Traditional Chinese medicine composition, antihypertensive active extract, application of antihypertensive active extract, foot bath liquid containing traditional Chinese medicine composition and acupoint patch containing traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition, an antihypertensive active extract and application thereof, and foot bath liquid and acupoint plaster containing the traditional Chinese medicine composition, the composition comprises the following components by weight: 1-5 parts of Radix Ophiopogonis, 1-4 parts of Radix Codonopsis, 1-4 parts of Chinese angelica, 1-4 parts of Ligusticum wallichii, 1-4 parts of Rhizoma Alismatis and 1-2 parts of Platycodon grandiflorum. According to the traditional Chinese medicine composition (formula), radix ophiopogonis and codonopsis pilosula are used as monarch drugs, angelica sinensis and rhizoma alismatis are used as ministerial drugs, ligusticum wallichii is used as an adjuvant drug, platycodon grandiflorum is used as a conductant drug, compatibility is proper, the antihypertensive effect is good, and particularly, the effect of completely curing yin-yang deficiency and phlegm-dampness type hypertension can be achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine compositions, more specifically, to a traditional Chinese medicine composition, a blood pressure lowering active extract and application, a foot bath liquid containing the traditional Chinese medicine composition and an acupoint patch. BACKGROUND

[0002] With the aging of the population and the change of lifestyle, the prevalence of hypertension is showing a trend of significant increase. According to the China Cardiovascular Health and Disease Report 2019 released by the state, there are 330 million patients with cardiovascular diseases in China, of which 245 million are hypertensive. Hypertension is also the most important risk factor for cardiovascular and cerebrovascular diseases, and the main complications such as stroke, coronary heart disease, chronic heart failure and chronic kidney disease have high disability and mortality. Existing antihypertensive Western medicine can effectively control the progression of hypertension and the occurrence of hypertension complications, but hypertensive patients face the situation of needing lifelong medication, which seriously consumes medical and social resources and causes heavy burden to families and the state; in addition, long-term use of antihypertensive drugs has side effects such as damage to the digestive system and liver and kidney function.

[0003] Traditional Chinese medicine has the characteristics of multiple pathways and multiple targets in treatment, and can regulate multiple pathological links that cause high blood pressure while lowering blood pressure, especially in protecting target organs, which has obvious advantages and less side effects, and is an effective means for treating hypertension. However, traditional Chinese medicine is faced with the current situation of large dosage, inconvenience of decoction and low patient compliance.

[0004] CN 102462758 B discloses a traditional Chinese medicine composition for lowering blood pressure and a foot bath liquid preparation thereof, which combines common herbs for treating hypertension such as Radix Cyathulae, Uncaria and Chrysanthemum indicum, and can achieve the effect of lowering blood pressure, but cannot solve the problem of high blood pressure from the root, and still needs lifelong medication. SUMMARY

[0005] Hypertension is equivalent to the category of dizziness, headache and other disease syndromes in traditional Chinese medicine. According to the development of hypertension, traditional Chinese medicine divides hypertension into four types: yang hyperactivity, yang hyperactivity due to yin deficiency, deficiency of both yin and yang, and yang deficiency, involving heart, liver, spleen and kidney, and the fundamental pathogenesis is yang hyperactivity due to yin deficiency, accompanied by wind, fire and phlegm. In the early stage, there are more real, in the middle stage, there are both real and virtual, and in the later stage, there are more virtual. Treatment should be combined with supplementation and purgation, blood circulation and phlegm elimination. The present application mainly designs a traditional Chinese medicine composition for the treatment of hypertension of yin and yang deficiency type with phlegm and dampness in the middle and late stages, which has good antihypertensive effect, especially for hypertension of yin and yang deficiency type with phlegm and dampness, which can achieve complete cure effect.

[0006] To achieve the above-mentioned purpose, the technical scheme adopted by the present application is as follows:

[0007] A traditional Chinese medicine composition, which is composed of the following components in parts by weight: Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, Platycodon grandiflorum 1-2 parts.

[0008] As a preferred embodiment of the present application, the composition is composed of the following components in parts by weight: Ophiopogon japonicus 5 parts, Codonopsis pilosula 3 parts, Angelica sinensis 3 parts, Ligusticum chuanxiong 4 parts, Alisma orientale 4 parts, Platycodon grandiflorum 2 parts.

[0009] The present application also provides a blood pressure lowering active extract, which is a water extract of the above-mentioned traditional Chinese medicine composition or the preferred traditional Chinese medicine composition.

