CN114306485A - Composition and medicine for treating cardiovascular and cerebrovascular diseases, and preparation method and application thereof - Google Patents

Composition and medicine for treating cardiovascular and cerebrovascular diseases, and preparation method and application thereof Download PDF

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CN114306485A
CN114306485A CN202111485927.5A CN202111485927A CN114306485A CN 114306485 A CN114306485 A CN 114306485A CN 202111485927 A CN202111485927 A CN 202111485927A CN 114306485 A CN114306485 A CN 114306485A
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extraction
radix
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李方瑞
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Qinghai Crystal Beads Tibetan Medicine High New Technology Industrial Co ltd
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Abstract

The invention provides a medicine for treating cardiovascular and cerebrovascular diseases, which is prepared from the following raw materials in parts by mass: 60-80 parts of saffron, 50-250 parts of rhodiola rosea, 200 parts of sappan wood, 100 parts of angelica, 50-150 parts of arisaema cum bile, 250 parts of ligusticum wallichii, 400 parts of astragalus mongholicus, 200 parts of earthworm and 200 parts of achyranthes bidentata. The preparation method comprises the following steps: 1) decocting radix astragali, Lumbricus, lignum sappan, and Achyranthis radix in water for three times, mixing extractive solutions, filtering, concentrating into paste, oven drying, and pulverizing; 2) extracting rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, and radix Rhodiolae with ethanol water solution for three times, mixing extractive solutions, concentrating into soft extract, oven drying, and pulverizing; 3) oven drying Arisaema cum bile, mixing with stigma croci Sativi, and pulverizing; mixing the above powders, and making into capsule. The invention improves the prescription and the preparation process, and improves the drug effect of the Jingzhu Shuanghong Huoxue capsule.

Description

Composition and medicine for treating cardiovascular and cerebrovascular diseases, and preparation method and application thereof
The application is a divisional application with application date of 2018, 11 and 21, application number of 201811390689.8 and invention name of 'a medicine for treating cardiovascular and cerebrovascular diseases and a preparation method thereof'.
Technical Field
The invention belongs to the field of traditional Chinese medicines, and particularly relates to a composition and a medicine for treating cardiovascular and cerebrovascular diseases, and a preparation method and application thereof.
Background
Cardiovascular and cerebrovascular diseases are collectively called cardiovascular and cerebrovascular diseases. At present, cardiovascular and cerebrovascular diseases jump over the diseases with high morbidity, high disability rate, high mortality, high recurrence rate, high medical cost and more complications (often called 'five-higher one or more') in China. The cardiovascular and cerebrovascular diseases mainly refer to 11 diseases such as coronary heart disease, myocardial infarction, cerebral thrombus, hypertension and the like, and are caused by hypertension, hyperlipidemia, hyperglycemia, hyperviscosity, blood platelet function enhancement, arteriosclerosis, high content of free radicals in vivo and microcirculation disturbance; the more blood fat is accumulated on the vessel wall, atherosclerosis is caused, the vessel lumen is narrow and small, the blood flow is blocked, substances such as nutrient components, oxygen and the like cannot be smoothly conveyed to the required part of a body, wastes such as carbon dioxide and the like cannot be sufficiently taken away, and the vessel wall is thinned, embrittled and loses elasticity.
A Chinese medicine in the form of capsule for treating cardiovascular and cerebrovascular diseases is disclosed. The original preparation method comprises the following steps: extracting radix astragali, Lumbricus, lignum sappan, and Achyranthis radix with water for three times, mixing the three extractive solutions, filtering, concentrating, oven drying, and pulverizing; reflux-extracting rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, and radix Rhodiolae with 70% ethanol for three times, mixing the three extractive solutions, recovering ethanol under reduced pressure, concentrating into paste, oven drying, and pulverizing. Oven drying Arisaema cum bile, mixing with stigma croci Sativi, pulverizing, mixing the three powders, adding adjuvants, and encapsulating.
