CN118021897A - Pharmaceutical composition and application thereof in medicines for treating coronary heart disease - Google Patents
Pharmaceutical composition and application thereof in medicines for treating coronary heart disease Download PDFInfo
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- CN118021897A CN118021897A CN202410438486.0A CN202410438486A CN118021897A CN 118021897 A CN118021897 A CN 118021897A CN 202410438486 A CN202410438486 A CN 202410438486A CN 118021897 A CN118021897 A CN 118021897A
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- sodium alginate
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- heart disease
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 56
- 208000029078 coronary artery disease Diseases 0.000 title claims abstract description 34
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- 229940079593 drug Drugs 0.000 title description 9
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Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a pharmaceutical composition and application thereof in medicaments for treating coronary heart disease, belonging to the field of medicaments for treating cardiovascular diseases. The medicine composition consists of terligustrin, magnolipids, fritillaria cirrhosa and sodium alginate. Animal experiments show that the traditional Chinese medicine has remarkable effect in rats with heart muscle infarction coronary heart disease models. In addition, the sodium alginate is added into the pharmaceutical composition and the preparation method is innovated, so that the defect that the terprivet glycoside and the magnoligenin are sensitive to high temperature and high humidity and are easy to decompose is overcome, the stability of the pharmaceutical composition is improved, and the efficacy is brought into play.
Description
Technical Field
The invention belongs to the field of medicaments for treating cardiovascular diseases, and in particular relates to a pharmaceutical composition and application thereof in medicaments for treating coronary heart diseases.
Background
The disclosure of this background section is only intended to increase the understanding of the general background of the invention and is not necessarily to be construed as an admission or any form of suggestion that this information forms the prior art already known to those of ordinary skill in the art.
Coronary heart disease is a cardiovascular disease, which is caused by coronary artery stenosis or occlusion due to plaque on the inner wall of the coronary artery (mainly deposition of substances such as cholesterol and calcium), and myocardial oxygen and nutrition deficiency. Coronary heart disease is often manifested as angina pectoris, myocardial infarction, arrhythmia, etc. The onset population of coronary heart disease mainly comprises middle-aged and elderly people, especially men. In general, people with age, unhealthy lifestyles, and other cardiovascular diseases and risk factors are more prone to coronary heart disease. The treatment method of coronary heart disease comprises drug treatment, interventional treatment, operation treatment, etc.
Fritillaria cirrhosa is a common traditional Chinese medicine, is known for the world by the effects of clearing heat, moistening lung, resolving phlegm, relieving cough, and the like, is often used for treating symptoms such as lung heat dry cough, excessive phlegm, and the like, and is generally used for treating symptoms such as cough, bronchitis, lung heat, and the like caused by upper respiratory tract infection. Modern pharmacological researches have shown that fritillaria cirrhosa contains various active ingredients and has various pharmacological effects of anti-inflammatory, antioxidant and antitumor. The Chinese patent publication No. CN102920899A discloses a medicine for treating coronary heart disease, which comprises 2-6 parts of fritillaria cirrhosa, but also comprises other 17 traditional Chinese medicine components, and the curative effect of fritillaria cirrhosa in treating coronary heart disease is not found at present.
The terprivet glycoside is a glycolipid compound separated from fruits of fructus Ligustri Lucidi, can be used for treating viral infection caused by herpes simplex virus infection, herpes zoster, varicella and other diseases, and has anti-inflammatory, antibacterial, antiaging, blood sugar and blood lipid lowering pharmacological effects. However, the stability of the terprivet glycoside is poor, the terprivet glycoside needs to be stored at a low temperature (2-8 ℃) and the content of the terprivet glycoside is reduced after the terprivet glycoside is exposed to the air for a long time. Chinese patent publication No. CN113521087A discloses the use of terprivet glycoside in preparing medicine for treating chronic renal insufficiency or renal osteosis. The terprivet glycoside intervenes in a 5/6 nephrectomy mouse, can effectively protect kidney functions, reduce apoptosis of kidney cells, improve kidney fibrosis, regulate calcium-phosphorus metabolic disorder caused by 5/6 nephrectomy and reduce bone mass loss.