[0010] The present application also provides a preparation method of the blood pressure lowering active extract, which comprises the following steps: weighing Ophiopogon japonicus, Codonopsis pilosula, Angelica sinensis, Ligusticum chuanxiong, Alisma orientale and Platycodon grandiflorum in proportion, crushing them into coarse powder, soaking them in water, ultrasonic treatment, filtration, collection of the filtrate; decocting the residue in water, filtration, combination of the decocting liquid and the ultrasonic extraction liquid, concentration, recovery of solvent, and freeze-drying to obtain the blood pressure lowering active extract.

[0011] The present application also provides the use of the above-mentioned blood pressure lowering active extract in the preparation of a drug for lowering the plasma ET-1 level and increasing the serum NO level of a patient.

[0012] As a preferred embodiment of the present application, the patient includes a hypertensive patient, a CHD patient, an ACI patient, an OSAHS patient, a DN patient, an OSAHS patient complicated with type 2 diabetes, and an acute myocardial ischemia patient.

[0013] The present application also provides a foot bath liquid containing a traditional Chinese medicine composition, which comprises water and effective components, and the traditional Chinese medicine composition is composed of the following components in parts by weight: Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, and Platycodon grandiflorum 1-2 parts; the traditional Chinese medicine composition is mixed in proportion, crushed, and the decocting liquid and residue after water decoction are used as the effective components of the foot bath liquid.

[0014] The present application also provides a preparation method of the foot bath liquid containing a traditional Chinese medicine composition, which comprises the following steps: mixing Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, and Platycodon grandiflorum 1-2 parts in proportion, crushing, passing through a No. 1 sieve, adding 10 times the amount of water, heating decoction, boiling for 10-15 minutes after the water is boiled, naturally cooling, and taking an appropriate amount of the foot bath liquid when the temperature is 32-36℃.

[0015] The application also provides an acupoint patch containing a traditional Chinese medicine composition, the acupoint patch comprising a blank acupoint patch and effective components filled in the blank acupoint patch, and the traditional Chinese medicine composition comprises, by weight, 1-5 parts of Ophiopogon japonicus, 1-4 parts of Codonopsis pilosula, 1-4 parts of Angelica sinensis, 1-4 parts of Chuanxiong Rhizoma, and 1-2 parts of Rhizoma Platycodi; the Ophiopogon japonicus, Codonopsis pilosula, Rhizoma Platycodi and Rhizoma Pinelliae in the traditional Chinese medicine composition are concentrated after being soaked and decocted with water, and the concentrated liquid is mixed with fine powder of Angelica sinensis and Chuanxiong Rhizoma to form a thick paste as the effective components of the acupoint patch.

[0016] The application also provides a preparation method of the acupoint patch containing the traditional Chinese medicine composition, and the specific steps are as follows.

[0017] (1) Ophiopogon japonicus, Codonopsis pilosula, Rhizoma Platycodi and Rhizoma Pinelliae are weighed according to the proportion, soaked in water for 20-40 minutes, and decocted twice for 20-40 minutes each time, and then the extraction liquids are combined and concentrated to obtain a mixed extraction liquid with a relative density of 1.2-2.0 g / mL;

[0018] (2) Angelica sinensis and Chuanxiong Rhizoma are crushed, and the medicinal ingredients are mixed according to the proportion, crushed into fine powder that can pass through a No. 5 sieve and not less than 95% of which can pass through a No. 6 sieve;

[0019] (3) the fine powder of step (2) and the mixed extraction liquid of step (1) are mixed according to the proportion to prepare a thick paste with moderate dryness and moisture, and the thick paste is filled in the blank acupoint patch to obtain the acupoint patch.

[0020] The application has the following advantages and beneficial effects:

[0021] (1) The traditional Chinese medicine composition provided by the application has the advantages of safety, effectiveness, stability and economy, and has a complete cure case for patients with yin and yang deficiency and phlegm-dampness resistance, which solves the problem of high blood pressure from the root and avoids lifelong medication.

[0022] (2) The traditional Chinese medicine composition provided by the application can be used for foot bath or pasting, which is convenient to use and solves the problem of low patient compliance; in addition, foot bath can make the active ingredients of the medicine directly reach the acupoints, significantly reduce the dosage, and achieve a treatment effect with small amount and remarkable effect.

[0023] (3) The traditional Chinese medicine composition provided by the application contains multiple effective components, and the saponin components (Platycodon saponin) in the traditional Chinese medicine composition can promote the dissolution of other active components during water decoction and extraction, thereby enhancing the drug efficacy and significantly reducing the blood pressure.