The first medicine of the Jingzhu Shuanghong Huoxue capsule is saffron. Saffron is a herb plant of crocus of iridaceae, the traditional medicinal part is dry stigma, and the saffron has the effects of promoting blood circulation to remove blood stasis, cooling blood and detoxifying, but the yield of crocus stigma is extremely low, and only accounts for 7.4% of the mass of the whole flower, that is, 13.5kg of whole saffron flowers are needed to obtain 1kg of crocus stigma. At present, saffron with picked stigma is discarded completely, which causes great resource waste. Research shows that the non-stigma part of saffron is rich in various chemical components such as flavone, phenolic acid, glycoside, etc., has good antioxidant activity, and has obvious regulating effect on blood fat, blood pressure, heart smooth muscle contraction and platelet aggregation. In order to improve the comprehensive utilization of saffron and optimize the curative effect of the Jingzhu Shuanghong Huoxue capsule, the medicine application part of saffron needs to be changed and the original medicine ratio needs to be adjusted.
In addition, in the original preparation process, no matter the water decoction or the ethanol extraction is carried out, the dissolution of the effective components does not reach the ideal level, and the exertion of the drug effect is limited, so the process conditions of the water decoction and the ethanol extraction need to be optimized respectively to improve the dissolution rate of the effective components. Therefore, the development of a novel method for preparing the crystal pearl double red blood-activating capsules which can overcome the defects has important practical significance.
Disclosure of Invention
The invention aims to provide a composition and a medicament for treating cardiovascular and cerebrovascular diseases and application of a preparation method thereof.
The invention provides a composition for treating cardiovascular and cerebrovascular diseases, which comprises the following components in parts by mass: 60-80 parts of saffron, 50-250 parts of rhodiola rosea, 200 parts of sappan wood, 100 parts of angelica, 50-150 parts of arisaema cum bile, 250 parts of ligusticum wallichii, 400 parts of astragalus mongholicus, 200 parts of earthworm and 200 parts of achyranthes bidentata.
Preferably, the composition consists of the following components in parts by mass: 70 parts of saffron, 200 parts of Hongjing day, 150 parts of sappan wood, 200 parts of angelica, 50 parts of arisaema cum bile, 200 parts of ligusticum wallichii, 300 parts of astragalus mongholicus, 150 parts of earthworm and 150 parts of radix achyranthis bidentatae.
The invention provides application of the composition in the technical scheme in preparing a medicament for treating cardiovascular and cerebrovascular diseases.
The invention provides a new Tibetan medicine for treating cardiovascular and cerebrovascular diseases, namely Jingzhu Shuanghong Huoxue Capsule, wherein the effective component of the medicine consists of the composition in claim 1 or 2, and is prepared from the following raw materials in parts by mass: 60-80 parts of saffron, 50-250 parts of rhodiola rosea, 200 parts of sappan wood, 100 parts of angelica, 50-150 parts of arisaema cum bile, 250 parts of ligusticum wallichii, 400 parts of astragalus mongholicus, 200 parts of earthworm and 200 parts of achyranthes bidentata.
Preferably, the Jingzhu Shuanghong Huoxue capsule is prepared from the following raw materials in parts by mass: 70 parts of saffron, 200 parts of rhodiola rosea, 150 parts of sappan wood, 200 parts of angelica, 50 parts of arisaema cum bile, 200 parts of ligusticum wallichii, 300 parts of astragalus mongholicus, 150 parts of earthworm and 150 parts of radix achyranthis bidentatae.
Wherein, the preferable mass fraction of the saffron crocus whole flowers is 70 parts, thus not only keeping the content of stigma parts not lower than the original formula, but also fully utilizing non-stigma parts.
