Soup for warming yang and strengthening body resistance as well as preparation method and application thereof

Abstract

The invention provides yang warming and body resistance strengthening decoction as well as a preparation method and application thereof, and belongs to the technical field of medicines. Comprising the following raw materials: prepared radix aconiti lateralis praeparata, bighead atractylodes rhizome, radix paeoniae alba, polyporus umbellatus, poria cocos, semen plantaginis, semen lepidii, rhizoma alismatis, honey-fried licorice root, fructus amomi, peach kernel, calcined dragon bone, ginseng, calcined oyster shell and euonymus fortunei. The Yang warming and body resistance strengthening formula prepared by the invention provides a new choice for treatment of cardiovascular patients, the preparation method provides a better pure traditional Chinese medicine granular preparation for the patients, the six-minute walking test of the cardiovascular patients can be remarkably improved, the life quality is improved, the short-term and long-term prognosis is obviously improved, and the Yang warming and body resistance strengthening formula has a wide application prospect.

Description

Technical Field

[0001] The present invention relates to the technical field of medicine, and in particular to a Wenyang Fuzheng decoction and a preparation method and application thereof. Background Art

[0002] Coronary heart disease and chronic heart failure are common chronic cardiovascular diseases with high morbidity and cost, impacting patients' quality of life. Their mortality rate ranks first among all causes of death, with two out of every five deaths attributed to cardiovascular disease.

[0003] In recent years, interventional treatment of coronary heart disease has developed rapidly, but patients still suffer from problems such as myocardial ischemia and decreased heart function after interventional surgery.

[0004] Drugs and device treatments for chronic heart failure have been continuously updated and developed, but epidemiology shows that the 5-year mortality rate of patients is as high as 50%-75%. The chronic course of the disease repeatedly worsens and is difficult to heal. The poor prognosis seriously affects the quality of life and survival of patients.

[0005] The pharmacological effects of traditional Chinese medicine are characterized by multiple levels, multiple targets, multiple directions, and multiple coverage, and are widely used in the clinical treatment of chronic heart failure. Summary of the Invention

[0006] The purpose of the present invention is to propose a Wenyang Fuzheng Decoction and its preparation method and application, to provide a new option for the treatment of cardiovascular patients. The preparation method provides such patients with a better pure Chinese medicine granule preparation, which can significantly improve the 6-minute walking test of cardiovascular patients, improve their quality of life, and significantly improve their short-term and long-term prognosis, and has broad application prospects.

[0007] The technical solution of the present invention is achieved as follows:

[0008] The invention provides a Wenyang Fuzheng Decoction, which comprises the following raw materials: cooked aconite root, white atractylodes macrocephala, white peony root, umbellate polyporus, poria, plantain seed, scutellaria baicalensis seed, oriental water chestnut, roasted liquorice root, amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster shell and fufang cao.

[0009] As a further improvement of the present invention, the raw materials include the following in parts by weight: 5-15 parts of cooked aconite root, 5-15 parts of white atractylodes, 3-10 parts of white peony root, 5-15 parts of umbellate polypore, 5-15 parts of poria, 2-5 parts of plantain seed, 2-5 parts of scutellaria baicalensis seed, 5-10 parts of oriental radix aristolochiae, 5-15 parts of roasted licorice root, 5-15 parts of amomum villosum, 5-15 parts of peach kernel, 5-10 parts of calcined dragon bone, 5-10 parts of ginseng, 5-10 parts of calcined oyster shell, and 5-15 parts of euonymus fortunei.

[0010] As a further improvement of the present invention, the present invention comprises the following raw materials in parts by weight: 10 parts of cooked aconite root, 10 parts of white atractylodes, 6 parts of white peony root, 10 parts of umbellate polypore, 10 parts of poria, 10 parts of plantago seed, 3 parts of scutellaria baicalensis seed, 7 parts of oriental radix aristolochiae, 10 parts of roasted licorice root, 10 parts of amomum villosum, 10 parts of peach kernel, 7 parts of calcined dragon bone, 7 parts of ginseng, 7 parts of calcined oyster shell, and 10 parts of euonymus fortunei.

