CN113616723B - Traditional Chinese medicine composition for treating chronic heart failure and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating chronic heart failure and preparation method thereof Download PDFInfo
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- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
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- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The invention belongs to the field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating chronic heart failure and a preparation method thereof. The traditional Chinese medicine composition is prepared from 9 raw medicinal materials of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, has the curative effects of relieving chest stuffiness and eliminating stagnation, removing blood stasis, promoting qi circulation and reducing phlegm, and can effectively treat chronic heart failure caused by phlegm turbidity obstruction and qi stagnation in chest. Pharmacodynamic experiment results show that the composition can reduce cardiac hypertrophy and pulmonary congestion caused by heart failure, effectively improve cardiac function, improve ventricular remodeling, slow down inflammatory reaction process, reduce adhesion and aggregation of platelets in blood vessels, and relieve pulmonary circulation and systemic circulation resistance, thereby playing an exact role in treating chronic heart failure.
Description
Technical Field
The invention relates to a traditional Chinese medicine composition and a preparation method thereof, in particular to a traditional Chinese medicine composition for treating chronic heart failure and a preparation method thereof, and belongs to the field of traditional Chinese medicines.
Background
Chronic Heart Failure (CHF) refers to a group of syndromes that impair ventricular filling or ejection capacity due to various organic or functional heart diseases, and is the terminal stage of development of various cardiovascular system diseases. Heart failure is a common disease and frequently encountered disease of clinically-aged diseases, and factors clinically inducing the heart failure are more, such as changes of life rhythm, eating habits and life pressure, and the incidence of primary diseases related to heart failure, such as hypertension, coronary heart disease, hyperlipidemia, diabetes, myocardial infarction and the like, which greatly increase the incidence of the heart failure. Heart failure, the ultimate outcome of the end-stage of heart disease, constitutes the leading cause of death in diseases of the cardiovascular system, and CHF has become a health killer that is severely life-threatening to humans.
According to epidemiological survey in China, the prevalence rate of chronic heart failure is 0.9%, the mortality rate is up to 40%, and about 80% of hospitalized patients with chronic heart failure are over 65 years old. The high incidence rate of chronic heart failure becomes a main public health problem, and patients with chronic heart failure are repeatedly hospitalized due to symptoms aggravated by various inducers, have long course of disease and expensive medical treatment, increase the social and economic burden and seriously reduce the life quality of the patients.
Heart failure is a medical problem, and the treatment method is continuously researched and innovated. At present, the treatment of chronic heart failure in western medicine changes from measures of increasing cardiac contraction in short term such as diuresis, cardiotonic, blood vessel expansion and the like into long-term and reparative strategies mainly comprising neuroendocrine inhibitors, and aims to perform ventricular remodeling, block malignant circulation and change the biological properties of failing heart. However, despite the development and improvement of western medicine, the defect of single target of the medicine is still not changed, and the prior art still has the limitations of long treatment period, strong medicine dependence, large side effect, unsatisfactory curative effect and the like.
According to the traditional Chinese medicine, chronic heart failure is mainly caused by heart and lung, spleen is affected after the chronic heart failure is caused by the chronic heart failure, and the heart failure belongs to the categories of palpitation, severe palpitation, asthma syndrome, edema and phlegm-fluid retention. The basic pathogenesis is that the principal deficiency indicates excess, the principal deficiency is caused by deficiency of qi, blood, yin and yang, the principal deficiency is caused by deficiency of both qi and yin, and the principal deficiency indicates excess and is caused by the combination of dampness, phlegm and blood stasis. The traditional Chinese medicine integrally regulates qi, blood and body fluid of patients by means of treatment ideas of syndrome differentiation and treatment and holism, can improve symptoms of heart failure, improve the capability of resisting pathogenic factors of the patients, reduce the frequency of repeated attack of the heart failure patients due to various induction factors, and has the advantages of less side effects, lasting curative effect, good compliance and the like.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating chronic heart failure, which is prepared from 9 raw medicinal materials including trichosanthes kirilowii maxim, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, has the effects of relieving chest stuffiness and dissipating stagnation, removing stasis and reducing phlegm, tonifying qi and warming yang, and promoting qi circulation and relieving pain, and can be used for treating chronic heart failure caused by phlegm turbidity and obstruction and qi stagnation in chest, and each effect is achieved.
