CN100435842C - Chinese-medicinal preparation for treating hypertension and its making method - Google Patents

Abstract

A Chinese medicine for treating hypertension, dizziness and insomnia is prepared from 6 Chinese-medicinal materials including evodia fruit, ginseng, alismatis rhizome, ginger, etc. Its preparing process is also disclosed.

Description

Traditional Chinese medicine preparation and preparation method for treating hypertension

technical field

The invention relates to a traditional Chinese medicine preparation for treating hypertension and a preparation method thereof, belonging to the technical field of traditional Chinese medicines.

Background technique

Hypertension is the most common cardiovascular disease, with a large number of patients, accounting for about 42.5% of the total death toll. It is the first killer of human beings, and its main clinical manifestation is elevated blood pressure. Hypertension is a chronic disease. At present, there are two major trends in the incidence of hypertension: one is that the incidence rate is increasing, and the outcome is serious, and most of them will eventually die from cardiovascular and cerebrovascular diseases and renal failure; the other is that the age of onset is decreasing, and young and middle-aged patients are increasing. The prevention and treatment of hypertension has become one of the most important global issues in the cardiovascular field.

At present, there are many kinds of medicines for the treatment of hypertension with western medicine at home and abroad, and they are updated quickly. However, with the deepening of clinical and experimental research, it is found that these medicines have some shortcomings of their own, such as the effect of the medicine is not mild enough, and the range of action is limited. Too extensive and many side effects. With the continuous improvement of living standards, people are more advocating natural therapy, and put forward higher requirements for the quality and quantity of medical care. Therefore, it is very necessary to seek a new long-term drug for the treatment of hypertension with high efficiency and low toxicity. After long-term clinical practice, Chinese medicine has formed its own unique theoretical understanding and accumulated rich experience in the treatment of hypertension. We have conducted in-depth discussions on the pathogenesis of hypertension, and believe that the imbalance of yin and yang, and the turbidity of phlegm are its basic pathogenesis. Only by examining the cause and treating it can the curative effect be improved.

Contents of the invention

The object of the present invention is to provide a traditional Chinese medicine preparation for treating hypertension and a preparation method thereof, so as to solve the problems in the prior art.

The purpose of the present invention is achieved through the following embodiments:

The traditional Chinese medicine preparation for treating hypertension of the present invention comprises 3-12 parts of Evodia rutaecarpa, 3-12 parts of ginseng, 3-12 parts of Alisma, 10-20 parts of Eucommia ulmoides, 2-15 parts of ginger and It is prepared from 5-20 parts of jujube and appropriate auxiliary materials.

Preferably, the traditional Chinese medicine preparation of the present invention is prepared by extracting 9g of Evodia rutaecarpa, 9g of ginseng, 9g of Alisma, 5g of ginger, 15g of Eucommia, and 7g of jujube, and adding appropriate amount of auxiliary materials.

Described Chinese medicine preparation can be made into granule preparation (containing: effervescent granule), capsule preparation (containing: hard capsule preparation, soft capsule preparation), tablet (containing: effervescent tablet, dispersible tablet, controlled-release tablet, slow-release tablet) tablet, orally disintegrating tablet, chewable tablet, sublingual tablet) or pill (including: pellet preparation, drop pill preparation), oral liquid preparation.

The preparation method of the traditional Chinese medicine preparation for treating hypertension is as follows: taking the raw medicinal materials Evodia rutaecarpa, ginseng and Alisma alisma, adding 8-20 times the weight of 50-80% ( v/v) ethanol extraction 1-5 times, every 1-2 hours, filter to get filtrate A, for subsequent use; take ginger slices, Eucommia ulmoides and jujube with a thickness of 1-8 mm, and weigh the Add 8-20 times the weight of water to ginger slices, eucommia and jujube, extract for 1-4 hours, extract 1-4 times in total, combine the decoction, filter, concentrate the filtrate to a clear paste with a certain relative density, and let it cool , add ethanol to make the alcohol content of the medicinal solution be 50-80% (w/w), let stand for 10-24 hours, filter to obtain filtrate B, merge filtrate A and filtrate B, reclaim ethanol and concentrate to a certain density Thick paste, dried, crushed into fine powder; adding appropriate amount of auxiliary materials to prepare the desired preparation.