Magnolipids are a plant compound, typically extracted from resins of the magnolia family. It is used as an agent and anti-inflammatory in traditional herbal medicine. Magnolipids have antibacterial, antiallergic, analgesic and antiinflammatory effects. Similarly, magnolipids also require storage at low temperatures (2-8 ℃), which is a problem with poor stability. The animal model of renal hypertension is established by Aleurium figure ya et al, the effect of magnolipids on the blood pressure change of rats is explored, and the result shows that magnolipids can reduce the systolic pressure and the diastolic pressure of the rats with renal hypertension in a certain concentration range, and have the effect of reducing blood pressure. (Altern fig. ya, zhang Hongping, tian Ge, etc. influence of magnaline on blood pressure of two-kidney-one-kidney hypertension rats [ J ]. Modern Chinese medicine research and practice 2017,31 (03): 28-31.)
Hypertension refers to a sustained elevation of blood pressure, i.e., a systolic (diastolic) pressure in excess of 140/90 mmhg. Coronary heart disease is myocardial ischemia due to coronary artery stenosis or occlusion, the most common symptom being angina (chest pain), hypertension and coronary heart disease are two different concepts. At present, no report of treating coronary heart disease by combining terligustrin, magnolipids and fritillaria cirrhosa is found, and the problem of poor stability of terligustrin and magnolipids is not solved in the prior art.
Disclosure of Invention
The invention provides a pharmaceutical composition for treating coronary heart disease, which comprises terprivet glycoside, magnolipids, unibract fritillary bulb and sodium alginate. In order to overcome the defects of the prior art, the invention solves the problems of poor stability of the terprivet glucoside and the magnolignan and sensitivity to temperature and humidity by utilizing the optimized auxiliary materials and improving the traditional preparation method, and obtains the pharmaceutical composition with high stability and good effect of treating the coronary heart disease.
Specifically, the technical scheme of the invention is as follows:
A first object of the present invention is to provide a pharmaceutical composition for treating coronary heart disease, which is prepared from the following components: 0.2-0.8 part of terprivet glucoside, 0.1-0.5 part of magnolipids, 1.2-3.5 parts of fritillaria cirrhosa and 0.5-1.2 parts of sodium alginate; the preparation method of the pharmaceutical composition comprises the following steps: removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 2-8 ℃, crushing, grinding and sieving to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form paste with a relative density of 1.25-1.35, drying at a low temperature of 2-8 ℃, grinding, and drying at a low temperature of 2-8 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
Tershi glossy privet glycoside with molecular formula C 31H42O17 is white-like crystal powder, CAS number 39011-92-2, purchased from Chengdopfield biotechnology Co., ltd, and HPLC is more than or equal to 98%. Magnolipids, molecular formula C 23H28O7, CAS number 31008-18-1, available from Shanghai Yuan Ye Biotechnology Co., ltd., HPLC not less than 98%.
In a preferred embodiment, the pharmaceutical composition is made of the following ingredients: 0.5 part of terprivet glycoside, 0.3 part of magnolipids, 2.5 parts of unibract fritillary bulb and 0.8 part of sodium alginate. The preparation method comprises the following steps: removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; pulverizing, sieving with 80 mesh sieve, and mixing with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
A second object of the present invention is to provide a tablet made of the above pharmaceutical composition. For convenience in taking medicine, the invention utilizes pharmaceutically common auxiliary materials and traditional preparation technology to prepare the pharmaceutical composition into tablets, wherein the tablets consist of the following components: 0.2-0.8 part of terprivet glucoside, 0.1-0.5 part of magnolipids, 1.2-3.5 parts of bulbus fritillariae cirrhosae, 0.5-1.2 parts of sodium alginate, 60-90 parts of starch, 10-20 parts of microcrystalline cellulose, 5-8 parts of carboxymethyl starch sodium and 0.5-1 part of magnesium stearate.
In a preferred embodiment, the tablet consists of the following ingredients: 0.5 part of terprivet glycoside, 0.3 part of magnolignan, 2.5 parts of fritillaria cirrhosa, 0.8 part of sodium alginate, 80 parts of starch, 15 parts of microcrystalline cellulose, 6 parts of carboxymethyl starch sodium and 0.8 part of magnesium stearate.