The invention relates to a traditional Chinese medicine composition for treating chronic heart failure, which is prepared from the following traditional Chinese medicine components:
40-60 parts of snakegourd fruit, 30-50 parts of allium macrostemon and 15-35 parts of cassia twig
30-50 parts of radix salviae miltiorrhizae, 15-35 parts of platycodon grandiflorum and 15-35 parts of ligusticum wallichii
15-35 parts of fructus aurantii, 10-25 parts of costustoot and 15-35 parts of mangnolia officinalis
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
45-55 parts of snakegourd fruit, 35-45 parts of allium macrostemon, 20-30 parts of cassia twig
35-45 parts of salvia miltiorrhiza, 20-30 parts of platycodon grandiflorum and 20-30 parts of ligusticum wallichii
20-30 parts of fructus aurantii, 15-20 parts of costustoot and 20-30 parts of mangnolia officinalis
Preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
50 parts of snakegourd fruit, 40 parts of allium macrostemon, 40 parts of cassia twig and 25 parts of cassia twig
Root of red rooted saliva 40 weight parts, root of balloonflower 25 weight parts, rhizome of Sichuan lovage 25 weight parts
25 parts of fructus aurantii, 18 parts of costustoot and 25 parts of magnolia officinalis
In the formula, the snakegourd fruit is sweet in taste and cold in nature, can promote qi circulation, promote diuresis, eliminate phlegm, remove blood stasis and promote fluid production, and has the effects of clearing heat and removing phlegm, and relieving chest stuffiness and eliminating stagnation. Xie Bai is pungent and bitter in flavor and can activate yang to dissipate nodulation, move qi and remove stagnation. Gua Lou and Xie Bai have synergistic action, and enhance the actions of relieving chest stuffiness, dissipating nodulation, removing blood stasis and resolving phlegm, so they are monarch drugs.
Salvia miltiorrhiza, being bitter in nature and slightly cold, activates blood circulation to dissipate blood stasis, cools blood and nourishes yin to activate blood. Chuan Xiong is pungent in flavor and warm in nature, and has the effects of promoting blood circulation, activating qi-flowing, dispelling wind and relieving pain. Hou Po is bitter and pungent in flavor, can descend qi and strengthen middle energizer, move qi and dry dampness. The 3 medicines are mutually reinforced to play the effect of promoting the circulation of qi, and the assistant monarch medicine can better play the functions of tonifying qi, activating blood circulation, removing dampness and reducing phlegm, and is used as a ministerial medicine.
Cassia twig, ramulus Cinnamomi is pungent and sweet in flavor and warm in nature, and has the effects of tonifying heart yang and warming and activating blood vessels. The bitter orange is bitter and pungent in taste and slightly cold in nature, can regulate qi, relieve epigastric distention, activate stagnancy and relieve distension, and can be used for treating qi disorder caused by blood stasis. The composition can exert the functions of activating yang, dispelling cold, lowering adverse qi and calming the Chong when used together with ramulus Cinnamomi, and the two are used as adjuvant drugs.
The platycodon root is bitter and pungent in taste and mild in nature, and has the effects of dispersing lung qi, eliminating phlegm and expelling pus. Mu Xiang is pungent, bitter and warm in nature, and has the actions of descending qi and checking adverse rise of qi. The 2 medicines are combined to be used as guiding medicines for promoting qi circulation to relieve pain, regulating middle warmer and removing food stagnation.
The 9 traditional Chinese medicines such as the snakegourd fruit, the allium macrostemon and the like are combined according to the compatibility theory of monarch, minister, assistant and guide and drug pair in the traditional Chinese medicine, the medicines are combined, the synergy is realized, the effects of widening chest, resolving masses, removing blood stasis, reducing phlegm, tonifying qi, warming yang, promoting qi circulation and relieving pain are realized, the treatment is carried out in combination with dialectical treatment, and the traditional Chinese medicine is used for treating chronic heart failure caused by phlegm turbidity obstruction and qi stagnation in chest, and has multiple good effects.
The invention also aims to provide a traditional Chinese medicine oral preparation containing the traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine oral preparation is one of oral liquid, granules, microcapsules, capsules, pills and tablets.