The preparation method of the crystal pearl double red blood-activating capsule provided by the invention comprises the following steps:
1) decocting radix astragali, Lumbricus, lignum sappan, and Achyranthis radix in water for three times, mixing the three extractive solutions, filtering, concentrating into soft extract, oven drying, and pulverizing to obtain medicinal powder 1;
2) extracting rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, and radix Rhodiolae with 70% ethanol water solution for three times, mixing the three extractive solutions, concentrating into soft extract, oven drying, and pulverizing to obtain medicinal powder 2;
3) drying the arisaema cum bile, mixing the dried arisaema cum bile with the whole saffron, and crushing to obtain medicinal powder 3;
4) mixing the powder 1, powder 2 and powder 3, and making into capsule.
The above steps 1) to 3) may be performed in any order or simultaneously.
Wherein, water is required to be added for soaking before the decoction and extraction in the step 1), the water addition amount is 10 times of the volume of the astragalus, the earthworm, the sappan wood and the radix achyranthis bidentatae, and the soaking time is 120 minutes.
The conditions for decoction and extraction are as follows: the water adding amount of the three times of decoction is 10 times, 7 times and 4 times of the volume of the astragalus, the earthworm, the suwood and the radix achyranthis bidentatae in turn; the time for three times of decoction is 4 hours, 2 hours and 1 hour in sequence.
In the step 2), ethanol water solution with the volume fraction of 70% is used for soaking before ethanol extraction, the dosage of the ethanol water solution with the volume fraction of 70% is 6 times of the volume of the ligusticum wallichii, the angelica sinensis and the rhodiola rosea, and the soaking time is 60 minutes.
The extraction conditions were as follows: the mass of the ethanol water solution added in the first extraction is 6 times of the mass of the medicinal materials, and the extraction is carried out for 3 hours; the mass of the ethanol water solution added in the second extraction is 4 times of the mass of the medicinal materials, and the extraction is carried out for 2 hours; the mass of the ethanol water solution added in the third extraction is 4 times of the mass of the medicinal materials, and the extraction is carried out for 1 hour.
In the step 1) and the step 2), the concentration into the paste is specifically to concentrate the extracting solution into a thick paste with the relative density of 1.30-1.35 (50 ℃).
The raw material medicines for preparing the capsule are proportioned according to parts by mass, and can be increased or decreased according to corresponding proportions during production, for example, the mass production can be in units of kilograms or tons, the small-scale production can also be in units of grams, the weight can be increased or decreased, but the mass proportioning proportion of the raw material medicines among the components is unchanged.
The crystal pearl Shuanghong blood-activating capsule prepared by the method also belongs to the protection scope of the invention.
The invention creatively solves the problem of comprehensive utilization of saffron by improving the existing prescription and preparation process, and simultaneously, the spray drying method is used for drying the thick paste of the medicinal material extract, so that the yield of the effective components is increased, and the drug effect of the Jingzhu Shuanghong blood-activating capsule is improved.
Pharmacodynamic tests prove that the Jingzhu Shuanghong blood-activating capsule prepared by the method has the functions of activating blood circulation, removing stasis, calming the heart, soothing the nerves, regulating qi and blood, regulating the balance of Longlong, Chiba and bacon; is suitable for preventing and treating diseases such as comprehensive wood-cloth disease spreading to heart (coronary arteriosclerosis, coronary heart disease, ischemic heart disease, angina pectoris) and head (hypertension, cerebral thrombosis, and apoplexy sequela). Compared with the existing Jingzhu Xinnaotong capsule, the capsule has higher cure rate and quicker response.
Detailed Description
The present invention will be described below with reference to specific examples, but the present invention is not limited thereto.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; the reagents, materials and the like used in the following examples are commercially available unless otherwise specified.
Materials, reagents and the like used in the following examples are commercially available unless otherwise specified.
Saffron, rhodiola rosea, sappan wood, angelica, arisaema cum bile, ligusticum wallichii, astragalus root, earthworm and achyranthes bidentata used in the following examples all meet the relevant regulations under each medicinal material item in the text of the Chinese pharmacopoeia (2015 edition). Before feeding, the material objects are identified to be consistent with the names of the medicinal materials, and the quality is in accordance with the standard.
