CN117959387B - Traditional Chinese medicine composition for treating hypertension, preparation method and application - Google Patents
Traditional Chinese medicine composition for treating hypertension, preparation method and application Download PDFInfo
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- CN117959387B CN117959387B CN202410176366.8A CN202410176366A CN117959387B CN 117959387 B CN117959387 B CN 117959387B CN 202410176366 A CN202410176366 A CN 202410176366A CN 117959387 B CN117959387 B CN 117959387B
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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
Technical Field
The invention belongs to the technical field of medicines, and particularly relates to a traditional Chinese medicine composition for treating hypertension, a preparation method and application thereof.
Background
Hypertension is a clinical syndrome characterized by elevated systemic arterial systolic pressure (SBP) and/or diastolic pressure (DBP).
Currently, six major classes of drugs for treating hypertension in western medicine are still the main antihypertensive drugs for clinical application. Most western medicines have certain side effects, such as adrenergic beta-receptor blocking medicines like propranolol, and patients with asthma cannot take the medicines, and if the medicines are taken excessively, heart conduction block and abnormal blood fat and blood sugar can be caused; the nifedipine and other calcium ion antagonists can cause symptoms such as edema of feet, redness of face, acceleration of heartbeat and the like; reserpine can cause sexual hypofunction, etc., in addition to gastric ulcers. The antihypertensive effect of the traditional Chinese medicine is lower than that of western medicines, but the traditional Chinese medicine has the advantages of overall regulation, mild antihypertensive effect, fewer side effects and the like. Unfortunately, the use of traditional Chinese medicine in the field of treating hypertension has been unsuccessful. Therefore, the developed compound traditional Chinese medicine with definite antihypertensive effect, small side effect and suitability for long-term administration has good social and economic significance.
Hypertension belongs to the category of dizziness, headache and the like in traditional Chinese medicine, and the dizziness can be localized in liver and kidney, is the symptom of deficiency and excess of the principal and subordinate symptoms, the principal deficiency is yin deficiency of liver and kidney, and the principal and excess is hyperactivity of liver yang and phlegm stasis obstructing collaterals. Liver yang transforming wind and blood stasis transforming wind all belong to the category of wind-qi internal-movement, so its pathogenesis can be summarized by deficiency, blood stasis, phlegm and wind. The patent ZL201010125992.2 which is authorized by the inventor of the application discloses a traditional Chinese medicine composition for treating hypertension, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 1 to 2 parts of Ligusticum wallichii, 1.5 to 2 parts of uncaria and 1 to 1.5 parts of dwarf lilyturf tuber, but the effects of the traditional Chinese medicine composition on the aspects of suppressing hyperactive liver, suppressing yang hyperactivity, calming endogenous wind, promoting blood circulation, resolving phlegm, relieving dizziness and lasting efficacy are still to be improved. 201410362490X discloses a traditional Chinese medicine composition for treating hypertension, which is prepared from the following traditional Chinese medicine raw materials in parts by weight: 0.5 to 2 parts of uncaria, 1 to 2 parts of ligusticum wallichii, 1 to 2 parts of angelica sinensis, 0 to 4 parts of devilpepper and 0 to 4 parts of apocynum venetum, can effectively improve each traditional Chinese medicine symptom of patients with hypertension yin deficiency and yang excess and blood stasis collateral obstruction, but has the problems of small blood pressure reduction amplitude and non-durable effect in clinical application, and still needs to be improved in the aspect of blood pressure reduction curative effect. CN107648479a discloses a traditional Chinese medicine formula for treating hypertension and a product thereof, wherein the traditional Chinese medicine comprises the following raw materials in parts by weight: 3 parts of gastrodia tuber, 2 parts of uncaria, 5 parts of devilpepper, 3 parts of szechuan lovage rhizome, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum flower, 2 parts of poria cocos and 2 parts of dried orange peel. The curative effect is still to be further improved.
Disclosure of Invention
The invention aims at overcoming the defects in the prior art and providing a traditional Chinese medicine composition for treating hypertension, a preparation method and application thereof so as to further improve the antihypertensive effect.