The preparation method of the traditional Chinese medicine oral preparation comprises the following steps:
A. weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicine in the step A, adding 6-10 times of water, decocting for 2 times, each time for 2-3h, filtering the decoction, and concentrating under reduced pressure to obtain extract for later use;
C. adding ethanol into the extract obtained in the step B to enable the ethanol content to reach 50% -70%, standing, performing cold precipitation, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract for later use;
D. and D, adding pharmaceutically acceptable excipient into the extract obtained in the step C according to a conventional process to prepare an oral pharmaceutical preparation.
Preferably, the decoction in the step B is concentrated under reduced pressure to an extract with the relative density of 1.10-1.20 at 50-60 ℃.
Preferably, the extract with the relative density of 1.22-1.28 at 50-60 ℃ is obtained by vacuum concentration in the step C.
Preferably, ethanol is added in the step C to ensure that the alcohol content reaches 50-70%, and the mixture is kept stand and subjected to cold precipitation for 24-48 h.
Step C, the conventional process includes but is not limited to the steps of water precipitation, filtration, concentration, spray drying, belt drying, crushing, sieving and the like.
Preferably, the acceptable excipient comprises one or more of a filler, a lubricant, a preservative, a flavoring agent, a disintegrating agent, a binder, a coloring agent and a dispersing agent.
Preferably, the pharmaceutically acceptable excipients include, but are not limited to, lactose, starch, dextrin, sugar powder, magnesium stearate, maltose, citric acid, tartaric acid, sodium hydroxide, aspartame, stevioside, sodium cyclamate, aspartame, potassium acesulfame, aspartame, sucralose, sodium benzoate, and the like.
In one embodiment, the oral formulation is a granule, and the preparation method of the granule comprises the following steps:
A. weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 8 times of water for the first time, decocting for 3h, adding 8 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.12 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the ethanol content to reach 70%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.26 at 50-60 ℃ for later use;
D. and (3) taking the extract in the step (C), carrying out belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding sucrose powder, dextrin and mannitol (weight ratio of 3: 1: 1) according to the formula, mixing uniformly, granulating, drying, and finishing granules to obtain granules.
In another embodiment, the oral formulation is a microcapsule prepared by a process comprising the steps of:
A. weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 10 times of water for the first time, decocting for 3h, adding 7 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.13 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.22 at 50-60 ℃ for later use;
D. taking the extract in the step C, performing belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, and crushing into fine powder, sodium complex protein: maltodextrin 3: 2 mixture as capsule wall material, octadecanol: titanium dioxide 3: 1 as an anti-sticking agent, polyethylene glycol: adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 55 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 34%, cooling to room temperature, adding the extract fine powder under stirring, and adding 1.19% of sucrose fatty acid ester in the total amount of the preparation formula: homogenizing and emulsifying soybean phospholipid 8: 5 composite emulsifier to obtain emulsion;
E. and D, carrying out spray drying on the emulsion in the step D under the conditions of air inlet temperature of 162 ℃, spray pressure of 0.45MPa and feeding speed of 22.5mL/min, collecting the microcapsules, and cooling to obtain the microcapsule.
In order to verify the efficacy of the traditional Chinese medicine composition for treating chronic heart failure, the inventor carries out pharmacodynamic test research. The selected drug in the pharmacodynamic test study is the drug obtained by the representative formula and the preparation method thereof. The other formulations and methods of preparation of the present invention are not intended to be exhaustive, and the tests and results thereof are not intended to be limiting.
Test example 1 Effect on rat model of Chronic Heart failure
1 materials of the experiment
1.1 Experimental animal 8 week old male healthy SPF SD rats 84 with weight of 180-. Animals are raised in cages in a special laboratory, and are raised adaptively for 1 week before the experiment, the room temperature is 20-25 ℃, the relative humidity is 40% -60%, the animals are naturally illuminated, and the animals can eat and drink water freely.
1.2 Instrument, reagent and drug AG285 model electronic analytical balance (Mettler-Toledo, Switzerland), Thermo Scientific Medifuge mini bench centrifuge (Sammer fly, USA), BT-300A full-automatic hemorheology tester (Nanjing Zhilun science and technology Co., Ltd.), color Doppler ultrasound system (Mirey medicine); ELISA kits (IL-1. beta., IL-10, TNF-. alpha.) (Sigma, USA); the tested drug is a granule sample prepared according to the formula and the preparation method in the example 3, the perhexiline group is perhexiline tablets (the specification: 0.38 g/tablet, the national standard Z20150028), Zhengda Qingchunbao pharmaceutical industry Co., Ltd; the positive control drug is enalapril maleate tablets (specification: 10 mg/tablet, national standard of medicine: H32026567), Yangziang pharmaceutical group Jiangsu pharmaceutical GmbH.
