CN114246905A - Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating coronary heart disease and restenosis after PCI (percutaneous coronary intervention) operation - Google Patents
Application of traditional Chinese medicine composition in preparation of medicine for preventing and treating coronary heart disease and restenosis after PCI (percutaneous coronary intervention) operation Download PDFInfo
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Abstract
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to application of a ginseng root-strengthening traditional Chinese medicine composition prepared from ginseng, rehmannia glutinosa, poria cocos, moutan bark, prepared rehmannia root, dogwood, Chinese yam, rhizoma alismatis, radix asparagi and radix ophiopogonis in preparation of a medicine for preventing and/or treating restenosis after PCI (coronary heart disease) operation.
Description
Technical Field
The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for treating restenosis after PCI operation, and belongs to the technical field of medicines.
Background
Coronary Heart Disease (CHD) is one of the diseases seriously harming human health at present, and statistics show that the morbidity and mortality of coronary heart disease in China are in an increasing trend. Percutaneous Coronary Intervention (PCI) has become an important means for treating coronary heart disease, but Restenosis (RS) rate in stent is as high as 30-50% after 6 months of operation, which seriously affects its long-range curative effect. The application of various stents greatly reduces the restenosis rate after PCI operation, but still can not radically cure the restenosis, so that the clinical application and development of the PCI operation are limited. Therefore, prevention and treatment of restenosis after PCI surgery becomes a significant challenge facing cardiovascular diseases in China at present.
The occurrence mechanism of restenosis after PCI operation is mainly considered by Western medicine to be local inflammatory infiltration, platelet adhesion, thrombosis, vascular smooth muscle cell proliferation and migration, intimal hyperplasia, elastic recoil, vascular remodeling and the like, and is generally considered to be hyperproliferation of vascular smooth muscle cells. Western medicine for preventing and treating coronary heart disease and restenosis after PCI operation is used in preparing medicine for resisting blood platelet, anticoagulant, statin, etc. Evidence shows that the patients undergoing PCI operation, especially ST-elevation myocardial infarction patients, insisting on taking clopidogrel is important for preventing and treating postoperative restenosis. However, the risk of bleeding is increased by taking anti-platelet drugs such as clopidogrel and aspirin for a long time, and other diseases can be induced.
The restenosis after PCI still belongs to the category of the chest stuffiness in traditional Chinese medicine, and various doctors have different insights about the pathogenesis of RS. Generally, the mechanism of restenosis after PCI operation, which is considered by traditional Chinese medicine, has the following four aspects: (1) the secondary excess is mainly marked by blood stasis, phlegm turbidity and heat-toxicity. (2) The principal deficiency with secondary excess is qi deficiency with blood stasis, deficiency of both qi and yin, blood stasis with turbid phlegm. (3) Theory of collateral diseases. (4) Theory of repair of injury. At present, medicines for tonifying qi and activating blood circulation, eliminating phlegm and removing blood stasis are mostly adopted for traditional Chinese medicine prevention and treatment of PCI postoperative restenosis, and patent 201410530321.2 discloses a traditional Chinese medicine composition which mainly utilizes traditional Chinese medicine effects of promoting blood circulation and removing blood stasis, dredging collaterals, tonifying qi and warming yang, and is assisted by the theory of relieving chest stuffiness and benefiting diaphragm, relieving restlessness and resolving depression to treat restenosis after myocardial infarction, so that a certain effect is achieved.
Disclosure of Invention
The invention is a new application of the ginseng root-securing oral liquid on the basis of the clinical feedback of the existing Chinese patent medicine product 'ginseng root-securing oral liquid', namely a new application of the ginseng root-securing oral liquid in treating restenosis diseases after PCI (coronary heart disease) operation. The invention aims to provide a new Chinese patent medicine product for treating restenosis after PCI (coronary heart disease) operation, and the medicine selectivity of a patient is increased.
