A pharmaceutical composition for treating acute coronary syndrome with kidney deficiency and blood stasis syndrome and application thereof

Abstract

The application provides a kind of drug composition for treating acute coronary syndrome kidney deficiency blood stasis syndrome and application thereof.The drug composition includes the following weight parts of raw medicinal materials: Radix Morindae Officinalis 6-20 parts, Salvia Miltiorrhiza 10-40 parts, Fructus Lycii 10-30 parts, Herba Cistanche 6-40 parts, Trichosanthes 6-40 parts and Panax Notoginseng 2-9 parts.The drug composition can significantly improve adverse symptoms of middle-aged and elderly patients with acute coronary syndrome kidney deficiency blood stasis syndrome, has certain advantages in improving clinical symptoms such as chest pain, chest tightness, fatigue, shortness of breath, soreness of waist and knees, dizziness, tinnitus and frequent nocturia, has good safety, and plays a role in improving blood clotting function and protecting kidney.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and specifically comprises a drug composition for treating acute coronary syndrome with kidney deficiency and blood stasis and application thereof. BACKGROUND

[0002] Heart disease and kidney disease are major diseases with high morbidity and mortality, which seriously threaten human health. In recent years, modern medical research has gradually found that heart disease and kidney disease are related. Many common indicators of chronic kidney disease are independent risk factors for the development of heart disease. Clinically, both often occur together. If not effectively controlled at an early stage, it is easy to develop into cardiorenal syndrome (CRS) at a later stage. One organ of the heart and kidney damages the function of the other organ, and they are causally related, forming a vicious cycle, ultimately leading to the common damage and failure of heart and kidney function. Although the existing secondary prevention concept and western medicine treatment methods have shown initial results, some patients still have recurrent angina pectoris, high blood coagulation, resistance to diuretics, worsening of renal function, and symptoms such as soreness of the waist and knees, frequent nocturia, and decreased quality of life. These are still clinical problems that need to be solved. Currently, there is little clinical and basic research on this mechanism, and no related drugs have been reported.

[0003] The inventors have found in many years of clinical practice that coronary artery disease often occurs in middle-aged and elderly people over the age of forty. Patients often have symptoms such as elevated blood urea nitrogen, soreness of the waist and knees, frequent nocturia, and other symptoms on the basis of blood stasis, appearing as a clinical manifestation of kidney deficiency and blood stasis with "yang deficiency and yin excess". The existing technology has the problem that current traditional Chinese medicine research mostly simply uses blood-activating drugs for intervention, and the outcome indicators are often only for the improvement of acute coronary syndrome angina pectoris, which limits the development of traditional Chinese medicine efficacy. There is an urgent need to treat middle-aged and elderly patients with acute coronary syndrome with kidney deficiency and blood stasis by improving the high coagulation state (such as thrombin time), improving the kidney-related physical and chemical indicators (such as urea nitrogen level), and symptom indicators (such as soreness of the waist and knees, frequent nocturia). SUMMARY

[0004] In view of the above problems existing in the prior art, a first object of the present application is to provide a drug composition for treating acute coronary syndrome with kidney deficiency and blood stasis.

[0005] Another object of the present application is to provide the use of the drug composition as described above in the preparation of a drug for treating acute coronary syndrome with kidney deficiency and blood stasis.

[0006] To achieve the above first object, the technical solution adopted by the present application comprises:

[0007] This invention discloses a pharmaceutical composition for treating acute coronary syndrome with kidney deficiency and blood stasis syndrome. The pharmaceutical composition comprises the following raw materials in parts by weight: Morinda officinalis 6-20 parts, Salvia miltiorrhiza 10-40 parts, Lycium barbarum 10-30 parts, Cistanche deserticola 6-40 parts, Trichosanthes kirilowii 6-40 parts, and Panax notoginseng 2-9 parts.

[0008] This formula, known as the Heart-Kidney Harmonizing Formula, was developed by the inventor based on years of clinical experience and has been experimentally verified. The main indications for this drug composition are: treatment of acute coronary syndrome with kidney deficiency and blood stasis, characterized by chest pain and tightness radiating to the shoulders and back, cyanosis of the lips, shortened thrombin time, lower back and knee weakness, frequent urination at night, and elevated blood urea nitrogen levels. Its effects include: harmonizing the heart and kidneys, tonifying the kidneys and strengthening the body's foundation, and promoting blood circulation and removing blood stasis.