[0024] (4) The traditional Chinese medicine composition provided by the application takes Ophiopogon japonicus and Codonopsis pilosula as monarch drugs, Angelica sinensis and Rhizoma Platycodi as ministerial drugs, Chuanxiong Rhizoma as auxiliary drugs, and Rhizoma Pinelliae as ministerial drugs, and the combination of these drugs can play the roles of multi-target regulation, blood pressure reduction and improvement of hypertension complications.

[0025] (5) The antihypertensive active extract can reduce the plasma ET-1 level of a patient, and increase the serum NO level, and is beneficial to patients with hypertension, CHD, ACI, OSAHS, DN, OSAHS combined with type 2 diabetes, and acute myocardial ischemia. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 The antihypertensive effects of the traditional Chinese medicine composition in different administration modes are compared, wherein the dosage of oral administration 1 is the same as that of foot bath, and the dosage of oral administration 2 is three times that of foot bath.

[0027] Figure 2 The effects of the antihypertensive active extract on the systolic pressure of rats.

[0028] Figure 3 The effects of the antihypertensive active extract on the diastolic pressure of rats. DETAILED DESCRIPTION

[0029] The application discloses a traditional Chinese medicine composition for reducing blood pressure, and application, a foot bath liquid containing the traditional Chinese medicine composition for reducing blood pressure and an acupoint patch.

[0030] The application mainly designs a formula for hypertension in the middle and late stages of yin and yang deficiency combined with phlegm-dampness, the traditional Chinese medicine composition (formula) takes Ophiopogon japonicas (Linn. f) Ker-Gawl. and Codonopsis pilosula (Franch) Nannf as monarch drugs, Angelica sinensis and Alisma orientale as ministerial drugs, Ligusticum chuanxiong as an auxiliary drug, and Platycodon grandiflorum as a ministerial drug, and is prepared by compounding the monarch drugs, the ministerial drugs, the auxiliary drug and the ministerial drug according to the following weight proportions: 1-5 parts of Ophiopogon japonicas (Linn. f) Ker-Gawl., 1-4 parts of Codonopsis pilosula (Franch) Nannf, 1-4 parts of Angelica sinensis, 1-4 parts of Ligusticum chuanxiong, 1-4 parts of Alisma orientale and 1-2 parts of Platycodon grandiflorum.

[0031] In the traditional Chinese medicine composition:

[0032] Ophiopogon japonicas (Linn. f) Ker-Gawl. is the dried tuber of Ophiopogon japonicas (Linn. f) Ker-Gawl. in the Liliaceae family. Ophiopogon japonicas (Linn. f) Ker-Gawl. tastes sweet and slightly bitter, is slightly cold in nature, and is related to the heart, lung and stomach channels, and has the effects of nourishing yin and generating fluid, moistening the lung and clearing the heart, and is used for treating yin deficiency consumption, fluid deficiency thirst, internal heat and thirst, and insomnia.

[0033] Codonopsis pilosula (Franch) Nannf is the dried root of Codonopsis pilosula (Franch) Nannf in the Codonopsis family. Codonopsis pilosula (Franch) Nannf tastes sweet and is flat in nature, and is related to the spleen and lung channels, and has the effects of invigorating the spleen and lung, nourishing blood and generating fluid, and is used for treating deficiency of the spleen and lung, deficiency of blood and fluid, and internal heat and thirst.

[0034] Angelica sinensis (Oliv.) Diels. Radix Angelicae sinensis is the dried root of Angelica sinensis (Oliv.) Diels. Angelica sinensis is warm in nature and sweet in taste, and belongs to the meridians of the liver, heart and spleen. It has the functions of tonifying blood, activating blood, regulating menstruation and relieving pain, and is used for blood deficiency, dizziness, palpitation and other symptoms.

[0035] Ligusticum chuanxiong hort. The dried rhizome of Ligusticum chuanxiong hort. is a member of the Umbelliferae family. Chuanxiong is warm in nature and bitter and slightly bitter in taste, and belongs to the meridians of the liver, gallbladder and pericardium. It has the effects of activating blood and resolving stasis, dispelling wind and relieving pain, and moving qi and relieving depression. It is used to treat various cardiovascular and cerebrovascular diseases such as atherosclerosis, ischemic stroke, angina pectoris, hypertension and migraine.

