Composite medicament for treating heart blood stasis type coronary heart disease and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a composite medicament for treating heart blood stasis type coronary heart disease and a preparation method thereof. The invention provides a composite medicament for treating heart blood stasis type coronary heart disease. The composite medicament comprises a composite injection and a sandwiched moxibustion patch, the composite injection comprises a ginkgo leaf extract injection and a sodium chloride injection; the sandwiched moxibustion comprises a sandwiched moxibustion cake, a substrate layer and a heating patch; the sandwiched moxibustion cake comprises pseudo-ginseng powder, peach kernel powder and a blender. The compound injection and the sandwiched moxibustion patch are combined for use, and the treatment effect on the heart blood stasis type coronary heart disease is remarkably improved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a composite medicament for treating coronary heart disease of the blood stasis type and a preparation method thereof. Background Art

[0002] Traditional moxibustion involves placing a moxa cone on certain medications and applying it to the affected area. It combines acupuncture points, medications, and moxibustion, and has the effects of warming the meridians and dispelling cold, supporting yang and strengthening deficiency, dissolving blood stasis and resolving stagnation, and promoting disease prevention and health. Modern medicine believes that moxibustion can dilate capillaries, relieve spasms, accelerate blood flow, enhance immunity, and promote recovery. Depending on the type of spacer, moxibustion can be divided into ginger moxibustion, salt moxibustion, garlic moxibustion, aconite cake moxibustion, and medicinal cake moxibustion. It has a wide range of applications, including internal medicine, surgery, rehabilitation, gynecology, pediatrics, dermatology, orthopedics, ENT, and preventive medicine, as well as beauty and health care. It can treat a variety of conditions, including yang deficiency, qi deficiency, phlegm-dampness, stagnation, dampness and toxins, and cold syndromes.

[0003] However, traditional moxibustion has many drawbacks. For example, burning moxa cones pose a risk of burns and fire. It must be performed in a designated area by professionals, making it difficult for patients to perform the procedure themselves. Patients may also be afraid of moxibustion, which can reduce compliance. Traditional moxibustion is not suitable for patients with allergies, such as allergic asthma or smoke allergies.

[0004] Coronary atherosclerotic heart disease (CHD) is a heart disease caused by atherosclerosis of the coronary arteries, resulting in narrowing, spasm, or obstruction of the coronary arteries, leading to myocardial ischemia, hypoxia, or necrosis. It is categorized as chronic myocardial ischemic syndrome (CIS) and acute coronary syndrome (ACS). With the aging population, the incidence and treatment rates of CHD remain high, and total hospitalization costs are high, placing a heavy burden on public health. CHD is caused by decreased coronary blood flow, leading to myocardial ischemia and hypoxia. Western medicine provides symptomatic treatments such as coronary dilation, heart rhythm regulation, and antiplatelet aggregation, with interventional therapy as necessary. Long-term use of Western medications can have significant adverse effects, such as impaired liver and kidney function, electrolyte imbalances, and secondary ulcers, and some symptoms are intractable. Traditional Chinese medicine believes that the decline of yang energy in the elderly, or improper maintenance, leads to depletion of heart yang and a failure to warm the heart. Over time, this leads to blood stasis, resulting in symptoms such as chest tightness, chest pain, palpitations, and shortness of breath. Clinically, the predominant form is heart blood stasis, which may also be accompanied by phlegm blocking the blood vessels and insufficient heart yang. Patients with coronary heart disease of the blood stasis type are most likely to suffer from myocardial infarction and sudden death, so it is very important to carry out treatments such as promoting blood circulation and removing blood stasis as early as possible.

[0005] Based on this, the present invention is proposed. Summary of the Invention

[0006] The purpose of the present invention is to provide a composite medicament for treating coronary heart disease of blood stasis type. The combined use of the composite injection and the moxibustion patch significantly improves the therapeutic effect on coronary heart disease of blood stasis type.

