Ginseng-flavored heart-strengthening soup as well as preparation method and application thereof

Abstract

The invention relates to a ginseng-flavored heart-strengthening soup and a preparation method and application thereof, and the ginseng-flavored heart-strengthening soup comprises the following components in parts by weight: 4-6 parts of ginseng, 11-15 parts of dalbergia wood, 8-10 parts of radix aconiti carmichaeli, 11-15 parts of parched white peony root, 8-10 parts of radix polygonati officinalis, 28-32 parts of semen lepidii, 11-15 parts of cassia twig, 11-15 parts of dogwood, 28-32 parts of calcined oyster shell and 5-7 parts of liquorice. The ginseng-flavor heart-strengthening decoction is good in effect, and especially has remarkable curative effects in the aspects of improving symptoms of patients with heart failure, improving the heart function of the patients, improving related detection indexes and the like.

Description

Technical Field

[0001] The present invention belongs to the field of chronic disease treatment, and particularly relates to a Shenxiang Qiangxin Decoction and its preparation method and application. Background Art

[0002] Current treatments for chronic heart failure (CHF) mainly include general treatment, drug treatment, and device treatment. General treatment is to avoid inducing factors that trigger heart failure attacks, such as infection and fatigue; drug treatment has evolved from the "golden triangle" to the "new quadruple combination" and now to the "five golden flowers", pushing the treatment of heart failure into a new era. In recent years, research results have shown that although treatment methods have made progress and the prognosis of CHF has improved in the past two decades, the overall incidence, mortality, and readmission rate due to heart failure are still high, and drug side effects are also real.

[0003] Traditional Chinese medicine has the characteristics of high efficiency and few side effects. The integrated traditional Chinese and Western medicine treatment of CHF has its unique advantages. It can not only improve the clinical symptoms of patients, enhance cardiac function, reduce the side effects of chemical drugs, but also have a positive impact on the prognosis of patients, enabling patients to benefit in the long term. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a Shenxiang Qiangxin Decoction and its preparation method and application. This prescription is safe and reliable, has good curative effects on chronic heart failure, has good clinical application value, and is worthy of further in-depth research and promotion.

[0005] The present invention provides a Shenxiang Qiangxin Decoction, which includes the following components in parts by weight: 4 - 6 parts of ginseng, 11 - 15 parts of dalbergia odorifera, 8 - 10 parts of aconite, 11 - 15 parts of stir-fried white peony root, 8 - 10 parts of polygonatum odoratum, 28 - 32 parts of semen lepidii, 11 - 15 parts of cassia twig, 11 - 15 parts of fructus corni, 28 - 32 parts of calcined oyster, and 5 - 7 parts of licorice.

[0006] Preferably, in parts by weight, the Shenxiang Qiangxin Decoction includes the following components: 5 parts of ginseng, 12 parts of dalbergia odorifera, 9 parts of aconite, 12 parts of stir-fried white peony root, 9 parts of polygonatum odoratum, 30 parts of semen lepidii, 12 parts of cassia twig, 12 parts of fructus corni, 30 parts of calcined oyster, and 6 parts of licorice.

[0007] The present invention also provides an application of the Shenxiang Qiangxin Decoction in the preparation of drugs for chronic heart failure.

[0008] Preferably, the drug is Shenxiang Qiangxin Decoction granules.

[0009] Preferably, the preparation method of the Shenxiang Qiangxin Decoction granules includes the following steps:

[0010] (1) Extracting the Chinese herbal pieces

[0011] Take ginseng, dalbergia wood, aconite, stir-fried white peony root, polygonatum odoratum, semen lepidii, cassia twig, cornel fruit, calcined oyster, and licorice root by weight parts, mix them, add water according to a solid-liquid ratio of 1:9 to 11, heat to boiling, keep slightly boiling for 1.0 to 2.0 h, and perform suction filtration; add water according to a solid-liquid ratio of 1:7 to 9, heat to boiling, keep slightly boiling for 0.8 to 1.5 h, and perform suction filtration; combine the two filtrates.

[0012] (2) Concentration

[0013] Under the condition of a temperature of 60 - 70 °C, concentrate the filtrate under reduced pressure to a clear paste with a specific gravity of 1.08 - 1.10.

[0014] (3) Spray drying

[0015] Add 4% - 6% of maltodextrin MD15 based on the mass percentage of the amount of crude drugs charged, dissolve the clear paste evenly, pass through a sieve, and then perform spray drying to obtain dry paste powder.

[0016] (4) Pass the obtained dry paste powder through a sieve and mix it evenly.

