Traditional Chinese medicine composition for treating sepsis and traditional Chinese medicine preparation thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine. Specifically, the traditional Chinese medicine composition for treating sepsis is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of lithospermum erythrorhizon, 10-20 parts of fructus forsythiae, 10-20 parts of salvia miltiorrhiza, 10-15 parts of astragalus membranaceus, 10-15 parts of schisandra chinensis and 3-10 parts of liquorice. In addition, the invention further provides a traditional Chinese medicine preparation for treating sepsis, and the traditional Chinese medicine preparation comprises the traditional Chinese medicine composition or the extract of the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials. The traditional Chinese medicine composition can effectively increase the survival rate of a patient and improve prognosis, the treatment cost of the patient is greatly saved, the economic burden of the patient is relieved, and meanwhile the life quality of the patient is improved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a Chinese medicine composition and a Chinese medicine preparation thereof for treating sepsis. Background Art

[0002] Sepsis is an infection caused by bacteria, fungi, viruses and parasites, which leads to an inflammatory response in the body. If the inflammatory response is aggravated, it will cause a deep suppression of immune function. The main symptoms of sepsis include chills, fever, palpitations, shortness of breath, changes in mental state, etc. Sepsis can develop into severe sepsis and septic shock, which can lead to organ dysfunction and circulatory disorders. The latest global epidemiological survey shows that the mortality rate of sepsis is 26.7% to 41.9%, which greatly endangers the life safety of patients.

[0003] At present, the main treatment for sepsis is antibiotic treatment and corresponding organ function support therapy, but this treatment method still cannot effectively improve the patient's symptoms or reduce the mortality rate. Considering that sepsis is a disease of systemic immune imbalance and its prominent characteristics in systemic inflammation, the use of traditional Chinese medicine to regulate the patient's overall function, improve the patient's immunity, and cooperate with mechanical ventilation, nutritional support and other treatment methods, has a better therapeutic effect and improves the prognosis.

[0004] Traditional Chinese medicine believes that the causes of sepsis mainly include insufficient vital energy, internal accumulation of toxic heat, blood stasis and obstruction of visceral qi. Patent 2014103109650 discloses a Chinese medicine preparation for treating heat-invading blood sepsis and its preparation method, but the method uses up to 37 kinds of Chinese medicinal materials, which invisibly increases the metabolic burden of the patient's liver and kidneys, so the efficacy is unclear. Patent 2017102210099 discloses a Chinese medicine composition for treating sepsis renal dysfunction and its preparation method, but the formula only has significant efficacy for the symptoms of renal dysfunction, and has no obvious effect on liver damage, pulmonary insufficiency and other problems. Therefore, the development of a Chinese medicine composition with a simple formula, a small metabolic burden on patients, and a wide range of therapeutic effects has better clinical application prospects and scientific research value. Summary of the invention

[0005] The technical problem to be solved by the present invention is to provide a Chinese medicine composition for treating sepsis, so as to solve the problems of high cost, large consumption of medical resources and long treatment cycle of the existing sepsis treatment using modern medical means, as well as increased metabolic burden on patients and unclear treatment effect caused by using traditional Chinese medicine, thereby effectively improving the survival rate of patients and prognosis, greatly saving the treatment costs of patients, reducing the economic burden of patients and improving the quality of life of patients.

[0006] In order to achieve the above-mentioned purpose, the technical scheme adopted by the present invention is: a traditional Chinese medicine composition for treating sepsis, which is prepared by the following traditional Chinese medicine raw materials in parts by weight: 10-20 parts of Lithospermum officinale, 10-20 parts of Forsythia suspensa, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Astragalus, 10-15 parts of Schisandra chinensis, and 3-10 parts of Licorice.

[0007] On the basis of the above technical solutions, the present invention may further have the following specific options or optimization options.

[0008] Specifically, the invention is prepared from the following Chinese medicinal raw materials by weight: 12-16 parts of Lithospermum officinale, 12-16 parts of Forsythia suspensa, 12-16 parts of Salvia miltiorrhiza, 8-12 parts of Astragalus, 8-12 parts of Schisandra chinensis, and 5-8 parts of Licorice.