Example 1 examination of the Effect of different Water extraction Process conditions on the active ingredients
The prescription composition is as follows:
70g of saffron, 200g of rhodiola rosea, 150g of sappan wood, 200g of angelica, 50g of arisaema cum bile, 200g of ligusticum wallichii, 300g of astragalus mongholicus, 150g of earthworm and 150g of radix achyranthis bidentatae.
The preparation method comprises the following steps:
1) decocting the astragalus, the earthworm, the sappan wood and the radix achyranthis bidentatae in water for three times, combining the three extracting solutions, filtering, concentrating the extracting solution to thick paste with the relative density of 1.30-1.35 (50 ℃), drying the thick paste at 90 ℃ and crushing the thick paste to obtain medicinal powder 1;
2) soaking ligusticum wallichii, angelica sinensis and rhodiola rosea (the dosage is 6 times of the volume of the ligusticum wallichii, the angelica sinensis and the rhodiola rosea) for 60 minutes, then extracting for three times by using ethanol aqueous solution with the volume fraction of 70% (adding 6 times of the volume of ethanol for extracting for 3 hours for the first time, adding 4 times of the volume of ethanol for extracting for 2 hours for the second time and adding 4 times of the volume of ethanol for extracting for 1 hour for the third time), combining extracting solutions, concentrating to obtain thick paste with the relative density of 1.30-1.35 (50 ℃), drying at 90 ℃, crushing and sieving by using a 80-mesh sieve to obtain medicinal powder 2;
3) drying Arisaema cum bile of a prescription amount, mixing with saffron crocus whole flowers, and crushing to obtain medicinal powder 3;
4) and (3) uniformly mixing the medicinal powder 1, the medicinal powder 2 and the medicinal powder 3, and filling into 1000 capsules to obtain the capsule.
In the step 1), an orthogonal test is designed through three factors (soaking time, water adding amount and extraction time) and three levels, the yield of the astragaloside is taken as a survey index, the orthogonal factors and the levels are shown in a table 1, and the orthogonal test result is shown in a table 2.
TABLE 1 Water decoction Process factors and levels of JINGZHUANGSHONGHUOXUE Capsule
Figure BDA0003397526210000051
(Note: optimization of the second and third extraction times not shown)
TABLE 2 Crystal-pearl Shuanghong Huoxue capsule water decoction process orthogonal test results
Serial number A B C Yield of astragaloside (mg/g)
1 1 1 1 0.849
2 2 2 2 0.961
3 3 3 3 1.075
4 1 2 3 0.877
5 2 3 1 0.983
6 3 1 2 0.879
7 1 3 2 0.974
8 2 1 3 1.136
9 3 2 1 0.988
K1 2.700 2.864 2.815
K2 3.080 2.826 2.814
K3 2.942 3.032 3.088
R 0.380 0.206 0.274
As can be seen from table 2, when the water decoction process condition is A2B3C3, the yield of astragaloside is higher than other process conditions, so the optimal process conditions are: soaking in 10 times of water for 120 min, decocting with water for three times, and extracting for 4 hr. Optimization was performed in the same manner, yielding a second extraction with 7 volumes of water for 2 hours and a third extraction with 4 volumes of water for 1 hour.
Example 2 examination of the Effect of different alcohol extraction Process conditions on the active ingredients
The formulation is the same as in example 1.