2 method of experiment
2.1 groups of healthy SD rats 84 were molded and randomly divided into 7 groups of 12 rats each, namely, a sham operation group, a model group, an enalapril group, a perhexiline group, and a test group (including a high dose group, a medium dose group, and a low dose group). Except for the sham group, other rats prepared a CHF rat model with reference to the method of constricting the abdominal aorta: anesthetizing a rat by injecting 3% pentobarbital sodium (30mg/kg) into the abdominal cavity, opening the abdominal cavity at the position 2-3cm away from the center of the lower abdomen of the xiphoid process, carrying out blunt muscle dissection, dissociating the abdominal aorta, placing a No. 7 surgical needle parallel to the abdominal aorta, ligating the aorta with a needle head by using a No. 4 silk thread, withdrawing the surgical needle, and confirming that the abdominal aorta is unobstructed and closing the abdomen. The normal control group rats were isolated from the abdominal aorta only and were not ligated. Rats were injected intraperitoneally daily for 3d post-surgery with 5 upen to prevent infection. The success of modeling the chronic heart failure model can be judged by general condition observation, electrocardiogram detection, cardiac ultrasonic function evaluation and BNP measurement in serum.
2.2 after 6 weeks of administration, 10 rats were randomly selected from the sham-operated group, and 10 successfully molded rats were selected from each group of the molding group. The clinical dose of the tested medicine is 6.5g crude drug/kg, and the rats in the high, medium and low dose groups are respectively administered 13g crude drug/kg, 6.5g crude drug/kg and 3.25g crude drug/kg per day for intragastric administration, which are respectively 2 times, equal times and 1/2 times of the clinical common dose of human; the positive control group is administrated with enalapril of 1.2mg/kg per day for intragastric administration, the perhexiline group is administrated with enalapril of 0.48g/kg per day for intragastric administration, and the rats of the sham operation group and the model group are administrated with physiological saline of the same volume for intragastric administration. Each group of rats was administered for 4 weeks.
2.3 detection index and method
(1) The survival status of rats such as food intake, water intake, body mass, respiration, activity, mental, stool and urine, fur and the like is observed every day at regular time, and if the rats die, the dead rats are registered.
(2) After the rat is administered last time, pentobarbital sodium 50mg/kg is injected into the abdominal cavity for anesthesia, the rat is fixed on the rat plate in a supine manner, and skin is prepared from the left anterior chest clavicle to the lower edge of the rib. The structure and function of the left heart of a rat are measured by Doppler ultrasound through the anterior chest wall, and cardiac function analysis is carried out by measuring the left ventricular systolic membrane diameter (LVESD), the left ventricular diastolic end diameter (LVEDD), the Left Ventricular Ejection Fraction (LVEF) and the left ventricular internal diameter shortening rate (LVFS) under the guidance of a left ventricular long-axis image.
(3) 6mL of blood is taken from abdominal aorta of a rat, 5mL of blood is taken and injected into a test tube, the test tube is shaken up, centrifuged at 3000r/min for 20min, and serum is separated and divided into 3 parts. The enzyme-linked immunosorbent assay (ELISA) is adopted to measure the contents of serum cytokines IL-1 beta (interleukin-1 beta), IL-10 (interleukin-10) and TNF-alpha (tumor necrosis factor-alpha).
(4) And (3) adding heparin into the 1mL of rat blood remained in the step (3) for anticoagulation, standing at room temperature for 2h, and measuring the whole blood high-cut viscosity (mPa & s), the whole blood low-cut viscosity (mPa & s), the plasma viscosity (mPa & s) and the erythrocyte aggregation index level of each group of rats by using a full-automatic hemorheology tester.
(5) After the rats were sacrificed, the heart and lung were removed, the residual blood was blotted with filter paper, weighed, and the heart index and lung index were calculated.