[0009] Specifically, the invention is prepared from the following Chinese medicinal raw materials by weight: 14 parts of Lithospermum officinale, 14 parts of Forsythia suspensa, 14 parts of Salvia miltiorrhiza, 10 parts of Astragalus, 10 parts of Schisandra chinensis, and 6 parts of Licorice.

[0010] In the above Chinese medicine formula, Lithospermum officinale is sweet, salty and cold in nature. It enters the heart and liver meridians. It has the functions of cooling blood, promoting blood circulation, detoxifying and clearing rashes. Lithospermum officinale can also inhibit a variety of bacteria and viruses, and has a certain effect on the infection of certain bacteria and viruses. In addition, Lithospermum officinale also has the effects of protecting the liver, anti-tumor, and stopping bleeding.

[0011] Forsythia suspensa has a dry and bitter taste and is slightly cold in nature. It enters the lung, heart, and small intestine meridians. It has the effects of reducing swelling, dispersing nodules, and evacuating wind-heat. In addition, Forsythia suspensa has a broad-spectrum antibacterial effect, and its antibacterial components are forsythia phenol, forsythia glycoside B, and volatile oil.

[0012] Danshen is bitter, slightly cold, and enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving pain. Moreover, modern research progress has found that the ingredients contained in Danshen have antioxidant, anti-tumor, anti-inflammatory, and anti-myocardial ischemia effects.

[0013] Astragalus is warm in nature and enters the spleen and lung meridians. It has the effects of replenishing qi and raising yang, strengthening the exterior and stopping sweating, promoting diuresis and reducing swelling, promoting body fluid and nourishing blood. Modern research progress has found that the ingredients contained in Astragalus can enhance the body's immune function, promote hematopoiesis, anti-virus, anti-cancer, liver protection and other pharmacological effects.

[0014] Schisandra chinensis is sour, sweet and warm in nature, and enters the lung, heart and kidney meridians. It has the effects of astringency, invigorating qi and promoting body fluid, nourishing the kidney and calming the mind. Modern research progress has found that the ingredients contained in Schisandra chinensis can enhance immunity, protect the liver, concentrate the mind, protect the myocardium and have anti-tumor effects.

[0015] Licorice is sweet and neutral in nature. It enters the heart, lung, spleen and stomach meridians. It has the functions of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, removing phlegm and relieving cough, relieving urgency and relieving pain, and harmonizing various medicines.

[0016] Therefore, the above-mentioned Chinese medicine composition for treating sepsis, based on the understanding of the medicinal properties of traditional Chinese medicine, adopts modern medical ideas, and adopts Lithospermum officinale and Forsythia suspensa for compatibility. The effect of clearing away heat and detoxifying in traditional Chinese medicine is understood by modern medicine as being significantly anti-inflammatory, antibacterial and antiviral; the medicinal properties of Salvia miltiorrhiza and Astragalus membranaceus have the effects of enhancing immunity and replenishing qi and consolidating the foundation; Schisandra chinensis has the effect of conditioning the lungs, heart and kidneys; Licorice alleviates the medicinal properties and harmonizes the various medicines, so it is an auxiliary of all medicines and a gentle nourishment for patients. The formula combination is simple, low-cost, can effectively regulate systemic inflammatory reactions, and is patient-oriented. While mobilizing the patient's own immunity, it protects the internal organs, has the characteristics of mild medicinal properties and significant efficacy, and is suitable for use by a wide range of people. At the same time, it can also be adjusted on the basis of this party according to different conditions and the patient's constitution, so as to have a more flexible treatment plan.

[0017] Preferably, the present invention also provides a method for preparing the above-mentioned Chinese medicine composition for treating sepsis, comprising the following steps:

[0018] 1) by weight, 10-20 parts of Lithospermum officinale, 10-20 parts of Forsythia suspensa, 10-20 parts of Salvia miltiorrhiza, 10-15 parts of Astragalus, 10-15 parts of Schisandra chinensis, and 3-10 parts of Licorice are mixed and soaked in water for 30-90 minutes, wherein the mass ratio of the total mass of the above Chinese medicinal materials to water is 1:5-10;

[0019] 2) boiling the Chinese medicinal materials and water in step 1) for 10-20 minutes over high heat, then boiling over low heat for 20-40 minutes, filtering the residue, and obtaining a Chinese medicinal liquid;

[0020] 3) Repeat step 2) 1-2 times, then combine the obtained Chinese medicine liquids and concentrate them to 1 / 4-1 / 6 of the original volume to obtain the Chinese medicine composition for treating sepsis.