The invention relates to a traditional Chinese medicine composition for treating hypertension, which 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.
As an optimal embodiment, the traditional Chinese medicine composition for treating hypertension is prepared from the following traditional Chinese medicine raw materials in parts by weight: 3 parts of gastrodia tuber, 2 parts of uncaria, 4 parts of devilpepper, 3 parts of szechuan lovage rhizome, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum flower, 2 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 3 parts of medicinal cyathula root.
The compound Chinese medicine can be decocted for administration, or extracted with water or ethanol for administration.
As one example, a clinically acceptable dosage form is made.
As one example, the composition can be made into tablet, capsule, granule, pill, or oral liquid.
As one example, soft capsule, dispersible tablet, orally disintegrating tablet, and dripping pill are prepared.
The invention provides a preparation method of a traditional Chinese medicine composition for treating hypertension, which comprises the following steps: adding 0-70% ethanol water solution (0% ethanol water solution is water, and the concentration of the invention is volume concentration) into the traditional Chinese medicine raw materials, extracting for 1-3 times, and adding 4-12 times of ethanol water solution each time; extracting for 1-2 hours each time, combining the extracting solutions, filtering, recovering the solvent, concentrating, drying and preparing into clinically acceptable dosage forms.
Preferably, the extraction solvent is 30% to 70% ethanol aqueous solution, more preferably 70% ethanol aqueous solution.
As one example, adding 0-70% ethanol water solution for 2 times, each time adding 10-12 times; extracting for 1-2 hr each time, filtering the extractive solution, recovering solvent, and concentrating.
As one example, adding 0-70% ethanol water solution for 2 times, adding 6-10 times of water for 2 hours for the first time, adding 4-8 times of water for 1 hour for the second time; filtering the extractive solution, recovering solvent, and concentrating.
As one example, the Chinese medicinal materials are soaked for 0.5h before the first extraction.
The invention provides an application of a traditional Chinese medicine composition for treating hypertension in preparing a medicine for treating hypertension.
The invention has the beneficial effects that the prescription has combined medicinal ingredients, has the functions of suppressing hyperactive liver, suppressing yang hyperactivity, calming endogenous wind, clearing heat, removing blood stasis and eliminating phlegm, and is used for treating hypertension belonging to liver yang hyperactivity and phlegm stasis. Pharmacodynamic studies have shown that: the compound traditional Chinese medicine can obviously reduce the systolic pressure and the diastolic pressure of model animals with spontaneous hypertension and renal hypertension, and has lasting antihypertensive effect.
The invention enhances the effects of activating blood circulation, removing blood stasis and dredging collaterals after adjusting the prescription, and has more remarkable antihypertensive effect.
Detailed Description
For the purpose of illustrating the invention in further detail, specific examples are given for the purpose of illustration only and are not intended to limit the scope of the invention.
EXAMPLE 1 granule dosage form of the pharmaceutical composition of the present invention
3 Parts of gastrodia elata, 2 parts of uncaria, 4 parts of devilpepper, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 3 parts of radix cyathulae are taken, soaked in water for 0.5 hour and then extracted for 2 times, the water addition amount is respectively 12 times and 10 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrates are combined, the concentration and the drying are carried out, the dry extract powder of the pharmaceutical composition is obtained after the pulverization, and then the granule is prepared.
EXAMPLE 2 tablet dosage form of the pharmaceutical composition of the invention
2 Parts of gastrodia tuber, 3 parts of uncaria, 6 parts of devilpepper, 2 parts of szechuan lovage rhizome, 1 part of rhizoma pinellinae praeparata, 2 parts of wild chrysanthemum, 4 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 2 parts of medicinal cyathula root are taken, 70% ethanol aqueous solution is added for soaking for 0.5 hour and then extracted for 2 times, the amount of the 70% ethanol aqueous solution is respectively 6 times and 4 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrate is combined, the concentration and the drying are carried out, the dry extract powder of the medicinal composition is obtained, and then the medicinal composition preparation in the form of a tablet is prepared.