[0009] The formula of the pharmaceutical composition is as follows: The principal ingredient is Morinda officinalis. Morinda officinalis: sweet and pungent in taste, slightly warm in nature, enters the kidney and liver meridians, tonifies kidney yang, strengthens tendons and bones, and dispels wind and dampness. The assistant ingredients are Salvia miltiorrhiza, Lycium barbarum, and Cistanche deserticola. Salvia miltiorrhiza: bitter and slightly cold in taste, enters the heart and liver meridians, and is good at promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling blood and eliminating carbuncles; its red color enters the heart, and it can break up stagnant blood and replenish new blood. It has the functions of promoting blood circulation and nourishing blood. The "Treatise on Women's Health" says, "One dose of Salvia miltiorrhiza powder has the same effect as Siwu Decoction." Lycium barbarum: sweet and neutral in taste, enters the liver and kidney meridians, nourishes the liver and kidneys, and benefits essence and improves eyesight. Cistanche deserticola: sweet, salty, and warm in taste, enters the kidney and large intestine meridians, tonifies the kidneys and benefits essence, and moistens the intestines and promotes bowel movement. The "Compendium of Materia Medica" says: Cistanche deserticola is a medicine that nourishes the gate of life, nourishes kidney qi, and replenishes essence and blood. It tonifies Yang without causing dryness, warms and invigorates kidney Yang to replenish kidney deficiency; it tonifies Yin without being greasy, moistens the intestines and relieves constipation, working synergistically with Morinda officinalis to tonify the kidneys and strengthen the body's foundation. The adjuvant herbs are Trichosanthes kirilowii and Panax notoginseng. Trichosanthes kirilowii: sweet, slightly bitter, and cold in nature, it enters the lung, stomach, and large intestine meridians; its bitter and cold properties lubricate and can open the chest and clear phlegm. Panax notoginseng: sweet and slightly bitter in nature, warm in nature, it enters the liver and stomach meridians; it disperses blood stasis, stops bleeding, reduces swelling, and relieves pain; it can assist Salvia miltiorrhiza in clearing the meridians and removing blood stasis, and can also prevent excessive blood-activating effects from other herbs, which could lead to bleeding.

[0010] Furthermore, the pharmaceutical composition comprises the following raw materials in parts by weight: 15 parts Morinda officinalis, 40 parts Salvia miltiorrhiza, 30 parts Lycium barbarum, 15 parts Cistanche deserticola, 20 parts Trichosanthes kirilowii, and 2 parts Panax notoginseng.

[0011] Furthermore, the pharmaceutical composition comprises the following raw materials in parts by weight: 20 parts Morinda officinalis, 30 parts Salvia miltiorrhiza, 30 parts Lycium barbarum, 40 parts Cistanche deserticola, 40 parts Trichosanthes kirilowii, and 9 parts Panax notoginseng.

[0012] Furthermore, the pharmaceutical composition comprises the following raw materials in parts by weight: 15 parts Morinda officinalis, 12 parts Salvia miltiorrhiza, 12 parts Lycium barbarum, 10 parts Cistanche deserticola, 15 parts Trichosanthes kirilowii, and 6 parts Panax notoginseng. Furthermore, it is prepared into a clinically acceptable pharmaceutical formulation according to conventional methods for preparing traditional Chinese medicine.

[0013] Furthermore, the pharmaceutical preparation includes decoctions, granules, powders, capsules, tablets, mixtures, or oral liquids.

[0014] Further, the raw materials of the traditional Chinese medicine composition are crushed and mixed, 6-10 times of water by mass is added to soak for 0.5-2 hours, and then decocted for 2-3 times, each time for 40-60 minutes, the decoction is combined, filtered, and concentrated to obtain the traditional Chinese medicine composition.

[0015] Further, the performance symptoms of the acute coronary syndrome are chest pain, chest tightness, pain radiating to the shoulder and back, purple lips, soreness of the waist and knees, and frequent nocturia.

[0016] To achieve the above second object, the technical scheme adopted by the present application comprises:

[0017] The present application discloses an application of the medicine composition in preparing a medicine for treating acute coronary syndrome with kidney deficiency and blood stasis.