[0011] The present invention further protects a method for preparing the above-mentioned Wenyang Fuzheng Decoction, comprising the following steps:

[0012] S1. Water extraction: The Chinese medicinal materials cooked aconite root, white atractylodes, white peony root, umbellate, poria, plantain seed, and scutellaria baicalensis seed were weighed in proportion, washed, added to water, soaked, heated and boiled for extraction, and then the heating was stopped and filtered to obtain extract A. The residue was added to water, heated and boiled for extraction, and then the heating was stopped and filtered to obtain extract B. Extract A and B were mixed to obtain extract C;

[0013] S2 reflux extraction: The Chinese medicinal materials Zexie, licorice, Amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster, Fufang Teng were weighed in proportion, washed, the Chinese medicinal materials were mixed with ethanol, soaked, heated under reflux extraction, and the heating was stopped after extraction to obtain aromatic water D;

[0014] S3. Preparation of Chinese medicine: concentrate the extract C under reduced pressure at low temperature to obtain an extract, cool it, add aromatic water D, spray granulate the auxiliary materials, and dry it to obtain Wenyang Fuzheng Decoction.

[0015] As a further improvement of the present invention, the solid-liquid ratio of the Chinese medicinal materials to water in step S1 is 1:(10-12) g / mL, and the solid-liquid ratio of the medicinal residue to water is 1:(6-10) g / mL.

[0016] As a further improvement of the present invention, the time for the heating and boiling extraction in step S1 is 50-70 minutes.

[0017] As a further improvement of the present invention, the soaking time in step S1 is 1-2 hours.

[0018] As a further improvement of the present invention, the solid-to-liquid ratio of the Chinese medicinal materials to ethanol in step S2 is 1: (4-8) g / mL.

[0019] As a further improvement of the present invention, the time for the heating reflux extraction in step S2 is 50-70 minutes, and the time for the soaking is 1-2 hours.

[0020] The present invention further protects the use of the above-mentioned Wenyang Fuzheng Decoction in preparing a medicine for treating chronic cardiovascular diseases.

[0021] The present invention has the following beneficial effects:

[0022] The inventors of this invention, based on their many years of clinical experience and the theory of "Yang transforms into Qi and Yin forms shape", have put forward the academic viewpoints of "Yang deficiency generates evil" and "Evil is removed and the body is in harmony with Yin and Yang", forming an academic thought and a treatment system for the treatment of chronic cardiovascular diseases. Wenyang Fuzheng Recipe is a Chinese medicine formula with clinical efficacy created by the inventors' team based on many years of clinical experience and scientific research results. Previous studies have shown that this medicine can significantly improve the 6-minute walk test of cardiovascular patients, improve their quality of life, and significantly improve their short- and long-term prognosis. Wenyang Fuzheng Recipe provides a new option for the treatment of cardiovascular patients, and its preparation method provides such patients with a better pure Chinese medicine granule preparation.

[0023] Traditional Chinese medicine decoctions must be freshly prepared before use, making them inconvenient to carry. Oral solutions are prone to precipitation, and the volatile oils are sensitive to light and heat. Granules are low-cost, easy to take and store, and readily available for widespread application. Therefore, this study intends to investigate the process improvements for the "Wen Yang Fu Zheng Formula" using a granular dosage form. The Wen Yang Fu Zheng Formula offers a new treatment option for cardiovascular patients with heart yang deficiency. Its preparation method yields a superior pure Chinese medicine granule preparation that maximizes the retention of the active ingredients. Under the same conditions, this preparation method for the Chinese medicine compound can extract a drug concentration twice that of previous techniques. This significantly increased effective drug concentration allows for greater efficacy.