The preparation method comprises the following steps:
1) decocting radix astragali, Lumbricus, lignum sappan and Achyranthis radix in water for three times (10 times of water for 120 min), wherein the water amount is 10 times, 7 times and 4 times of the volume of radix astragali, Lumbricus, lignum sappan and Achyranthis radix; the time for three times of decoction is 4 hours, 2 hours and 1 hour in sequence. ) Mixing the three extracting solutions, filtering, concentrating to obtain thick paste with the relative density of 1.30-1.35 (50 ℃), drying at 90 ℃, and crushing to obtain medicinal powder 1;
2) extracting rhizoma ligustici wallichii, angelica and rhodiola rosea according to the prescription amount with an ethanol water solution for three times, combining extracting solutions, concentrating the extracting solutions to form thick paste with the relative density of 1.30-1.35 (50 ℃), drying the thick paste at 90 ℃, crushing the thick paste, and sieving the thick paste with a 80-mesh sieve to obtain medicinal powder 2;
3) drying Arisaema cum bile of a prescription amount, mixing with saffron crocus whole flowers, and crushing to obtain medicinal powder 3;
4) and (3) uniformly mixing the medicinal powder 1, the medicinal powder 2 and the medicinal powder 3, and filling into 1000 capsules to obtain the capsule.
In the step 2), an orthogonal test is designed by three factors (ethanol concentration, ethanol adding amount and extraction time) and three levels, the extraction rate of salidroside is taken as a survey index, and the orthogonal factors and levels are shown in Table 3.
TABLE 3 ethanol extraction process factors and levels of JINGZHUANGSHUOXUE Capsule
Figure BDA0003397526210000061
TABLE 4 Quadrature test results of ethanol extraction process of Jingzhu Shuanghong Huoxue capsule
Figure BDA0003397526210000062
Figure BDA0003397526210000071
As can be seen from table 4, when the ethanol extraction process condition is A2B1C3, the salidroside extraction rate is maximized, and thus the optimal process conditions for ethanol extraction are: ethanol concentration 70%, 6 times volume of 70% ethanol, first extraction time 3 hours. Optimization was performed in the same manner, resulting in a second 4-fold volume of 70% ethanol extraction for 2 hours and a third 4-fold volume of 70% ethanol extraction for 1 hour.
Example 3 comparison of drug effects of saffron crocus after administration to different sites
According to different application parts of saffron crocus, the following two jinzhu shuanghong blood-activating capsule preparations are respectively prepared, and the protective effect of the two jinzhu shuanghong blood-activating capsule preparations on myocardial ischemia reperfusion injury of rats is observed.
(1) Preparation A: 70g of saffron, 200g of rhodiola rosea, 150g of sappan wood, 200g of angelica, 50g of arisaema cum bile, 200g of ligusticum wallichii, 300g of astragalus mongholicus, 150g of earthworm and 150g of radix achyranthis bidentatae, and the preparation method is carried out according to the method in the example 1.
(2) Preparation B: 5g of saffron stigma, 200g of rhodiola rosea, 150g of sappan wood, 200g of angelica, 50g of arisaema cum bile, 200g of ligusticum wallichii, 300g of astragalus mongholicus, 150g of earthworm and 150g of radix achyranthis bidentatae, and the preparation method is carried out according to the method in the example 1.
The results are shown in Table 5. ATP/ADP: the A preparation group is obviously higher than the B preparation group, and the A preparation group and the B preparation group are both obviously higher than the model group; na (Na)+/K+-ATPase: the A preparation group is obviously higher than the B preparation group, and simultaneously the A preparation group and the B preparation group are both obviously higher than the model group; lactate Dehydrogenase (LDH): the A preparation group is obviously higher than the B preparation group and the model group, and the B preparation group has no obvious difference with the model group. The results show that the Jingzhu Shuanghong Huoxue capsule prepared by using the Tibetan safflower whole flower as the medicine has stronger protective effect on myocardial ischemia reperfusion injury of rats than the Jingzhu Shuanghong Huoxue capsule prepared by using the saffron stigma as the medicine, and the active component in the non-stigma part of the saffron is supposed to cause the differenceOne of the reasons for this, however, further intensive pharmacological studies have been required. TABLE 5 Effect of Jingzhu Shuanghong Huoxue capsule preparations administered from different parts of saffron on myocardial ischemia reperfusion of rats
Figure BDA0003397526210000072
Figure BDA0003397526210000081
Note: p < 0.05 compared to group B; # P < 0.05 in comparison with the model group
Example 4 preparation of Jingzhu Shuanghong Huoxue capsule under optimum Process conditions
The formulation is the same as in example 1.