The preferred preparation method of the present invention is as follows: Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng and 9 g of Alisma, add 8-20 times the weight of 50-80% (v/v) ethanol and extract 1-5 times, every 1-2 hours , filtered to get the filtrate A, for subsequent use; 5g of ginger slices, 15g of Eucommia ulmoides and 7g of jujube, which are cut into 1-3 mm in thickness, are added with 8-20 times the weight of water, and the extraction time is 1-4 hours, and 1-4 Second, combine the decoction, filter, and the filtrate is concentrated to a certain relative density clear paste, let cool, add ethanol to make the alcohol content of the medicinal solution be 50-80% (w/w), leave standstill for 10-24 hours, filter After filtering, the filtrate B is obtained, the filtrate A and the filtrate B are combined, the ethanol is recovered and concentrated to a thick paste of a certain density, dried, and pulverized into a fine powder; an appropriate amount of auxiliary materials is added, mixed evenly, and 1000 g of granules are made to obtain granules.

The adjuvant used in the traditional Chinese medicine preparation of the present invention is a conventional adjuvant in the field of traditional Chinese medicine pharmacy. The specific type and usage amount of the adjuvant are determined according to the specific dosage form. Those of ordinary skill in the art can easily determine the adjuvant used and the dosage form prepared according to the needs. Dosage.

The traditional Chinese medicine preparation of the present invention has the effects of regulating the liver and purging turbidity, lowering blood pressure and consolidating the foundation, and is mainly used for symptoms such as yin and yang imbalance, panting of phlegm turbidity, dizziness, headache and insomnia caused by Jueyin phlegm turbidity, and is commonly used in the treatment of hypertension. Compared with the prior art, the invention has less toxic and side effects, better therapeutic effect, simple preparation, and is convenient to take and carry.

The present invention is a prescription composed of Evodia rutaecarpa as the king drug, combined with the characteristics of pathology and pathogenesis of hypertension, and combined with traditional Chinese medicines for regulating the liver, purging turbidity, lowering blood pressure and strengthening the root.

In the prescription, Evodia rutaecarpa is used as the king drug: Evodia rutaecarpa is bitter in taste and warm in nature, and it returns to the liver, spleen, stomach, and kidney meridian. From the point of view of function, its acrimony enhances bitterness, lowers qi, soothes the liver and relieves stagnation. Turbidity stops reverse, warming and descending. Modern pharmacological studies have confirmed that Evodia rutaecarpa has pharmacological effects such as analgesia, tranquilization, antibacterial, antihypertensive and anti-oxidation. And Evodia rutaecarpa is one of the five famous medicines in Guizhou, so it is taken as the king medicine.

Ginseng is used as a minister drug in the prescription: Ginseng is sweet and slightly bitter, slightly warm in nature, and has the function of nourishing qi and tonifying deficiency. From a functional point of view, its nature and flavor are sweet, which can nourish the qi of the viscera. Modern pharmacological studies have found that ginseng has the effects of anti-shock, lowering blood sugar, and enhancing the immune function of the body. Compatible with Evodia rutaecarpa in the prescription, it has the effect of benefiting qi and tonifying deficiency, and enhances the effect of Evodia rutaecarpa on warming, reducing blood pressure, nourishing yuan and lowering blood pressure, so it is a ministerial drug.

Use Alisma, Eucommia, and Ginger as adjuvant drugs: Alisma is cold in nature, sweet and light in taste, diuretic and damp, and has the effect of purging heat; Eucommia, warm in nature and sweet in taste, returns to the liver and kidney meridian, can nourish the liver and kidney, Strong pangu; Ginger, slightly pungent in taste, has the functions of warming the middle and dispelling cold, warming the lungs and relieving cough. The three flavors are adjuvant medicines, which actually take Alisma diarrhea for purging turbidity and dampness, Eucommia for nourishing the kidney and nourishing the essence to lower blood pressure, and ginger for warming the middle and reducing adverse effects, and together help Evodia rutaecarpa to lower blood pressure.