EXAMPLE 3 Capsule dosage form of the pharmaceutical composition of the invention
Taking 4 parts of gastrodia elata, 1 part of uncaria, 3 parts of devilpepper, 4 parts of ligusticum wallichii, 3 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 3 parts of bighead atractylodes rhizome, 1 part of dried orange peel and 2 parts of medicinal cyathula root, adding 60% ethanol aqueous solution, soaking for 0.5 hour, extracting for 2 times, adding the 60% ethanol aqueous solution with the amounts of 7 times and 5 times respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering, merging filtrate, concentrating, drying and crushing to obtain the dry extract powder of the medicinal composition, and preparing the medicinal composition preparation in a capsule form.
EXAMPLE 4 dripping pill-type composition of the present invention
2 Parts of gastrodia tuber, 1 part of uncaria, 3 parts of devilpepper, 2 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 5 parts of wild chrysanthemum, 2 parts of bighead atractylodes rhizome, 3 parts of dried orange peel and 4 parts of medicinal cyathula root are taken, 50% ethanol aqueous solution is added for soaking for 0.5 hour and then extracted for 2 times, the amount of the 50% ethanol aqueous solution is respectively 6 times and 4 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrate is combined, the concentration and the drying are carried out, the dry extract powder of the medicinal composition is obtained after the crushing, and a proper amount of auxiliary materials are added after the crushing, so that the dripping pill of the medicinal composition is prepared.
EXAMPLE 5 Soft Capsule dosage form of the pharmaceutical composition of the invention
Taking 4 parts of gastrodia elata, 2 parts of uncaria, 3 parts of devilpepper, 2 parts of ligusticum wallichii, 3 parts of rhizoma pinellinae praeparata, 4 parts of wild chrysanthemum, 2 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 2 parts of medicinal cyathula root, adding 50% ethanol aqueous solution, soaking for 0.5 hour, extracting for 2 times, adding 7 times and 5 times of 50% ethanol aqueous solution respectively, extracting for 2 hours for the first time, extracting for 1 hour for the second time, filtering, merging filtrate, concentrating, drying, crushing to obtain dry extract powder of the medicinal composition, crushing, adding a proper amount of auxiliary materials, uniformly mixing, using gelatin as a capsule shell material, and pressing into soft capsules to prepare the soft capsules of the medicinal composition.
EXAMPLE 6 micropill-type pharmaceutical compositions of the invention
2 Parts of gastrodia elata, 3 parts of uncaria, 3 parts of devilpepper, 4 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 4 parts of wild chrysanthemum, 3 parts of bighead atractylodes rhizome, 1 part of dried orange peel and 2 parts of medicinal cyathula root are taken, 30% ethanol aqueous solution is added for soaking for 0.5 hour and then extracted for 2 times, the amount of the 30% ethanol aqueous solution is respectively 6 times and 4 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrate is combined, the concentration and the drying are carried out, the dry extract powder of the medicinal composition is obtained after the crushing, and a proper amount of auxiliary materials are added after the crushing, so that the micropill of the medicinal composition is prepared.
EXAMPLE 7 micropellet-type pharmaceutical compositions of the invention
Taking 4 parts of gastrodia elata, 2 parts of uncaria, 5 parts of devilpepper, 2 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 2 parts of wild chrysanthemum, 3 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 2 parts of medicinal cyathula root, soaking in water for 0.5 hour, extracting for 2 times, wherein the water addition amount is 6 times and 4 times respectively, extracting for 2 hours for the first time and extracting for 1 hour for the second time, filtering, combining the filtrates, concentrating, drying, crushing to obtain dry extract powder of the medicinal composition, adding a proper amount of auxiliary materials after crushing, and preparing the micropill of the medicinal composition.
EXAMPLE 8 pharmacological test of the invention
The aim of the test is to observe the therapeutic effect of the compound traditional Chinese medicine of the invention on the hypertension model rat. The tested compositions A, B, C, D were dry extract powders and were prepared with purified water to the desired concentration.
The preparation method of the tested composition is the same, and the specific steps are as follows:
Composition A: 3 parts of gastrodia tuber, 2 parts of uncaria, 5 parts of devilpepper, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of poria cocos and 2 parts of dried orange peel are taken, water is added for soaking for 0.5 hour, then the materials are extracted for 2 times, the water addition amounts are respectively 12 times and 10 times, the first extraction time is 2 hours, the second extraction time is 1 hour, the filtrates are combined, concentrated, dried and crushed, and then the dry extract powder of the composition A is obtained.