[0036] Alisma orientalis (Sam.) Juzep. The dried tuber of Alisma orientalis (Sam.) Juzep. is a member of the Alismataceae family. It is sweet and cold in nature, and belongs to the meridians of the kidney and bladder. It has the effects of promoting water and reducing swelling, and is used for edema, difficulty urinating, diarrhea, turbid urine, leukorrhea and phlegm retention.

[0037] Platycodon grandiflorus (Jacq.) A.Dc. The dried root of Platycodon grandiflorus (Jacq.) A.Dc. is a member of the Campanulaceae family. It is bitter and pungent in nature, and belongs to the lung meridian. It has the effects of promoting the lungs, benefiting the throat, expelling phlegm and expelling pus, and is used for cough with much phlegm, chest tightness, sore throat and hoarseness, and lung abscess with pus.

[0038] The traditional Chinese medicine composition is properly matched, and has good antihypertensive effect, especially for hypertension with yin and yang deficiency and phlegm-dampness, which can achieve complete cure.

[0039] The application will be further described in detail in combination with the accompanying drawings and examples.

[0040] Example 1

[0041] The antihypertensive traditional Chinese medicine composition provided in this example is composed of the following components by weight fraction: Ophiopogon japonicus 5g, Codonopsis pilosula 3g, Angelica sinensis 3g, Ligusticum chuanxiong hort. 4g, Alisma orientalis 4g, and Platycodon grandiflorus 2g.

[0042] In this example, the above-mentioned antihypertensive traditional Chinese medicine composition is mixed and crushed into coarse powder. Water is added and soaked for 1 hour, the solid-liquid ratio is 1:10, and ultrasonic extraction is performed at 40°C for 30 minutes. The filtrate is collected by filtration. The filtrate is added with water and decocted for extraction twice, the solid-liquid ratio is 1:5, and each time is 30 minutes. The filtrate is collected by filtration, and the decocting liquid and the ultrasonic extraction liquid are combined. The combined liquid is concentrated, the solvent is recovered, and the freeze-dried to obtain the compound antihypertensive active extract.

[0043] Example 2

[0044] The embodiment provides a preparation method of foot bath liquid containing a traditional Chinese medicine composition for reducing blood pressure, and the specific steps are as follows: the traditional Chinese medicine composition for reducing blood pressure in embodiment 1 is mixed in proportion, crushed, passed through a No. 1 sieve, 10 times the amount of water is added, heated and decocted, and after the water is boiled, the decoction is boiled for 10 minutes on a small fire.

[0045] The above amount is a dose for one time of foot therapy. During the foot therapy, the temperature of the foot bath liquid (foot therapy) is 32-36 DEG C, the amount of the foot bath liquid is appropriate to reach the calf, and the foot bath time is 30 minutes; in the first 2 weeks, the foot bath is performed once a day, after 2 weeks, the foot bath is continuously performed 5 times a week, and 2 months are a treatment course.

[0046] Embodiment 3

[0047] The embodiment provides a preparation method of acupoint paste containing a traditional Chinese medicine composition for reducing blood pressure, and the specific steps are as follows:

[0048] (1) 5g of ophiopogon japonicus, 3g of radix codonopsis, 4g of alisma orientalis and 2g of platycodon grandiflorum are weighed, soaked in water for 30 minutes, decocted twice for 30 minutes each time, the extraction liquids are combined, and concentrated to obtain a mixed extraction liquid with a relative density of 1.2-2.0g / mL;

[0049] (2) angelica and ligusticum wallichii are crushed, and the medicinal ingredients are mixed in proportion (3g of angelica and 4g of ligusticum wallichii), crushed into fine powder which can pass through a No. 5 sieve and 95% or more of which can pass through a No. 6 sieve;

[0050] (3) the fine powder in step (2) and the mixed extraction liquid in step (1) are mixed to prepare a thick paste with moderate dryness and wetness, and the paste is filled into blank acupoint pastes to obtain acupoint pastes.

[0051] The above amount is a dose for one time of foot therapy. During the foot therapy, the temperature of the foot bath liquid (foot therapy) is 32-36 DEG C, the amount of the foot bath liquid is appropriate to reach the calf, and the foot bath time is 30 minutes; in the first 2 weeks, the foot bath is performed once a day, after 2 weeks, the foot bath is continuously performed 5 times a week, and 2 months are a treatment course.

[0052] I. The present application uses the blood pressure reducing active extract in embodiment 1, the foot bath liquid in embodiment 2 and the acupoint paste in embodiment 3 to conduct human body tests, and verifies the influence of the traditional Chinese medicine composition on blood pressure of patients with hypertension.