The preparation method comprises the following steps:
1) decocting radix astragali, Lumbricus, lignum sappan and Achyranthis radix in water for three times (10 times of water for 120 min), wherein the water amount is 10 times, 7 times and 4 times of the volume of radix astragali, Lumbricus, lignum sappan and Achyranthis radix; the time for three times of decoction is 4 hours, 2 hours and 1 hour in sequence. ) Mixing the three extracting solutions, filtering, concentrating to obtain thick paste with the relative density of 1.30-1.35 (50 ℃), drying at 90 ℃, and crushing to obtain medicinal powder 1;
2) extracting rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, and radix Rhodiolae with 70% ethanol water solution for three times (adding 6 times of 70% ethanol water solution, soaking for 60 min; the dosage of ethanol aqueous solution extracted for three times is 6 times, 4 times and 4 times of the volume of the hemlock parsley, the angelica and the rhodiola; the time for three times of extraction is 3 hours, 2 hours and 1 hour in sequence. ) Mixing the extracting solutions, concentrating the extracting solutions to thick paste with the relative density of 1.30-1.35 (50 ℃), drying the thick paste at 90 ℃, crushing the thick paste, and sieving the powder with a 80-mesh sieve to obtain medicinal powder 2;
3) drying Arisaema cum bile of a prescription amount, mixing with saffron crocus whole flowers, and crushing to obtain medicinal powder 3;
4) and mixing the medicinal powder 1, the medicinal powder 2 and the medicinal powder 3 uniformly, adding auxiliary materials, and filling into 1000 capsules to obtain the capsule.
Comparative example (c),
The formulation is the same as in example 1.
Extracting with water for three times (the water added for three times is 5 times, 5 times and 5 times of the volumes of the astragalus, the earthworm, the sappan wood and the radix achyranthis bidentatae in turn, and the water added for three times is 2 hours, 2 hours and 2 hours) in the formula, combining the three extracting solutions, filtering, concentrating, drying and crushing; extracting rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, and radix Rhodiolae with 70% ethanol under reflux for three times (first extracting with 6 times of ethanol for 2 hr, second extracting with 6 times of ethanol for 2 hr, and third extracting with 6 times of ethanol for 2 hr), mixing the three extractive solutions, recovering ethanol under reduced pressure, concentrating into paste, oven drying, and pulverizing; drying the dannan star, mixing with the saffron crocus, crushing, uniformly mixing the three medicinal powders according to a proportion, adding auxiliary materials, and filling into 1000 capsules to obtain the product of the invention.
Example 5 test of drug efficacy
The following compares 5 lot numbers of each of the jinzhu shuanghonghuo capsules prepared by the preparation method of the invention example 4 and the comparative example method, and evaluates the difference between the two in the content of active ingredients and clinical efficacy.
1. The comparison of the active ingredient contents was performed using salidroside, astragaloside iv, crocin i/ii as evaluation indices, and the elution amounts of the respective active ingredients were measured by high performance liquid chromatography, and the results are shown in table 6.
TABLE 6 comparison of active ingredients of Jingzhu Shuanghong Huoxue capsule prepared by different methods
Figure BDA0003397526210000091
As can be seen from Table 6, the dissolution amounts of the active ingredients of the rhodiola rosea glycoside, the astragaloside IV and the crocin I/II in the Jingzhuangshengxue capsule are obviously higher than those of the original preparation method by adopting the preparation method of the invention, and the differences have statistical significance (P is less than 0.05).