Composition B: 3 parts of gastrodia tuber, 2 parts of uncaria, 5 parts of devilpepper, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of poria cocos, 2 parts of dried orange peel and 4 parts of eucommia ulmoides are taken, water is added for soaking for 0.5 hour, then the materials are extracted for 2 times, the water addition amount is respectively 12 times and 10 times, the first extraction time is 2 hours, the second extraction time is 1 hour, the filtration is carried out, the filtrates are combined, the concentration and the drying are carried out, and the dry extract powder of the composition B is obtained after the pulverization.
Composition C: 3 parts of gastrodia tuber, 2 parts of uncaria, 5 parts of devilpepper, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of poria cocos, 2 parts of dried orange peel and 4 parts of earthworm are taken, water is added for soaking for 0.5 hour, then the materials are extracted for 2 times, the water addition amount is respectively 12 times and 10 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrates are combined, the concentration and the drying are carried out, and the dry extract powder of the composition C is obtained after the pulverization.
Composition D: 3 parts of gastrodia tuber, 2 parts of uncaria, 4 parts of devilpepper, 3 parts of ligusticum wallichii, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum, 2 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 3 parts of medicinal cyathula root are taken, soaked in water for 0.5 hour and then extracted for 2 times, the water addition amount is respectively 12 times and 10 times, the first extraction is carried out for 2 hours, the second extraction is carried out for 1 hour, the filtration is carried out, the filtrates are combined, the concentration and the drying are carried out, and the composition D dry extract powder is obtained after the crushing.
1. Influence on SHR rat blood pressure
Experimental animals were selected from 8 week old male SHR 60 animals, stratified according to blood pressure, and randomly divided into 6 groups of 10 animals each: model control group, irbesartan group 13.5 mg/kg -1·d-1 group, composition A group 3.0 g/kg -1·d-1, composition B group 3.0 g/kg -1·d-1, composition C group 3.0 g/kg -1·d-1, composition D group 3.0 g/kg -1·d-1, composition A, B, C, D group are crude drug dosages. 10 WKY rats were also set as normal control group. All drugs are prepared into required concentration by distilled water, and are administrated by lavage according to the volume of 10ml/kg for 1 time per day at the ratio of 8:00 per day, and the administration volume is 10ml/kg for 28 days. The model group and the normal control group were given equal volumes of distilled water, respectively.
Index detection each group began measuring blood pressure 1h after gastric lavage. Blood pressure was measured once a week. The measurement environment is quiet and constant temperature (26 ℃), a BP-2006A intelligent noninvasive sphygmomanometer is adopted, the systolic pressure and the diastolic pressure of the rat are measured in a waking state and a non-irritating state, the continuous measurement is carried out for 4 times, and the average value is obtained.
The test data are processed by EXCEL software, and the results are subjected to group-to-group test by t-test analysis. The statistical result takes alpha=0.05 as a checking limit, wherein p.ltoreq.0.05 represents a statistical significance and p.ltoreq.0.01 represents a very significant significance of the checked differences.
1.1 Effect on SHR rat systolic blood pressure
The difference in shrink pressure between rats in each group of SHRs before dosing was statistically not significant and was significantly higher than that in the normal control group. Compared with the normal group, the shrinkage pressure of the rats in the model group is continuously increased, and the difference has statistical significance (P is less than 0.01).
Compared with a model group, the positive drug irbesartan is obviously reduced in 1-4 weeks of shrinkage pressure after continuous administration (P is less than 0.01 or P is less than 0.05), the composition A is obviously reduced in 1-4 weeks of shrinkage pressure after administration (P is less than 0.01), the composition B, C is obviously reduced in 2-4 weeks of shrinkage pressure after administration (P is less than 0.01), and the composition D is obviously reduced in 1-4 weeks of shrinkage pressure after administration (P is less than 0.01). It can be seen that the onset time of composition A, D group is better than that of composition B, C group.