[0053] Test objects and screening standards of patients with hypertension:

[0054] 1. Screening standards:

[0055] 1) Patients with hypertension without cardiovascular surgery and foot trauma and inflammation.

[0056] 2) Hypertension diagnostic criteria: patients with a history of hypertension, without taking or taking antihypertensive drugs, continuous 3 days of blood pressure systolic pressure > 140 mmHg and (or) diastolic pressure > 90 mmHg is diagnosed as hypertension.

[0057] 3) Total number of cases: 41 cases; among them, 20 cases of foot bath; 10 cases of acupoint sticking; 11 cases of oral.

[0058] 4) Different types of hypertension patients diagnosed on the basis of:

[0059] (a) Yin and Yang deficiency type of hypertension features: performance of anorexia, fatigue, palpitation, shortness of breath, pulse thin and weak.

[0060] (b) Phlegm resistance type of hypertension features: performance of headache, drowsiness, sticky stool, tongue fat, slippery pulse.

[0061] The following list, each type has corresponding two or more signs.

[0062] 2, efficacy evaluation criteria:

[0063] Marked effect: ① diastolic pressure decreased by > 10 mmHg and reached normal range; or ② diastolic pressure decreased by ≥ 20 mmHg or more.

[0064] Effective: ① diastolic pressure decreased by ≤ 10 mmHg and reached normal range (60-90 mmHg); or ② diastolic pressure decreased by < 10-20 mmHg, but not reached normal range; or ③ systolic pressure decreased by > 30 mmHg or more.

[0065] Invalid: blood pressure did not meet the above criteria.

[0066] Total effective rate: the proportion of the total number of people who are effective and effective.

[0067] Human trial results:

[0068] After 41 people tried, the results showed that foot bath and sticking effect is better than oral effect, and the amount is less.

[0069] 1, foot bath results: 20 cases of hypertension patients, foot bath 2 weeks after the results as shown in Table 1 and Figure 1 The effective rate of foot bath for one week is 60%, and the total effective rate of foot bath for two weeks is 95%.

[0070] 2, acupoint sticking results: 10 cases of hypertension patients, sticking 2 weeks after the results as shown in Table 2 and Figure 1 The effective rate of foot bath for one week is 60%, and the total effective rate of foot bath for two weeks is 95%.

[0071] 3. Oral results: 5 patients with hypertension, the dose was equal to the foot bath dose (oral administration of the compound antihypertensive active extract of Example 1 from 6am to 8am), the blood pressure level after 2 weeks is shown in Table 3 and Figure 1 as shown, the total effective rate after 1 week was 0%, and the total effective rate after 2 weeks was 20%.

[0072] 6 patients with hypertension, the dose was 3 times of the foot bath dose (oral administration of 3 times of the antihypertensive active extract of Example 1 from 6am to 8am), the blood pressure level after 2 weeks is shown in Table 4 and Figure 1 as shown, the total effective rate after 1 week was 50%, and the total effective rate after 2 weeks was 66.67%.

[0073] Table 1 Effect of the Chinese medicine composition (foot bath) on blood pressure of patients with hypertension

[0074]

[0075]

[0076] Table 2 Effect of the Chinese medicine composition (acupoint sticking) on blood pressure

[0077]

[0078] Table 3 Effect of the Chinese medicine composition (oral administration) on blood pressure of patients with hypertension (the dose is equal to the foot bath dose)

[0079]

[0080]

[0081] Table 4 Effect of the Chinese medicine composition (oral administration) on blood pressure of patients with hypertension (the dose is 3 times of the foot bath dose)

[0082]

[0083] The present application carries out follow-up tracking on 20 patients who perform foot bath, and it is found that after 2 months of foot bath with the Chinese medicine composition of the present application, 15% of the patients with hypertension (patients with hypertension of yin and yang deficiency and phlegm-dampness resistance type) are completely cured, and after the cure, they do not need to take antihypertensive drugs and do not need to perform foot bath, and normal diet can maintain the systolic pressure at 90-130mmHg and the diastolic pressure at 60-90mmHg.

[0084] Secondly, the antihypertensive active extract of Example 1 is used to carry out pharmacodynamic test, to verify the regulation effect of the Chinese medicine composition on blood pressure of spontaneous hypertension rats.