[0007] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0008] The present invention provides a composite medicament for treating coronary heart disease of the blood stasis type, the composite medicament comprising a composite injection and a moxibustion patch;

[0009] The compound injection includes ginkgo leaf extract injection and sodium chloride injection;

[0010] The volume ratio of the ginkgo leaf extract injection to the sodium chloride injection is 10-20:200-300;

[0011] The moxibustion patch comprises a moxibustion cake, a base layer and a heating patch;

[0012] The moxibustion cake comprises notoginseng powder, peach kernel powder and a blending agent;

[0013] The mass volume ratio of the Panax notoginseng powder and the blending agent is 1-3 g: 3-7 ml;

[0014] The mass volume ratio of the peach kernel powder and the blending agent is 3-7 g:3-7 ml.

[0015] Preferably, the initial concentration of the ginkgo leaf extract injection is 2-5%; the initial concentration of the sodium chloride injection is 0.8-1.0%.

[0016] Preferably, the heating patch is a moxibustion patch or an ironing patch.

[0017] Preferably, the base layer is non-woven fabric.

[0018] Preferably, the particle size of the Panax notoginseng powder is 70-80 μm, and the particle size of the peach kernel powder is 75-85 μm.

[0019] Preferably, the conditioning agent includes one or more of vinegar, wine, egg white, and vegetable oil.

[0020] The present invention also provides a method for preparing the composite medicament, comprising the following steps:

[0021] (1) mixing the Ginkgo biloba extract injection and the sodium chloride injection to obtain a compound injection;

[0022] (2) mixing Panax notoginseng powder, peach kernel powder and a blending agent to obtain a moxibustion cake;

[0023] (3) Stack the heating patch, moxibustion cake, and base layer in sequence from top to bottom to obtain the moxibustion patch.

[0024] Beneficial effects of the present invention:

[0025] The present invention provides a composite medicament for treating coronary heart disease of the heart blood stasis type. The composite medicament combines a composite injection (gingko leaf extract injection and sodium chloride injection) with a moxibustion patch (moxibustion cake, basal layer and heating patch), thereby significantly improving the therapeutic effect on coronary heart disease of the heart blood stasis type.

[0026] Moxibustion, based on the Traditional Chinese Medicine theory of "warming the cold," involves applying medicinal patches to the body, introducing heat energy into the body. This invigorates Qi and warms Yang, dispels cold and unclogs the meridians, ultimately strengthening the body's immune system and dispelling cold, dampness, and stasis. Modern moxibustion avoids the risks of traditional moxibustion, such as burns and fires, and is easy to perform, allowing it to be applied anytime, anywhere. DETAILED DESCRIPTION

[0027] The present invention provides a composite medicament for treating coronary heart disease of the blood stasis type, the composite medicament comprising a composite injection and a moxibustion patch;

[0028] The compound injection includes ginkgo leaf extract injection and sodium chloride injection;

[0029] The volume ratio of the ginkgo leaf extract injection to the sodium chloride injection is 10-20:200-300, preferably 13-17:230-270, and more preferably 15:250;

[0030] The moxibustion patch comprises a moxibustion cake, a base layer and a heating patch;

[0031] The moxibustion cake comprises notoginseng powder, peach kernel powder and a blending agent;

[0032] The mass volume ratio of the Panax notoginseng powder and the blending agent is 1-3 g: 3-7 ml, preferably 1.5-2.5 g: 4-6 ml, more preferably 2 g: 5 ml;

[0033] The mass volume ratio of the peach kernel powder and the blending agent is 3-7 g:3-7 ml, preferably 4-6 g:4-6 ml, and more preferably 5 g:5 ml.

[0034] In the present invention, the main components of the Ginkgo biloba extract injection are ginkgolides and ginkgo flavonoids, which have the effects of promoting blood circulation and removing blood stasis, unblocking meridians and lowering lipids, protecting vascular endothelial cells, improving myocardial ischemia, enhancing the body's antioxidant capacity, improving body circulation, and protecting ischemic tissues;