[0021] Preferably, the present invention also provides a traditional Chinese medicine preparation for treating sepsis, which comprises the above-mentioned traditional Chinese medicine composition or its extract and a pharmaceutically acceptable excipient.

[0022] Specifically, the extract is a water extract or an alcohol extract of the traditional Chinese medicine composition described herein.

[0023] Specifically, the pharmaceutically acceptable excipient is selected from one or more of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, flavoring agents, preservatives, suspending agents, coating materials, integrities, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, inclusion agents, humectants, flocculants and deflocculating agents, filter aids, release retardants, polymer skeleton materials and film-forming materials.

[0024] Specifically, the Chinese medicine preparation is selected from one of tablets, capsules, powders, pills, granules, oral liquids, syrups, decoctions, suppositories, gels, sprays or injections. In some embodiments, the dosage form of the preparation in the present application includes capsules, tablets, pills, liquids, powders, granules, fine granules, film coatings, pills, lozenges, sublingual agents, peptizers, buccal preparations, pastes, syrups, suspensions, elixirs, emulsions, coatings, ointments, plasters, poultices, transdermal preparations, lotions, inhalants, aerosols, injections and suppositories.

[0025] More preferably, the present invention also provides use of the above-mentioned Chinese medicine composition or Chinese medicine preparation in the preparation of a medicament for treating and / or preventing sepsis.

[0026] More preferably, the present invention also provides a method for treating and / or preventing sepsis, the method comprising: administering the Chinese medicine composition or the Chinese medicine preparation described herein to a subject.

[0027] It should be noted that, in some embodiments, the subject is a human, rat, mouse, cat, dog, horse, sheep, cow, monkey, etc. The present application describes multiple embodiments, but the description is exemplary rather than restrictive, and it is obvious to those of ordinary skill in the art that there may be more embodiments and implementations within the scope of the embodiments described in the present application. Although discussed in the specific embodiments, many other combinations of the disclosed features are also possible. Unless specifically limited, any feature of any embodiment may be used in combination with any other feature in any other embodiment, or may replace any other feature in any other embodiment.

[0028] The present application includes and contemplates combinations of features known to those of ordinary skill in the art. The embodiments and features disclosed in the present application may also be combined with any conventional features to form a unique invention scheme defined by the claims. Any feature of any embodiment may also be combined with features from other invention schemes to form another unique invention scheme defined by the claims. Therefore, it should be understood that any feature shown and / or discussed in the present application may be implemented individually or in any appropriate combination. Therefore, except for the limitations made according to the attached claims and their equivalents, the embodiments are not subject to other restrictions. In addition, various modifications and changes may be made within the scope of protection of the attached claims.

[0029] In addition, when describing representative embodiments, the specification may have presented the method and / or process as a specific sequence of steps. However, to the extent that the method or process does not rely on the specific order of the steps described herein, the method or process should not be limited to the steps of the specific order described. As will be understood by those of ordinary skill in the art, other sequences of steps are also possible. Therefore, the specific sequence of the steps set forth in the specification should not be interpreted as a limitation to the claims. In addition, the claims for the method and / or process should not be limited to the steps of performing them in the order written, and those skilled in the art can easily understand that these sequences can be changed and still remain within the spirit and scope of the embodiments of the present application. DETAILED DESCRIPTION

[0030] In order to better understand the present invention, the content of the present invention is further explained below in conjunction with specific embodiments, but the content of the present invention is not limited to the following embodiments.