2. Clinical effects
Ischemic cardiovascular and cerebrovascular diseases are caused by abnormal lipid metabolism, which causes blood fat to deposit on the inner wall of blood vessels, resulting in coronary artery and cerebrovascular blood circulation disorders. The Jingzhu Shuanghong Huoxue capsule has the functions of benefiting qi, activating blood circulation, removing blood stasis and dredging collaterals, and can be used for treating thoracic obstruction and apoplexy caused by qi deficiency and blood stasis, and cardiovascular and cerebrovascular diseases such as coronary heart disease, angina pectoris, cerebral embolism recovery period and the like belonging to the above symptoms. The Beijing Jingzhu Chinese medical hospital makes a preliminary observation on this.
The observation was included in 94 outpatients of ischemic cardiovascular and cerebrovascular diseases and hyperlipidemia, and were randomly divided into A group and B group. Group A48 cases, 26 men and 20 women, age 34-82 years, course 1-16 years; 21 cases of coronary heart disease, 10 cases of cerebral thrombosis and 17 cases of hyperlipidemia. Group B46, 24 men and 22 women, age 35-80 years, course 1-18 years; 19 cases of coronary heart disease, 12 cases of cerebral thrombosis and 15 cases of hyperlipidemia. Patients with coronary heart disease all have symptoms of chest distress, chest pain, short breath, debilitation, palpitation and the like with different degrees, and the electrocardiographic examination has myocardial ischemia, ST segment downward shift and Creatine Phosphokinase (CPK) change, thereby meeting the diagnosis standard of coronary heart disease. Cerebral thrombosis patients have dizziness, language handicap, limb disturbance, and intelligence or memory deterioration of different degrees, and cerebral CT shows that plaques of different degrees exist at different parts, and accords with the diagnostic standard of cerebral thrombosis. Patients with hyperlipidemia all have symptoms of dizziness, hypodynamia, chest distress and somnolence. All patients were examined 2 times within 2 weeks for fasting serum Total Cholesterol (TC) of ≥ 60mmol/L or Triglyceride (TG) of ≥ 1.54mmol/L under normal dietary conditions.
Patients in group A receive the treatment of the Jingzhu Shuanghong Huoxue capsules prepared by the method of the invention, and patients in group B receive the treatment of the Jingzhu Shuanghong Huoxue capsules prepared by the original method. The two groups of administration modes are 4 granules once, 3 times a day, and oral administration is carried out, and 3 months is a treatment course. The electrocardiogram was reviewed every 15 days during the treatment period, and TC, TG and CPK were reviewed at the end of the treatment period, followed up for 2 treatment periods.
The clinical efficacy of both groups is shown in Table 7, and the results of the laboratory examinations before and after treatment are shown in Table 8. Wherein the total effective rate of the group A is 89.6%, which is obviously higher than that of the group B (78.3%, P < 0.05). In terms of laboratory examination results, the TC, TG and CPK levels were significantly decreased after A, B both groups post-treatment compared to pre-treatment (P both < 0.05), while TC and CPK levels after a group a treatment were significantly lower than after B group treatment (P both < 0.05). In conclusion, the comprehensive curative effect of the Jingzhu Shuanghong Huoxue capsule prepared by the method of the invention on ischemic cardiovascular and cerebrovascular diseases is better than that of the Jingzhu Shuanghong Huoxue capsule prepared by the original method.
TABLE 7A, B comparison of clinical efficacy of two groups of patients
Figure BDA0003397526210000101
TABLE 8A, B comparison of laboratory examination results before and after treatment for two groups of patients
Figure BDA0003397526210000102
Note: p < 0.05 compared to the group before treatment; #: p was < 0.05 compared to group B after treatment. .
In conclusion, the Jingzhu Shuanghong blood-activating capsule prepared by the method has the functions of activating blood and dissolving stasis, relieving uneasiness, calming the nerves, regulating qi and blood, and balancing the balance of Longlong, Chiba and bacon; is suitable for preventing and treating diseases such as comprehensive wood-cloth disease spreading to heart (coronary arteriosclerosis, coronary heart disease, ischemic heart disease, angina pectoris) and head (hypertension, cerebral thrombosis, and apoplexy sequela). Compared with the existing Jingzhu Xinnaotong capsule, the capsule has higher cure rate and quicker response.