[0035] The Panax notoginseng in the moxibustion cake can promote blood circulation and stop bleeding, disperse blood stasis and relieve pain. Its main chemical component is saponins, which have the effects of anti-arrhythmia, inhibiting platelet aggregation, sedation and analgesia, anti-inflammatory, dilating coronary arteries, improving myocardial microcirculation, reducing myocardial oxygen consumption, and improving myocardial cell tolerance to hypoxia; peach kernel can promote blood circulation and remove blood stasis, moisten the intestines and promote bowel movements, relieve cough and asthma. Modern pharmacological studies have shown that peach kernel can inhibit platelet aggregation, anti-coagulation, improve hemodynamics, protect cardiovascular and cerebrovascular endothelium, inhibit arteriosclerosis, and improve arteriosclerosis. The modulator is edible white vinegar, which contains organic acids, amino acids, alcohols and other ingredients. It is sour in nature and has astringent properties. It can lead the medicine into the liver, relieve liver depression, reduce drug toxicity and irritation, and promote the dissolution or absorption of the active ingredients of the medicine, thereby enhancing bioavailability. Grinding Panax notoginseng and peach kernel into powder and mixing with vinegar is beneficial to the dissolution of the active ingredients of Panax notoginseng and peach kernel and the absorption of the effective substances. The three ingredients complement each other and enhance the effects of promoting blood circulation, removing blood stasis, softening hard masses and relieving pain.

[0036] In the present invention, the initial concentration of the ginkgo leaf extract injection is 2-5%, preferably 3-4%, and more preferably 3.5%; the initial concentration of the sodium chloride injection is 0.8-1.0%, preferably 0.9%.

[0037] In the present invention, the heating patch is a moxibustion patch or an ironing patch.

[0038] The heating patch consists of a heating bag, non-woven fabric, a far-infrared center area, pressure-sensitive adhesive, and silicone oil paper. It has a temperature range of 40°C to 70°C, and a far-infrared emission wavelength range of 8μm to 15μm. It uses a chemical heating object to generate heat to stimulate acupuncture points or local skin, replacing the heat generated by traditional moxibustion. The warming effect dilates local capillaries, enhances blood circulation and lymphatic circulation in local tissues, improves microcirculation, promotes and strengthens the metabolic capacity of skin tissue, and facilitates the excretion of metabolic products. It can stimulate the meridians and mobilize the functions of the meridians, so that they can better play the overall role of promoting the circulation of qi and blood and regulating yin and yang. It also has minimal irritation to the skin, and the warming effect is long-lasting, which can promote the absorption of drugs through the skin.

[0039] The moxibustion patch allows the Chinese herbal ingredients to be absorbed through the skin, avoiding the gastrointestinal irritation of oral medications, the first-pass effect on the liver, and the negative oral experience experienced by patients. It penetrates the skin and reaches the affected area directly, improving the poor percutaneous absorption of traditional Chinese medicine alone and enhancing the local therapeutic effect. It also avoids the risks of burns and fire associated with traditional moxibustion, is easy to use, and can be applied anytime, anywhere. Doctors can improve patient compliance, as it is a non-invasive, painless, and simple acupoint warming moxibustion method.

[0040] In the present invention, the base layer is a non-woven fabric.

[0041] In the present invention, the particle size of the Panax notoginseng powder is 70-80 μm, preferably 73-77 μm, and more preferably 75 μm; the particle size of the peach kernel powder is 75-85 μm, preferably 78-82 μm, and more preferably 80 μm.

[0042] In the present invention, the blending agent includes one or more of vinegar, wine, egg white, and vegetable oil, preferably vinegar, and more preferably white vinegar.

[0043] In the present invention, the method of using the moxibustion patch in the composite medicine is to apply it externally to the Tanzhong acupoint for 6 hours every day;

[0044] The compound injection is used by intravenous injection once a day.

[0045] The present invention also provides a method for preparing the composite medicament, comprising the following steps:

[0046] (1) mixing the Ginkgo biloba extract injection and the sodium chloride injection to obtain a compound injection;

[0047] (2) mixing Panax notoginseng powder, peach kernel powder and a blending agent to obtain a moxibustion cake;

[0048] (3) Stack the heating patch, moxibustion cake, and base layer in sequence from top to bottom to obtain the moxibustion patch.