[0024] Internal Chinese medicine uses warming yang and promoting diuresis, dissolving stasis and promoting diuresis. The prescription used is Wenyang Fuzheng Decoction, a combination of Zhenwu Decoction, Tingli Dazao Xiefei Decoction, and Shenfu Decoction. Shenfu Decoction, composed of raw sun-dried ginseng and aconite root, can support heart yang, tonify kidney yang, and strengthen spleen qi. The main ingredient in Zhenwu Decoction, roasted aconite root, is highly pungent and hot, restoring kidney yang and promoting qi transformation. Water is a yin evil, and "yin is transformed when yang is supported"; this is the principle of "strengthening primordial yang to eliminate yin." The auxiliary ingredients, Atractylodes macrocephala and Poria cocos, are sweet, bitter, and warming, drying dampness and strengthening the spleen, perfectly aligning with the principle that the spleen favors dryness and dislikes dampness. Aconite root first invigorates kidney yang, while Atractylodes macrocephala restores spleen qi. Poria cocos is sweet, mild, and neutral, entering the spleen and kidney meridians. It supports Atractylodes macrocephala's spleen-strengthening and transporting properties, while also dissipating dampness, allowing yin evil to be expelled through urination. The adjuvant is peony, which softens the liver to relieve abdominal pain, astringes yin and protects fluids, relieving urgency and treating physical agitation. It also prevents the harmful effects of warm and dry herbs like tangerine peel and aconite on yin, and the Ben Jing states that peony "can promote urination." Amomum villosum is aromatic and promotes digestion and resolves turbidity. In the Tingli Dazaoshaifei Decoction, Tingli seed is the main ingredient, promoting diuresis and reducing swelling. It is supplemented with Alisma orientalis, Poria cocos, and Plantago seed to promote diuresis, peach kernel and Fufang vine to activate blood circulation and unclog the meridians, calcined dragon bone and oyster shell to calm the body and retain yang energy in the lower burner, and roasted licorice root to nourish the spleen, harmonize the middle, and harmonize the other herbs. DETAILED DESCRIPTION

[0025] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0026] Example 1

[0027] This embodiment provides a preparation method of Wenyang Fuzheng Decoction, comprising the following steps:

[0028] Raw material composition (by weight): 5 parts of cooked aconite root, 5 parts of white atractylodes, 3 parts of white peony root, 5 parts of umbellate polyporus, 5 parts of poria, 2 parts of plantain seed, 2 parts of scutellaria baicalensis, 5 parts of orientalism, 5 parts of roasted licorice root, 5 parts of amomum villosum, 5 parts of peach kernel, 5-10 parts of calcined dragon bone, 5 parts of ginseng, 5 parts of calcined oyster shell, and 5 parts of euonymus fortunei.

[0029] S1. Water Extraction: Weigh the Chinese medicinal materials (Aconite root, Atractylodes macrocephala, White Peony Root, Polyporus umbellatus, Poria cocos, Plantago seed, and Ledebouriella tiliacea) in appropriate proportions, wash them, and add them to water at a solid-to-liquid ratio of 1:10 g / mL. Soak for 1 hour, then heat and boil for 50 minutes. After extraction, stop heating and filter to obtain Extract A. Add the medicinal residue to water at a solid-to-liquid ratio of 1:6 g / mL, heat and boil for 50 minutes, stop heating and filter to obtain Extract B. Mix Extracts A and B to obtain Extract C.

[0030] S2. Reflux extraction: Weigh the Chinese medicinal herbs Alisma orientalis, prepared liquorice root, Amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster shell, and Euonymus fortunei in appropriate proportions, wash them, and mix them with ethanol at a solid-to-liquid ratio of 1:4 g / mL. Soak for 1 hour and heat under reflux for 50 minutes. After extraction, stop heating to obtain aromatic water D.

[0031] S3. Preparation of Chinese medicine: concentrate the extract C under reduced pressure at low temperature to obtain an extract, cool it, add aromatic water D, spray granulate the auxiliary materials, and dry it to obtain Wenyang Fuzheng Decoction.

