CN117959387A - Traditional Chinese medicine composition for treating hypertension, preparation method and application - Google Patents

Abstract

The application relates to a traditional Chinese medicine composition for treating hypertension, a preparation method and application, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine raw materials in parts by weight: 2-4 parts of gastrodia elata, 1-3 parts of uncaria, 3-6 parts of devilpepper, 2-4 parts of ligusticum wallichii, 1-3 parts of rhizoma pinellinae praeparata, 2-5 parts of wild chrysanthemum, 2-4 parts of bighead atractylodes rhizome, 0.8-3 parts of dried orange peel and 2-4 parts of radix cyathulae.

Description

A Chinese medicine composition for treating hypertension, preparation method and application

Technical Field

The present invention belongs to the field of medical technology, and in particular relates to a Chinese medicine composition for treating hypertension, a preparation method and an application thereof.

Background technique

Hypertension is a clinical syndrome characterized by elevated systemic arterial systolic blood pressure (SBP) and/or diastolic blood pressure (DBP).

At present, the six major types of drugs used in Western medicine to treat hypertension are still the main antihypertensive drugs used in clinical practice. Most Western medicines have certain side effects. For example, adrenergic β-receptor blockers such as propranolol cannot be taken by patients with asthma, and if these drugs are taken in excess, they may also cause heart block and abnormal blood lipids and blood sugar; calcium ion antagonists such as nifedipine can cause symptoms such as edema of the feet, redness of the face, and increased heart rate; in addition to causing gastric ulcers, reserpine can also cause sexual dysfunction. Although the blood pressure reduction rate of traditional Chinese medicine in the treatment of hypertension is not as fast as that of Western medicine, it has the advantages of overall regulation, mild antihypertensive effect, and fewer side effects. Unfortunately, the application of traditional Chinese medicine in the field of hypertension treatment has not been very successful. Therefore, the development of compound traditional Chinese medicine with definite antihypertensive efficacy, few side effects, and suitable for long-term use has good social and economic significance.

Hypertension belongs to the category of "vertigo" and "headache" in traditional Chinese medicine. Vertigo can be located in the liver and kidney, which is a syndrome of deficiency of the root and excess of the superficial. The root deficiency is liver and kidney yin deficiency, and the superficial excess is liver yang hyperactivity and phlegm and blood stasis blocking the collaterals. Liver yang transforming into wind and blood stasis transforming into wind both belong to the category of wind-qi internal movement, so its pathogenesis can be summarized as "deficiency, stasis, phlegm, and wind". The patent ZL201010125992.2 authorized by the inventor of this application discloses a Chinese medicine composition for treating hypertension, which is made of the following Chinese medicine raw materials in weight proportions: 1-2 parts of Chuanxiong, 1.5-2 parts of Uncaria rhynchophylla, and 1-1.5 parts of Radix Ophiopogonis. However, the effect of the Chinese medicine composition in calming the liver, suppressing yang and stopping wind, promoting blood circulation, resolving phlegm and stopping dizziness, and lasting efficacy needs to be improved. 201410362490X discloses a Chinese medicine composition for treating hypertension, which is made of the following Chinese medicine raw materials in the following weight ratios: 0.5-2 parts of Uncaria rhynchophylla, 1-2 parts of Chuanxiong, 1-2 parts of Angelica sinensis, 0-4 parts of Rauwolfia oleifera, and 0-4 parts of Apocynum venetum, which can effectively improve the various TCM symptoms of patients with hypertension due to Yin deficiency and Yang hyperactivity and blood stasis and obstruction of collaterals, but it is found in clinical applications that the blood pressure reduction amplitude is small and the effect is not lasting, and the blood pressure reduction effect still needs to be improved. CN107648479A discloses a Chinese medicine formula for treating hypertension and its products, wherein the weight ratios of the Chinese medicine raw materials are: 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 5 parts of Rauwolfia oleifera, 3 parts of Chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 2 parts of Poria cocos, and 2 parts of Tangerine peel. The efficacy needs to be further improved.

Summary of the invention

The purpose of the present invention is to provide a Chinese medicine composition for treating hypertension, a preparation method and an application thereof, in view of the defects existing in the prior art, so as to further improve the antihypertensive effect.