[0049] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0050] Example 1 A composite drug for treating coronary heart disease of blood stasis type

[0051] (1) Add 15 ml of 3.5% Ginkgo biloba extract injection (each 5 ml vial contains 17.5 mg of Ginkgo biloba extract, including 4.2 mg of Ginkgo flavonoid glycosides) to 250 ml of 0.9% sodium chloride injection and mix to obtain a composite injection;

[0052] (2) Mix 2g of Panax notoginseng powder (74μm), 5g of peach kernel powder (80μm) and 5ml of water to form a cake to obtain a moxibustion cake;

[0053] (3) Stack the Haixu moxibustion device (registration number: Lu Xie No. 20152090594), moxibustion cake, and non-woven fabric in order from top to bottom to obtain a moxibustion patch.

[0054] Example 2 A composite drug for treating coronary heart disease of blood stasis type

[0055] (1) Add 12 ml of 3.5% Ginkgo biloba extract injection (each 5 ml vial contains 17.5 mg of Ginkgo biloba extract, including 4.2 mg of Ginkgo flavonoid glycosides) to 270 ml of 0.9% sodium chloride injection to obtain a composite injection;

[0056] (2) Mix 1 g of Panax notoginseng powder (70 μm), 7 g of peach kernel powder (85 μm) and 6 ml of white vinegar to form a cake to obtain a moxibustion cake;

[0057] (3) Stack the ironing patch, moxibustion cake, and non-woven fabric in order from top to bottom to obtain the moxibustion patch.

[0058] Example 3 A composite drug for treating coronary heart disease of blood stasis type

[0059] (1) Add 20 ml of 3.5% Ginkgo biloba extract injection (each 5 ml tube contains 17.5 mg of Ginkgo biloba extract, including 4.2 mg of Ginkgo flavonoid glycosides) to 300 ml of 0.9% sodium chloride injection and mix to obtain a composite injection;

[0060] (2) Mix 3 g of Panax notoginseng powder (80 μm), 3 g of peach kernel powder (75 μm) and 4 ml of white vinegar to form a cake to obtain a moxibustion cake;

[0061] (3) Stack the Haixu moxibustion device (registration number: Lu Xie No. 20152090594), moxibustion cake, and non-woven fabric in order from top to bottom to obtain a moxibustion patch.

[0062] Experimental Example 1

[0063] Patients diagnosed with coronary heart disease of the heart blood stasis type who visited the Department of Geriatrics and Department of Cardiology of the Hospital of Integrated Traditional Chinese and Western Medicine in Minhang District, Shanghai from January 2022 to April 2023 were selected and treated with the composite agent and composite injection described in Example 1, respectively. The specific method is as follows:

[0064] Treatment group (34 cases): intravenous injection of compound injection once a day, followed by application of moxibustion patch on the Tanzhong point for 6 hours, changed every day;

[0065] Control group (35 cases): intravenous injection of compound injection once a day;

[0066] After 14 days of treatment, the patients in the treatment group and the control group were observed for the following symptoms: chest tightness, palpitations, chest pain, fatigue, dizziness, shortness of breath, cold body and limbs, distension and pain in the ribs, expectoration, heaviness in limbs, and poor appetite. The statistical results are shown in Table 1 (P < 0.05). Then, the TCM syndrome scores and TCM syndrome efficacy rates before and after treatment were calculated with reference to the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines" (Trial Version). The calculated results are shown in Tables 2 and 3 (P < 0.05).

[0067] Table 1 Comparison of main symptoms in patients with coronary heart disease of blood stasis type after 14 days of treatment (%)

[0068] Group Treatment group control group Number of cases 34 35 chest tightness 8(23.53) 18(51.43) Palpitations and anxiety 1(2.9) 4(11.43) chest pain 0(0) 4(11.43) Tired and lazy 7(20.59) 10(28.57) dizziness 2(5.88) 5(14.28) shortness of breath 4(11.76) 11(31.43) Cold body and limbs 2(5.88) 13(37.14) swelling and pain in the flanks 4(11.76) 11(31.43) Heaviness of limbs 5(14.70) 13(37.14) expectoration 6(17.65) 14(40.00) Poor appetite 5(14.70) 9(25.71)

[0069] Table 2 Comparison of TCM syndrome scores in patients with coronary heart disease of blood stasis type before and after treatment ( point)