Compared with the positive drug irbesartan, the effect of reducing the systolic pressure at each detection time point of the administration of the composition D for 1-4 weeks is obviously better, and the difference is statistically significant (P is less than 0.01). While none of the group A, B, C compositions had a significant advantage over irbesartan.
Compared with the composition A, the effect of the composition B, C after 1-4 weeks of administration is equivalent, and no obvious improvement (P > 0.05) exists; the effect of reducing systolic blood pressure is obviously better when the composition D is administered for 1-4 weeks, and the difference is statistically significant (P < 0.01 or P < 0.05). In addition, the effect of reducing the systolic pressure of the composition D is obviously better than that of the composition B and the composition C (P is less than 0.01)
The above experiments demonstrate that, although composition A, B, C, D has a significant effect of reducing systolic blood pressure in SHR rats, composition A, B, C has a significant effect of reducing systolic blood pressure, and the efficacy of composition D in reducing systolic blood pressure is significantly better than that of positive control drug irbesartan and composition A, B, C, and the onset time of composition D is better than that of composition B, C. The results are shown in Table 1.
TABLE 1 influence of 4 weeks of continuous administration of the compositions of the invention on SHR systolic blood pressure±s,mmHg,n=10)
Note that: p <0.05, P <0.01 compared to normal control; compared with the model control group, the, #P is <0.05, and the, #P is <0.01; comparing with irbesartan group, P <0.05, < P <0.01; comparison to composition a group: p <0.05, four-point P <0.01; comparison to composition D group: ■ P <0.05, ■ ■ P <0.01.
1.2 Effect on SHR diastolic pressure
Compared with the normal control group, the difference of continuous rising of the diastolic blood pressure of the rats in the model control group in distilled water for 4 weeks is statistically significant (P is less than 0.01).
Compared with a model control group, the positive drug irbesartan has significantly reduced diastolic pressure (P < 0.01 or P < 0.05); the diastolic pressure of the composition A, D of the invention is obviously reduced (P is less than 0.01) after 1 to 4 weeks of administration; the diastolic pressure is obviously reduced (P < 0.01) after 3-4 weeks of administration of the composition B; the diastolic pressure is significantly reduced (P < 0.01 or P < 0.05) in the group C of the composition after 2-4 weeks of administration. It can be seen that the onset time of the reduction of diastolic pressure by composition A, D is superior to that of composition B, C.
Compared with the positive drug irbesartan, the effect of reducing diastolic pressure after 1-4 weeks of administration of the composition D is obviously better, and the difference is statistically significant (P is less than 0.01 or P is less than 0.05).
There was no significant difference in the effect of reducing diastolic blood pressure (P > 0.05) between 1-4 weeks of administration of composition B, C as compared to composition a; the effect of reducing diastolic blood pressure is obviously better when the composition D is administrated for 1-4 weeks, and the difference is statistically significant (P is less than 0.01 or P is less than 0.05). In addition, the effect of the composition D on reducing diastolic pressure is obviously better than that of the composition B, C (P is less than 0.01).
The above results demonstrate that composition A, B, C, D has a significant effect of reducing diastolic blood pressure in SHR rats, but composition A, B, C has a comparable effect of reducing diastolic blood pressure, while composition D has a significantly better effect of reducing diastolic blood pressure than the positive control agent irbesartan and composition A, B, C, and has a faster onset of action than composition B, C. The results are shown in Table 2.
TABLE 2 influence of 4 weeks of continuous administration of the compositions of the invention on SHR diastolic pressure±s,mmHg,n=10)
Note that: comparison to the normal control group: * P <0.05, < P <0.01; compared with the model control group, the, #P is <0.05, and the, #P is <0.01; compared to the irbesartan group: p <0.05, <, > P <0.01; comparison to composition a group: p <0.05, four-point P <0.01; comparison to composition D group: ■ P <0.05, ■ ■ P <0.01.