[0017] (5) Use dry granulation to make the dry paste powder into granules.

[0018] Preferably, in the step (2), the yield of the clear paste = [weight of clear paste (kg) / amount of crude drugs charged (kg) × 100%], and the index is ≥ 100%; the quality requirement of the clear paste is no drug residues and burnt scraps.

[0019] Preferably, the process parameters of spray drying in the step (3) are an inlet air temperature of 165 - 195 °C and an outlet air temperature of 80 - 105 °C.

[0020] Preferably, the quality requirement of the dry paste powder in the step (3) is that the moisture content ≤ 6.0%, and there are no burnt scraps and soft lumps.

[0021] According to traditional Chinese medicine, the pathogenesis of CHF is "deficiency of the root and excess of the superficial", where the root deficiency is the deficiency of qi, blood, yin and yang, and the superficial excess is the pathological products of water retention, blood stasis, etc. Based on the recognition and summary of clinical experience of predecessors, the present invention further emphasizes the relationship between "yang qi and water retention" in CHF, and believes that the pathogenesis of heart failure is deficiency of heart and kidney yang as the root, and water retention in the heart as the superficial, and proposes "invigorating qi, warming yang, promoting water and reducing swelling" as the basic treatment method for heart failure. The relationship between the monarch, minister, assistant and envoy of the ginseng and dalbergia in the present invention is: ginseng and dalbergia are the monarch, ginseng greatly replenishes the vital energy, and the heart qi is replenished by replenishing the middle qi; dalbergia is aromatic and turbid, regulates qi, activates blood circulation and relieves pain. Aconite, scutellaria, cinnamon twig, white peony root and cornus officinalis are the ministers. Aconite is very pungent and hot, it helps the heart yang and smoothes the blood vessels, warms the spleen yang and promotes the production of qi and blood, and nourishes the kidney yang and benefits the source of fire; scutellaria baicalensis can relieve the lungs and relieve asthma, promote diuresis and reduce swelling; cinnamon twig warms and smoothes the blood vessels; white peony root can restrain yin and nourish blood; cornus can restrain sweating and strengthen the body, nourish the liver and kidney. Polygonatum odoratum and calcined oyster are adjuvants. Polygonatum odoratum nourishes yin, and together with Polygonatum odoratum, it controls the pungent and hot nature of aconite; calcined oyster can calm and consolidate the yang qi that is out of control. The whole formula has the effects of tonifying the heart qi, warming the kidney yang, and promoting diuresis, and is clinically used to treat heart failure and kidney yang deficiency syndrome.

[0022] Beneficial effects

[0023] The ginseng and fragrant heart-strengthening soup of the present invention has good effects, especially in improving the symptoms of heart failure patients, improving the heart function of patients, improving relevant detection indicators, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is the UPLC-HRMS base peak ion chromatogram (BPC) - negative ion mode of the Shenxiang Qiangxin Decoction sample in the example.

[0025] Figure 2 This is the UPLC-HRMS base peak ion chromatogram (BPC) - positive ion mode of the Shenxiang Qiangxin Decoction sample in the example.

[0026] Figure 3 (A) cardiac color ultrasound images, (B) HE staining results, (C) LVEF, (D) LVFS, (E) LV Vol;s, (F) LV Vol;d, (G) NT-proBNP, and (H) body weight ratio of each group of mice in the example.

[0027] Figure 4 (A) TUNEL staining results, (B) TUNEL staining quantitative analysis results, (C) LDH, (D) GSH,

[0028] Figure 5 (A) Collagen I test results, (B) Collagen II test results, (C) Masson staining results, (D) Collagen I quantitative analysis results, and (E) Collagen II quantitative analysis results of each group of mice in the example.

[0029] Figure 6 (A) p-PI3K immunofluorescence detection, (B) p-AKT immunofluorescence detection, (C) immunoblotting of p-PI3K, PI3K, AKT, p-AKT, (D) quantitative analysis of p-PI3K / PI3K, (E) quantitative analysis of p-AKT / AKT, (F) immunoblotting of THBS4 and SPP1, (G) quantitative analysis of THBS4, (H) quantitative analysis of SPP1 for each group of mice in the examples.

[0030] Figure 7 (A) Echocardiogram images, (B) HE staining results, (C) Masson staining results, (D) LVEF, (E) LVFS, (F) LV Vol;s, (G) LV Vol;d, (H) body weight ratio for each group of mice in the examples.

[0031] Figure 8 (A) TUNEL staining results, (B) IHC images of BAX and Col III, (C) IF images of IL-1β for each group of mice in the examples.