The traditional Chinese medicine composition for treating hypertension of the present invention is prepared from the following traditional Chinese medicine raw materials in proportions by weight: 2-4 parts of Gastrodia elata, 1-3 parts of Uncaria rhynchophylla, 3-6 parts of Rauwolfia oleifera, 2-4 parts of Ligusticum chuanxiong, 1-3 parts of Pinellia ternata, 2-5 parts of Chrysanthemum indici, 2-4 parts of Atractylodes macrocephala, 0.8-3 parts of Citrus reticulata peel and 2-4 parts of Cyathula capitata.

As a preferred embodiment, the Chinese medicine composition for treating hypertension described in the present invention is made of the following Chinese medicine raw materials in the following weight proportions: 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 4 parts of Rauwolfia oleifera, 3 parts of Ligusticum chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indica, 2 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 3 parts of Cyathula capitata.

The above compound Chinese medicine can be taken after being decocted, or can be taken after being extracted with water or ethanol.

As one embodiment, a clinically acceptable dosage form is prepared.

As one embodiment, the composition can be made into tablets, capsules, granules, pills or oral liquid.

As one embodiment, soft capsules, dispersible tablets, orally disintegrating tablets, and dropping pills are prepared.

The invention provides a method for preparing a traditional Chinese medicine composition for treating hypertension. The method is as follows: adding 0-70% ethanol aqueous solution (0% ethanol aqueous solution is water, and the concentrations in the invention are all volume concentrations) to a traditional Chinese medicine raw material, extracting 1-3 times, adding 4-12 times the amount of ethanol aqueous solution each time; extracting for 1-2 hours each time, combining the extracts, filtering, recovering the solvent, concentrating, and drying to prepare a clinically acceptable dosage form.

Preferably, the extraction solvent is 30% to 70% ethanol aqueous solution, more preferably 70% ethanol aqueous solution.

As one embodiment, 0-70% ethanol aqueous solution is added for extraction twice, with 10-12 times the amount added each time; each extraction takes 1-2 hours, the extract is filtered, the solvent is recovered and concentrated to obtain the product.

As one embodiment, 0-70% ethanol aqueous solution is added for extraction twice, 6-10 times the amount of water is added for the first time, and the extraction is carried out for 2 hours, and 4-8 times the amount of water is added for the second time, and the extraction is carried out for 1 hour; the extract is filtered, the solvent is recovered and concentrated to obtain the product.

As one embodiment, before the first extraction, the Chinese medicinal material is soaked for 0.5h.

The invention provides application of a traditional Chinese medicine composition for treating hypertension in preparing a medicine for treating hypertension.

The beneficial effect of the present invention is that the prescription of the present invention has the functions of calming the liver, suppressing yang and relieving wind, clearing away heat, removing blood stasis and removing phlegm, and is used for patients with hypertension with hyperactivity of liver yang and phlegm and blood stasis. Pharmacodynamic studies have shown that the compound Chinese medicine can significantly reduce the systolic and diastolic blood pressure of spontaneous hypertension and renal hypertension model animals, and the antihypertensive effect is long-lasting.

After the prescription is adjusted, the effect of promoting blood circulation, removing blood stasis and unblocking collaterals is enhanced, and the blood pressure lowering effect is more significant.

Detailed ways

In order to further describe the present invention in detail, specific embodiments are given, but are only for illustrating the present invention rather than for limiting the scope of the present invention.

Example 1 Granule dosage form of the pharmaceutical composition of the present invention

Take 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 4 parts of Rauwolfia oleifera, 3 parts of Chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 2 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 3 parts of Cyathula officinalis, soak them in water for 0.5 hour, extract them twice, the amount of water added is 12 times and 10 times respectively, the first extraction takes 2 hours, the second extraction takes 1 hour, filter, combine the filtrate, concentrate, dry, and crush to obtain the dry extract powder of the pharmaceutical composition of the present invention, and then prepare granules.

Example 2 Tablet dosage form of the pharmaceutical composition of the present invention

Take 2 parts of Gastrodia elata, 3 parts of Uncaria rhynchophylla, 6 parts of Rauwolfia oleifera, 2 parts of Chuanxiong, 1 part of Pinellia ternata, 2 parts of Chrysanthemum indici, 4 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 2 parts of Cyathula officinalis, soak them in 70% ethanol aqueous solution for 0.5 hour, extract them twice, add 70% ethanol aqueous solution in an amount of 6 times and 4 times, respectively, extract them for 2 hours for the first time and for 1 hour for the second time, filter, combine the filtrate, concentrate, dry, and pulverize to obtain the dry extract powder of the pharmaceutical composition of the present invention, and then prepare the pharmaceutical composition preparation in tablet dosage form.