The second aim of the invention is to provide an oral liquid prepared from the pharmaceutical composition. In order to facilitate medicine taking, the invention utilizes auxiliary materials commonly used in pharmacy and the traditional preparation process to prepare the oral liquid of the pharmaceutical composition, and the oral liquid consists of the following components: 0.2-0.8 part of terprivet glucoside, 0.1-0.5 part of magnolipids, 1.2-3.5 parts of bulbus fritillariae cirrhosae, 0.5-1.2 parts of sodium alginate, 2-7 parts of sucrose, 0.1-0.3 part of benzoic acid and 10-20 parts of water.
In a preferred embodiment, the oral liquid is composed of the following components: 0.5 part of terprivet glycoside, 0.3 part of magnolipidine, 2.5 parts of fritillaria cirrhosa, 0.8 part of sodium alginate, 4 parts of sucrose, 0.2 part of benzoic acid and 12 parts of water.
Further, the coronary heart disease is asymptomatic coronary heart disease, angina pectoris coronary heart disease, myocardial infarction coronary heart disease, ischemic coronary heart disease and sudden death coronary heart disease.
Compared with the prior art, the invention has the technical effects that:
According to the invention, the terprivet glycoside, the magnolin and the fritillaria cirrhosa are combined to play a role in treating coronary heart disease, and animal experiments show that the pharmaceutical composition provided by the invention has remarkable traditional Chinese medicine effect in rats with myocardial infarction coronary heart disease models, effectively relieves myocardial infarction areas of rats, reduces myocardial infarction marker content of the rats, and promotes immunohistochemical expression of neovascular VEGF protein in myocardial infarction marginal areas of the rats.
According to the invention, sodium alginate is added into the pharmaceutical composition, and the preparation method is innovated, in particular, sodium alginate and glycerin are mixed into paste with certain relative density, and then the steps of low-temperature drying are carried out twice, so that the defect that terligustrin and magnolignan are unstable in sensitivity to high temperature and high humidity is overcome, the stability is improved, and the efficacy is brought into play.
Drawings
Fig. 1: the pharmaceutical compositions of examples 1-3 and the pharmaceutical compositions of comparative examples 4-6 are subjected to accelerated test to obtain a variation curve of the content of the terprivet glycoside.
Fig. 2: the pharmaceutical compositions of examples 1-3 and the pharmaceutical compositions of comparative examples 4-6 were subjected to accelerated test of the magnolignan content change curve.
Fig. 3: percent myocardial infarction area in each group of rats.
Fig. 4: immunohistochemical expression of neovascular VEGF protein in myocardial infarction border area of rats in each group.
Detailed Description
The present invention will be further described with reference to examples for the purpose of making the objects and technical aspects of the present invention more apparent, but the scope of the present invention is not limited to these examples, which are only for explaining the present invention. It will be understood by those skilled in the art that variations or equivalent substitutions that do not depart from the spirit of the invention are intended to be included within the scope of the invention.
EXAMPLE 1 pharmaceutical composition
The components are as follows:
Terligustroside 0.5g
Magnolipids 0.3g
Fritillaria cirrhosa 2.5g
Sodium alginate 0.8g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and 80 mesh sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
EXAMPLE 2 pharmaceutical compositions
The components are as follows:
Terligustroside 0.2g
Magnolipids 0.1g
Bulbus Fritillariae Cirrhosae 1.2g
Sodium alginate 0.5g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 2 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.25, drying at a low temperature of 2 ℃, grinding, and drying at a low temperature of 2 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and 80 mesh sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
EXAMPLE 3 pharmaceutical compositions
The components are as follows:
Terligustroside 0.8g
Magnolipids 0.5g
Bulbus Fritillariae Cirrhosae 3.5g
Sodium alginate 1.2g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 8 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.35, drying at a low temperature of 8 ℃, grinding, and drying at a low temperature of 8 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and 80 mesh sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
EXAMPLE 4 pharmaceutical composition tablets
The components are as follows:
Terligustroside 0.5g
Magnolipids 0.3g
Fritillaria cirrhosa 2.5g
Sodium alginate 0.8g
80G of starch
Microcrystalline cellulose 15g
Carboxymethyl starch sodium 6g
Magnesium stearate 0.8g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing the crushed and 80 mesh sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder, adding starch, microcrystalline cellulose, carboxymethyl starch sodium and magnesium stearate, mixing, and tabletting.