[0018] The present application has the following beneficial effects:

[0019] The medicine composition provided by the present application not only significantly reduces the TCM syndrome score of acute coronary syndrome with kidney deficiency and blood stasis, improves the symptoms of chest pain, chest tightness, fatigue, and shortness of breath of the patient, increases the thrombin time (P=0.037), reduces the urea nitrogen level (P=0.040), improves the clinical symptoms of the patient such as soreness of the waist and knees and frequent nocturia, and has good effectiveness and safety, and plays a role in improving blood coagulation function and protecting the kidney. DETAILED DESCRIPTION

[0020] In order to more clearly illustrate the present application, the present application will be further described below in combination with preferred embodiments. It should be clear that the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0021] Embodiment 1

[0022] Formula: Radix Morindae Officinalis 15 parts, Radix Salviae Miltiorrhizae 40 parts, Fructus Lycii 30 parts, Herba Cistanche 15 parts, Fructus Trichosanthis 20 parts, and Radix Notoginseng 2 parts.

[0023] The above raw materials are crushed and mixed, 6-10 times of water by mass is added to soak for 0.5-2 hours, and then decocted for 2-3 times, each time for 40-60 minutes, the decoction is combined, filtered, and concentrated to the filtrate to 0.2-3g of crude drug per milliliter of medicinal liquid under reduced pressure, to obtain the traditional Chinese medicine composition.

[0024] Embodiment 2

[0025] Formula: 20 parts of Radix Morindae Officinalis, 30 parts of Radix Salviae Miltiorrhizae, 30 parts of Fructus Lycii, 40 parts of Herba Cistanche, 40 parts of Fructus Trichosanthis, and 9 parts of Radix Notoginseng. The above raw medicinal materials are mixed after being crushed, soaked in 6-10 times the mass of water for 0.5-2 hours, and decocted for 2-3 times, each time for 40-60 minutes. The decoction is combined, filtered, and concentrated under reduced pressure to 0.2-3 g of crude drug per milliliter of medicinal liquid, to obtain the traditional Chinese medicine composition.

[0026] Example 3

[0027] Formula: 15 parts of Radix Morindae Officinalis, 12 parts of Radix Salviae Miltiorrhizae, 12 parts of Fructus Lycii, 10 parts of Herba Cistanche, 15 parts of Fructus Trichosanthis, and 6 parts of Radix Notoginseng.

[0028] The above raw medicinal materials are mixed after being crushed, soaked in 6-10 times the mass of water for 0.5-2 hours, and decocted for 2-3 times, each time for 40-60 minutes. The decoction is combined, filtered, and concentrated under reduced pressure to 0.2-3 g of crude drug per milliliter of medicinal liquid, to obtain the traditional Chinese medicine composition.

[0029] Clinical trials

[0030] I. Materials and methods

[0031] 1.1 Case source: 80 cases of acute coronary syndrome with kidney deficiency and blood stasis syndrome diagnosed by coronary angiography were included. The cases were from patients who visited the cardiovascular department of outpatients or inpatients of Guang'anmen Hospital of China Academy of Chinese Medical Sciences from September 2019 to June 2021. This study has been approved by the Ethics Committee of Guang'anmen Hospital of China Academy of Chinese Medical Sciences (Ethics Approval No.: 2019-224-KY).

[0032] 1.2 Syndrome diagnosis standard: see Table 1.

[0033] Table 1 Diagnosis standard of kidney deficiency and blood stasis syndrome

[0034] Syndrome Main symptoms Score Syndrome Main symptoms Score A blood stasis Fixed pain in chest 4 B kidney deficiency Acidic soreness of waist and knees 5 Purple tongue or tongue with blood stasis 4 Dizziness and tinnitus 3 Purple sublingual vein 3 Hair loss or tooth shaking 3 Purple complexion 3 Residual urine or incontinence 3 Body with blood stasis 3 Sexual function decline 3 Limb numbness 2 Forgetfulness 3 Purple or dark red lips 2 Sessile pulse 2

[0035] Note: At least one of A and one of B are required, and the total score is ≥8 points to diagnose.

[0036] 1.3 Inclusion criteria: (1) clinically diagnosed as acute coronary syndrome with kidney deficiency and blood stasis syndrome; (2) diagnosed as kidney deficiency and blood stasis syndrome in traditional Chinese medicine; (3) aged 40-80 years; (4) voluntarily signed the informed consent form.

