorrhiza, sophora japonica, reed rhizome and radix puerariae according to the parts by weight of any one of claims 1 to 3, adding water with the weight of 8-10 times of the weight of the medicinal materials, decocting or extracting under reflux for 2-3 times, each time for 1-2 hours, combining the extracting solutions, and concentrating to obtain an extract for later use;

(3) and (3) mixing the extract obtained in the step (1) and the extract obtained in the step (2) with a pharmaceutically acceptable carrier, and preparing the mixture into the medicaments in the dosage forms of oral liquid, granules, capsules, tablets, powder injection, dropping pills or injection.

6. The use of the compound Chinese medicinal composition for treating hypertension complicated with diabetes as claimed in any one of claims 1 to 3 in the preparation of a medicament for treating hypertension complicated with diabetes.