2.4 statistical methods SPSS 19.0 statistical software was used for analytical processing. Data of the experiment are mean ± standard deviation
"Format means comparison of differences between groups using one-way analysis of variance, with P < 0.05 indicating that the differences are statistically significant.
3 results of the experiment
3.1 influence on the body quality, heart and lung of rats with heart failure
No rats died during the whole experiment. After 6 weeks of modeling, the rats in the sham operation group are agile in action, have glossy hair and can normally eat drinking water; the rest 6 groups of rats had withered and lusterless fur, no tendency to lie in crouch, reduced activity, shortness of breath and red secretion in the mouth and nose.
After 2 weeks of administration, the hair and mental state of rats in the enalapril group, the perhexiline group and each test group were slightly improved compared with the model group, but the activity was slow, and the diet and water intake were still low; with the treatment time extended, the symptoms gradually decreased, and the condition was significantly lighter than the model group.
After 4 weeks of administration, the heart index and lung index of the model group were significantly increased (P < 0.05) compared with those of the sham operation group; compared with the model group, the heart index and the lung index of the enalapril group, the coronary heart disease group and the experimental high, medium and low dose groups are obviously reduced (the average P is less than 0.05); the heart index and the lung index of the test group are reduced along with the increase of the dosage of the medicament, wherein the reduction effect of the test high-dosage and medium-dosage group is better than that of the coronary heart disease group (the average P is less than 0.05). The results are shown in Table 2.
TABLE 1 Effect of the tested drugs on rat body Mass, Heart and Lung
Note: compared to the sham group: p < 0.05 is denoted by "+"; and a moldComparison of control group type: p < 0.05 for "#"means; compared with the perhexiline group: p < 0.05 for "▲"means.
3.2 comparison of cardiac function index of rats in each group
The results are shown in table 2, the model group rats showed a significant increase in LVESD and LVEDD and a significant decrease in LVEF and LVFS (both P < 0.05) compared to the sham group; compared with the model group, the rats LVESD and LVEDD of the enalapril group, the coronary disease group and the experimental high, medium and low dose groups are obviously reduced, and the LVEF and LVFS are obviously increased (the P is less than 0.05); the LVESD and LVEDD are gradually reduced and the LVEF and LVFS are increased along with the increase of the drug dosage of the test group, wherein the treatment effect of the middle and high dose groups is obviously better than that of the coronary heart disease group (the average P is less than 0.05).
TABLE 2 comparison of cardiac function index of rats in each group
Note: compared to the sham group: p < 0.05 for "*"means; compared to the model set: p < 0.05 for "#"means; compared with the perhexiline group: p < 0.05 for "▲"means.
3.3 comparison of inflammatory factor levels in rats of various groups
The results are shown in Table 3, compared with the sham operation group, the contents of the cytokines IL-1 beta, IL-10 and TNF-alpha in the serum of the rat in the model group are obviously increased (the average P is less than 0.05); compared with the model group, the content of proinflammatory factors IL-1 beta and TNF-alpha in the serum of rats in the enalapril group, the perhexiline group and the experimental high, medium and low dose groups is obviously reduced, and the content of the anti-inflammatory factor IL-10 is obviously increased (the P is less than 0.05); with the increase of the drug dosage of the test group, the IL-1 beta and TNF-alpha contents are gradually reduced, the IL-10 content of the anti-inflammatory factor is gradually increased, the effect of reducing the IL-1 beta and TNF-alpha contents and improving the IL-10 content of the test high-dosage group is better than that of the perhexiline group, and the effect of reducing the TNF-alpha content and improving the IL-10 content of the test high-dosage group is better than that of the perhexiline group (the average P is less than 0.05).
TABLE 3 comparison of cytokine content in rats of various groups
Note: compared to the sham group: p < 0.05 is denoted by "+"; compared to the model set: p < 0.05 for "#"means; compared with the perhexiline group: p < 0.05 for "▲"means.
3.4 comparison of hemorheology levels in rats of various groups
Compared with a sham operation group, the rat whole blood high cut viscosity, the whole blood low cut viscosity, the plasma viscosity and the erythrocyte aggregation index of the model group are obviously increased (the mean P is less than 0.05); compared with the model group, the enalapril group, the perhexiline group and the experimental high, medium and low dose groups of rats have obviously reduced whole blood high cut viscosity, whole blood low cut viscosity, blood plasma viscosity and erythrocyte aggregation index (the average P is less than 0.05); the indexes of the test group are obviously reduced along with the increase of the administration dosage, wherein the blood rheology reduction level of rats in the middle and high dose groups is better than that of the perhexiline group (Table 4). .