[0085] 1. Experimental materials:

[0086] 8 male Wistar rats, 32 spontaneously hypertensive rats (SHR), 16 males and 16 females, 8 weeks old, weighing 220 - 280 g. Shanghai Model Organisms Center, Inc., License No.: SCXK(Shanghai)2019 - 0002, Rat Nitric Oxide (NO) ELISA Kit (Lot No.: MM20607R1), Rat Endothelin - 1 (ET - 1) ELISA Kit (MM0560R1), Jiangsu Feiya Biotechnology Co., Ltd.

[0087] 2. Experimental Methods and Results:

[0088] 1) Effect of the Traditional Chinese Medicine Composition on the Blood Pressure of Spontaneously Hypertensive Rats

[0089] Animal Grouping and Administration: The spontaneously hypertensive rats (SHR) were divided into 4 groups: model control group, positive drug control group, high - dose compound group, and low - dose compound group, with 8 rats in each group. The normal control group was Wistar rats, totaling 5 groups. The administration doses for each group were as follows: valsartan in the positive control group at 10 mg / kg / day, the antihypertensive active extract in the high - dose compound group at 400 mg / kg / day, the antihypertensive active extract in the low - dose compound group at 100 mg / kg / day. The model control group and the normal control group were given an equal volume of normal saline. Administration was continuous for 8 weeks.

[0090] Blood Pressure Monitoring: An non - invasive tail - cuff plethysmograph was used to detect the blood pressure changes of rats in each group. Measurement was performed 2 hours after administration every week for 8 weeks. Ensure that the rats were awake and in a quiet environment during measurement, and the measurement process should be gentle to avoid irritating the rats and causing blood pressure fluctuations. Record the systolic and diastolic blood pressures of rats in each group. Each blood pressure measurement was repeated 3 times and the average value was taken.

[0091] Data Processing: SPSS 24.0 software was used for statistical processing. The data was expressed as and ANOVA variance analysis for comparing the means of multiple samples was used.

[0092] Experimental Results:

[0093] As Figure 2 shown, the antihypertensive active extract of Example 1 of the present invention can effectively reduce the systolic blood pressure of SHR rats, and among these two doses, the larger the dose, the greater the blood pressure reduction. The high - dose compound group showed a significant difference compared with the valsartan group (P < 0.05).

[0094] As Figure 3 shown, the antihypertensive active extract of Example 1 of the present invention can effectively reduce the diastolic blood pressure of SHR rats, and within a certain dose range, the blood pressure reduction amplitude is proportional to the dose. Among them, the high - dose compound group showed a significant difference compared with the valsartan group (P < 0.05).

[0095] 2) Effect of Chinese medicine composition on vascular active substances of spontaneous hypertension rats

[0096] Vascular active substance index detection: after the last administration, the rats were anesthetized by intraperitoneal injection of 3% sodium pentobarbital (30 mg·kg-1), 8 mL of blood was taken from the abdominal aorta, and the supernatant was obtained by centrifugation at 3500 rpm for 10 min, and the levels of endothelin 1 (ET-1) and nitric oxide (NO) were determined by enzyme-linked immunoassay (ELISA).

[0097] Experimental results:

[0098] As shown in Table 5, the compound administration group and the positive drug control group significantly increased the NO content of SHR rats (P<0.05), and the high and low dose compound groups had significant differences compared with the positive control group (P<0.05), the compound administration group and the positive drug control group reduced the content of ET-1 in SHR rats, and had statistical significance (P<0.05), and the high dose compound group had significant difference compared with the positive control group (P<0.05).

[0099] Table 5 ET-1 and NO in plasma of rats in each group n=8

[0100]

[0101]

[0102] Note: compared with the normal control group, a P<0.05; compared with the model group, b P<0.05; compared with the treatment group and the positive control group, c P<0.05.

[0103] Therefore, the antihypertensive active extract provided by the present application can be applied in the preparation of drugs for reducing the plasma ET-1 level and increasing the serum NO level of patients, wherein the patients include hypertensive patients, CHD patients, ACI patients, OSAHS patients, DN patients, OSAHS patients complicated with type 2 diabetes, and acute myocardial ischemia patients.