[0037] 1.4 Exclusion criteria: (1) severe valvular heart disease, severe neurosis, cervical spondylosis, gastroesophageal reflux and other non-coronary lesions caused by chest pain; (2) poor control of hypertension (resting blood pressure measured within one week ≥ 160 / 100 mmHg), severe cardiopulmonary insufficiency (ejection fraction < 35%), severe arrhythmia (paroxysmal ventricular tachycardia, rapid atrial fibrillation, type II0 II or more atrioventricular block, and complete bundle branch block, etc.); (3) combined with liver and kidney dysfunction, alanine aminotransferase or aspartate aminotransferase value > 3 times the upper limit of normal, or glomerular filtration rate < 30 ml / min / 1.73m 2 ; (4) combined with depression or anxiety, patients who cannot cooperate or are unwilling to cooperate; (5) pregnant or lactating women; (6) patients with malignant tumors; (7) allergic constitution; (8) patients with poor compliance and possible loss of follow-up; (9) other major diseases or factors that interfere with the completion of the trial or affect the interpretation of the results.

[0038] 1.5 Exclusion criteria: (1) after randomization, it was found that the subjects did not meet the inclusion criteria, or there were exclusion criteria; (2) subjects who did not take the trial drug after inclusion; (3) violation of the combined medication provisions in the protocol, so that the effectiveness and safety of the trial drug cannot be determined.

[0039] 1.6 Termination criteria: (1) serious adverse reactions occur during the trial, and the subject and the researcher make a comprehensive decision to terminate the trial in a timely manner; (2) the trial finds that the drug treatment is ineffective, even ineffective, and does not have clinical research value, and the clinical trial should be terminated.

[0040] 1.7 Randomization and randomization: The subjects were randomly divided into trial and control groups in a 1:1 ratio using the network version of the central randomization system provided by the Clinical Evaluation Center of the China Academy of Chinese Medical Sciences.

[0041] 1.8 Blinded design and unblinding: The researchers, subjects, outcome evaluators and statisticians in this study were blinded to reduce bias that may occur during the implementation of the clinical trial and the outcome evaluation process. A two-level blinded method was used, with the first blind based on the intervention group code (i.e. Group A or Group B), and the second blind based on the corresponding intervention measure (i.e. trial group or control group). The China Academy of Chinese Medical Sciences completed the entire drug numbering process, and the drug number corresponded to the random number.

[0042] 1.9 Treatment regimen: The test group takes the decoction prepared in Example 3, and the control group takes 10wt% of the formula in Example 3 + 90wt% of excipients (including malt dextrin, starch, caramel, and sucrose octaacetate), both of which are consistent in appearance, color, and smell, and cannot be distinguished by researchers and subjects. The test group takes Jiaotong Xinshen Decoction in warm boiled water 0.5h after conventional Western medicine treatment, 1 dose per day, 2 times in the morning and evening. The control group takes Jiaotong Xinshen Decoction simulation agent in warm boiled water 0.5h after conventional Western medicine treatment, 1 dose per day, 2 times in the morning and evening. The induction period is 1 week, the treatment period is 4 weeks, and the follow-up period after drug withdrawal is 6 months. Conventional Western medicine treatment includes anti-platelet drugs, statins, nitrate drugs, anticoagulant drugs, beta blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, or angiotensin II receptor antagonists, etc. At the same time, symptomatic treatment is given according to the patient's comorbidities.

[0043] 1.10 Observation indicators: (1) General clinical data. The clinical basic data of patients in the test group and the control group are observed, including: gender, age, height, weight, smoking history, drinking history, past medical history, and concurrent medication, etc. (2) Efficacy indicators. TCM syndrome score, single symptom and sign score, coagulation index, and renal function index.

[0044] 1.11 Handling of adverse reactions: During the test, whether the patients in the two groups have adverse reactions or not, and according to the relevant standards of adverse reactions, the correlation between adverse reactions and test drugs is divided into five categories, namely "definitely, very likely, likely, suspicious, and unlikely". Once any adverse reaction occurs in the patient, the researcher should handle it in time, analyze the cause of its occurrence, and report it to the research director and the ethics committee, while taking appropriate protective measures.

[0045] 1.12 Data management: All clinical patient data are recorded in the case observation table by the researcher in a timely, accurate, and complete manner, and are supervised, managed, and checked by a special person. After all data collection is completed, all data are entered into the database using Epidata (Version 3.1) software by double independent entry, and then carefully checked by a special person, and then handed over to the statistical analysis personnel for data statistics and analysis.