Example 3 Capsule dosage form of the pharmaceutical composition of the present invention

Take 4 parts of Gastrodia elata, 1 part of Uncaria rhynchophylla, 3 parts of Rauwolfia oleifera, 4 parts of Ligusticum chuanxiong, 3 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 3 parts of Atractylodes macrocephala, 1 part of Citrus reticulata, and 2 parts of Cyathula officinalis, soak them in 60% ethanol aqueous solution for 0.5 hour, extract them twice, add 60% ethanol aqueous solution in an amount of 7 times and 5 times, respectively, extract them for 2 hours for the first time and for 1 hour for the second time, filter, combine the filtrate, concentrate, dry, and crush to obtain the dry extract powder of the pharmaceutical composition of the present invention, and then prepare the pharmaceutical composition preparation in capsule form.

Example 4 Dropping pills of the composition of the present invention

Take 2 parts of Gastrodia elata, 1 part of Uncaria rhynchophylla, 3 parts of Rauwolfia oleifera, 2 parts of Ligusticum chuanxiong, 2 parts of Pinellia ternata, 5 parts of Chrysanthemum indici, 2 parts of Atractylodes macrocephala, 3 parts of Citrus reticulata, and 4 parts of Cyathula officinalis, soak them in 50% ethanol aqueous solution for 0.5 hour, extract them twice, add 50% ethanol aqueous solution in an amount of 6 times and 4 times, respectively, extract them for 2 hours for the first time and for 1 hour for the second time, filter, combine the filtrate, concentrate, dry, and grind to obtain the dry extract powder of the pharmaceutical composition of the present invention, add appropriate amount of auxiliary materials after grinding to prepare the dripping pills of the pharmaceutical composition.

Example 5 Soft capsule dosage form of the pharmaceutical composition of the present invention

Take 4 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 3 parts of Rauwolfia oleifera, 2 parts of Ligusticum chuanxiong, 3 parts of Pinellia ternata, 4 parts of Chrysanthemum indici, 2 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 2 parts of Cyathula officinalis, soak them in 50% ethanol aqueous solution for 0.5 hour, extract them twice, add 7 times and 5 times the amount of 50% ethanol aqueous solution, extract them for 2 hours for the first time and 1 hour for the second time, filter, combine the filtrate, concentrate, dry, and crush to obtain the dry extract powder of the pharmaceutical composition of the present invention, add appropriate amount of auxiliary materials after crushing, mix well, use gelatin as capsule shell material, press into soft capsules, and prepare soft capsules of the pharmaceutical composition.

Example 6 Micropellet Formulation of the Pharmaceutical Composition of the Present Invention

Take 2 parts of Gastrodia elata, 3 parts of Uncaria rhynchophylla, 3 parts of Rauwolfia oleifera, 4 parts of Ligusticum chuanxiong, 2 parts of Pinellia ternata, 4 parts of Chrysanthemum indici, 3 parts of Atractylodes macrocephala, 1 part of Citrus reticulata, and 2 parts of Cyathula officinalis, soak them in 30% ethanol aqueous solution for 0.5 hour, extract them twice, the amount of 30% ethanol aqueous solution added is 6 times and 4 times respectively, the first extraction takes 2 hours, the second extraction takes 1 hour, filter, combine the filtrate, concentrate, dry, and grind to obtain the dry extract powder of the pharmaceutical composition of the present invention, add an appropriate amount of auxiliary materials after grinding to prepare the micropills of the pharmaceutical composition.

Example 7 Micropellet Formulation of the Pharmaceutical Composition of the Present Invention

Take 4 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 5 parts of Rauwolfia oleifera, 2 parts of Chuanxiong, 2 parts of Pinellia ternata, 2 parts of Chrysanthemum indici, 3 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 2 parts of Cyathula officinalis, soak them in water for 0.5 hour, extract them twice, the amount of water added is 6 times and 4 times respectively, the first extraction is for 2 hours, the second extraction is for 1 hour, filter, combine the filtrate, concentrate, dry, and grind to obtain the dry extract powder of the pharmaceutical composition of the present invention, add appropriate amount of auxiliary materials after grinding to prepare micropills of the pharmaceutical composition.