The invention aims to provide application of a traditional Chinese medicine composition mainly prepared from ginseng, rehmannia root, prepared rehmannia root, dogwood fruit, Chinese yam, tree peony bark, oriental waterplantain rhizome, poria cocos, asparagus fern and dwarf lilyturf tuber in preparing medicines for treating coronary heart disease PCI postoperative restenosis.
The restenosis after the PCI operation of the coronary heart disease comprises, but is not limited to, restenosis after percutaneous balloon coronary angioplasty, restenosis after coronary stent implantation and restenosis after ablation technology of atheromatous plaque.
The restenosis disease after percutaneous saccule coronary angioplasty comprises but is not limited to postoperative coronary local inflammatory reaction, thrombosis formation, platelet adhesion, vascular smooth muscle cell proliferation and migration, intimal hyperplasia, elastic retraction and vascular reconstruction.
The intimal hyperplasia includes an increase in intimal thickness and intimal area.
The second purpose of the invention is to provide a traditional Chinese medicine preparation containing the traditional Chinese medicine composition, namely the traditional Chinese medicine composition can be prepared into clinically acceptable dosage forms directly by a conventional process or after pharmaceutically acceptable auxiliary materials are added.
The clinically acceptable dosage form is one or more of capsules, tablets, granules, pills and oral liquid;
the traditional Chinese medicine composition is a ginseng root-strengthening traditional Chinese medicine composition;
the ginseng root-strengthening traditional Chinese medicine composition is a ginseng root-strengthening oral liquid.
The ginseng root-strengthening traditional Chinese medicine composition is prepared from the following medicinal materials in parts by weight: 60-90 parts of ginseng, 170 parts of rehmannia root 130-.
Animal experiments show that the ginseng root-strengthening oral liquid prepared from the traditional Chinese medicine composition can relieve the thickening of the inner membrane of the abdominal aorta of a restenosis model rabbit after a PCI (percutaneous coronary intervention) operation, reduce the area increase of the inner membrane and the area ratio of the middle membrane, and has the effects of relieving intimal hyperplasia and improving the restenosis after the PCI operation.
The invention has the following advantages:
the ginseng root-strengthening oral liquid provided by the invention is prepared from ginseng, rehmannia root, poria cocos, moutan bark, prepared rehmannia root, dogwood fruit, Chinese yam, rhizoma alismatis, asparagus cochinchinensis and radix ophiopogonis, has definite medicinal components, reasonable compatibility and good clinical use safety, and solves the problem that postoperative restenosis in the prior coronary heart disease intervention technology influences the curative effect.
The basic pathogenesis of restenosis after PCI (coronary heart disease) operation is' essential deficiency and excess, which is considered by traditional Chinese medicine and comprises qi deficiency and blood stasis, deficiency of both qi and yin, blood stasis and phlegm turbidity, early heart qi deficiency, excessive yin and blood damage in the middle period and yin and yang and qi and blood damage in the later period. The traditional Chinese medicine treatment should adopt the functions of invigorating qi and activating blood circulation, nourishing yin and kidney, promoting qi circulation and relieving depression, expelling phlegm and removing dampness and resolving turbidity. The ginseng root-strengthening oral liquid has the effects of tonifying qi and yin and strengthening the foundation and can be used for treating deficiency of yin and weak qi, consumptive disease cough, palpitation and shortness of breath, bone-steaming tidal fever, waist soreness and tinnitus, spermatorrhea and night sweat, and dry stool, and plays the advantages of integral treatment and disease-seeking basis in symptomatic treatment corresponding to the pathogenesis of traditional Chinese medicine, so that the oral liquid is used for preventing and treating restenosis after PCI (coronary heart disease) operation, effectively relieves hyperplasia of intimal cells after PCI operation, and achieves the effect of preventing and treating restenosis after PCI operation of coronary heart disease.
Detailed Description
The application of the invention is derived from clinical use feedback of the ginseng root-strengthening oral liquid. In the clinical use process of the ginseng root-securing oral liquid, the ginseng root-securing oral liquid is unexpectedly found to improve clinical symptoms of angina, coronary artery angiography stenosis and the like of a patient to a certain extent for the individual patient with the coronary heart disease PCI postoperative restenosis disease.
Based on the clinical use feedback of the ginseng root-securing oral liquid, the inventor develops a series of developments aiming at the application of the ginseng root-securing oral liquid in the treatment of coronary heart disease, and in order to verify the efficacy of the ginseng root-securing oral liquid in the treatment of restenosis after PCI (coronary heart disease) operation, the inventor carries out animal experimental research, and only a part of experimental models are taken as examples to explain the restenosis after PCI operation or restenosis after other angioplasty recorded in the specification, and the inventor also carries out pharmacological experimental research, so that the composition can achieve the same or similar effect, and the effects are not described one by one.
Example 1 Effect of Ginseng radix oral liquid for consolidating constitution on the proliferation of intima hyperplasia of abdominal aorta of rabbit model of restenosis after PCI operation
Test drugs:
the ginseng root-strengthening oral liquid sold in the market is 10ml per bottle, Lunan Thick pharmaceutical Co.
Commercially available aspirin, 100 mg/tablet, Bayer pharmaceutical group, Inc.
Commercially available rosuvastatin calcium tablet, 5mg, lucinanfibrate pharmaceutical ltd.
Mixed liquid of rosuvastatin calcium and aspirin: each ml of the mixed solution contains 0.27mg of aspirin and 0.32mg of rosuvastatin calcium.
Experimental animals and feed:
the weight of a healthy New Zealand big ear white rabbit is 2-2.5kg, 60 rabbits are suitable for feeding for one week before the experiment, and the number of the rabbits is not limited by the number of the females.
Rabbit high fat feed composition: 79% of common rabbit feed, 15% of egg yolk powder, 5% of lard and 1% of cholesterol.
Grouping: the experimental animals are randomly divided into a blank group, a model group, a positive control group, a ginseng root-strengthening oral liquid low-dose group, a ginseng root-strengthening oral liquid medium-dose group and a ginseng root-strengthening oral liquid high-dose group according to the weight, and each group contains 10 animals.
Molding: except for the blank group of animals normally fed, 5 groups were given high fat diet for 4 weeks to create an atherosclerosis model, followed by abdominal aortic intimal stripping surgery modeling: taking 1.5ml/kg of sodium pentobarbital with the concentration of 2.5 percent for intravenous anesthesia, fixing an animal, depilating and disinfecting the right inguinal part, then carrying out small amount of local anesthesia on lidocaine, slicing, fleshing and separating femoral artery, respectively clamping the proximal and distal end of the femoral artery to expose about 2cm, cutting off one third of the circumference of the artery, introducing a balloon catheter (which is determined according to the diameter of a blood vessel) with the diameter of 1.5-2.0mm into the lower part of the renal artery, filling the balloon with saline water with the pressure of 4-6Kpa, slowly pulling the catheter back to the incision to evacuate the liquid in the balloon, reducing the pressure to zero, repeating the process for 3 times, and achieving the purpose of peeling off the abdominal aorta endothelium. The catheter was withdrawn, the femoral artery was ligated, the skin was sutured, and penicillin was continuously administered to the affected area for 3 days, 80 uU/day, to prevent infection.