Use jujube as an envoy: jujube is warm and sweet in nature, can moderate the properties of the medicine, has the function of regulating the spleen and stomach, and reconciling various medicines, and using it as an envoy can help ginseng invigorate the spleen, replenish qi and invigorate deficiency.

Looking at the whole prescription, it has the characteristics of combining tonifying and purging turbidity, reflecting the pathogenesis of TCM treatment of hypertension, "deficiency", "phlegm", and "reversal". Deficiency is the spleen and stomach, and it also emphasizes kidney deficiency. It refers to obstruction of phlegm (dampness) turbidity, and 'Ni' refers to imbalance of yin and yang, liver disorder, and qi mechanism reversed. To remove spleen dampness, specifically, it regulates the liver, purifies the turbidity, strengthens the root and lowers blood pressure." Therefore, it can effectively treat the imbalance of yin and yang, the panting of phlegm turbidity, and the hypertension caused by Jueyin phlegm turbidity.

Evodia rutaecarpa mainly contains volatile oil, alkaloids and other components. The main components of the alkaloids are evodiamine and evodiamine, which have pharmacological effects such as analgesia, antihypertensive and antihypertensive.

Ginseng mainly contains saponins, polysaccharides, trace elements and other components. Among them, ginsenoside is the main active ingredient of ginseng, which is commonly used for qi deficiency, faint pulse, weak lung qi, deficiency of qi and blood, and blood deficiency syndrome.

Alisma mainly contains fat-soluble components such as triterpenoids, sesquiterpenoids and diterpenoids. Modern pharmacological studies have shown that Alisma has the effects of inhibiting arteriosclerosis, lowering blood fat, diuresis, lowering blood pressure, and anti-fatty liver; at the same time, A large number of modern clinical data also show that Alisma and its compound have achieved good curative effects in the treatment of common diseases such as hypertension and hyperlipidemia.

The main active ingredients of ginger are volatile oil, gingerol, diphenylheptane and other components. It has the effects of sweating to relieve the exterior, warming the middle and relieving vomiting, warming the lungs and relieving cough.

Eucommia mainly contains alkaloids, lignans, iridoids, flavonoids and other components, among which pinoresinol diglucoside and syringalis diglucoside have obvious antihypertensive effect; Ivioden-drin, Asperoside and syringaresin It is an inhibitor of angiotensin and cyclic adenosylic acid (CAMP), so it can dilate blood vessels and increase coronary blood flow. Modern pharmacological experiments have also proved that the water extract of Eucommia ulmoides has obvious antihypertensive effect on dogs, and the curative effect is stable, without toxic and side effects.

Jujube contains flavonoids, various amino acids, sugars and other water-soluble components. Jujube decoction can increase the weight of mice and prolong the swimming time under load. The flavonoids contained in it have obvious sedative, hypnotic and blood pressure-lowering effects.

In order to complete the present invention, we have carried out a series of experimental studies using the Evodia rutaecarpa preparation extract of the present invention (that is: the compound extract of the present invention prepared in Example 1 of the present invention), and the results are as follows:

Pharmacology and Toxicology:

Main pharmacodynamic studies:

The test results of the influence on blood pressure and heart rate of normal rats showed that:

After administration through the duodenum, the high-dose Evodia rutaecarpa extract group (2.0g/kg) had a significant antihypertensive effect 30 minutes after administration, and produced the maximum effect at 60 minutes. The normal systolic blood pressure and diastolic blood pressure of rats decreased by 17% respectively and 20%, compared with before administration, there is a significant difference (P<0.05, P<0.01), blood pressure can also slow down the heart rate, compared with before administration, there is a significant difference (P<0.05). The middle dose group (1.0g/kg) also significantly lowered blood pressure 45 minutes after administration, and produced the maximum effect at 90 minutes. SAP and DAP were respectively reduced by 19% and 14%, which were significantly different from those before administration (P<0.05, P<0.01) , The duration of antihypertensive effect is more than 4h. The effect is similar to that of the compound apocynum group with equal doses. No significant effect on HR.