Example 8 Pharmacological Test of the Present Invention

The purpose of this experiment is to observe the therapeutic effect of the compound Chinese medicine of the present invention on hypertension model rats. The test compositions A, B, C, and D are all dry extract powders, which are prepared with purified water to the required concentration.

The preparation method of the above-mentioned test composition is the same, which is as follows:

Composition A: 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 5 parts of Rauwolfia ovata, 3 parts of Chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 2 parts of Poria cocos and 2 parts of Citrus reticulata are soaked in water for 0.5 hours, and then extracted twice with the amount of water added being 12 times and 10 times respectively. The first extraction takes 2 hours and the second extraction takes 1 hour. The mixture is filtered, the filtrate is combined, concentrated, dried and crushed to obtain a dry extract powder of composition A.

Composition B: Take 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 5 parts of Rauwolfia ovata, 3 parts of Chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 2 parts of Poria cocos, 2 parts of Citrus reticulata, and 4 parts of Eucommia ulmoides, soak them in water for 0.5 hour, then extract them twice with the amount of water added being 12 times and 10 times respectively, the first extraction taking 2 hours and the second extraction taking 1 hour, filter, combine the filtrate, concentrate, dry, and grind to obtain a dry extract powder of composition B.

Composition C: Take 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 5 parts of Rauwolfia ovata, 3 parts of Chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 2 parts of Poria cocos, 2 parts of Citrus reticulata, and 4 parts of Pheretima, soak them in water for 0.5 hour, and then extract them twice, with the amount of water added being 12 times and 10 times respectively, the first extraction taking 2 hours, and the second extraction taking 1 hour, filter, combine the filtrate, concentrate, dry, and grind to obtain a dry extract powder of composition C.

Composition D: Take 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 4 parts of Rauwolfia oleifera, 3 parts of Chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indici, 2 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 3 parts of Cyathula officinalis, soak them in water for 0.5 hour, and then extract them twice, with the amount of water added being 12 times and 10 times respectively, the first extraction taking 2 hours and the second extraction taking 1 hour, filter, combine the filtrate, concentrate, dry, and grind to obtain the dry extract powder of composition D.

1. Effects on blood pressure in SHR rats

Sixty 8-week-old male SHRs were selected as experimental animals and randomly divided into 6 groups according to blood pressure stratification, with 10 rats in each group: model control group, 13.5 mg·kg ^-1 ·d ^-1 group of irbesartan, 3.0 g·kg ^-1 ·d ^-1 group of composition A, 3.0 g·kg ^-1 ·d ^-1 group of composition B, 3.0 g·kg ^-1 ·d ^-1 group of composition C, 3.0 g·kg ^-1 ·d ^-1 group of composition D, and the composition A, B, C, and D groups were crude drug doses. In addition, 10 WKY rats were set as the normal control group. All drugs were prepared into the required concentration with distilled water, and administered by gavage at 8:00 a.m. every day at a volume of 10 ml/kg, once a day, with a dosage of 10 ml/kg, for 28 consecutive days. The model group and the normal control group were given equal volumes of distilled water.

Index detection Blood pressure was measured in each group 1 hour after intragastric administration. Blood pressure was measured once a week. The measurement environment was quiet and constant temperature (26°C). The BP-2006A intelligent non-invasive sphygmomanometer was used to measure the systolic and diastolic blood pressure of rats in a sober and non-irritated state. The measurements were performed four times in a row and the average was taken.

The data of this experiment were processed by EXCEL software, and the results were analyzed by t test for inter-group test. The statistical results were tested with α=0.05 as the test limit, where P ≤ 0.05 indicated statistical significance, and P ≤ 0.01 indicated that the difference tested was very significant.

1.1 Effects on systolic blood pressure in SHR rats

Before administration, the systolic blood pressure of SHR rats in each group was similar and had no significant difference, and was significantly higher than that of the normal control group. Compared with the normal group, the systolic blood pressure of rats in the model group continued to increase, and the difference was statistically significant (P＜0.01).

Compared with the model group, the systolic blood pressure of the positive drug irbesartan group was significantly reduced after continuous administration for 1-4 weeks (P<0.01 or P<0.05), the systolic blood pressure of the composition A group of the present invention was significantly reduced after administration for 1-4 weeks (P<0.01), the systolic blood pressure of the composition B and C groups was significantly reduced after administration for 2-4 weeks (P<0.01), and the systolic blood pressure of the composition D group was significantly reduced after administration for 1-4 weeks (P<0.01). It can be seen that the onset time of the composition A and D groups is better than that of the composition B and C groups.