[0046] 1.13 Sample size estimation: This study is a randomized controlled trial, with the test group being the Jiaotong Xinshen Decoction group and the control group being the placebo group. According to the literature review and the results of the previous pre-test, a bilateral α = 0.05 is set with a confidence level of 90%. The PASS 15.0 software is used to calculate the sample size N1 = 32 for the treatment group and the sample size N2 = 32 for the control group. Considering 20% loss of follow-up and refusal, a total of at least 80 patients, including at least 40 patients in the treatment group and the control group, are required.

[0047] II. Results

[0048] 2.1 Completion of clinical trials

[0049] This study included 80 subjects from September 2019 to June 2021 in the Guang'anmen Hospital of China Academy of Chinese Medical Sciences, with 40 cases in each of the test and control groups. One patient in the test group withdrew due to work reasons, and two patients in the control group withdrew, with a total of 77 patients completing the observation, including 39 cases in the test group and 38 cases in the control group. The test dropout rate was 3.75%, which met the requirements of the trial plan.

[0050] 2.2 Baseline

[0051] By comparing the baseline data of the 77 patients who completed the clinical study, it was found that there was no significant difference between the test and control groups in terms of gender, age, height, weight, smoking history, and drinking history (P>0.05); in terms of comorbidities, there was no significant difference between the two groups in terms of hypertension, type 2 diabetes, dyslipidemia, and cerebral infarction (P>0.05); in terms of medication, there was also no significant difference between the two groups in terms of the proportion of patients taking aspirin and statins (P>0.05), as shown in Table 2. There was no significant difference in baseline data between the test and control groups, and the two groups were comparable.

[0052] Table 2 Baseline characteristics of subjects

[0053]

[0054] 2.3 Effectiveness analysis

[0055] 2.3.1 TCM syndrome score

[0056] After 4 weeks of treatment, both the test group (P<0.001) and the control group (P=0.009) could reduce the TCM syndrome score of patients. Under the premise that there was no difference in TCM syndrome score between the two groups before treatment (P=0.141), the test group could more significantly reduce the TCM syndrome score compared with the control group (P<0.001), as shown in Table 3. It can be seen that Jiaotong Xinshen Decoction can significantly reduce the TCM syndrome score of patients with acute coronary syndrome and kidney deficiency and blood stasis syndrome.

[0057] Table 3 Changes in TCM syndrome scores before and after treatment

[0058] Group (part) Before treatment After treatment P value Test group 44.41±13.12 31.74 ± 13.17 ##△△ ]] 0.000 Control group 48.58±11.37 44.16 ± 12.21 ** ]] 0.009

[0059] Note: Compared with the control group before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, △P<0.05,

[0060] △△ P<0.05; compared with the test group before treatment, # P<0.05, ## P<0.01.

[0061] 2.3.2 Single symptom and sign score

[0062] The study found that after 4 weeks of treatment, Jiaotong Xinshenfang could significantly improve the clinical symptoms of chest pain (P=0.001), chest tightness (P<0.001), palpitation (P=0.001), fatigue (P=0.003), shortness of breath (P=0.003), soreness of waist and knees (P<0.001), dizziness and tinnitus (P<0.001), aversion to cold and cold limbs (P=0.004), panting on movement (P=0.003), forgetfulness (P=0.010), and frequent nocturia (P=0.001) in patients, while the control group could improve the symptoms of chest tightness (P=0.001), palpitation (P=0.023), and aversion to cold and cold limbs (P=0.033) in patients. In the comparison between groups, there was no significant difference between the symptoms and signs of patients in the two groups before treatment (P>0.05), and after treatment, Jiaotong Xinshenfang could better improve the symptoms of chest pain (P=0.012), chest tightness (P=0.023), fatigue (P=0.001), shortness of breath (P=0.001), soreness of waist and knees (P=0.001), dizziness and tinnitus (P=0.001), panting on movement (P=0.034), forgetfulness (P=0.009), and frequent nocturia (P<0.001) compared with placebo, as shown in Table 4. It can be seen that Jiaotong Xinshenfang has certain advantages in improving the clinical symptoms of chest pain, chest tightness, fatigue, shortness of breath, soreness of waist and knees, dizziness and tinnitus, etc.

