Traditional Chinese medicine preparation for treating sepsis and preparation method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine preparation for treating sepsis and a preparation method thereof. The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: 20 to 25 parts of camptotheca acuminate fruit, 15 to 20 parts of peach kernel, 10 to 15 parts of pericarpium trichosanthis, 12 to 15 parts of sedum sarmentosum, 10 to 15 parts of radix cynanchi atrati, 6 to 10 parts of codonopsis pilosula, 5 to 10 parts of semen armeniacae amarae, 6 to 10 parts of adenophora tetraphylla and 4 to 8 parts of liquorice. The traditional Chinese medicine preparation provided by the invention is reasonable in set prescription, monarch, minister, assistant and guide complement each other, and the camptotheca acuminate and peach kernel are used as monarch drugs in the prescription to play the effect of promoting blood circulation to remove blood stasis; the snakegourd peel, the sedum sarmentosum and the cynanchum atratum root are used as ministerial drugs and are matched with the monarch drugs, so that the effects of clearing away heat and toxic materials can be enhanced while the effects of activating blood and removing stasis are enhanced; radix codonopsis, adenophora tetraphylla and semen armeniacae amarae are used as assistants to tonify middle-Jiao and Qi, nourish blood and promote salivation, and licorice is used as a conductant drug to harmonize all the drugs, introduce the drugs into the meridians and eliminate pathogens The whole formula is reasonable in compatibility and has a good treatment effect on sepsis.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine preparation for treating sepsis and a preparation method thereof. BACKGROUND

[0002] Sepsis is a systemic inflammatory response syndrome caused by infection, and its induced infection range is wide, and there is no gold standard for diagnosis method, which is the main cause of critical illness and livestock death worldwide. The global annual prevalence is nearly 20 million, and the mortality rate is more than 25%. Researching the pathogenesis of sepsis and developing related therapeutic drugs have become the focus at present. In the pathogenesis of sepsis, the high load of antigen and the secretion level of proinflammatory cytokines (IL-6 and TNF-α, etc.) are increased, thereby causing the weakening of the innate and adaptive immune responses of the body, failing to produce effective anti-infection immune response, and eventually leading to immunoparalysis or even death.

[0003] At present, the treatment methods of sepsis mainly include anti-infection treatment, fluid resuscitation and symptomatic support treatment. However, the existing treatment methods have some obvious defects. First, in terms of anti-infection treatment, the antibacterial spectrum of antibiotics is limited, and the infection is not easy to control, resulting in unsatisfactory treatment effect. Secondly, the individual differences of sepsis patients are large, and a single treatment method is often difficult to meet the needs of all patients. Therefore, it is particularly important to pay attention to comprehensive treatment and combine multiple treatment methods to improve the treatment effect.

[0004] In recent years, traditional Chinese medicine treatment of sepsis has gradually attracted attention. Traditional Chinese medicine believes that the occurrence of sepsis is related to factors such as internal accumulation of toxic heat, toxin damaging collaterals, acute deficiency syndrome and abdominal qi obstruction. For these etiological factors, traditional Chinese medicine treatment methods such as clearing heat and resolving toxins, promoting blood circulation to remove blood stasis, supporting the healthy and tonifying the root and purgation can be adopted. For example, traditional Chinese medicine prescriptions such as Xianfang Huoming Drink, Buyang Huanwu Decoction, Bazhen Decoction and Dachengqi Decoction have certain curative effects in the treatment of sepsis. In addition, traditional Chinese medicine preparations such as Angong Niuhuang Pill and Jixuesuigeng Ointment are also widely used in the treatment of sepsis, which can improve the symptoms such as elevated body temperature and body weakness of patients, and reduce the harmfulness of the disease.

[0005] Although traditional Chinese medicine treatment of sepsis has achieved certain effect, the existing traditional Chinese medicine preparations still need to be further improved in terms of preparation process, drug components and treatment effect. