Traditional Chinese medicine composition for treating atherosclerosis complicated with frequent atrial premature beat as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating atherosclerosis complicated with frequent atrial premature beat. The traditional Chinese medicine composition is a medicament prepared from the following raw material medicines in parts by weight: 12-15 parts of radix rehmanniae preparata, 9-12 parts of herba cistanche, 12-15 parts of raw radix astragali, 12-15 parts of radix codonopsis, 12-15 parts of radix ophiopogonis, 12-15 parts of semen boitae, 12-15 parts of radix notoginseng and 12-15 parts of lucid ganoderma. In addition, the invention also relates to a preparation method and application of the traditional Chinese medicine composition.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine composition for treating atherosclerosis combined with frequent atrial premature beats. In addition, the invention also relates to a preparation method and application of the traditional Chinese medicine composition. Background Art

[0002] 1. The current status of atherosclerosis in my country's health sector.

[0003] At present, the leading cause of death among community residents in my country is cardiovascular and cerebrovascular diseases, which account for more than 40% of the total death rate, higher than tumors and other diseases. Data released by the American College of Cardiology and the European Society of Cardiology also show that cardiovascular disease is the leading cause of death, among which the burden of coronary heart disease ranks first. Atherosclerosis (AS) is the most common pathological basis of cardiovascular and cerebrovascular diseases. How to effectively limit the progression of atherosclerosis and prevent the occurrence of serious cardiovascular and cerebrovascular events is of great significance.

[0004] 2. Atherosclerosis and frequent atrial premature beats.

[0005] Patients with atherosclerosis often have arrhythmias, among which frequent premature atrial beats are one of the most common arrhythmias in clinical practice. With age, the incidence of atherosclerosis combined with frequent premature atrial beats increases. If frequent premature atrial beats are not controlled in time and are combined with chronic heart disease, it is easy to lead to reduced cardiac output, tissue hypoxia, insufficient organ perfusion, and further hemodynamic instability, inducing malignant arrhythmias, and even causing risks of sudden cardiac death. In addition, patients with frequent premature atrial beats are often accompanied by symptoms of palpitations and restlessness, which make patients nervous and anxious, seriously affecting their physical and mental health and reducing their quality of life.

[0006] 3. Overview of traditional Chinese medicine treatment for atherosclerosis combined with frequent atrial premature beats.

[0007] At present, modern medicine commonly uses antiarrhythmic drugs such as beta-blockers, propafenone, and amiodarone to treat frequent premature atrial beats. However, antiarrhythmic drugs have great side effects. Long-term use may cause bradycardia, sinus arrest, etc., which may further aggravate arrhythmias and even cause cardiovascular and cerebrovascular events. Close follow-up of electrocardiograms, dynamic electrocardiograms, etc. is required during use.

[0008] In the treatment of atherosclerosis combined with frequent atrial premature beats, traditional Chinese medicine, through syndrome differentiation and treatment, combined with the use of traditional Chinese medicine on the basis of Western medicine treatment, can reduce the occurrence of atrial premature beats, limit the progression of atherosclerosis, improve patients' clinical symptoms, reduce the occurrence of cardiovascular endpoint events, reduce adverse reactions, and has a synergistic effect. Summary of the invention

[0009] In view of the above-mentioned deficiencies in the prior art, according to an embodiment of the present invention, it is hoped to provide a Chinese medicine composition that can treat atherosclerosis, resist arrhythmias, and improve the quality of life for patients with atherosclerosis combined with frequent premature atrial beats, and propose a preparation method and use of the Chinese medicine composition.

[0010] In order to solve the above technical problems, the present invention provides a traditional Chinese medicine composition for treating atherosclerosis combined with frequent atrial premature beats, which is a medicine prepared from the following raw medicines in parts by weight: 12-15 parts of cooked rehmannia, 9-12 parts of cistanche deserticola, 12-15 parts of raw astragalus, 12-15 parts of codonopsis pilosula, 12-15 parts of ophiopogon japonicus, 12-15 parts of pine nuts, 12-15 parts of panax notoginseng, and 12-15 parts of ganoderma lucidum.

[0011] Preferably, the weight parts of the above-mentioned traditional Chinese medicine composition of the present invention are respectively: 12 parts of Rehmannia glutinosa, 9 parts of Cistanche deserticola, 12 parts of Raw Astragalus, 12 parts of Codonopsis pilosula, 12 parts of Ophiopogon japonicus, 12 parts of Platycladus orientalis, 12 parts of Panax notoginseng, and 12 parts of Ganoderma lucidum.

[0012] Preferably, the above-mentioned medicament of the present invention is a mixture.

[0013] Preferably, the above-mentioned medicament of the present invention is a granule.

[0014] The preparation method of the Chinese medicine composition of the present invention is as follows: weigh the raw medicine according to the proportion, add 9-11 times and 7-9 times of water respectively, decoct two to three times, combine the filtrate, and concentrate the filtrate to 5 grams of raw medicine per milliliter; add 2-4 times of ethanol to the concentrated solution, the alcohol content is 60%, refrigerate and stand for 22-26 hours, filter, and recover ethanol from the filtrate until there is no alcohol taste; boil the recovered solution, add 2-4 grams of sodium benzoate and 0.23-0.27 grams of ethyl paraben, filter and cool, add water to 480-520 ml, and fill it while it is hot.

[0015] In addition, the above-mentioned Chinese medicine composition of the present invention can also be prepared by the following method: weighing Rehmannia glutinosa, Cistanche deserticola and Astragalus membranaceus in proportion, crushing to 10-40 mesh, extracting volatile oil by steam distillation or supercritical extraction for later use; adding 5-10 times of water to the residues of Rehmannia glutinosa, Cistanche deserticola and Astragalus membranaceus and the remaining raw materials weighed in proportion, decocting two to three times, combining the filtrate, and concentrating the filtrate to 5 grams of raw medicine per milliliter; using a flocculation precipitation method, standing for 22-26 hours, centrifugation filtering, the centrifugal speed is 4980-5020 rpm, adding Rehmannia glutinosa, Cistanche deserticola and Astragalus membranaceus volatile oil to the filtrate, mixing, adding 2-4 grams of sodium benzoate and 0.23-0.27 grams of ethyl paraben, filtering and cooling, adding water to 480-520 ml, and filling while hot.

[0016] The preparation method of the Chinese medicine composition granules of the present invention is as follows: weigh the raw medicine according to proportion, add 9-11 times and 7-9 times of water respectively, decoct two to three times, combine the filtrate, and concentrate the filtrate to 5 grams of raw medicine per milliliter; add 2-4 times of ethanol to the concentrated solution, the alcohol content is 60%, refrigerate and stand for 22-26 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, concentrate the recovered liquid to a relative density of 1.25-1.30, add an appropriate amount of dextrin or starch, wet granulate, dry, make 480-520 grams of granules, and pack them.

[0017] In addition, the above-mentioned Chinese medicine composition granules of the present invention can also be prepared by the following method: weighing cooked rehmannia, cistanche and raw astragalus according to proportion, crushing to 10-40 mesh, and extracting volatile oil by steam distillation or supercritical extraction for later use; adding 5-10 times of water to the residues of cooked rehmannia, cistanche and raw astragalus and the remaining raw materials weighed according to proportion, decocting two to three times, combining the filtrate, and concentrating the filtrate to 5 grams of raw medicine per milliliter; using chitosan decoction flocculation precipitation method, standing for 22-26 hours, centrifugal filtration, concentrating the mixed solution to a relative density of 1.25-1.30, adding an appropriate amount of dextrin or starch and a β-cyclodextrin inclusion compound of the volatile oil of cooked rehmannia, cistanche and raw astragalus, wet granulating or one-step granulating method granulating, low temperature or vacuum drying, making granules of 480-520 grams, and packaging.

[0018] The Chinese medicine composition of the present invention is based on the treatment principle of tonifying the kidney and replenishing essence, nourishing yin and promoting blood circulation, and is composed of Radix Rehmanniae Preparata, Cistanche deserticola, raw Radix Astragali, Codonopsis pilosula, Panax notoginseng, Ganoderma lucidum, Radix Ophiopogonis and Semen Platycladi. In this group of medicines, Radix Rehmanniae Preparata and Cistanche deserticola can tonify the kidney and replenish essence, raw Radix Astragali and Codonopsis pilosula can invigorate the spleen and replenish qi, Panax notoginseng and Ganoderma lucidum can promote blood circulation and dredge collaterals, Radix Ophiopogonis can nourish yin and promote the production of body fluid, and Semen Platycladi can nourish the heart and calm the mind.

[0019] Modern pharmacological studies have confirmed that Radix Rehmanniae Preparata and Herba Cistanches have antioxidant effects, improve blood rheology, and have excellent therapeutic effects on neurodegenerative diseases. They can increase coronary flow after reperfusion, reduce coronary resistance, and promote the recovery of myocardial contractility. Astragalus and Codonopsis Pilosula have the effects of improving myocardial ischemia, dilating blood vessels, resisting thrombosis, and reducing blood viscosity. The effective component of Astragalus, total flavonoids of Astragalus, can eliminate triggering activity and reentry excitement, increase the depolarization threshold of fast-response cells, and reduce the incidence of arrhythmias; Panax notoginseng and Ganoderma lucidum can promote blood circulation and remove blood stasis, and increase coronary blood flow; the main chemical component of Ophiopogon japonicus, total saponins of Ophiopogon japonicus, can convert bidirectional tachycardia induced by barium chloride into sinus rhythm and reduce the automaticity of papillary muscles induced by adrenaline.

[0020] Subsequent examples and test examples demonstrate that the Chinese medicine composition of the present invention (hereinafter also referred to as the kidney-tonifying and yin-nourishing prescription) has obvious effects in treating atherosclerosis, reducing the frequency of atrial premature beats, improving the patient's symptoms and anxiety and depression, and reducing the occurrence of complications associated with atherosclerosis combined with frequent atrial premature beats. DETAILED DESCRIPTION

[0021] The present invention will be further described below in conjunction with specific embodiments. These embodiments should be understood to be only used to illustrate the present invention and not to limit the scope of protection of the present invention. After reading the content of the present invention, those skilled in the art may make various changes or modifications to the present invention, and these equivalent changes and modifications also fall within the scope defined by the claims of the present invention.

[0022] The cooked rehmannia used in the following examples of the present invention is confirmed to be produced in Shanghai, and is the tuberous root of Rehmannia glutinosa, a plant of the Scrophulariaceae family.

[0023] The origin of the Cistanche deserticola used in the following examples of the present invention is confirmed to be Inner Mongolia, and it is the fleshy stem with scale leaves of the plant Cistanche deserticola YCMa of the Orobanchaceae family.

[0024] The raw astragalus used in the following examples of the present invention is confirmed to be produced in Inner Mongolia, and is the root of Astragalus membranaceus (Fisch.) Bge.var. mongholicus (Bge.) Hsiao, a perennial herb of the Leguminosae family.

[0025] The origin of the Codonopsis pilosula used in the following examples of the present invention is confirmed to be Gansu, and it is the dried rhizome of Codonopsis pilosula (Franch.) Nannf., a perennial herbaceous vine of the genus Codonopsis in the family Campanulaceae.

[0026] The origin of the Ophiopogon japonicus used in the following examples of the present invention is confirmed to be Sichuan, and it is a block root of the herbaceous plant Ophiopogon japonicus (Lf) Ker Gawl. of the Liliaceae family.

[0027] The origin of the cypress seeds used in the following embodiments of the present invention is confirmed to be Shandong, and they are the dried mature seeds of Platycladus orientalis (L.) Franco of the Cupressaceae family.

[0028] The Panax notoginseng used in the following examples of the present invention is confirmed to be produced in Yunnan, and is the dried root of Panax notoginseng (Burk.) FHChen, a plant of the Araliaceae family.

[0029] The Ganoderma lucidum used in the following examples of the present invention is confirmed to be produced in Shandong, and is the dried fruiting body of the Polyporaceae fungus Ganoderma lucidum (Leyss. ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang.

[0030] Example 1 (Preparation of a mixture)

[0031] Weigh 6 days' worth of the above medicinal materials in proportion, add 9 times and 7 times the amount of water respectively, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 grams of crude drug per milliliter; add 2 times the amount of ethanol to the concentrated solution until the alcohol content reaches about 60%, refrigerate and stand for 22 hours, filter, and recover ethanol from the filtrate until there is no alcohol taste; boil the recovered liquid, add 2 grams of sodium benzoate and 0.23 grams of ethyl paraben (dissolved in water), filter and cool, add water to 480 ml, and fill it while it is hot.

[0032] Example 2 (Preparation of mixture)

[0033] Weigh the 7-day amount of the above medicinal materials in proportion, add 10 times and 8 times the amount of water respectively, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 grams of crude drug per milliliter; add 3 times the amount of ethanol to the concentrated solution until the alcohol content reaches about 60%, refrigerate and stand for 24 hours, filter, and recover ethanol from the filtrate until there is no alcohol taste; boil the recovered liquid, add 3 grams of sodium benzoate and 0.25 grams of ethyl paraben (dissolved in water), filter and cool, add water to 500 ml, and fill it while it is hot.

[0034] Example 3 (Preparation of mixture)

[0035] Weigh 8 days' worth of the above medicinal materials in proportion, add 11 times and 9 times the amount of water respectively, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 grams of crude drug per milliliter; add 4 times the amount of ethanol to the concentrate until the alcohol content reaches about 60%, refrigerate and stand for 26 hours, filter, and recover ethanol from the filtrate until there is no alcohol taste; boil the recovered liquid, add 4 grams of sodium benzoate and 0.27 grams of ethyl paraben (dissolved in water), filter and cool, add water to 520 ml, and fill while hot.

[0036] Example 4 (Preparation of mixture)

[0037] Weigh 6 days' worth of Radix Rehmanniae, Herba Cistanches and Radix Astragali in proportion, crush to 10-40 mesh, extract volatile oil by steam distillation or supercritical extraction for later use; add 5-10 times amount of water to the residues of Radix Rehmanniae, Herba Cistanches and Radix Astragali and the other raw materials weighed in proportion, decoct two to three times, combine the filtrate, and concentrate the filtrate to 5 g of the raw medicine per milliliter; adopt flocculation precipitation method, let stand for 22 hours, centrifuge and filter at a centrifugal speed of 4980 rpm, add volatile oil of Radix Rehmanniae, Herba Cistanches and Radix Astragali to the filtrate, mix well, add 2 g of sodium benzoate and 0.23 g of ethyl paraben, filter and cool, add water to 480 ml, and fill while hot.

[0038] Example 5 (Preparation of a mixture)

[0039] Weigh 7 days' worth of Radix Rehmanniae, Herba Cistanches and Radix Astragali in proportion, crush to 10-40 mesh, extract volatile oil by steam distillation or supercritical extraction for later use; add 5-10 times amount of water to the residues of Radix Rehmanniae, Herba Cistanches and Radix Astragali and the other raw materials weighed in proportion, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 g of the raw medicine per milliliter; adopt flocculation precipitation method, let stand for 24 hours, centrifuge and filter at a centrifugal speed of 5000 rpm, add volatile oil of Radix Rehmanniae, Herba Cistanches and Radix Astragali to the filtrate, mix well, add 3 g of sodium benzoate and 0.25 g of ethyl paraben (dissolved in water), filter and cool, add water to 500 ml, and fill while hot.

[0040] Example 6 (Preparation of a mixture)

[0041] Weigh 8 days' worth of Radix Rehmanniae, Herba Cistanches and Radix Astragali in proportion, crush to 10-40 mesh, extract volatile oil by steam distillation or supercritical extraction for later use; add 5-10 times amount of water to the residues of Radix Rehmanniae, Herba Cistanches and Radix Astragali and the other raw materials weighed in proportion, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 g of the raw medicine per milliliter; adopt flocculation precipitation method, let stand for 26 hours, centrifuge and filter at a centrifugal speed of 5020 rpm, add volatile oil of Radix Rehmanniae, Herba Cistanches and Radix Astragali to the filtrate, mix well, add 4 g of sodium benzoate and 0.27 g of ethyl paraben, filter and cool, add water to 520 ml, and fill while hot.

[0042] Example 7 (Preparation of granules)

[0043] Weigh 6 days' worth of the raw material medicine in proportion, add 9 times and 7 times the amount of water respectively, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 grams of the raw material medicine per milliliter; add 2 times the amount of ethanol to the concentrate, with an alcohol content of 60%, refrigerate and stand for 22 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, concentrate the recovered liquid to a relative density of 1.25-1.30 (room temperature), add an appropriate amount of dextrin or starch, wet granulate, dry, and make 480 grams of granules, which are packaged.

[0044] Example 8 (Preparation of granules)

[0045] Weigh the 7-day amount of raw medicine in proportion, add 10 times and 8 times the amount of water respectively, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 grams of raw medicine per milliliter; add 3 times the amount of ethanol to the concentrated solution until the alcohol content reaches about 60%, refrigerate and stand for 24 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, concentrate the recovered liquid to a relative density of 1.25-1.30 (room temperature), add an appropriate amount of dextrin or starch, wet granulate, dry, make 500 grams of granules, and package them.

[0046] Example 9 (Preparation of granules)

[0047] Weigh 8 days' worth of the raw material medicine in proportion, add 11 times and 9 times the amount of water respectively, decoct two to three times, combine the filtrates, and concentrate the filtrate to 5 grams of the raw material medicine per milliliter; add 4 times the amount of ethanol to the concentrate, with an alcohol content of 60%, refrigerate and stand for 26 hours, filter, recover ethanol from the filtrate until there is no alcohol taste, concentrate the recovered liquid to a relative density of 1.25-1.30 (room temperature), add an appropriate amount of dextrin or starch, wet granulate, dry, and make 520 grams of granules, which are packaged.

[0048] Example 10 (Preparation of granules)

[0049] Weigh 6 days' worth of Radix Rehmanniae, Herba Cistanches and Radix Astragali according to proportion, crush to 10-40 meshes, extract volatile oil by steam distillation or supercritical extraction for later use; add 5-10 times amount of water to the residues of Radix Rehmanniae, Herba Cistanches and Radix Astragali and the other raw materials weighed according to proportion, decoct for two to three times, combine the filtrates, and concentrate the filtrates to 5 g of the raw medicine per milliliter; adopt Chijutang flocculation precipitation method, stand for 22 hours, centrifuge and filter, mix, concentrate the mixed solution to a relative density of 1.25-1.30 (room temperature), add appropriate amount of dextrin or starch and β-cyclodextrin inclusion compound of volatile oil of Radix Rehmanniae, Herba Cistanches and Radix Astragali, granulate by wet method or one-step granulation method, dry at low temperature or in vacuum, prepare 480 g of granules, and pack them.

[0050] Example 11 (Preparation of granules)

[0051] Weigh 7 days' worth of Radix Rehmanniae, Herba Cistanches and Radix Astragali according to proportion, crush to 10-40 meshes, extract volatile oil by steam distillation or supercritical extraction for later use; add 5-10 times amount of water to the residues of Radix Rehmanniae, Herba Cistanches and Radix Astragali and the other raw materials weighed according to proportion, decoct for two to three times, combine the filtrates, and concentrate the filtrates to 5 grams of the raw medicine per milliliter; adopt Chijutang flocculation precipitation method, stand for 24 hours, centrifuge and filter, mix, concentrate the mixed solution to a relative density of 1.25-1.30 (room temperature), add appropriate amount of dextrin or starch and β-cyclodextrin inclusion compound of volatile oil of Radix Rehmanniae, Herba Cistanches and Radix Astragali, granulate by wet method or one-step granulation method, dry at low temperature or in vacuum, prepare 500 grams of granules, and pack them.