Administration: feeding the animals in each group with normal feed after operation, starting administration on the next day, and performing intragastric administration on each group according to the following scheme, wherein the administration is performed for 1 time per day and is continuously performed for 4 weeks, and the administration dose is converted according to a conversion table of equivalent doses of human and animals:
blank group: normal saline was administered at a dose of 10ml/kg
Model group: normal saline was administered at a dose of 10ml/kg
Positive control group: administering a mixture of aspirin and rosuvastatin calcium at a dose of 10ml/kg
The ginseng root strengthening oral liquid low dose group comprises: the ginseng root strengthening oral liquid is given, and the dosage is 0.94ml/kg
The ginseng root-strengthening oral liquid comprises the following dosage groups: the ginseng root strengthening oral liquid is given, and the dosage is 1.88ml/kg
The ginseng root strengthening oral liquid high-dose group comprises: the ginseng root strengthening oral liquid is given, and the dosage is 3.76ml/kg
After 4 weeks, the white rabbits with big ears in New Zealand are killed, the abdominal cavity is exposed by cutting the abdominal wall, the intestinal canal is turned to one side, the abdominal aorta and the inferior vena cava are seen to be parallel to the side of the spinal column, the abdominal aorta is separated, 2cm long abdominal aorta is cut out, washed by physiological saline and then fixed in 10 percent formaldehyde solution, then dehydrated by alcohol, transparent by xylene, embedded by conventional paraffin, and stained by section, the intimal thickness, the intimal area and the media area of the section are measured by Imaging-Pro Plus6.0 image processing software, and the intimal-media area ratio is calculated, and the result is shown in Table 1.
Data miningRepresents the t-test and one-way analysis of variance, P, using a sps 10.0<0.01 indicates that the difference is very significant, P<0.05 means that the difference is significant and statistically significantAnd (5) defining.
Results of the experiment
Table 1 effect of ginseng root-securing oral liquid on intimal thickness and area in rabbit left iliac artery at 4 weeks after surgery (n-10,)
p < 0.05, P < 0.01 compared to blank; comparison with model group#P<0.05
As shown in Table 1, compared with the blank group, the thickness of the intima, the area of the intima and the area ratio of the intima to the media of the intima of the model group are increased, the difference is very obvious (P is less than 0.01), and the statistical significance is achieved; the difference of the mesomembrane area is not obvious and has no statistical significance (P is more than 0.05). Compared with the model group, the ginseng root-strengthening oral liquid has the advantages that the intima thickness, the intima area and the intima-media area ratio of the low, medium and high dose groups are all reduced, the difference is obvious (P is less than 0.05), and the statistical significance is achieved. Therefore, the ginseng root-strengthening oral liquid can relieve the thickening of the blood vessel intima, reduce the area increase of the intima and the area ratio of the intima to the intima-media, and has the effects of resisting intimal hyperplasia and improving the restenosis of the artery after PCI.
Claims (9)
1. Application of ginseng root-strengthening traditional Chinese medicine composition in preparing medicine for preventing and/or treating coronary heart disease and restenosis after PCI operation.
2. The use of claim 1, wherein the post-PCI restenosis of coronary heart disease is selected from the group consisting of post-percutaneous balloon coronary angioplasty restenosis, post-coronary stent restenosis, post-ablation restenosis of atheromatous plaque.
3. The use according to claim 1, wherein the restenosis disease after PCI surgery in coronary heart disease is post-operative coronary thrombosis, platelet adhesion, vascular smooth muscle cell proliferation and migration, intimal hyperplasia, recoil or vascular remodeling.
4. The use of claim 1, wherein the ginseng root-strengthening Chinese medicinal composition is prepared from ginseng, rehmannia root, poria cocos, moutan bark, prepared rehmannia root, cornus officinalis, Chinese yam, alisma orientale, asparagus and ophiopogon root.
5. The use of claim 4, wherein the ginseng root-strengthening traditional Chinese medicine composition is prepared from the following medicinal materials in parts by weight: 60-90 parts of ginseng, 170 parts of rehmannia root 130-.
6. The use as claimed in any one of claims 1 to 5, wherein the ginseng root-strengthening traditional Chinese medicine composition further comprises one or more pharmaceutically acceptable pharmaceutical excipients.
7. The use as claimed in any one of claims 1 to 5, wherein the ginseng root-strengthening traditional Chinese medicine composition is processed into capsules, tablets, granules, powder, pills or oral liquid by the prior art.
8. The use of claim 7, wherein the ginseng root-securing traditional Chinese medicine composition is a ginseng root-securing oral liquid.
9. The use of any one of claims 1-5, wherein the ginseng root-securing traditional Chinese medicine composition can be used in combination with other conventional medicines for improving the symptoms of restenosis after PCI surgery in coronary heart disease.
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