[0104] Analysis of antihypertensive mechanism of the Chinese medicine composition in the present application:

[0105] Compatibility principle: TCM divides hypertension into several types, including liver yang hyperactivity, yin deficiency and yang hyperactivity, liver and kidney yin deficiency, spleen deficiency and phlegm, liver wind, phlegm turbidity and blood stasis. Ophiopogon japonicus is cold in flavor and sweet in taste, and can nourish yin and produce fluid. Codonopsis pilosula is sweet in flavor and can tonify qi and nourish blood. The two herbs can nourish yin and dryness, tonify qi and nourish blood, and are the monarch herbs. Angelica sinensis is warm in flavor and can nourish blood and remove blood stasis. Alisma orientalis can remove water and swelling. The two herbs can nourish blood, remove dampness and remove blood stasis, and are the ministerial herbs. Chuanxiong is warm in flavor and can promote blood circulation. It is the auxiliary herb. The prunella vulgaris can remove phlegm and pus. The formula uses tonification and reduction, upward and downward transmission, tonification of yin and yang, and removal of blood stasis. It is mainly used for the treatment of hypertension caused by yin and yang deficiency and phlegm and dampness.

[0106] Acupoint analysis: TCM treats hypertension mainly through four acupoints, namely, Baihui, Yongquan, Kunlun and Taichong. The last three acupoints are all located in the foot. Yongquan is the first acupoint of the kidney meridian, and it plays an important role in stabilizing blood pressure. Kunlun is one of the main acupoints of the bladder meridian, and it can treat headache and hypertension. It can make the blood in the whole body from the head to the tip of the foot smooth, promote metabolism and blood circulation, and stabilize blood pressure. Taichong can treat headache, dizziness, hypertension and cerebrovascular disease. It has the functions of calming the liver and suppressing yang, promoting qi and relieving depression, thereby achieving the effect of lowering blood pressure and helping the treatment of primary hypertension. Acupoints are special parts of the body where the organs, meridians, blood and qi are injected and withdrawn. They have strong chemical sensitivity and high sensitivity. Foot bath can make the active ingredients of drugs directly reach the acupoints, achieving a small amount of effective treatment.

[0107] Meridian analysis: The kidney meridian, liver meridian and spleen meridian run through the foot. These three meridians are the main meridians for treating edema, headache and dizziness caused by hypertension. The active ingredients of the compound penetrate and absorb through the skin of the foot, run through the kidney, liver and spleen, and distribute throughout the body, regulating the functions of the heart, blood vessels and kidneys, and achieving the effect of lowering blood pressure.

[0108] Chemical component analysis: After superfine grinding of traditional Chinese medicinal materials, the particle size is small, the specific surface area is greatly increased, and the dissolution of active ingredients is increased. The dissolution of active ingredients such as ophiopogonin, prunella saponin, ligusticum lactone, chuanxiongazine, alismol, flavonoids and codonopsis polysaccharide is increased, and the dissolution of unknown trace active ingredients is also increased. The multi-target synergistic effect between components ultimately achieves a small amount of effective treatment. In addition, saponins such as prunella saponin have surfactant effects, which can promote the dissolution of other active ingredients and enhance the efficacy.

[0109] Pharmacological analysis: the party in the formula has the regulation nerve-endocrine-immune system; Ophiopogon japonicus has the effect of anti-thrombosis, improving microcirculation, anti-myocardial ischemia, protecting cardiovascular endothelium; Angelica sinensis has the effect of improving blood rheology, anti-thrombosis, improving atherosclerosis, promoting hematopoiesis; Alisma orientalis has the effect of diuresis, protecting vascular endothelium, reducing blood lipids, improving blood vessels, promoting blood circulation; Chuanxiong has the effect of expanding blood vessels, reducing blood pressure, anti-thrombosis, treating hypertension; Anemarrhena asphodeloides has the effect of reducing blood sugar, reducing blood lipids, eliminating phlegm. Hypertensive patients generally have high blood lipids, atherosclerosis, poor microcirculation, and poor heart and kidney function. The compatibility of these drugs can play the role of multi-target regulation, reducing blood pressure, and improving the complications of hypertension.

[0110] Ophiopogon japonicus, Radix Codonopsis, Angelica sinensis, Chuanxiong, Alisma orientalis and Anemarrhena asphodeloides are commonly used traditional Chinese medicines. Angelica sinensis and Chuanxiong are commonly used in the treatment of cardiovascular system diseases. Ophiopogon japonicus is used for yin deficiency, and Radix Codonopsis is used for qi deficiency. Both of them are commonly used in tonifying deficiency drugs. Alisma orientalis is a diuretic and dampness-removing drug, mainly used for improving kidney function. Anemarrhena asphodeloides is a phlegm-eliminating and cough-relieving drug. There are few traditional Chinese medicines for treating hypertension or other cardiovascular diseases containing Ophiopogon japonicus, Radix Codonopsis, and Anemarrhena asphodeloides. So far, there is no application of the compatibility of these six drugs, especially in the antihypertensive formula.