[0032] Example 2

[0033] This embodiment provides a preparation method of Wenyang Fuzheng Decoction, comprising the following steps:

[0034] Raw material composition (by weight): 15 parts of cooked aconite root, 15 parts of white atractylodes, 10 parts of white peony root, 15 parts of umbellate polypore, 15 parts of poria, 15 parts of plantago seed, 5 parts of scutellaria baicalensis seed, 10 parts of oriental zedoaria, 15 parts of roasted licorice root, 15 parts of amomum villosum, 15 parts of peach kernel, 10 parts of calcined dragon bone, 10 parts of ginseng, 10 parts of calcined oyster shell, and 5-15 parts of euonymus fortunei.

[0035] S1. Water Extraction: Weigh the Chinese medicinal materials (Aconite root, Atractylodes macrocephala, White Peony Root, Polyporus umbellatus, Poria cocos, Plantago seed, and Ledebouriella tiliacea) in appropriate proportions, wash them, and add them to water at a solid-to-liquid ratio of 1:12 g / mL. Soak for 2 hours, then heat and boil for 70 minutes. After extraction, stop heating and filter to obtain Extract A. Add the medicinal residue to water at a solid-to-liquid ratio of 1:10 g / mL, heat and boil for 70 minutes, stop heating and filter to obtain Extract B. Mix Extracts A and B to obtain Extract C.

[0036] S2. Reflux extraction: Weigh the Chinese medicinal herbs Alisma orientalis, prepared liquorice root, Amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster shell, and Euonymus fortunei in appropriate proportions, wash them, and mix them with ethanol at a solid-to-liquid ratio of 1:8 g / mL. Soak for 2 hours and heat under reflux for 70 minutes. After extraction, stop heating to obtain aromatic water D.

[0037] S3. Preparation of Chinese medicine: concentrate the extract C under reduced pressure at low temperature to obtain an extract, cool it, add aromatic water D, spray granulate the auxiliary materials, and dry it to obtain Wenyang Fuzheng Decoction.

[0038] Example 3

[0039] This embodiment provides a preparation method of Wenyang Fuzheng Decoction, comprising the following steps:

[0040] Raw material composition (by weight): 10 parts of cooked aconite root, 10 parts of white atractylodes, 6 parts of white peony root, 10 parts of umbellate polypore, 10 parts of poria, 10 parts of plantago seed, 3 parts of scutellaria seed, 7 parts of oriental radix aristolochiae, 10 parts of roasted licorice root, 10 parts of amomum villosum, 10 parts of peach kernel, 7 parts of calcined dragon bone, 7 parts of ginseng, 7 parts of calcined oyster shell, and 10 parts of euonymus fortunei.

[0041] S1. Water Extraction: Weigh the Chinese medicinal materials (Aconite root, Atractylodes macrocephala, White Peony Root, Polyporus umbellatus, Poria cocos, Plantago seed, and Ledebouriella tiliacea) in appropriate proportions, wash them, and add them to water at a solid-to-liquid ratio of 1:11 g / mL. Soak for 1.5 hours, then heat and boil for 60 minutes. After extraction, stop heating and filter to obtain Extract A. Add the medicinal residue to water at a solid-to-liquid ratio of 1:8 g / mL, heat and boil for 60 minutes, stop heating and filter to obtain Extract B. Mix Extracts A and B to obtain Extract C.

[0042] S2. Reflux extraction: Weigh the Chinese medicinal materials Alisma orientale, prepared liquorice root, Amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster shell, and Euonymus fortunei in appropriate proportions, wash them, and mix them with ethanol at a solid-to-liquid ratio of 1:6 g / mL. Soak for 1.5 hours and heat under reflux for 50-70 minutes. After extraction, stop heating to obtain aromatic water D.

[0043] S3. Preparation of Chinese medicine: concentrate the extract C under reduced pressure at low temperature to obtain an extract, cool it, add aromatic water D, spray granulate the auxiliary materials, and dry it to obtain Wenyang Fuzheng Decoction.