EXAMPLE 5 pharmaceutical composition tablets
The components are as follows:
Terligustroside 0.2g
Magnolipids 0.1g
Bulbus Fritillariae Cirrhosae 1.2g
Sodium alginate 0.5g
60G of starch
Microcrystalline cellulose 10g
Carboxymethyl starch sodium 5g
0.5G of magnesium stearate.
The preparation method comprises the following steps:
removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 2 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.25, drying at a low temperature of 2 ℃, grinding, and drying at a low temperature of 2 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing the crushed and 80 mesh sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder, adding starch, microcrystalline cellulose, carboxymethyl starch sodium and magnesium stearate, mixing, and tabletting.
EXAMPLE 6 pharmaceutical composition tablets
The components are as follows:
Terligustroside 0.8g
Magnolipids 0.5g
Bulbus Fritillariae Cirrhosae 3.5g
Sodium alginate 1.2g
Starch 90g
Microcrystalline cellulose 20g
Carboxymethyl starch sodium 8g
Magnesium stearate 1g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 8 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.35, drying at a low temperature of 8 ℃, grinding, and drying at a low temperature of 8 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing the crushed and 80 mesh sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder, adding starch, microcrystalline cellulose, carboxymethyl starch sodium and magnesium stearate, mixing, and tabletting.
EXAMPLE 7 pharmaceutical composition oral liquid
The components are as follows:
Terligustroside 0.5g
Magnolipids 0.3g
Fritillaria cirrhosa 2.5g
Sodium alginate 0.8g
Sucrose 4g
Benzoic acid 0.2g
12G of water.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and 80 mesh sieved terprivet glycoside and magnolin with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder, dissolving in appropriate amount of water, adding sucrose and benzoic acid, mixing, and adding water to full amount.
EXAMPLE 8 pharmaceutical composition oral liquid
The components are as follows:
Terligustroside 0.2g
Magnolipids 0.1g
Bulbus Fritillariae Cirrhosae 1.2g
Sodium alginate 0.5g
Sucrose 2g
Benzoic acid 0.1g
10G of water.
The preparation method comprises the following steps:
removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 2 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.25, drying at a low temperature of 2 ℃, grinding, and drying at a low temperature of 2 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and 80 mesh sieved terprivet glycoside and magnolin with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder, dissolving in appropriate amount of water, adding sucrose and benzoic acid, mixing, and adding water to full amount.
Example 9 pharmaceutical composition oral liquid
The components are as follows:
Terligustroside 0.8g
Magnolipids 0.5g
Bulbus Fritillariae Cirrhosae 3.5g
Sodium alginate 1.2g
Sucrose 7g
Benzoic acid 0.3g
20G of water.
The preparation method comprises the following steps:
removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 8 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.35, drying at a low temperature of 8 ℃, grinding, and drying at a low temperature of 8 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and 80 mesh sieved terprivet glycoside and magnolin with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder, dissolving in appropriate amount of water, adding sucrose and benzoic acid, mixing, and adding water to full amount.
Comparative example 1 pharmaceutical composition
The components are as follows:
Magnolipids 0.3g
Fritillaria cirrhosa 2.5g
Sodium alginate 0.8g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing the obtained magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
Comparative example 2 pharmaceutical composition
The components are as follows:
Terligustroside 0.5g
Fritillaria cirrhosa 2.5g
Sodium alginate 0.8g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing the crushed and 80 mesh sieved terprivet glycoside with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
Comparative example 3 pharmaceutical composition
The components are as follows:
Terligustroside 0.5g
Magnolipids 0.3g
Sodium alginate 0.8g.
The preparation method comprises the following steps:
Mixing sodium alginate and a proper amount of glycerol to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerol powder; mixing the crushed and 80 mesh sieved terprivet glycoside, magnolignan and sodium alginate glycerol powder.
Comparative example 4 pharmaceutical composition
The components are as follows:
Terligustroside 0.5g
Magnolipids 0.3g
2.5G of fritillaria cirrhosa.
The preparation method comprises the following steps:
removing fibrous root, crude skin and silt from Bulbus Fritillariae Cirrhosae, drying at 5deg.C, pulverizing, grinding, sieving with 80 mesh sieve to obtain Bulbus Fritillariae Cirrhosae powder, and mixing with terligustroside, magnolin, and Bulbus Fritillariae Cirrhosae powder after pulverizing and sieving with 80 mesh sieve.
Comparative example 5 pharmaceutical composition
The components are as follows:
terligustroside 0.1g
Magnolipids 0.8g
4.5G of fritillaria cirrhosa
Sodium alginate 2.0g.
The preparation method comprises the following steps:
Removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 5 ℃, crushing, grinding, sieving with a 80-mesh sieve to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form a paste with a relative density of 1.30, drying at a low temperature of 5 ℃, grinding, and drying at a low temperature of 5 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; pulverizing, sieving with 80 mesh sieve, and mixing with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
Comparative example 6 pharmaceutical composition
The components are as follows:
Terligustroside 0.5g
Magnolipids 0.3g
Fritillaria cirrhosa 2.5g
Sodium alginate 0.8g.
The preparation method comprises the following steps:
Removing fibrous root, crude skin and silt from Bulbus Fritillariae Cirrhosae, drying at 5deg.C, pulverizing, grinding, sieving with 80 mesh sieve to obtain Bulbus Fritillariae Cirrhosae powder, adding terligustrin, magnolignan and sodium alginate, pulverizing, sieving with 80 mesh sieve, and mixing.
Accelerated test stability of the pharmaceutical compositions of the invention
And (3) placing the pharmaceutical compositions of examples 1-3 and comparative examples 4-6 at the temperature of 40+/-2 ℃ and the relative humidity of 75+/-5% for 6 months, sampling at the end of the 1 st month, the end of the 2 nd month, the end of the 3 rd month and the end of the 6 th month in the test period, and measuring the content of the terprivet glycoside and the content of the magnolignan.
Fig. 1 shows the variation curves of the content of the specnuezhenide in the accelerated test of the pharmaceutical compositions of examples 1-3 and comparative examples 4-6, and fig. 2 shows the variation curves of the content of the magnolignan in the accelerated test of the pharmaceutical compositions of examples 1-3 and comparative examples 4-6. The results show that the invention overcomes the defects of easy decomposition and instability of the terprivet glycoside and the magnolignan, the contents of the terprivet glycoside and the magnolignan in the pharmaceutical composition in the examples 1-3 are stable, and the contents of the terprivet glycoside and the magnolignan can be maintained above 98.8% after the accelerated test for 6 months.
The invention provides a method for exploring the treatment effect of the pharmaceutical composition on rats with coronary heart disease
The following experimental study is carried out on the basis of the safety of the drug proved by an acute toxicity test and a long-term toxicity test, and the administration dosage in the experimental study is within the safe dosage range.
1 Material
1.1 Experimental drugs and reagents
1.1.1 Medicament
Examples 1, 2 and 3 are pharmaceutical compositions, comparative examples 1, 2 and 3 are pharmaceutical compositions, and compound red sage root dripping pills.
1.1.2 Dosage of medication
Example 1 pharmaceutical composition: 0.46g/kg.
Example 2 pharmaceutical composition: 0.23g/kg.
Example 3 pharmaceutical composition: 0.68g/kg.
Comparative example 1 pharmaceutical composition: 0.41g/kg.
Comparative example 2 pharmaceutical composition: 0.43g/kg.
Comparative example 3 pharmaceutical composition: 0.18g/kg.
Compound red sage dripping pill: 4.08g/kg.
1.2 Experimental animal
SD rats, SPF grade, 180-220g, experimental animal license number: SYXK (robust) 20180008, were fed adaptively under standard conditions for 1 week prior to the experiment.