[0063] Table 4 Change in single symptom and sign score before and after treatment

[0064]

[0065] Note: compared with the control group before treatment, * P<0.05, ** P<0.01; compared with the control group after treatment, △ P<0.05, △△ P<0.05; compared with the test group before treatment, # P<0.05, ## P<0.01

[0066] 2.3.3 Coagulation function and renal function

[0067] There was no significant difference in coagulation function and renal function between the treatment group and the placebo group (P>0.05), and the Jiaotong Xinshen Fang had good safety. At the same time, it could increase the thrombin time (P=0.037) and reduce the urea nitrogen level (P=0.040) within the normal range, as shown in Table 5.

[0068] Table 5 Effect on liver and kidney function before and after treatment

[0069]

[0070] Note: Compared with the treatment group before treatment, # P<0.05

[0071] 2.4 Adverse reactions

[0072] During the medication, no adverse reactions were observed in the patients of the test group and the control group.

[0073] 2.5 Summary

[0074] In summary, the Jiaotong Xinshen Fang can not only significantly reduce the TCM syndrome score of the patients with acute coronary syndrome and kidney deficiency and blood stasis, improve the symptoms of chest pain, chest tightness, fatigue, shortness of breath, increase the thrombin time (P=0.037), reduce the urea nitrogen level (P=0.040), improve the clinical symptoms of soreness of waist and knees and frequent urination at night, and has good effectiveness and safety, while playing the role of improving coagulation function and protecting the kidney.

[0075] Obviously, the above embodiments of the present application are only examples for clearly illustrating the present application, and are not the limitation of the embodiments of the present application. For ordinary skilled in the art, other different forms of changes or variations can be made on the basis of the above description, and it is impossible to enumerate all the embodiments here. Any changes or variations which belong to the technical solutions of the present application and are obvious are still within the protection scope of the present application.

Claims

1. A pharmaceutical composition for treating acute coronary syndrome with kidney deficiency and blood stasis, characterized in that, The pharmaceutical composition comprises the following raw materials in parts by weight: Morinda officinalis 6-20 parts, Salvia miltiorrhiza 10-40 parts, Lycium barbarum 10-30 parts, Cistanche deserticola 6-40 parts, Trichosanthes kirilowii 6-40 parts, and Panax notoginseng 2-9 parts.

2. The pharmaceutical composition according to claim 1, characterized in that, The pharmaceutical composition comprises the following raw materials in parts by weight: 15 parts Morinda officinalis, 40 parts Salvia miltiorrhiza, 30 parts Lycium barbarum, 15 parts Cistanche deserticola, 20 parts Trichosanthes kirilowii, and 2 parts Panax notoginseng.

3. The pharmaceutical composition according to claim 1, characterized in that, The pharmaceutical composition comprises the following raw materials in parts by weight: 20 parts Morinda officinalis, 30 parts Salvia miltiorrhiza, 30 parts Lycium barbarum, 40 parts Cistanche deserticola, 40 parts Trichosanthes kirilowii, and 9 parts Panax notoginseng.

4. The pharmaceutical composition according to claim 1, characterized in that, The pharmaceutical composition comprises the following raw materials in parts by weight: 15 parts Morinda officinalis, 12 parts Salvia miltiorrhiza, 12 parts Lycium barbarum, 10 parts Cistanche deserticola, 15 parts Trichosanthes kirilowii, and 6 parts Panax notoginseng.

5. The pharmaceutical composition according to claim 1, characterized in that, Prepare clinically acceptable pharmaceutical formulations according to conventional Chinese medicine preparation methods.

6. The pharmaceutical composition according to claim 5, characterized in that, The pharmaceutical preparation is a decoction, granules, powder, capsule, tablet, or mixture.

7. The pharmaceutical composition according to claim 1, characterized in that, The raw materials of the Chinese herbal medicine composition are pulverized and mixed, soaked in 6-10 times the weight of water for 0.5-2 hours, and then decocted 2-3 times, each time for 40-60 minutes. The decoctions are combined, filtered, and concentrated to obtain the final product.

8. The pharmaceutical composition according to claim 1, characterized in that, The symptoms of acute coronary syndrome include chest pain and tightness, pain radiating to the shoulder and back, cyanosis of the lips, weakness in the lower back and knees, and frequent urination at night.

9. The use of the pharmaceutical composition according to any one of claims 1-8 in the preparation of a medicament for treating acute coronary syndrome with kidney deficiency and blood stasis.

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