[0070] Group Number of cases Before treatment After 14 days of treatment Treatment group 34 25.38±0.91 11.82±0.56 control group 35 24.05±0.85 14.42±0.68

[0071] Table 3 Comparison of TCM syndrome efficacy in patients with coronary heart disease of blood stasis type after 14 days of treatment (%)

[0072] Group Number of cases get well Significantly effective efficient invalid Total effective Treatment group 34 5(14.70) 18(52.94) 9(26.47) 2(5.88) 32(94.12) control group 35 1(2.86) 15(42.86) 13(37.14) 8(22.86) 27(77.14)

[0073] The results showed that after treatment, the total score of TCM symptoms and the proportion of patients with chest tightness, chest pain, shortness of breath, cold body and limbs, distension and pain in the ribs, sputum, and heaviness of limbs in the treatment group were significantly lower than those in the control group; the total effective rate of the treatment group was significantly higher than that of the control group.

[0074] After 14 days of treatment, the levels of serum cardiac function-related indices were measured in the treatment group and the control group respectively [the levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP, pg / ml) and high-sensitive troponin T (hs-cTnT, ng / ml) were measured by electrochemiluminescence, the levels of serum fibrinogen (FIB, g / l) and D-dimer (DD, μg / ml) were measured by immunoturbidimetry, the level of serum C-reactive protein (CPR, g / l) was measured by nephelometry, the level of serum creatinine (SCr, μmol / l) was measured by enzyme method, the level of serum urea nitrogen (BUN, mmol / l) was measured by urease ultraviolet rate method, and the level of serum uric acid (UA, μmol / l) was measured by uricase colorimetry]. The results are shown in Table 4 (P < 0.05).

[0075] Table 4 Comparison of serum cardiac function-related indexes before and after treatment in patients with coronary heart disease of blood stasis type

[0076]

[0077] The results showed that the combined use of compound injection and moxibustion patch can significantly improve the patient's symptoms of yang deficiency, phlegm and blood stasis, improve the patient's hypercoagulable state and inflammatory response, and promote myocardial repair. Its effect is significantly better than using compound injection alone.

[0078] As can be seen from the above examples, the present invention provides a composite medicament for treating coronary heart disease of blood stasis type and its preparation method. The present invention combines the composite injection with the moxibustion patch to significantly improve the therapeutic effect of coronary heart disease of blood stasis type.

[0079] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A composite medicament for treating coronary heart disease of blood stasis type, characterized in that: The compound medicine includes a compound injection and a moxibustion patch; The compound injection includes ginkgo leaf extract injection and sodium chloride injection; The volume ratio of the ginkgo leaf extract injection to the sodium chloride injection is 10-20:200-300; The moxibustion patch comprises a moxibustion cake, a base layer and a heating patch; The moxibustion cake comprises notoginseng powder, peach kernel powder and a blending agent; The mass volume ratio of the Panax notoginseng powder and the blending agent is 1-3 g: 3-7 ml; The mass volume ratio of the peach kernel powder and the blending agent is 3-7 g:3-7 ml.

2. The composite pharmaceutical according to claim 1, characterized in that The initial concentration of the ginkgo leaf extract injection is 2-5%; the initial concentration of the sodium chloride injection is 0.8-1.0%.

3. The composite pharmaceutical according to claim 2, characterized in that The heating patch is a moxibustion patch or an ironing patch.

4. The composite pharmaceutical according to claim 3, characterized in that The base layer is non-woven fabric.

5. The composite pharmaceutical according to claim 4, characterized in that The particle size of the Panax notoginseng powder is 70-80 μm, and the particle size of the peach kernel powder is 75-85 μm.

6. The composite pharmaceutical according to claim 5, characterized in that: The blending agent includes one or more of vinegar, wine, egg white and vegetable oil.

7. The method for preparing the composite pharmaceutical according to any one of claims 1 to 6, characterized in that: The steps include: (1) mixing the Ginkgo biloba extract injection and the sodium chloride injection to obtain a compound injection; (2) mixing Panax notoginseng powder, peach kernel powder and a blending agent to obtain a moxibustion cake; (3) Stack the heating patch, moxibustion cake, and base layer in sequence from top to bottom to obtain the moxibustion patch.

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