2. Method of
2.1 Modeling method and grouping
Taking a plurality of rats, fixing, anaesthetizing, intubation, opening chest to expose heart, ligating coronary artery at the position 0.1-0.2mm away from the lower edge of left auricle at the front descending start part of left coronary artery between the lower edge of left auricle and pulmonary artery cone, after observing for several minutes, injecting penicillin sodium 2X 10 5 U/d, qd into the rats after the step-by-step chest closing operation after thoroughly stopping bleeding, continuously resisting infection for 3d, carrying out the third day after operation, anaesthetizing, observing the pulsation amplitude of left ventricular myocardium, measuring EF, and removing rats with infarct area not reaching 30-40% of the left ventricular area, rats with infarct area exceeding the requirement and rats with severe pericardial effusion. Rats successfully molded were divided into example 1, example 2, example 3, comparative example 1, comparative example 2, comparative example 3, model, and positive drug groups of 10 rats each.
Blank group: 10 normal rats were taken, and needles with the same size were taken only at the anterior descending branch of the left coronary artery between the lower edge of the left auricle and the pulmonary artery cone without knotting, and the rest of the operations were the same as those of the operation group.
2.2 Administration of drugs
The rats of each administration group are subjected to gastric lavage and corresponding medicines, the positive medicine group is subjected to compound red sage root dripping pills, the blank group and the model group are subjected to gastric lavage and equivalent physiological saline, and the administration is carried out for 1 time a day and is continued for 14d.
3. Statistical treatment
The SPSS22.0 software is adopted to carry out statistical analysis on the obtained data, and the metering data (expressed, the comparison among multiple groups adopts single-factor analysis of variance, and the analysis among two groups adopts independent sample T test mode.
4. Experimental index and result analysis
4.1 Myocardial infarction area
After 14 days of administration, rats were anesthetized, hearts were removed by thoracotomy, surrounding connective tissues were cut off, washed with ice physiological saline, and after the filter paper had absorbed water, the heart tissue was quickly snap frozen with liquid nitrogen, and was cut into 1-2 mm flakes uniformly, and stained in a 37 ℃ water bath in 1% ttc staining solution for 10min. After TTC staining, normal myocardial tissue appeared rose red and infarcted tissue appeared white. After taking the photo, the infarct area percentage is calculated by Image-Proplus6 Image analysis software, and the calculation formula is as follows: infarct area/left ventricular area x 100%.
FIG. 3 is a graph showing the percent myocardial infarction area of each group of rats. After 14 days of administration, the myocardial infarction areas of the rats in the examples 1-3 are obviously smaller than those of the rats in the model group and those of the rats in the comparative examples 1-3. In the examples 1 to 3, the difference was statistically significant (P < 0.05) compared to the model group, and the difference was statistically significant (P < 0.05) compared to the positive drug group.
4.2 Rat myocardial injury markers of groups
After 14 days of administration, the rats were opened, the abdominal aorta was exposed, blood was taken, and the upper serum was collected by centrifugation to measure LDH, CKMB, AST, CK values.
Table 1 rat myocardial injury markers of each group
| LDH（U/L） | CKMB（U/L） | AST（U/L） | CK（U/L） | |
| Blank group | 113.64±3.61 | 95.45±2.97 | 19.40±1.84 | 135.65±3.36 |
| Model group | 298.17±4.01 | 267.81±3.34 | 40.19±3.03 | 277.44±3.99 |
| Example 1 group | 156.40±3.59 | 136.56±3.11 | 23.21±2.25 | 177.86±3.52 |
| Example 2 group | 164.83±3.12 | 148.42±3.71 | 25.44±2.53 | 180.21±3.34 |
| Example 3 group | 162.52±4.23 | 140.69±3.85 | 24.11±2.60 | 179.05±2.94 |
| Comparative example 1 group | 238.77±4.38 | 198.25±4.04 | 31.26±2.15 | 244.60±3.72 |
| Comparative example 2 group | 207.08±4.16 | 195.48±3.65 | 30.74±2.68 | 242.58±4.08 |
| Comparative example 3 group | 185.59±3.83 | 177.36±3.05 | 28.90±2.78 | 231.15±3.50 |
| Positive medicine group | 192.04±3.75 | 180.63±4.09 | 30.51±2.53 | 230.62±3.63 |
Table 1 shows the comparison of myocardial injury markers in each group of rats. After 14 days of administration, the myocardial damage markers of the rats in the groups of examples 1-3 are obviously lower than those of the rats in the groups of models and the rats in the groups of comparative examples 1-3. Compared with the model group, the differences between the groups 1-3 have statistical significance (P is smaller than 0.05).