[0031] Embodiment 1:

[0032] The present invention provides a Chinese medicine composition for treating sepsis, which is prepared from the following Chinese medicinal materials, in parts by weight: 14 parts of Lithospermum officinale, 14 parts of Forsythia suspensa, 14 parts of Salvia miltiorrhiza, 10 parts of Astragalus, 10 parts of Schisandra chinensis, and 6 parts of Licorice. The specific preparation method is as follows:

[0033] 1) By weight, 14 parts of Lithospermum officinale, 14 parts of Forsythia suspensa, 14 parts of Salvia miltiorrhiza, 10 parts of Astragalus, 10 parts of Schisandra chinensis, and 6 parts of Licorice were mixed and soaked in water for 60 minutes, wherein the mass ratio of the total mass of the above Chinese medicinal materials to water was 1:8;

[0034] 2) boiling the Chinese medicinal materials and water in step 1) for 15 minutes over high heat, then boiling over low heat for 30 minutes, filtering the residue, and obtaining a Chinese medicinal liquid;

[0035] 3) Repeat step 2) twice, then combine the obtained Chinese medicine liquids and concentrate them to 1 / 5 of the original volume to obtain the Chinese medicine composition for treating sepsis.

[0036] Embodiment 2:

[0037] The present invention provides a Chinese medicine composition for treating sepsis, which is prepared from the following Chinese medicinal materials, in parts by weight: 10 parts of Lithospermum officinale, 15 parts of Forsythia suspensa, 18 parts of Salvia miltiorrhiza, 15 parts of Astragalus, 10 parts of Schisandra chinensis, and 8 parts of Licorice. The specific preparation method is as follows:

[0038] 1) By weight, 10 parts of Lithospermum officinale, 15 parts of Forsythia suspensa, 18 parts of Salvia miltiorrhiza, 15 parts of Astragalus, 10 parts of Schisandra chinensis, and 8 parts of Licorice were mixed and soaked in water for 40 minutes, wherein the mass ratio of the total mass of the above Chinese medicinal materials to water was 1:5;

[0039] 2) boiling the Chinese medicinal materials and water in step 1) for 20 minutes over high heat, then boiling over low heat for 20 minutes, filtering the residue, and obtaining a Chinese medicinal liquid;

[0040] 3) Repeat step 2) twice, then combine the obtained Chinese medicine liquids and concentrate them to 1 / 6 of the original volume to obtain the Chinese medicine composition for treating sepsis.

[0041] Embodiment 3:

[0042] The present invention provides a Chinese medicine composition for treating sepsis, which is prepared from the following Chinese medicinal materials, in parts by weight: 16 parts of Lithospermum officinale, 16 parts of Forsythia suspensa, 16 parts of Salvia miltiorrhiza, 8 parts of Astragalus, 8 parts of Schisandra chinensis, and 5 parts of Licorice. The specific preparation method is as follows:

[0043] 1) By weight, 16 parts of Lithospermum officinale, 16 parts of Forsythia suspensa, 16 parts of Salvia miltiorrhiza, 8 parts of Astragalus, 8 parts of Schisandra chinensis, and 5 parts of Licorice were mixed and soaked in water for 60 minutes, wherein the mass ratio of the total mass of the above Chinese medicinal materials to water was 1:10;

[0044] 2) boiling the Chinese medicinal materials and water in step 1) for 15 minutes over high heat, then boiling over low heat for 40 minutes, filtering the residue, and obtaining a Chinese medicinal liquid;

[0045] 3) Repeat step 2) once, then combine the obtained Chinese medicine liquids and concentrate them to 1 / 4 of the original volume to obtain the Chinese medicine composition for treating sepsis.