The test results of the influence on the blood pressure of conscious renal hypertensive rats show that:

The extract of Evodia rutaecarpa preparation was administered by intragastric administration: the effect of reducing systolic blood pressure and diastolic blood pressure in the high-dose group (2.0g/kg) was significantly different from that before administration (P<0.05); the middle-dose group (1.0g/kg) was given The obvious antihypertensive effect was seen on the same day of the medicine, and the systolic blood pressure and diastolic blood pressure decreased by 25% and 35% compared with before the medicine, and the difference was significant (P<0.01). The diastolic blood pressure lowering effect was stronger than that of the compound apocynum group, and the blood pressure group did not return to before the administration for 9 days after drug withdrawal in this group; each group had no significant effect on the heart rate of conscious renal hypertensive rats.

Observation of analgesic effect:

The test results of the effect on the pain induced by hot plate in mice showed that the high-dose Evodia rutaecarpa extract group could prolong the licking time of mice induced by hot plate no matter whether it was given for 3 days or 6 days, and the pain threshold was compared with that of the blank control group. Significantly increased (P<0.05). The results of the experiment on the effect of acetic acid-induced pain on mice showed that the high-dose and medium-dose groups of Evodia rutaecarpa extract significantly reduced the number of writhing reactions of mice induced by glacial acetic acid, and the difference was significant compared with the blank control group (P<0.05) .

Sedative and hypnotic effect observation test:

The test results of the effect on the subthreshold hypnotic dose of pentobarbital sodium in mice showed that the three dosage groups of Evodia rutaecarpa preparations were administered for a single time or continuously for 3 days, and had no effect on the hypnotic effect of subthreshold dose pentobarbital sodium on mice. no effect. The results of the observation test on the hypnotic dose of pentobarbital sodium in mice showed that after continuous administration for 3 days, the low-dose group of Evodia rutaecarpa preparation had a synergistic effect on the sleep induced by the hypnotic dose of pentobarbital sodium in mice, which was comparable to that of the blank control group. In comparison, the sleep duration of mice was significantly prolonged (P<0.05).

Experiments on the effect on the spontaneous activity of mice showed that:

After continuous administration for 3 days, the low-dose Evodia rutaecarpa extract group can significantly reduce the spontaneous activity of the mice, which is significantly different from the blank control group (P<0.05).

The results of pharmacodynamic tests show that it can reduce the blood pressure (SAP and DAP) of normal (anesthetized) rats, and slow down the heart rate of rats while lowering blood pressure; it has a significant effect on reducing blood pressure (SAP and DAP) in conscious renal hypertensive rats And stable, especially in the middle-dose group, the effect of reducing DAP is more stable than that of the antihypertensive drug compound apocynum of the same dose, and the original antihypertensive drug effect is still maintained for 9 days after drug withdrawal. The pharmacodynamic study also confirmed that the drug can increase the pain threshold of mice to pain caused by hot plates, inhibit the writhing response caused by acetic acid, prolong the duration of sleep in mice induced by a hypnotic dose of pentobarbital sodium, and reduce The number of spontaneous activities of the mice shows that the drug has a certain auxiliary effect on alleviating the symptoms of hypertension.

The results of this study show that the compound Evodia rutaecarpa preparation of the present invention has obvious and stable antihypertensive effect, and has good development prospects and clinical application value.

Acute Toxicity Study:

This product is with the maximum concentration (60%), the maximum volume (0.5ml/10g/day) in 24 hours after 2 times of intragastric administration (0.25ml/10g/time), continuous observation for 7 days, as a result, 40 experimental small No death or obvious poisoning was seen in the mice, and the body weight increased significantly after 7 days (P<0.001). The adult clinical dosage of this product is: 8g extract powder/day, and the tolerance dose of each mouse is: 0.614g, the average weight of mice : 20.45g, the calculated maximum tolerated dose of mice is: 187.5 times.

Pharmacy Section:

The determination of the prescription process route of the present invention is on the basis of consulting the modern research literature of traditional Chinese medicine at home and abroad, according to the functions and indications of the prescription and the physicochemical properties of the active ingredients contained in the prescription, formulate the method of extracting alcohol with alcohol + water. Shen's preparation process. And carry out orthogonal experiment optimization to this process:

1. Alcohol extraction process: Weigh the medicinal materials of Evodia rutaecarpa, ginseng and Alisma respectively according to the prescription ratio, and optimize according to the orthogonal table L ₉ (3 ⁴ ). Taking the total alkaloids of Evodia rutaecarpa as an index, the four factors of ethanol concentration, ethanol dosage, extraction time and extraction times were optimized and investigated, and the best alcohol extraction process was selected.