[0032] Figure 9 (A) p-PI3K immunofluorescence detection, (B) p-AKT immunofluorescence detection, (C) immunoblotting of p-PI3K / PI3K, (D) quantitative analysis of p-PI3K / PI3K, (E) quantitative analysis of p-AKT / AKT for each group of mice in the examples.

[0033] Figure 10 NT-proBNP of each group of mice in the examples: (A) before and after treatment in the control group, (B) before and after treatment in the treatment group, (C) after treatment in the control group and the treatment group.

[0034] Figure 11 (A) LVEF, (B) LVFS, (C) LVESD, (D) LVEDD of the control group and the treatment group of mice before and after treatment in the examples.

[0035] Figure 12 NYHA cardiac function grades of the control group and the treatment group of mice before and after treatment in the examples. Detailed implementation manners

[0036] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also fall within the scope defined by the appended claims of this application.

[0037] Examples

[0038] In this embodiment, the formula of Shenxiang Qiangxin Decoction is 5 parts of ginseng, 12 parts of dalbergia wood, 9 parts of aconite, 12 parts of stir-fried white peony root, 9 parts of polygonatum odoratum, 30 parts of semen lepidii, 12 parts of cassia twig, 12 parts of fructus corni, 30 parts of calcined oyster, and 6 parts of licorice.

[0039] The preparation method of Shenxiang Qiangxin Decoction granules in this embodiment includes the following steps:

[0040] (1) Decoction piece extraction: Take ginseng, dalbergia wood, aconite, stir-fried white peony root, polygonatum odoratum, semen lepidii, cassia twig, fructus corni, calcined oyster, and licorice according to the weight parts, mix them, add water according to the solid-liquid ratio of 1:10, heat to boiling, keep slightly boiling for 1.5 h, and filter (200 mesh); add water according to the solid-liquid ratio of 1:8, heat to boiling, keep slightly boiling for 1 h, and filter (200 mesh); combine the two filtrates;

[0041] (2) Concentration: Under the condition of a temperature of 60-70 °C, concentrate the filtrate under reduced pressure to a clear paste with a specific gravity of 1.08-1.10, and ensure that there is no medicinal residue and scorched debris in the clear paste;

[0042] (3) Spray drying: Add 4%-6% of maltodextrin MD15 based on the mass percentage of the decoction piece input amount, dissolve the clear paste evenly, and sieve (100 mesh); then set the inlet air temperature at 165-195 °C and the outlet air temperature at 80-105 °C for spray drying to obtain dry extract powder; ensure that the moisture content of the dry extract powder ≤ 6.0%, and there is no scorched debris and soft lumps;

[0043] (4) Sieve the obtained dry extract powder (80 mesh) and mix evenly for 30 minutes;

[0044] (5) Use dry granulation to make the dry extract powder into 12-40 mesh granules.

[0045] The mass spectrometry spectrum of the Shenxiang Qiangxin Decoction granule sample in this embodiment is as Figures 1 - 2 shown.

[0046] This embodiment also established a mechanism study on the treatment of chronic heart failure with Shenxiang Qiangxin Decoction, and the research proved that the present invention has a good effect on the treatment of chronic heart failure.

[0047] Research design: A randomized, controlled, multi-center clinical study.

[0048] Research object: Mice with heart failure after myocardial infarction

[0049] Animal grouping: The grouping for the pharmacodynamic study is as follows: Normal mice were only sutured without ligation and set as the sham operation group (sham group, n = 10). Heart failure mice were randomly divided into a model group (Model group, n = 10), a low-dose Shenxiang Qiangxin Decoction group (SXQXT-L group, n = 10, 8.905 g / kg / d), a high-dose Shenxiang Qiangxin Decoction group (SXQXT-H group, n = 10, 35.62 g / kg / d), and an enalapril group (Enalapril group, n = 10, 2 mg / kg / d).

[0050] When conducting pathway verification, the animal grouping was as follows: Sham operation group (sham group, n = 6). Heart failure mice were randomly divided into a model group (Model group, n = 6), a high-dose Shenxiang Qiangxin Decoction group (SXQXT-H group, n = 6, 35.62 g / kg / d), and an inhibitor group (LY294002 group, n = 6, given SXQXT + LY294002). The inhibitor group was given Shenxiang Qiangxin Decoction by gavage at a dose of 35.62 g / kg / d for 1 month, and LY294002 was intraperitoneally injected at a dose of 10 mg / kg / d for 5 consecutive days.