2. Effects on renal hypertension rat blood pressure
The experimental animals replicate a renal hypertension rat model using a two kidney one clamp method with a silver clamp having an inner diameter of 0.25 mm. 50 RHR model rats successfully modeled were stratified according to blood pressure, randomly divided into 5 groups of 10 animals each: model control group, irbesartan 13.5mg kg -1·d-1 group, composition A group 3.0g kg -1·d-1, composition B group 3.0g kg -1·d-1, composition C group 3.0g kg -1·d-1, composition D group 3.0g kg -1·d-1. The composition A, B, C is prepared from crude drugs. 10 sham rats were also designated as sham control. All drugs were formulated with distilled water to the desired concentration and administered by intragastric administration at a volume of 10ml/kg 10:00 a day, 1 time a day for 4 weeks. The sham surgery group and the model control group were given the same volume of distilled water.
The index detection selects BP-2006A intelligent noninvasive sphygmomanometer to measure the blood pressure of the rat, and continuously measures for 4 times, and the average value is taken as the systolic pressure. Blood pressure was measured for each group prior to dosing. Blood pressure was measured once a week, and systolic and diastolic blood pressure of the rats were measured in a awake and non-irritated state.
The test data are processed by EXCEL software, and the results are subjected to group-to-group test by t-test analysis.
2.1 Effect on systolic blood pressure in renally hypertensive rats
Compared with the sham operation control group, the shrinkage pressure of the rats in the model control group is continuously increased, and the difference is statistically significant (P is less than 0.01).
The positive drug (irbesartan tablets) group was administered for 3-4 weeks with significantly reduced systolic blood pressure (P <0.01 or P < 0.05) compared to the model control group; the shrinkage pressure of the composition A of the invention is obviously reduced (P is less than 0.05 or P is less than 0.01) after 3-4 weeks of administration; no significant systolic blood pressure lowering effect (P > 0.05) was seen for 1-4 weeks of administration of the combination B, C group; the systolic blood pressure is significantly reduced between 2 and 4 weeks with group D compositions, and the differences are statistically significant (P <0.01 or P < 0.05). It can be seen that the onset of action of composition D is faster than that of irbesartan and composition a. And, the effect of reducing systolic blood pressure after 4 weeks of administration of composition D is significantly better than that of composition A, B, C (P < 0.05).
The above results demonstrate that composition A, D has the effect of reducing systolic blood pressure in renal hypertensive rats, whereas compositions B and C have no apparent effect, and that composition D has better onset time and potency for reducing systolic blood pressure in renal hypertensive rats than irbesartan and composition a. The results are shown in Table 3.
TABLE 3 influence of 4 weeks of continuous administration of the invention on systolic blood pressure in rat tail with renal hypertension±s,mmHg,n=10)
Note that: comparison with sham-operated control group: * P <0.05, < P <0.01; comparison to model control group: #P <0.05, #P <0.01; comparing with irbesartan group, P <0.05, < P <0.01; compared to composition a: p <0.05, four-point P <0.01; comparison with composition D: ■ P <0.05, ■ ■ P <0.01.
2.2 Effect on diastolic blood pressure in rats with renal hypertension
Compared with the sham operation control group, the diastolic blood pressure of the rats in the model control group is obviously increased, and the difference has statistical significance (P is less than 0.01).
The positive drug irbesartan group was administered with a 2-4 week reduction in diastolic blood pressure (P <0.01 or P < 0.05) compared to the model control group; the diastolic blood pressure is obviously reduced (P <0.01 or P < 0.05) after the administration of the composition A of the invention for 2 to 4 weeks; no significant diastolic pressure lowering effect (P > 0.05) was seen for 1-4 weeks of administration of composition B, C group; the diastolic blood pressure was significantly reduced (P < 0.01) for 2-4 weeks of composition D administration. The effect of composition D on lowering diastolic blood pressure was comparable to that of composition A (P > 0.05), but significantly better than that of composition B, C (P < 0.05).
It is demonstrated that composition A, D has a significant effect of reducing diastolic blood pressure in renally hypertensive rats, whereas composition B, C does not have a significant hypotensive effect, and that composition D has a significantly better efficacy than composition B, C. The results are shown in Table 4.