Compared with the positive drug irbesartan group, the effect of reducing systolic blood pressure in the combination group D at each test time point from 1 to 4 weeks of administration was significantly better, and the difference was statistically significant (P < 0.01). However, the combination groups A, B, and C had no obvious advantages over irbesartan.

Compared with the composition group A, the effects of the composition groups B and C after 1-4 weeks of administration were comparable, with no significant improvement (P>0.05); the composition group D had a significantly better effect in reducing systolic blood pressure after 1-4 weeks of administration, with a statistically significant difference (P<0.01 or P<0.05). Moreover, the effect of the composition group D in reducing systolic blood pressure was also significantly better than that of the composition groups B and C (P<0.01).

The above experiments show that although compositions A, B, C, and D all have the effect of significantly reducing the systolic blood pressure of SHR rats, compositions A, B, and C have similar effects in reducing systolic blood pressure, while composition D has a significantly better effect in reducing systolic blood pressure than the positive control drug irbesartan and compositions A, B, and C, and the onset time of composition D is better than that of compositions B and C. The results are shown in Table 1.

Table 1 Effect of continuous administration of the composition of the present invention for 4 weeks on systolic blood pressure of SHR ( ±s, mmHg, n=10)

Note: Compared with the normal control group: *P<0.05, **P<0.01; compared with the model control group: #P<0.05, ##P<0.01; compared with the irbesartan group: ▲P<0.05, ▲▲P<0.01; compared with the combination group A: ☆P<0.05, ☆☆P<0.01; compared with the combination group D: ■P<0.05, ■■P<0.01.

1.2 Effects on SHR diastolic blood pressure

Compared with the normal control group, the diastolic blood pressure of rats in the model control group continued to increase after being given distilled water for 4 weeks, and the difference was statistically significant (P＜0.01).

Compared with the model control group, the diastolic blood pressure of the positive drug irbesartan group was significantly reduced (P < 0.01 or P < 0.05); the diastolic blood pressure of the composition A and D groups of the present invention was significantly reduced after 1-4 weeks of administration (P < 0.01); the diastolic blood pressure of the composition B group was significantly reduced after 3-4 weeks of administration (P < 0.01); the diastolic blood pressure of the composition C group was significantly reduced after 2-4 weeks of administration (P < 0.01 or P < 0.05). It can be seen that the onset time of the composition A and D in reducing diastolic blood pressure is better than that of the composition B and C.

Compared with the positive drug irbesartan group, the effect of reducing diastolic blood pressure in the combination D group after administration for 1-4 weeks was significantly better, and the difference was statistically significant (P < 0.01 or P < 0.05).

Compared with the composition group A, the effect of the composition groups B and C on reducing diastolic blood pressure after administration for 1-4 weeks had no significant difference (P>0.05); the effect of the composition group D on reducing diastolic blood pressure after administration for 1-4 weeks was significantly better, and the difference was statistically significant (P<0.01 or P<0.05). In addition, the effect of the composition D on reducing diastolic blood pressure was also significantly better than that of the compositions B and C (P<0.01).

The above results show that compositions A, B, C, and D all have the effect of significantly reducing diastolic blood pressure in SHR rats, but compositions A, B, and C have similar effects in reducing diastolic blood pressure, while composition D has a significantly better effect in reducing diastolic blood pressure than the positive control drug irbesartan and compositions A, B, and C, and its onset time is faster than compositions B and C. The results are shown in Table 2.

Table 2 Effect of continuous administration of the composition of the present invention for 4 weeks on diastolic blood pressure in SHR ( ±s, mmHg, n=10)

Note: Compared with the normal control group: *P<0.05, **P<0.01; compared with the model control group: #P<0.05, ##P<0.01; compared with the irbesartan group: ▲P<0.05, ▲▲P<0.01; compared with the combination A group: ☆P<0.05, ☆☆P<0.01; compared with the combination D group: ■P<0.05, ■■P<0.01.