[0052] Example 12 (Preparation of granules)

[0053] Weigh 8 days' worth of Radix Rehmanniae, Herba Cistanches and Radix Astragali according to proportion, crush to 10-40 mesh, extract volatile oil by steam distillation or supercritical extraction for later use; add 5-10 times amount of water to the residues of Radix Rehmanniae, Herba Cistanches and Radix Astragali and the other raw materials weighed according to proportion, decoct for two to three times, combine the filtrate, and concentrate the filtrate to 5 grams of raw medicine per milliliter; adopt Chijutang flocculation precipitation method, stand for 26 hours, centrifuge and filter, mix, concentrate the mixed solution to a relative density of 1.25-1.30 (room temperature), add appropriate amount of dextrin or starch and β-cyclodextrin inclusion compound of volatile oil of Radix Rehmanniae, Herba Cistanches and Radix Astragali, granulate by wet method or one-step granulation method, dry at low temperature or in vacuum, prepare 520 grams of granules, and pack them.

[0054] The beneficial effects of the drug of the present invention are further illustrated by test examples below:

[0055] Experimental case (clinical study on the intervention of Bushen Yangyin prescription on atherosclerosis combined with frequent atrial premature beats)

[0056] 1. Test subjects

[0057] This study selected patients who visited the geriatric outpatient clinic, ward, and atherosclerosis specialist clinic of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.

[0058] 2. Experimental Design

[0059] The patients were required to meet the Western medical diagnostic criteria for carotid atherosclerosis and frequent atrial premature beats and the TCM diagnostic criteria for heart-kidney yin deficiency. According to the random number table method, patients with carotid atherosclerosis of heart-kidney yin deficiency combined with frequent atrial premature beats were randomly divided into a treatment group and a control group.

[0060] 3. Treatment options

[0061] (1) Control group: conventional western medicine treatment, including propafenone hydrochloride tablets as antiarrhythmic drug, 150 mg per time, once every 8 hours, orally.

[0062] (2) Treatment group: In addition to conventional Western medicine treatment, a prescription for nourishing the kidney and nourishing yin was used (prescription composition: 12 parts of cooked rehmannia, 9 parts of cistanche deserticola, 12 parts of raw astragalus, 12 parts of codonopsis, 12 parts of ophiopogon, 12 parts of cypress seeds, 12 parts of panax notoginseng, 12 parts of ganoderma lucidum. This preparation is a Chinese medicine decoction, uniformly provided by Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine. Dosage: 1 packet each time, once in the morning and once in the evening, warm after meals).

[0063] (3) The treatment course for both groups was 12 weeks, and the treatment group and the control group were prohibited from using other Chinese herbal preparations related to the treatment of this disease.

[0064] 4. Observation indicators:

[0065] (1) General information: name, age, gender, concomitant medication, allergy history, etc.

[0066] (2) Physical examination: heart rate, blood pressure, respiration, body weight, etc. were recorded before treatment, 4 weeks after treatment, and 12 weeks after treatment.

[0067] (3) Safety observation: ① Routine blood, urine, stool, liver and kidney function, etc. were recorded before treatment, 4 weeks after treatment, and 12 weeks after treatment. ② Adverse reactions.

[0068] (4) Efficacy observation: Testing and recording were performed before treatment and 12 weeks after treatment.

[0069] Main efficacy indicators: Dynamic electrocardiogram to detect the number of premature beats, carotid artery ultrasound to detect carotid intima-media thickness and plaque area.

[0070] Secondary efficacy indicators: ① TCM syndrome score was scored and recorded according to the TCM syndrome score table in accordance with the Guiding Principles for Clinical Research of New Chinese Medicines. The main symptoms were divided into four levels: none, mild, moderate, and severe, with scores of 0, 2, 4, and 6 points respectively; the secondary symptoms were divided into four levels: none, mild, moderate, and severe, with scores of 0, 1, 2, and 3 points respectively.

[0071] ②After completing 12 weeks of clinical observation, continue taking the medicine for 12 weeks for hard endpoint observation, and finally compare the average medication time, the incidence of endpoint events such as acute coronary syndrome and acute cerebrovascular accident between the two groups.