TABLE 4 comparison of the hemorheological levels of the various groups of rats
Note: compared to the sham group: p < 0.05 is denoted by "+"; compared to the model set: p < 0.05 for "#"means; compared with the perhexiline group: p < 0.05 is indicated by "A".
The pharmacodynamic test results show that the composition can reduce cardiac hypertrophy and pulmonary congestion caused by heart failure, effectively improve cardiac function, improve ventricular remodeling, slow down inflammatory reaction process, reduce adhesion and aggregation of platelets in blood vessels, and relieve pulmonary circulation and systemic circulation resistance, thereby exerting exact treatment effect on chronic heart failure, and the treatment effect has dose dependence.
Detailed Description
The present invention is further illustrated below by specific examples in order to provide those skilled in the art with a full understanding of the present invention, but it should be understood by those skilled in the art that the examples of the present invention are not to be construed as limiting the present invention in any way.
EXAMPLE 1 preparation of oral liquid
0.55kg of snakegourd fruit, 0.45kg of allium macrostemon and 0.25kg of cassia twig
Radix Salviae Miltiorrhizae 0.35kg, radix Platycodonis 0.2kg, rhizoma Chuanxiong 0.25kg
Fructus Aurantii 0.25kg radix aucklandiae 0.18kg cortex Magnolia officinalis 0.25kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 10 times of water for the first time, decocting for 3h, adding 8 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.18 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.26 at 50-60 ℃ for later use;
D. and D, taking the extract obtained in the step C, adding cane sugar for flavoring, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the oral liquid.
EXAMPLE 2 preparation of oral liquid
0.5kg of snakegourd fruit, 0.4kg of allium macrostemon and 0.25kg of cassia twig
Radix Salviae Miltiorrhizae 0.45kg, radix Platycodonis 0.25kg, rhizoma Chuanxiong 0.25kg
Fructus Aurantii 0.2kg and radix aucklandiae 0.15kg and cortex Magnolia officinalis 0.2kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. taking decoction pieces of the raw material medicinal materials in the step A, uniformly mixing, adding 8 times of water for the first time, decocting for 2.5 hours, adding 6 times of water for the second time, decocting for 2 hours, filtering decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.15 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the ethanol content to reach 70%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.28 at 50-60 ℃ for later use;
D. and C, adding sodium benzoate into the extract obtained in the step C, adding purified water to the total preparation amount, filtering until the clarity is qualified, filling, sterilizing and packaging to obtain the oral liquid.
EXAMPLE 3 preparation of granules
0.5kg of snakegourd fruit, 0.4kg of allium macrostemon and 0.25kg of cassia twig
Radix Salviae Miltiorrhizae 0.4kg, radix Platycodonis 0.25kg, rhizoma Chuanxiong 0.25kg
Fructus Aurantii 0.25kg radix aucklandiae 0.18kg cortex Magnolia officinalis 0.25kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 8 times of water for the first time, decocting for 3h, adding 8 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.12 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the ethanol content to reach 70%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.26 at 50-60 ℃ for later use;
D. and (3) taking the extract in the step (C), carrying out belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding sucrose powder, dextrin and mannitol (weight ratio of 3: 1) according to the formula amount, mixing uniformly, granulating, drying, and finishing granules to obtain granules.
EXAMPLE 4 preparation of granules
0.45kg of snakegourd fruit, 0.35kg of allium macrostemon and 0.35kg of cassia twig
Radix Salviae Miltiorrhizae 0.5kg, radix Platycodonis 0.15kg, and rhizoma Chuanxiong 0.25kg
Fructus Aurantii 0.35kg and radix aucklandiae 0.2kg and cortex Magnolia officinalis 0.15kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 9 times of water for the first time, decocting for 2.5h, adding 9 times of water for the second time, decocting for 2.5h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.10 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.25 at 50-60 ℃ for later use;
D. and (4) taking the extract in the step (C), carrying out belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding dextrin with the formula amount for inclusion, adding 0.2% of aspartame, uniformly mixing, granulating, drying and finishing granules to obtain the granules.