2. Effects on blood pressure in rats with renal hypertension

The experimental animals used the two-kidney-one-clip method to replicate the renal hypertension rat model using a silver clip with an inner diameter of 0.25 mm. The 50 successfully modeled RHR model rats were stratified by blood pressure and randomly divided into 5 groups, with 10 animals in each group: model control group, 13.5 mg·kg ^-1 ·d ^-1 group of irbesartan, 3.0 g·kg ^-1 ·d ^-1 group of composition A, 3.0 g·kg ^-1 ·d ^-1 group of composition B, 3.0 g·kg ^-1 ·d ^-1 group of composition C, and 3.0 g·kg ^-1 ·d ^-1 group of composition D. Composition groups A, B, and C are all crude drug doses. In addition, 10 sham-operated rats were set as sham-operated control groups. All drugs were prepared into the required concentration with distilled water and administered orally at 10:00 a.m. daily at a volume of 10 ml/kg, once a day, for 4 weeks. The sham-operated group and the model control group were given the same volume of distilled water.

Index detection BP-2006A intelligent non-invasive sphygmomanometer was used to measure the blood pressure of rats, and the measurement was performed 4 times in a row, and the average value was used as the systolic blood pressure. Blood pressure was measured in each group before administration. Blood pressure was measured once a week, and the systolic and diastolic blood pressure of rats were measured in the awake and non-irritated state.

The experimental data were processed by EXCEL software, and the results were analyzed by t test for inter-group test.

2.1 Effects on systolic blood pressure in rats with renal hypertension

Compared with the sham operation control group, the systolic blood pressure of rats in the model control group continued to increase, and the difference was statistically significant (P＜0.01).

Compared with the model control group, the systolic blood pressure of the positive drug (Irbesartan Tablets) group was significantly reduced after 3-4 weeks of administration (P<0.01 or P<0.05); the systolic blood pressure of the composition A group of the present invention was significantly reduced after 3-4 weeks of administration (P<0.05 or P<0.01); there was no significant effect of reducing systolic blood pressure in the combination B and C groups after 1-4 weeks of administration (P>0.05); the systolic blood pressure of the composition D group was significantly reduced after 2-4 weeks of administration, and the difference was statistically significant (P<0.01 or P<0.05). It can be seen that the onset time of composition D is faster than that of Irbesartan and composition A. In addition, the effect of composition D on reducing systolic blood pressure after 4 weeks of administration is significantly better than that of compositions A, B, and C (P<0.05).

The above results show that compositions A and D have the effect of reducing systolic blood pressure in rats with renal hypertension, while compositions B and C have no obvious effect, and composition D has better onset time and efficacy than irbesartan and composition A in reducing systolic blood pressure in rats with renal hypertension. The results are shown in Table 3.

Table 3 Effect of continuous administration of the present invention for 4 weeks on the systolic pressure of the tail artery in rats with renal hypertension ( ±s, mmHg, n=10)

Note: Compared with the sham-operation control group: *P<0.05, **P<0.01; compared with the model control group: #P<0.05, ##P<0.01; compared with the irbesartan group: ▲P<0.05, ▲▲P<0.01; compared with the composition A: ☆P<0.05, ☆☆P<0.01; compared with the composition D: ■P<0.05, ■■P<0.01.

2.2 Effects on diastolic blood pressure in rats with renal hypertension

Compared with the sham operation control group, the diastolic blood pressure of rats in the model control group was significantly increased, and the difference was statistically significant (P＜0.01).

Compared with the model control group, the diastolic blood pressure of the positive drug irbesartan group decreased after 2-4 weeks of administration (P<0.01 or P<0.05); the diastolic blood pressure of the composition A group of the present invention decreased significantly after 2-4 weeks of administration (P<0.01 or P<0.05); there was no significant effect of reducing diastolic blood pressure in the composition B and C groups after 1-4 weeks of administration (P>0.05); the diastolic blood pressure of the composition D group decreased significantly after 2-4 weeks of administration (P<0.01). The effect of composition D on reducing diastolic blood pressure was equivalent to that of composition A (P>0.05), and was significantly better than that of compositions B and C (P<0.05).

This indicates that compositions A and D have the effect of significantly reducing the diastolic blood pressure of rats with renal hypertension, while compositions B and C have no significant antihypertensive effect, and the efficacy of composition D is significantly better than that of compositions B and C. The results are shown in Table 4.

Table 4 Effect of continuous administration of the present invention for 4 weeks on the diastolic pressure of the tail artery in rats with renal hypertension ( ±s, mmHg, n=10)

Note: Compared with the sham-operated control group: *P<0.05, **P<0.01; compared with the model control group: #P<0.05, ##P<0.01; compared with the irbesartan group: ▲P<0.05, ▲▲P<0.01; compared with the composition A: ☆P<0.05, ☆☆P<0.01; compared with the composition D: ■P<0.05, ■■P<0.01.