TABLE 4 influence of 4 weeks of continuous administration of the invention on the diastolic blood pressure of the tail artery of a renally hypertensive rat±s,mmHg,n=10)
Note that: p <0.05, P <0.01 compared to sham-operated control group; compared with the model control group, the, #P is <0.05, and the, #P is <0.01; comparing with irbesartan group, P <0.05, < P <0.01; compared to composition a: p <0.05, four-point P <0.01; comparison with composition D: ■ P <0.05, ■ ■ P <0.01.
3. Conclusion(s)
The pharmacological test results show that the composition A, B, C, D has the effect of obviously reducing the systolic pressure and the diastolic pressure of the spontaneous hypertension rat, wherein the blood pressure reducing effect of the composition D is better than A, B, C; composition A, D has the effect of obviously reducing the systolic pressure and the diastolic pressure of the rat with renal hypertension, and composition B, D has no obvious effect of reducing the renal hypertension. The composition D is characterized in that based on the composition A, poria cocos is changed into bighead atractylodes rhizome, and achyranthes root is matched, so that the dosage of the devilpepper is reduced, the blood pressure reducing effect is obviously enhanced, and the overall efficacy is further improved.
Those of ordinary skill in the art will appreciate that: the discussion of any of the embodiments above is merely exemplary and is not intended to suggest that the scope of protection of the application is limited to these examples; the technical features of the above embodiments or in the different embodiments may also be combined within the idea of the application, the steps may be implemented in any order and there are many other variations of the different aspects of one or more embodiments of the application as described above, which are not provided in detail for the sake of brevity.
One or more embodiments of the present application are intended to embrace all such alternatives, modifications and variations as fall within the broad scope of the present application. Accordingly, any omissions, modifications, equivalents, improvements and others which are within the spirit and principles of the one or more embodiments of the application are intended to be included within the scope of the application.
Claims (11)
1. A traditional Chinese medicine composition for treating hypertension is characterized in that: 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.
2. The traditional Chinese medicine composition for treating hypertension according to claim 1, wherein: is prepared from the following traditional Chinese medicine raw materials in parts by weight: 3 parts of gastrodia tuber, 2 parts of uncaria, 4 parts of devilpepper, 3 parts of szechuan lovage rhizome, 2 parts of rhizoma pinellinae praeparata, 3 parts of wild chrysanthemum flower, 2 parts of bighead atractylodes rhizome, 2 parts of dried orange peel and 3 parts of medicinal cyathula root.
3. The traditional Chinese medicine composition for treating hypertension according to any one of claims 1-2, characterized in that: can be made into clinically acceptable dosage forms.
4. The traditional Chinese medicine composition for treating hypertension according to claim 3, wherein: making into tablet, capsule, granule, pill, or oral liquid.
5. The traditional Chinese medicine composition for treating hypertension according to claim 4, wherein: making into soft capsule, dispersible tablet, orally disintegrating tablet, and dripping pill.
6. A method for preparing a Chinese medicinal composition for treating hypertension according to any one of claims 1 to 5, wherein 0 to 70% ethanol aqueous solution is added to the raw materials of the Chinese medicine, and the mixture is extracted for 1 to 3 times, each time by 4 to 12 times; extracting for 1-2 hr each time, mixing extractive solutions, filtering, collecting filtrate, recovering solvent, and concentrating.
7. The method of manufacturing according to claim 6, wherein: extracting with 0-70% ethanol water solution for 2 times, each time with 10-12 times of the total amount; extracting for 1-2 hr each time, filtering the extractive solution, recovering solvent, and concentrating.
8. The method of manufacturing according to claim 6, wherein: extracting with 0-70% ethanol water solution for 2 times, 6-10 times for 2 hr, and 4-8 times for 1 hr; filtering the extractive solution, recovering solvent, and concentrating.
9. The method of claim 8, wherein 70% ethanol aqueous solution is added for extraction.
10. The method of manufacturing according to claim 8, wherein: before the first extraction, the Chinese medicinal materials are soaked for 0.5h.
11. Use of a traditional Chinese medicine composition for treating hypertension according to any one of claims 1 to 5 or a traditional Chinese medicine composition for treating hypertension prepared by a preparation method according to any one of claims 6 to 10 in preparation of a medicament for treating hypertension.
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