Although the invention has been described in detail above with reference to a general description and specific examples, it will be apparent to one skilled in the art that modifications or improvements may be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims (10)

1. The composition for treating cardiovascular and cerebrovascular diseases is characterized by comprising the following components in parts by mass: 60-80 parts of saffron, 50-250 parts of rhodiola rosea, 200 parts of sappan wood, 100 parts of angelica, 50-150 parts of arisaema cum bile, 250 parts of ligusticum wallichii, 400 parts of astragalus mongholicus, 200 parts of earthworm and 200 parts of achyranthes bidentata.
2. The composition according to claim 1, wherein the composition consists of the following components in parts by mass: 70 parts of saffron, 200 parts of rhodiola rosea, 150 parts of sappan wood, 200 parts of angelica, 50 parts of arisaema cum bile, 200 parts of ligusticum wallichii, 300 parts of astragalus mongholicus, 150 parts of earthworm and 150 parts of radix achyranthis bidentatae.
3. Use of a composition according to claim 1 or 2 for the manufacture of a medicament for the treatment of cardiovascular and cerebrovascular diseases.
4. A medicament for the treatment of cardiovascular and cerebrovascular diseases, wherein the active ingredient of said medicament consists of the composition of claim 1 or 2.
5. The process for the preparation of the medicament of claim 4, characterized in that it consists of the following steps:
1) decocting radix astragali, Lumbricus, lignum sappan, and Achyranthis radix in water for three times, mixing the three extractive solutions, filtering, concentrating into soft extract, oven drying, and pulverizing to obtain medicinal powder 1;
2) extracting rhizoma Ligustici Chuanxiong, radix Angelicae sinensis, and radix Rhodiolae with 70% ethanol water solution for three times, mixing the three extractive solutions, concentrating into soft extract, oven drying, and pulverizing to obtain medicinal powder 2;
3) drying the arisaema cum bile, mixing the arisaema cum bile with the saffron crocus, and crushing to obtain medicinal powder 3;
4) mixing the powder 1, powder 2 and powder 3, and making into capsule.
The above steps 1) to 3) are arbitrarily changed in order or steps 1) to 3) are performed simultaneously.
6. The method of claim 3, wherein: in the step 1), the decocting and extracting conditions are as follows: the water adding amount of the three times of decoction is 10 times, 7 times and 4 times of the volume of the astragalus, the earthworm, the sappan wood and the radix achyranthis bidentatae in turn; the time for three times of decoction is 4 hours, 2 hours and 1 hour in sequence.
7. The method according to claim 3 or 4, characterized in that: in the step 1), water is added for soaking before decoction and extraction, wherein the water addition amount is 10 times of the volume of the astragalus, the earthworm, the sappan wood and the radix achyranthis bidentatae, and the soaking is carried out for 120 minutes.
8. The method according to any one of claims 5, wherein: in the step 2), the extraction conditions are as follows: the mass of the ethanol water solution added in the first extraction is 6 times of the mass of the medicinal materials, and the extraction is carried out for 3 hours; the mass of the ethanol water solution added in the second extraction is 4 times of the mass of the medicinal materials, and the extraction is carried out for 2 hours; the mass of the ethanol water solution added in the third extraction is 4 times of the mass of the medicinal materials, and the extraction is carried out for 1 hour.
9. The method according to any one of claims 5 or 8, wherein: in the step 2), ethanol water solution with the volume fraction of 70% is required to be soaked before ethanol extraction, the using amount of the ethanol water solution with the volume fraction of 70% is 6 times of the volume of the ligusticum wallichii, the angelica sinensis and the rhodiola rosea, and the soaking time is 60 minutes.
10. The method of claim 5, 6 or 8, wherein: in the step 1) and the step 2), the concentration to obtain the thick paste is specifically carried out by concentrating the extracting solution to obtain the thick paste with the relative density of 1.30-1.35 at 50 ℃.
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