4.3 Immunohistochemical expression of neovascular VEGF protein in myocardial infarction border area in rat
Immunohistochemistry was performed to detect VEGF expression in rat myocardium at infarct border zone.
FIG. 4 shows immunohistochemical expression of VEGF protein in myocardial infarction border area in rats. After 14 days of administration, the immunohistochemical expression of the VEGF protein in the neovasculature in the cardiac muscle of the rats of examples 1-3 is obviously increased, and the difference is statistically significant (P < 0.05) compared with the model group.
Claims (10)
1. A pharmaceutical composition for treating coronary heart disease, characterized in that the pharmaceutical composition is prepared from the following components: 0.2-0.8 part of terprivet glucoside, 0.1-0.5 part of magnolipids, 1.2-3.5 parts of fritillaria cirrhosa and 0.5-1.2 parts of sodium alginate; the preparation method of the pharmaceutical composition comprises the following steps: removing fibrous roots, crude skin and sediment from the fritillaria cirrhosa, drying at a low temperature of 2-8 ℃, crushing, grinding and sieving to obtain fritillaria cirrhosa powder, mixing sodium alginate and a proper amount of glycerin to form paste with a relative density of 1.25-1.35, drying at a low temperature of 2-8 ℃, grinding, and drying at a low temperature of 2-8 ℃ for 2-4 hours to obtain sodium alginate glycerin powder; mixing pulverized and sieved terprivet glycoside and magnolignan with sodium alginate glycerol powder and Bulbus Fritillariae Cirrhosae powder.
2. The composition of claim 1, wherein the pharmaceutical composition is made from the following ingredients: 0.5 part of terprivet glycoside, 0.3 part of magnolipids, 2.5 parts of unibract fritillary bulb and 0.8 part of sodium alginate.
3. The composition of claim 1, wherein the low temperature drying temperature is 5 ℃.
4. The composition of claim 1 wherein the mesh size of the screen is 80 mesh.
5. The composition of claim 1, wherein the relative density is 1.30.
6. A tablet made from the pharmaceutical composition of claim 1, wherein the tablet consists of: 0.2-0.8 part of terprivet glucoside, 0.1-0.5 part of magnolipids, 1.2-3.5 parts of bulbus fritillariae cirrhosae, 0.5-1.2 parts of sodium alginate, 60-90 parts of starch, 10-20 parts of microcrystalline cellulose, 5-8 parts of carboxymethyl starch sodium and 0.5-1 part of magnesium stearate.
7. An oral liquid made from the pharmaceutical composition of claim 1, characterized in that the oral liquid is composed of the following components: 0.2-0.8 part of terprivet glucoside, 0.1-0.5 part of magnolipids, 1.2-3.5 parts of bulbus fritillariae cirrhosae, 0.5-1.2 parts of sodium alginate, 2-7 parts of sucrose, 0.1-0.3 part of benzoic acid and 10-20 parts of water.
8. The tablet of claim 6, wherein the tablet consists of the following ingredients: 0.5 part of terprivet glycoside, 0.3 part of magnolignan, 2.5 parts of fritillaria cirrhosa, 0.8 part of sodium alginate, 80 parts of starch, 15 parts of microcrystalline cellulose, 6 parts of carboxymethyl starch sodium and 0.8 part of magnesium stearate.
9. The oral liquid according to claim 7, characterized in that it consists of the following components: 0.5 part of terprivet glycoside, 0.3 part of magnolipidine, 2.5 parts of fritillaria cirrhosa, 0.8 part of sodium alginate, 4 parts of sucrose, 0.2 part of benzoic acid and 12 parts of water.
10. The composition according to claim 1, wherein the coronary heart disease is asymptomatic coronary heart disease, angina coronary heart disease, myocardial infarction coronary heart disease, ischemic coronary heart disease, sudden death coronary heart disease.
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