Example 5 preparation of microcapsules
0.6kg of snakegourd fruit, 0.3kg of allium macrostemon and 0.15kg of cassia twig
Radix Salviae Miltiorrhizae 0.4kg, radix Platycodonis 0.35kg, and rhizoma Chuanxiong 0.15kg
Fructus Aurantii 0.3kg and radix aucklandiae 0.25kg and cortex Magnolia officinalis 0.15kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 10 times of water for the first time, decocting for 3h, adding 7 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.13 at 50-60 ℃ for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.22 at 50-60 ℃ for later use;
D. taking the extract in the step C, performing belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, and crushing into fine powder, sodium complex protein: maltodextrin 3: 2 mixture as capsule wall material, octadecanol: titanium dioxide 3: 1 as an anti-sticking agent, polyethylene glycol: adding the capsule wall material, the anti-sticking agent and the plasticizer into purified water, heating and stirring at 55 ℃ to dissolve the capsule wall material, preparing a capsule wall material solution with the mass fraction of 34%, cooling to room temperature, adding the extract fine powder under stirring, and adding 1.19% of sucrose fatty acid ester in the total amount of the preparation formula: homogenizing and emulsifying soybean phospholipid 8: 5 composite emulsifier to obtain emulsion;
E. and D, carrying out spray drying on the emulsion in the step D under the conditions of air inlet temperature of 162 ℃, spray pressure of 0.45MPa and feeding speed of 22.5mL/min, collecting the microcapsules, and cooling to obtain the microcapsule.
EXAMPLE 6 preparation of tablets
0.4kg of snakegourd fruit, 0.3kg of allium macrostemon and 0.3kg of cassia twig
Radix Salviae Miltiorrhizae 0.5kg, radix Platycodonis 0.3kg, rhizoma Chuanxiong 0.35kg
Fructus Aurantii 0.15kg radix aucklandiae 0.1kg cortex Magnolia officinalis 0.35kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 9 times of water for the first time, decocting for 2.5h, adding 7 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain extract with a relative density of 1.14 at 50-60 deg.C for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 50%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.23 at 50-60 ℃ for later use;
D. and (3) taking the extract in the step (C), carrying out belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding a proper amount of starch, uniformly mixing, adding 85% ethanol solution to prepare a soft material, granulating, drying, granulating, adding a proper amount of magnesium stearate, mixing, and tabletting to obtain tablets.
EXAMPLE 7 preparation of capsules
0.5kg of fructus trichosanthis, 0.5kg of allium macrostemon and 0.2kg of cassia twig
Radix Salviae Miltiorrhizae 0.3kg, radix Platycodonis 0.3kg, and rhizoma Chuanxiong 0.3kg
Fructus Aurantii 0.15kg radix aucklandiae 0.18kg cortex Magnolia officinalis 0.3kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 8 times of water for the first time, decocting for 2.5h, adding 8 times of water for the second time, decocting for 2h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20 at 50-60 deg.C for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 55%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.24 at 50-60 ℃ for later use;
D. and (3) performing belt vacuum drying on the extract obtained in the step (C) under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding the starch and the microcrystalline cellulose in a formula ratio (weight ratio is 7: 3), uniformly mixing, granulating, drying, and encapsulating to obtain the capsule.
EXAMPLE 8 preparation of capsules
0.45kg of fructus trichosanthis, 0.45kg of allium macrostemon, 0.25kg of cassia twig
Radix Salviae Miltiorrhizae 0.4kg, radix Platycodonis 0.3kg, and rhizoma Chuanxiong 0.2kg
Fructus Aurantii 0.25kg and radix aucklandiae 0.2kg and cortex Magnolia officinalis 0.25kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 10 times of water for the first time, decocting for 2h, adding 7 times of water for the second time, decocting for 2.5h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.16 at 50-60 deg.C for later use;
C. adding ethanol into the extract obtained in the step B to enable the ethanol content to reach 65%, standing, performing cold precipitation for 48 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.27 at 50-60 ℃ for later use;
D. and (3) taking the extract in the step (C), carrying out belt type vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding the starch, the silica gel micropowder and the low-substituted hydroxypropyl cellulose (the weight ratio is 2: 1) according to the formula ratio, uniformly mixing, granulating, drying, grading, filling, polishing in a polishing machine, and removing damaged capsules to obtain the traditional Chinese medicine composition.