[0111] The above is a specific embodiment of the present application, but the protection scope of the present application is not limited thereto, any skilled person in the art can easily think of changes or replacements within the technical range disclosed by the present application, which should be covered within the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A traditional Chinese medicine composition, characterized in that, The composition consists of the following components in parts by weight: Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, Platycodon grandiflorum 1-2 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The composition consists of the following components in parts by weight: Ophiopogon japonicus 5 parts, Codonopsis pilosula 3 parts, Angelica sinensis 3 parts, Ligusticum chuanxiong 4 parts, Alisma orientale 4 parts, Platycodon grandiflorum 2 parts.

3. A blood pressure lowering active extract, characterized in that, The antihypertensive active extract is a water extract of the traditional Chinese medicine composition of claim 1 or 2.

4. The method for the preparation of the antihypertensive active extract according to claim 3, characterized in that, The specific steps are as follows: Ophiopogon japonicus, Codonopsis pilosula, Angelica sinensis, Ligusticum chuanxiong, Alisma orientale and Platycodon grandiflorum are weighed according to the proportion, crushed into coarse powder, soaked with water, treated with ultrasonic, filtered, and the filtrate is collected; the residue is decocted with water, filtered, and the decocting liquid and the ultrasonic extraction liquid are combined, concentrated, solvent is recovered, and freeze-dried to obtain the antihypertensive active extract.

5. The use of the antihypertensive active extract of claim 3 in the preparation of a drug for reducing the plasma ET-1 level and increasing the serum NO level of a patient.

6. Use according to claim 5, characterized in that, The patient includes a hypertensive patient, a CHD patient, an ACI patient, an OSAHS patient, a DN patient, an OSAHS patient complicated with type 2 diabetes, and an acute myocardial ischemia patient.

7. A foot bath liquid containing traditional Chinese medicine composition, the foot bath liquid comprising water, an effective component, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, and Platycodon grandiflorum 1-2 parts; the traditional Chinese medicine composition is mixed according to the proportion, crushed, and the liquid and residue after water decoction are used as the effective components of the foot bath liquid.

8. The method for preparing the foot bath liquid containing traditional Chinese medicine composition according to claim 7, characterized in that, The specific steps are as follows: Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, and Platycodon grandiflorum 1-2 parts are mixed according to the proportion, crushed, and passed through a No. 1 sieve, 10 times the amount of water is added, heated and decocted, and after boiling, small fire is used for decocting for 10-15 minutes, and when the temperature is 32-36℃, an appropriate amount is taken for foot bath, and the amount of foot bath liquid is appropriate to reach the calf.

9. An acupoint patch containing a traditional Chinese medicine composition, the acupoint patch comprising a blank acupoint patch, and an effective component filled in the blank acupoint patch, characterized in that, The traditional Chinese medicine composition consists of the following components in parts by weight: Ophiopogon japonicus 1-5 parts, Codonopsis pilosula 1-4 parts, Angelica sinensis 1-4 parts, Ligusticum chuanxiong 1-4 parts, Alisma orientale 1-4 parts, and Platycodon grandiflorum 1-2 parts; Ophiopogon japonicus, Codonopsis pilosula, Alisma orientale and Platycodon grandiflorum in the traditional Chinese medicine composition are soaked and decocted with water, the liquid is concentrated, and the concentrated liquid is mixed with the fine powder of Angelica sinensis and Ligusticum chuanxiong to prepare a thick paste as the effective component of the acupoint patch.

10. The method for preparing the acupoint patch containing traditional Chinese medicine composition according to claim 9, characterized in that, The specific steps are as follows: (1) Ophiopogon japonicus, Codonopsis pilosula, Alisma orientale and Platycodon grandiflorum are weighed according to the proportion, soaked with water for 20-40 minutes, and decocted twice for 20-40 minutes each time, and the extraction liquid is combined and concentrated to obtain a mixed extraction liquid with a relative density of 1.2-2.0 g / mL; (2) Angelica sinensis and Ligusticum chuanxiong are crushed, mixed according to the proportion, and crushed into fine powder that can pass through a No. 5 sieve and not less than 95% can pass through a No. 6 sieve; (3) the fine powder of step (2) and the mixed extraction liquid of step (1) are mixed according to the proportion to prepare a thick paste with moderate dryness and moisture, and filled into a blank acupoint patch to obtain the acupoint patch.

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