[0046] Embodiment 4:

[0047] Animal experiments

[0048] 40 SPF male C57BL / 6 mice, 8-10 weeks old, weighing 25±2g, were selected and purchased from Saiye (Suzhou) Biotechnology Co., Ltd. 30 mice were randomly selected to establish a model group according to the scheme proposed in "Establishment and Evaluation of Mouse Sepsis Model" (Jing Xizhong, Jia Huanhuan, Luo Ting, et al. Establishment and Evaluation of Mouse Sepsis Model [J]. Journal of Chinese Experimental Animals, 2016, 24 (2): 158-163.); the remaining 10 mice were used as blank control groups. The model group was randomly divided into 3 groups, each with 10 mice. One group was not treated and was the model control group; the other 2 groups (model groups 1 and 2) were each fed with the Chinese medicine composition in Example 1 of the present invention, twice a day, once in the morning and once in the evening, each time 5 and 10 mL respectively. Carotid artery blood was collected from mice in each group after 48h and 96h, respectively, to detect the expression levels of tumor necrosis factor α (TNF-α) and inflammatory factor IL-6, and the average values ​​were calculated; at the same time, the body weight of mice in each group was measured to evaluate the survival status of the mice. The results are shown in Table 1.

[0049] Table 1 Effects of different treatments on inflammatory factors and tumor necrosis factor

[0050]

[0051]

[0052] As can be seen from the above table, the expression levels of tumor necrosis factor α (TNF-α) and inflammatory factor IL-6 in the model control group were significantly increased compared with the blank control group, indicating that the mouse sepsis model was successfully modeled. Artificial observation shows that the mice in the model control group were depressed and their activity was significantly reduced compared with the blank control group. The expression levels of tumor necrosis factor α (TNF-α) and inflammatory factor IL-6 in model groups 1 and 2 after treatment with the Chinese medicine composition in Example 1 of the present invention were reduced, indicating that the Chinese medicine composition in Example 1 of the present invention can significantly reduce the body's inflammatory response and sepsis symptoms. Artificial observation shows that the mice in model groups 1 and 2 treated with the Chinese medicine composition in Example 1 of the present invention are significantly better in spirit and activity than the model control group, and their weight has recovered compared with the model control group mice, indicating that the Chinese medicine composition in Example 1 of the present invention can significantly improve the survival status of mice. In addition, it can be seen from the comparison between model groups 1 and 2 after treatment with the Chinese medicine composition in Example 1 of the present invention that the treatment effect of mice in the high-dose group is relatively high, and no adverse reactions have been found for the time being.

[0053] 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 principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating sepsis, characterized in that: The invention is prepared from the following Chinese medicinal raw materials by weight: 10-20 parts of lithospermum officinale, 10-20 parts of forsythia, 10-20 parts of salvia miltiorrhiza, 10-15 parts of astragalus, 10-15 parts of schisandra chinensis and 3-10 parts of liquorice.

2. The Chinese medicine composition for treating sepsis according to claim 1, characterized in that: The invention is prepared from the following Chinese medicinal raw materials by weight: 12-16 parts of lithospermum officinale, 12-16 parts of forsythia suspensa, 12-16 parts of salvia miltiorrhiza, 8-12 parts of astragalus, 8-12 parts of schisandra chinensis and 5-8 parts of liquorice.

3. The Chinese medicine composition for treating sepsis according to claim 2, characterized in that: The invention is prepared from the following Chinese medicinal raw materials by weight: 14 parts of Lithospermum officinale, 14 parts of Forsythia suspensa, 14 parts of Salvia miltiorrhiza, 10 parts of Astragalus membranaceus, 10 parts of Schisandra chinensis and 6 parts of Licorice.

4. A Chinese medicine preparation for treating sepsis, characterized in that: The invention comprises the Chinese medicine composition or extract thereof according to any one of claims 1 to 3, and pharmaceutically acceptable excipients.

5. The Chinese medicine preparation for treating sepsis according to claim 4, characterized in that: The extract is a water extract or an alcohol extract of the traditional Chinese medicine composition described herein.

6. The Chinese medicine preparation for treating sepsis according to claim 4, characterized in that: The pharmaceutically acceptable excipients are selected from one or more of pharmaceutically acceptable solvents, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, flavoring agents, preservatives, suspending agents, coating materials, integrities, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, thickeners, inclusion agents, humectants, flocculants and deflocculating agents, filter aids, release retardants, polymer skeleton materials and film-forming materials.

7. The Chinese medicine preparation for treating sepsis according to claim 4, characterized in that: The Chinese medicine preparation is selected from one of tablets, capsules, powders, pills, granules, oral liquids, syrups, decoctions, suppositories, gels, sprays or injections.

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