[0051] Intervention time: 1 month

[0052] Observation indicators: Echocardiogram indicators, serological index detection, pathological staining, immunoblotting, PCR.

[0053] Participating center: Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.

[0054] The index test results of each group of mice are as Figures 3 - 9 shown. The markings in the figure indicate: "*": p < 0.05, "**": p < 0.01 compared with the sham group; "#": p < 0.05, "##": p < 0.01 compared with the Model group.

[0055] Figures 10 - 12 For the clinical study, both groups adopted standard Western medicine treatment. Among them, the treatment group was given Shenxiang Qiangxin Decoction, and the control group was given a placebo.

[0056] It can be seen from the above data that

[0057] (1) Shenxiang Qiangxin Decoction can significantly improve the cardiac function of heart failure mice;

[0058] (2) Shenxiang Qiangxin Decoction can inhibit myocardial fibrosis and ventricular remodeling;

[0059] (3) Shenxiang Qiangxin Decoction activates the PI3K / AKT signaling pathway and regulates the PI3K / AKT pathway induced by myocardial infarction and heart failure in vivo;

[0060] (4) Clinical data show that compared with before treatment, Shenxiang Qiangxin Decoction can significantly improve the NYHA cardiac function class;

[0061] (5) The inhibitor LY294002 partially blocked the effects of Shenxiang Qiangxin Decoction on improving cardiac function, reducing apoptosis, fibrosis and inflammation, thereby verifying that Shenxiang Qiangxin Decoction exerts a protective effect on cardiac function by activating the PI3K / AKT pathway.

Claims

1. A Shenxiang Qiangxin Decoction, characterized in that, By weight parts, it comprises the following components: 4-6 parts of ginseng, 11-15 parts of dalbergia odorifera, 8-10 parts of aconite, 11-15 parts of stir-fried white peony root, 8-10 parts of polygonatum odoratum, 28-32 parts of semen lepidii, 11-15 parts of cassia twig, 11-15 parts of cornel fruit, 28-32 parts of calcined oyster, 5-7 parts of licorice root.

2. The Shenxiang Qiangxin Decoction according to claim 1, characterized in that By weight parts, the Shenxiang Qiangxin Decoction comprises the following components: 5 parts of ginseng, 12 parts of dalbergia odorifera, 9 parts of aconite, 12 parts of stir-fried white peony root, 9 parts of polygonatum odoratum, 30 parts of semen lepidii, 12 parts of cassia twig, 12 parts of cornel fruit, 30 parts of calcined oyster, 6 parts of licorice root.

3. Use of the Shenxiang Qiangxin Decoction as described in claim 1 in the preparation of a drug for chronic heart failure.

4. The application according to claim 3, wherein The drug is Shenxiang Qiangxin Decoction granules.

5. The application according to claim 4, characterized in that, The preparation method of the Shenxiang Qiangxin Decoction granules comprises the following steps: (1) Extracting the Chinese herbal pieces Take ginseng, dalbergia odorifera, aconite, stir-fried white peony root, polygonatum odoratum, semen lepidii, cassia twig, cornel fruit, calcined oyster, and licorice root by weight parts and mix them. Add water according to a solid-liquid ratio of 1:9-11, heat to boiling, keep it boiling gently for 1.0-2.0 h, and filter by suction; add water according to a solid-liquid ratio of 1:7-9, heat to boiling, keep it boiling gently for 0.8-1.5 h, and filter by suction; combine the two filtrates; (2) Concentrating Under the condition of a temperature of 60-70 °C, concentrate the filtrate under reduced pressure to a clear paste with a specific gravity of 1.08-1.10; (3) Spray drying Add 4%-6% of maltodextrin MD15 based on the mass percentage of the Chinese herbal pieces input, dissolve the clear paste evenly, sieve it, and then spray dry to obtain dry paste powder; (4) Sieve the obtained dry paste powder and mix it evenly; (5) Use dry granulation to make the dry paste powder into granules.

6. The application according to claim 5, characterized in that, In the step (2), the yield of the clear paste = [weight of the clear paste (kg) / input amount of the Chinese herbal pieces (kg) × 100%], and the index is ≥ 100%; the quality requirement of the clear paste is no medicinal residues and scorched scraps.

7. The application according to claim 5, characterized in that In the step (3), the process parameters of spray drying are an inlet air temperature of 165-195 °C and an outlet air temperature of 80-105 °C.

8. The application according to claim 5, wherein In the step (3), the quality requirement of the dry paste powder is that the moisture content ≤ 6.0%, and there are no scorched scraps and soft lumps.

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