3. Conclusion

The above pharmacological test results show that compositions A, B, C, and D have the effect of significantly reducing the systolic and diastolic blood pressure of spontaneously hypertensive rats, among which the antihypertensive effect of composition D is better than that of A, B, and C; compositions A and D have the effect of significantly reducing the systolic and diastolic blood pressure of rats with renal hypertension, and compositions B and D have no obvious antihypertensive effect on renal hypertension. This shows that composition D, based on composition A, replaces Poria with Atractylodes macrocephala, and is combined with Achyranthes bidentata, and reduces the dosage of Rauwolfia oleifera, and the antihypertensive effect is significantly enhanced, and the overall efficacy is further improved.

A person skilled in the art should understand that the discussion of any of the above embodiments is merely illustrative and is not intended to imply that the scope of protection of the present application is limited to these examples. In line with the concept of the present application, the technical features in the above embodiments or different embodiments may be combined, the steps may be implemented in any order, and there are many other variations of different aspects of one or more embodiments of the present application as described above, which are not provided in detail for the sake of simplicity.

One or more embodiments of the present application are intended to cover all such substitutions, modifications and variations that fall within the broad scope of the present application. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of one or more embodiments of the present application should be included in the protection scope of the present application.

Claims (11)

1. A Chinese medicine composition for treating hypertension, characterized in that it is made from the following Chinese medicine raw materials in the following weight proportions: 2-4 parts of Gastrodia elata, 1-3 parts of Uncaria rhynchophylla, 3-6 parts of Rauwolfia oleifera, 2-4 parts of Ligusticum chuanxiong, 1-3 parts of Pinellia ternata, 2-5 parts of Chrysanthemum indica, 2-4 parts of Atractylodes macrocephala, 0.8-3 parts of Citrus reticulata, and 2-4 parts of Cyathula capitata. 2. The Chinese medicine composition for treating hypertension according to claim 1 is characterized in that it is made from the following Chinese medicine raw materials in the following weight proportions: 3 parts of Gastrodia elata, 2 parts of Uncaria rhynchophylla, 4 parts of Rauwolfia oleifera, 3 parts of Ligusticum chuanxiong, 2 parts of Pinellia ternata, 3 parts of Chrysanthemum indica, 2 parts of Atractylodes macrocephala, 2 parts of Citrus reticulata, and 3 parts of Cyathula capitata. 3. The Chinese medicine composition for treating hypertension according to any one of claims 1-2, characterized in that it is prepared into a clinically acceptable dosage form. 4. The Chinese medicine composition for treating hypertension according to claim 3, characterized in that it is made into tablets, capsules, granules, pills, and oral liquids. 5. The Chinese medicine composition for treating hypertension according to claim 4, characterized in that it is made into soft capsules, dispersible tablets, orally disintegrating tablets, and dripping pills. 6. A method for preparing a Chinese medicine composition for treating hypertension according to any one of claims 1 to 5, characterized in that 0-70% ethanol aqueous solution is added to the Chinese medicine raw material, extracted 1-3 times, and 4-12 times the amount is added each time; each extraction takes 1-2 hours, the extracts are combined, filtered, the filtrate is taken, the solvent is recovered and concentrated to obtain the product. 7. The preparation method according to claim 6 is characterized in that: 0-70% ethanol aqueous solution is added for extraction twice, 10-12 times the amount is added each time; each extraction takes 1-2 hours, the extract is filtered, the solvent is recovered and concentrated to obtain the product. 8. The preparation method according to claim 6, characterized in that: 0-70% ethanol aqueous solution is added for extraction twice, 6-10 times the amount is added for the first time, and the extraction is carried out for 2 hours, and 4-8 times the amount is added for the second time, and the extraction is carried out for 1 hour; the extract is filtered, the solvent is recovered and concentrated to obtain the product. 9. The preparation method according to claim 8, characterized in that 70% ethanol aqueous solution is added for extraction. 10. The preparation method according to claim 8, characterized in that: before the first extraction, the Chinese medicinal material is soaked for 0.5h. 11. Use of the Chinese medicinal composition for treating hypertension according to any one of claims 1 to 5 or the Chinese medicinal composition for treating hypertension prepared by the preparation method according to any one of claims 6 to 10 in preparing a drug for treating hypertension.