EXAMPLE 9 preparation of pellets
0.5kg of snakegourd fruit, 0.4kg of allium macrostemon and 0.25kg of cassia twig
Radix Salviae Miltiorrhizae 0.4kg, radix Platycodonis 0.25kg, rhizoma Chuanxiong 0.25kg
Fructus Aurantii 0.25kg radix aucklandiae 0.18kg cortex Magnolia officinalis 0.25kg
A. Weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material medicinal materials in the step A, adding 9 times of water for the first time, decocting for 3h, adding 6 times of water for the second time, decocting for 2.5h, filtering the decoction, and concentrating under reduced pressure to obtain an extract with a relative density of 1.11 at 50-60 deg.C for later use;
C. adding ethanol into the extract obtained in the step B to enable the alcohol content to reach 60%, standing, performing cold precipitation for 24 hours, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract with the relative density of 1.26 at 50-60 ℃ for later use;
D. and (4) taking the extract in the step (C), performing belt vacuum drying under the conditions of vacuum degree of-0.09 MPa to-0.10 MPa and 60 ℃, crushing into fine powder, sieving, adding dextrin, uniformly mixing, preparing pills, drying, coating and polishing to obtain the pills.
Claims (7)
1. A traditional Chinese medicine composition for treating chronic heart failure is characterized by being prepared from the following traditional Chinese medicine components:
50 parts of snakegourd fruit, 40 parts of allium macrostemon, 40 parts of cassia twig and 25 parts of cassia twig
Root of red rooted saliva 40 weight parts, root of balloonflower 25 weight parts, rhizome of Sichuan lovage 25 weight parts
25 parts of fructus aurantii, 18 parts of costustoot and 25 parts of mangnolia officinalis.
2. An oral preparation of a Chinese medicine, comprising the Chinese medicinal composition as claimed in claim 1.
3. The oral Chinese medicinal preparation according to claim 2, wherein the oral Chinese medicinal preparation is one of oral liquid, granule, microcapsule, capsule, pill or tablet.
4. A method for preparing the oral Chinese medicinal preparation of claim 3, which comprises the following steps:
A. weighing 9 raw material medicines of snakegourd fruit, allium macrostemon, cassia twig, salvia miltiorrhiza, platycodon grandiflorum, ligusticum wallichii, fructus aurantii, elecampane and mangnolia officinalis, wherein the snakegourd fruit and the fructus aurantii are cleaned and then cut into threads, the allium macrostemon is cleaned and then the cassia twig, the salvia miltiorrhiza, the platycodon grandiflorum, the ligusticum wallichii, elecampane and the mangnolia officinalis are cleaned and then cut into slices for later use;
B. mixing the decoction pieces of the raw material herbs in the step A, adding 6-10 times of water, decocting for 2 times (each time for 2-3 h), filtering the decoction, and concentrating under reduced pressure to obtain extract for later use;
C. adding ethanol into the extract obtained in the step B to enable the ethanol content to reach 50% -70%, standing, performing cold precipitation, filtering, recovering ethanol from the filtrate, and concentrating to obtain an extract for later use;
D. and D, adding pharmaceutically acceptable excipient into the extract obtained in the step C according to a conventional process to prepare an oral pharmaceutical preparation.
5. The preparation method according to claim 4, wherein the decoction in the step B is concentrated under reduced pressure to obtain an extract with a relative density of 1.10-1.20 at 50-60 ℃.
6. The preparation method according to claim 4, wherein the step C is performed with reduced pressure concentration to obtain an extract with a relative density of 1.22-1.28 at 50-60 ℃.
7. The preparation method according to claim 4, wherein ethanol is added in the step C to make the alcohol content reach 50% -70%, and the mixture is left for 24-48h of cold precipitation.
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| 瓜蒌薤白桂枝汤加味治疗慢性心功能不全128例;杨旭;《四川中医》;20001231;第18卷(第12期);第19-20页 * |
| 祛痰通阳汤治疗慢性心力衰竭的临床观察;赵惠 等;《中医药信息》;20111231;第28卷(第4期);要，第109页左栏第1段、右栏2.治疗方法，第110页4.讨论 * |
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