2. Water extraction and alcohol precipitation process: Weigh Eucommia ulmoides, jujube, and ginger slices according to the proportion of the prescription, conduct an orthogonal test according to the orthogonal table L ₉ (3 ⁴ ), use the total amount of chlorogenic acid as an index to compare the amount of water added, decocted The three factors of boiling time and decoction times were optimized and investigated, and the best water decoction process was selected; in order to remove the ineffective components in the water extract of traditional Chinese medicine as much as possible and retain the active components as much as possible, the proportion of the prescription was weighed respectively. , jujube, and ginger slices were extracted according to the optimal conditions determined by the above-mentioned water decoction process. After the extract was concentrated to the corresponding density, the orthogonal test was carried out according to the orthogonal table L ₉ (3 ⁴ ) and the total amount of chlorogenic acid was Index, optimize the two factors of extract relative density and alcohol precipitation conditions, and optimize the best alcohol precipitation process. Finally, the selection of the granulation method, the determination of the type and dosage of the excipients, and the determination of the physical properties of the granules were carried out, and the formulation and preparation method were determined. The pilot scale-up test proved that the process is simple and easy to operate, and the operability is strong. , to meet the requirements of mass production.

According to " Chinese Pharmacopoeia " 2005 edition one appendix IC granule item relevant requirement and " drug registration management method " regulation, and carried out a large amount of document searches, formulated clinical trial drug quality standard of the present invention on this basis ( draft) and drafting instructions.

Ginseng, Alisma, Evodia, and Jujube in this product were qualitatively identified by thin-layer chromatography. Evodiamine and Evodiamine reference substances were used as controls to identify Evodia rutaecarpa, and oleanolic acid reference substances were used as controls to identify Jujube , using ginseng reference materials, ginsenoside Rb1, ginsenoside Rg1, and ginsenoside Re reference substances as controls to identify ginseng, and Alisma control materials as controls to identify Alisma. The results showed that three batches of samples (batch numbers: 050301, 050302, and 050303) all showed spots or fluorescent spots of the same color at positions corresponding to the chromatogram of the reference substance or the reference medicinal material, and there was no interference in the negative.

With reference to the method of content determination under the item of Evodia rutaecarpa on page 118 of the 2005 edition of "Chinese Pharmacopoeia", and referring to the high-performance liquid chromatography "Chinese Pharmacopoeia" 2005 edition of an appendix VID, the content of the total alkaloids of Evodia rutaecarpa in this product was determined. Determination, through the methodological system investigation and the content determination of three batches of samples (batch numbers: 050301, 050302, 050303 respectively), the evodiamine and evodiamine in this product are well separated from other components, and the evodiamine is 0.3280～1.640ug, The linearity of evodiamine was good in the range of 0.2360-1.180ug. The average recovery rate of evodiamine was 101.19%, RSD=1.01%. The average recovery rate of evodiamine was 101.19%, RSD=1.31%. The results show that this method is simple, rapid, specific, sensitive and accurate. At the same time, it has been determined that each index of the granule meets the relevant regulations under the item of Appendix I granule of "Chinese Pharmacopoeia" 2005 edition.

The results show that this standard is stable and easy to implement, with strong controllability and good repeatability, and can control the quality of this product.

The research results of the above pharmacy part show that the process of the present invention is reasonable and feasible, and the quality is stable and controllable.

Detailed ways:

The present invention is further illustrated below by way of examples. It should be understood that the embodiments of the present invention are used to illustrate the present invention rather than limit the present invention. The simple improvements made to the present invention according to the essence of the present invention all belong to the protection scope of the present invention. In addition, in the present invention, (v/v) represents volume specific concentration or volume ratio; (w/w) represents weight specific concentration or weight ratio; (min) represents minute. Percentages in this invention are by weight unless otherwise indicated.