[0072] Efficacy evaluation criteria: The standard for marked effect is that the dynamic electrocardiogram shows that the atrial premature beats completely disappear or decrease by more than 90% compared with the previous period, and the symptoms of chest tightness and palpitations are significantly improved; the effective standard is that the dynamic electrocardiogram shows that the number of atrial premature beats decreases by between 50% and 90% compared with the previous period, and the symptoms of chest tightness and palpitations are improved; the ineffective standard is that the number of atrial premature beats decreases by less than 50% or remains unchanged, and the symptoms of chest tightness and palpitations are not improved.

[0073] 5. Results

[0074] 5.1 General Information

[0075] A total of 64 cases were included in this study, including 32 cases in the treatment group and 32 cases in the western medicine group. There was no significant difference in gender, age, body mass index, and underlying diseases between the two groups (P>0.05).

[0076] 5.2 Comparison of efficacy indicators

[0077] (1) Dynamic electrocardiogram

[0078] Before treatment, there was no significant difference in the number of atrial premature beats between the two groups (P>0.05). After treatment, the number of atrial premature beats in both the treatment group and the control group was lower than that before treatment, and the difference was statistically significant (P<0.05). The number of atrial premature beats in the treatment group was lower than that in the control group, and the total effective rate was higher, and the difference was statistically significant (P<0.05).

[0079] (2) Carotid artery ultrasound

[0080] Before treatment, there was no significant difference in carotid intima-media thickness and plaque area between the two groups (P>0.05). After treatment, there was no significant difference in carotid intima-media thickness between the control group and before treatment (P>0.05), and the plaque area was larger than before treatment, with a statistically significant difference (P<0.05). After treatment, the carotid intima-media thickness and plaque area of ​​the treatment group were smaller than those of the control group, and the total effective rate was higher, with a statistically significant difference (P<0.05).

[0081] (3) TCM syndrome score

[0082] Before treatment, there was no significant difference in TCM syndrome scores between the two groups (P>0.05). After treatment, the TCM syndrome scores of both the treatment group and the control group were lower than those before treatment, and the difference was statistically significant (P<0.05). Compared with the control group, the TCM syndrome scores of the treatment group were lower, and the TCM syndrome effective rate was higher, and the difference was statistically significant (P<0.05).

[0083] (4) End point event

[0084] Follow-up was conducted 12 weeks after the end of treatment. No primary endpoint event occurred in the treatment group, and 1 secondary endpoint event occurred; 1 primary endpoint event occurred in the control group, and 8 secondary endpoint events occurred. The number of secondary endpoint events and the cumulative number of endpoint events in the treatment group were significantly lower than those in the control group (P<0.05).

[0085] 5.3 Security Analysis

[0086] During the treatment, no obvious adverse reactions occurred in both groups, and there was no statistically significant difference in safety indicators between the two groups (P>0.05).

[0087] 6. Conclusion

[0088] The Chinese medicine composition of the present invention is combined with conventional Western medicine to treat atherosclerosis combined with frequent atrial premature beats, which can limit the progression of atherosclerotic plaques in patients, reduce the number of atrial premature beats, improve the traditional Chinese medicine symptoms of patients, and reduce the occurrence of endpoint events.

Claims

1. A Chinese medicine composition for treating atherosclerosis combined with frequent atrial premature beats, characterized in that: The Chinese medicine composition is a medicine prepared from the following raw materials in parts by weight: 12-15 parts of cooked rehmannia, 9-12 parts of cistanche deserticola, 12-15 parts of raw astragalus, 12-15 parts of codonopsis pilosula, 12-15 parts of ophiopogon japonicus, 12-15 parts of cypress seeds, 12-15 parts of panax notoginseng and 12-15 parts of ganoderma lucidum.

2. The Chinese medicine composition for treating atherosclerosis combined with frequent atrial premature beats according to claim 1, characterized in that: The weight parts of each raw material medicine are respectively: 12 parts of cooked rehmannia, 9 parts of cistanche deserticola, 12 parts of raw astragalus, 12 parts of codonopsis pilosula, 12 parts of ophiopogon japonicus, 12 parts of cypress seed, 12 parts of panax notoginseng, and 12 parts of ganoderma lucidum.