[0044] Test Case 1: Study on the Effect of Wenyang Fuzheng Decoction on Improving Myocardial Perfusion after Intervention in Acute Myocardial Infarction

[0045] 1. Research Plan

[0046] Twenty patients with acute ST-segment elevation myocardial infarction who underwent percutaneous coronary intervention were randomly divided into a Wenyang Fuzheng group (8.8 g of Wenyang Fuzheng group was taken before surgery, and 4.4 g of Wenyang Fuzheng group was taken once after surgery, twice a day for 30 consecutive days) and a control group (Western medicine group).

[0047] All patients took enteric-coated aspirin tablets 100 mg once daily, clopidogrel (Plavix) 75 mg once daily or ticagrelor tablets 90 mg twice daily, and atorvastatin calcium tablets 40 mg once daily.

[0048] 2. Observation indicators: cardiac ultrasound, cardiac function classification, NT-proBNP, CTNT, 6-minute walk test, and TCM syndrome score of the two groups.

[0049] 3. Conclusion: The results are shown in Table 1 or Table 2. Compared with the control group, the Wenyang Fuzheng prescription group had a higher proportion of patients with postoperative cardiac ultrasound (EF, left ventricular end-diastolic diameter), CTNT, BNP, and TCM syndrome score (P < 0.05).

[0050] Table 1 Comparison of NT-pr BNP, CTNT, and 6-minute walk test

[0051]

[0052] Note: Comparison of data before treatment between the two groups, *P>0.05; comparison of data after treatment, #P<0.05.

[0053] Table 2 Comparison of cardiac function indicators (LVEF, LVEDD) among the groups (x±s)

[0054]

[0055]

[0056] Note: *P>0.05 for comparison of data before treatment between the two groups; #P<0.05 for comparison of data after treatment

[0057] Table 3 Comparison of TCM syndrome scores (x±s)

[0058] Group Before treatment After treatment Wenyang Fuzheng Decoction 18.45±3.29 6.46±2.86 Western medicine group 18.61±3.14* 12.03±1.11#

[0059] Note: Comparison of data before treatment between the two groups, *P>0.05; comparison of data after treatment, #P<0.05.

[0060] Typical Case 1

[0061] Yu Yongjun, a 45-year-old male, presented with a chief complaint of bilateral lower extremity edema lasting over a month. His medical history included perianal abscesses. Upon admission, chest CT revealed pleural effusion, and echocardiography revealed an EF of 21%, global cardiomegaly, generalized hypokinesis of the ventricular wall, and left ventricular apical mural thrombus formation.

[0062] Coronary angiography ruled out coronary heart disease and diagnosed dilated heart disease. After precise dialectical treatment and cardiac rehabilitation, along with the use of a Wenyang Fuzheng prescription, the patient experienced no significant discomfort at follow-up visits two, six, and ten months later. Echocardiography revealed an EF increase from 21% to 49%, 50%, and 53% (see Table 1), with a decrease in left ventricular end-diastolic diameter. Pro-brain natriuretic peptide measurements and CTNT quantification showed no significant abnormalities, and cardiac function significantly improved without any adverse events. During a follow-up call with medical staff, the patient was in high spirits and expressed his and his family's appreciation for the efficacy of the treatment.

[0063] Table 1

[0064]

[0065]

[0066] Compared with previous technologies, this patent application can provide a new treatment option for patients with chronic heart failure and coronary heart disease. The medicine has the functions of "warming yang and promoting qi, removing blood stasis and promoting diuresis", and the whole formula has the characteristics of expelling evil without harming the body, achieving the effects of warming yang and strengthening the body, restoring yang qi to the smooth circulation of qi and blood, and restoring the body's yin and yang advantages. Under the premise of ensuring stable quality, it provides a better pure Chinese medicine granule preparation for patients with cardiovascular diseases caused by heart yang deficiency.

[0067] Typical Case 2

[0068] Ma, a 67-year-old male, presented with recurrent chest tightness for over three months, which worsened six days later. Following admission, he underwent coronary angiography, which confirmed the diagnosis of acute myocardial infarction. He underwent interventional therapy, with supportive measures including antiplatelet therapy, lipid-lowering therapy, and plaque stabilization.