Embodiment 1: Preparation of compound extract of the present invention and granules thereof

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A for subsequent use; take 5 g of ginger slices, 15 g of Eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the weight of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio Decoct in water twice, 1.5 hours each time, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), and let stand overnight , filtered to obtain filtrate B, combined filtrate B and filtrate A, reclaimed ethanol and concentrated to 60°C to measure a thick paste with a relative density of 1.20-1.25, dried under reduced pressure, crushed into fine powder, and obtained the compound extract of the present invention Add dextrin and appropriate amount of powdered sugar, mix well, dry and granulate, and make 1000g of granules to obtain granules. Take this product with boiling water, one bag at a time, three times a day.

Embodiment 2: preparation compound extract of the present invention and capsule thereof

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A, which is set aside; take 5 g of ginger slices, 15 g of eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the thickness of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio. Decoct in heavy water twice, each time for 1.5 hours, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), let it stand Overnight, filter to get filtrate B, combine filtrate B and filtrate A, recover ethanol and concentrate to 60°C to measure thick paste with relative density of 1.20-1.25, dry, grind into fine powder or add appropriate amount of carboxymethyl cellulose Sodium, add water to moisten the granules, mix well, put into capsules, and obtain capsules.

Embodiment 3: preparation compound extract of the present invention and tablet thereof

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A, which is set aside; take 5 g of ginger slices, 15 g of eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the thickness of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio. Decoct in heavy water twice, each time for 1.5 hours, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), let it stand Overnight, filter to obtain filtrate B, combine filtrate B and filtrate A, recover ethanol and concentrate to 60°C to measure a thick paste with a relative density of 1.20-1.25, dry, grind into fine powder; add appropriate amount of carboxymethyl cellulose Sodium, add water to moisten the granules, dry, compress into tablets, and obtain tablets.

Embodiment 4: Preparation of compound extract of the present invention and oral liquid thereof

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A, which is set aside; take 5 g of ginger slices, 15 g of eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the thickness of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio. Decoct in heavy water twice, each time for 1.5 hours, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), let it stand Overnight, filter to obtain filtrate B, combine filtrate B and filtrate A, recover ethanol and concentrate to an appropriate amount, add appropriate amount of preservative and flavoring agent, adjust the total amount to 1000ml, stir well, filter, fill, and sterilize , to obtain oral liquid.

Embodiment 5: Preparation of the compound extract of the present invention and its soft capsule preparation

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A, which is set aside; take 5 g of ginger slices, 15 g of eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the thickness of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio. Decoct in heavy water twice, each time for 1.5 hours, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), let it stand Overnight, filter to get filtrate B, combine filtrate B and filtrate A, recover ethanol and concentrate to 60°C to measure thick paste with relative density of 1.20-1.25, dry under reduced pressure, crush into fine powder; add vegetable oil and beeswax to form Grind the diluent evenly, and set aside; take another gelatin solution (100 parts of gelatin, 50 parts of glycerin, and 120 parts of water) for use; under the conditions of room temperature 23±2°C and relative humidity of 40%, the liquid medicine and gelatin are hydraulically prepared Soft capsules, that is, soft capsule preparations, the vegetable oil can be one or a mixture of soybean oil, peanut oil, and camellia oil; the vegetable oil can also be replaced with PEG400.

Embodiment 6: preparation compound extract of the present invention and dropping pill thereof

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A, which is set aside; take 5 g of ginger slices, 15 g of eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the thickness of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio. Decoct in heavy water twice, each time for 1.5 hours, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), let it stand Overnight, filter to obtain filtrate B, combine filtrate B and filtrate A, recover ethanol and concentrate to 60°C to measure a thick paste with a relative density of 1.20-1.25, dry under reduced pressure, and pulverize into fine powder; add appropriate amount of polyethylene Glycol 4000, after heating and mixing well, drop into another immiscible cooling liquid, simethicone, and drop into pills to obtain drop pills. The polyethylene glycol 4000 can be replaced with polyoxyethylene (40) monostearate, and the simethicone coolant can be replaced with any one of liquid paraffin or vegetable oil.