3. The Chinese medicine composition for treating atherosclerosis combined with frequent atrial premature beats according to claim 1 or 2, characterized in that: The medicine is a mixture.

4. The Chinese medicine composition for treating atherosclerosis combined with frequent atrial premature beats according to claim 1 or 2, characterized in that: The medicine is a granule.

5. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: The method comprises the following steps: weighing the raw medicine according to a proportion, adding 9-11 times and 7-9 times of water respectively, decocting two to three times, combining the filtrate, and concentrating the filtrate to a value that each milliliter is equivalent to 5 grams of the raw medicine; adding 2-4 times of ethanol to the concentrated solution, with an alcohol content of 60%, refrigerating and standing for 22-26 hours, filtering, and recovering ethanol from the filtrate until there is no alcohol taste; boiling the recovered solution, adding 2-4 grams of sodium benzoate and 0.23-0.27 grams of ethyl paraben, filtering and cooling, adding water to 480-520 ml, and filling while hot to obtain the product.

6. The method for preparing the Chinese medicine composition according to claim 3, characterized in that: The steps include: Weigh Rehmannia glutinosa, Cistanche deserticola, and Astragalus membranaceus according to the proportion, crush them into 10-40 mesh, and extract volatile oil by steam distillation or supercritical extraction for later use; The residues of Radix Rehmanniae, Herba Cistanches, and Radix Astragali are added with 5-10 times of water and the rest of the raw materials weighed in proportion, and boiled two to three times, the filtrates are combined, and the filtrates are concentrated to 5 g of the raw materials per milliliter; Adopt flocculation sedimentation method, let stand for 22-26 hours, centrifuge and filter at a centrifugal speed of 4980-5020 rpm, add volatile oils of Codonopsis pilosula, Ophiopogon japonicus and Semen Platycladi to the filtrate, mix well, add 2-4 g of sodium benzoate and 0.23-0.27 g of ethyl paraben, filter and cool, add water to 480-520 ml, and bottle while hot.

7. The method for preparing the Chinese medicine composition granules according to claim 4, characterized in that: The method comprises the following steps: weighing the raw medicine according to a proportion, adding 9-11 times and 7-9 times of water respectively, decocting two to three times, combining the filtrate, and concentrating the filtrate to a value that each milliliter is equivalent to 5 grams of the raw medicine; adding 2-4 times of ethanol to the concentrated solution, with an alcohol content of 60%, refrigerating and standing for 22-26 hours, filtering, recovering ethanol from the filtrate until there is no alcohol taste, concentrating the recovered solution to a relative density of 1.25-1.30, adding an appropriate amount of dextrin or starch, wet granulating, drying, preparing granules of 480-520 grams, and packaging the granules.

8. The method for preparing the Chinese medicine composition granules according to claim 4, characterized in that: The steps include: Weigh Rehmannia glutinosa, Cistanche deserticola, and Astragalus membranaceus according to the proportion, crush them into 10-40 mesh, and extract volatile oil by steam distillation or supercritical extraction for later use; The residues of Radix Rehmanniae, Herba Cistanches, and Radix Astragali are added with 5-10 times of water and the rest of the raw materials weighed in proportion, and boiled two to three times, the filtrates are combined, and the filtrates are concentrated to 5 g of the raw materials per milliliter; The mixture is concentrated to a relative density of 1.25-1.30 by using a chitosan decoction flocculation precipitation method, standing for 22-26 hours, and centrifugally filtered. An appropriate amount of dextrin or starch and a β-cyclodextrin inclusion complex of volatile oils of Rehmannia glutinosa, Cistanche deserticola, and raw Astragalus membranaceus are added. The mixture is granulated by a wet method or a one-step granulation method, and dried at low temperature or in a vacuum to obtain 480-520 g granules, which are then packaged.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating atherosclerosis combined with frequent premature atrial beats.