[0069] The patient took Wen Yang Fu Zheng prescription after the operation and took it continuously for more than one month after leaving the hospital. The patient's cardiac function was significantly improved during the 6-month follow-up examination. No obvious abnormalities were found in the myocardial enzyme, brain natriuretic peptide precursor and CTNT quantification, and no adverse events occurred.

[0070] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A Wenyang Fuzheng Decoction, characterized in that: The following raw materials are included: cooked aconite root, white atractylodes, white peony root, umbellate polypore, poria, plantain seed, scutellaria baicalensis seed, Alisma orientale, roasted licorice root, Amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster shell, and clematis fangfang cao.

2. The Wenyang Fuzheng Decoction according to claim 1, characterized in that The invention comprises the following raw materials in parts by weight: 5-15 parts of cooked aconite root, 5-15 parts of white atractylodes, 3-10 parts of white peony root, 5-15 parts of umbellate polypore, 5-15 parts of poria, 2-5 parts of plantain seed, 2-5 parts of scutellaria baicalensis seed, 5-10 parts of oriental arisaema, 5-15 parts of roasted licorice root, 5-15 parts of amomum villosum, 5-15 parts of peach kernel, 5-10 parts of calcined dragon bone, 5-10 parts of ginseng, 5-10 parts of calcined oyster shell, and 5-15 parts of euonymus fortunei.

3. The Wenyang Fuzheng Decoction according to claim 2, characterized in that: The invention comprises the following raw materials in parts by weight: 10 parts of cooked aconite root, 10 parts of white atractylodes, 6 parts of white peony root, 10 parts of umbellate polypore, 10 parts of poria, 10 parts of plantago seed, 3 parts of scutellaria seed, 7 parts of oriental radix aristolochiae, 10 parts of roasted licorice root, 10 parts of amomum villosum, 10 parts of peach kernel, 7 parts of calcined dragon bone, 7 parts of ginseng, 7 parts of calcined oyster shell, and 10 parts of euonymus fortunei.

4. A method for preparing the Wenyang Fuzheng Decoction according to any one of claims 1 to 3, characterized in that: The following steps are involved: S1. Water extraction: The Chinese medicinal materials cooked aconite root, white atractylodes, white peony root, umbellate, poria, plantain seed, and scutellaria baicalensis seed were weighed in proportion, washed, added to water, soaked, heated and boiled for extraction, and then the heating was stopped and filtered to obtain extract A. The residue was added to water, heated and boiled for extraction, and then the heating was stopped and filtered to obtain extract B. Extract A and B were mixed to obtain extract C; S2 reflux extraction: The Chinese medicinal materials Zexie, licorice, Amomum villosum, peach kernel, calcined dragon bone, ginseng, calcined oyster, Fufang Teng were weighed in proportion, washed, the Chinese medicinal materials were mixed with ethanol, soaked, heated under reflux extraction, and the heating was stopped after extraction to obtain aromatic water D; S3. Preparation of Chinese medicine: concentrate the extract C under reduced pressure at low temperature to obtain an extract, cool it, add aromatic water D, spray granulate the auxiliary materials, and dry it to obtain Wenyang Fuzheng Decoction.

5. The preparation method according to claim 4, characterized in that In step S1, the solid-liquid ratio of the Chinese medicinal materials to water is 1:(10-12) g / mL, and the solid-liquid ratio of the medicinal residue to water is 1:(6-10) g / mL.

6. The preparation method according to claim 4, characterized in that The time for the heating and boiling extraction in step S1 is 50-70 minutes.

7. The preparation method according to claim 4, characterized in that The soaking time in step S1 is 1-2 hours.

8. The preparation method according to claim 4, characterized in that The solid-liquid ratio of the Chinese medicinal materials to ethanol in step S2 is 1: (4-8) g / mL.

9. The preparation method according to claim 4, characterized in that The time for the heating reflux extraction in step S2 is 50-70 minutes, and the time for the soaking is 1-2 hours.

10. Use of the Wenyang Fuzheng Decoction according to any one of claims 1 to 3 in the preparation and treatment of chronic cardiovascular diseases.

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