Embodiment 7: preparation compound extract of the present invention and pill thereof

Weigh 9 g of raw materials Evodia rutaecarpa, 9 g of ginseng, and 9 g of Alisma, and extract twice with ethanol of 10 times the weight of 70% (v/v) of Evodia rutaecarpa, ginseng, and Alisma eczema in the weight ratio, each time for 1.5 hours, Filtrate and combine the filtrates to obtain filtrate A, which is set aside; take 5 g of ginger slices, 15 g of eucommia ulmoides, and 7 g of jujube with a thickness of 2 mm, and add 10 times the thickness of ginger slices, eucommia ulmoides, and jujube with a thickness of 2 mm in the weight ratio. Decoct in heavy water twice, each time for 1.5 hours, combine the decoction, filter, concentrate the filtrate to a relative density of 1.05-1.10 (60°C), add ethanol to make the alcohol content 70% (w/w), let it stand Overnight, filter to obtain filtrate B, combine filtrate B and filtrate A, recover ethanol and concentrate to 60°C to measure a thick paste with a relative density of 1.20-1.25, dry under reduced pressure, crush into fine powder, and pass through a 60-mesh sieve ; Add refined honey and medicine to make honeyed pills, that is, pills.

Claims (6)

1. A traditional Chinese medicine preparation for treating hypertension, characterized in that: according to weight components, it consists of 3-12 parts of Evodia rutaecarpa, 3-12 parts of ginseng, 3-12 parts of Alisma, 10-20 parts of Eucommia, and 2 parts of ginger. -15 parts, 5-20 parts of jujube and appropriate auxiliary materials. 2. The traditional Chinese medicine preparation for treating hypertension according to claim 1, characterized in that it is prepared from 9g of Evodia rutaecarpa, 9g of ginseng, 9g of Alisma, 15g of Eucommia ulmoides, 5g of ginger and 7g of jujube plus appropriate amount of auxiliary materials. 3. The traditional Chinese medicine preparation for treating hypertension according to claim 1 or 2, characterized in that said traditional Chinese medicine preparation is: granule preparation, capsule preparation, tablet, pill or oral liquid preparation. 4. The traditional Chinese medicine preparation for treating hypertension according to claim 3, characterized in that said traditional Chinese medicine preparation is a granule preparation. 5. The preparation method of the traditional Chinese medicine preparation for treating hypertension according to any one of claims 1-4, characterized in that: taking the raw materials Evodia rutaecarpa, ginseng and Alisma, adding 8- The volume ratio of 20 times the weight is 50-80% ethanol extraction 1-5 times, every 1-2 hours, filter, and get the filtrate A for subsequent use; Ginger, Eucommia and jujube that are cut into 1-8 mm in thickness are added 8-20 times the weight of water, the extraction time is 1-4 hours, a total of 1-4 times, the decoction is combined, filtered, the filtrate is concentrated to a certain relative density of clear paste, let it cool, add ethanol to increase the alcohol content of the liquid The weight ratio is 50-80%, standing for 10-24 hours, filtering to obtain filtrate B, combining filtrate A and filtrate B, recovering ethanol and concentrating to a thick paste with a certain density, drying, and pulverizing into fine powder; adding auxiliary materials Appropriate amount is prepared into required preparations. 6. According to the preparation method of the traditional Chinese medicine preparation for treating hypertension according to claim 5, it is characterized in that: the volume ratio of weighing 9g of raw materials Evodia rutaecarpa, 9g of ginseng and 9g of Alisma 9g plus 8-20 times the weight is 50-80% Extract 1-5 times with ethanol, and filter every 1-2 hours to obtain filtrate A for subsequent use; add 8-20 times the weight of water to 5 g of ginger slices, 15 g of Eucommia ulmoides and 7 g of jujube cut into 1-8 mm in thickness, The extraction time is 1-4 hours, and a total of 1-4 times is extracted, the decoction is combined, filtered, the filtrate is concentrated to a certain relative density of clear paste, let it cool, and ethanol is added to make the alcohol content of the liquid medicine 50-80% by weight , stand still for 10-24 hours, filter to obtain filtrate B, combine filtrate A and filtrate B, recover ethanol and concentrate to a thick paste with a certain density, dry, and pulverize into fine powder; add appropriate amount of auxiliary materials, mix well, and make 1000g of granules to obtain granules.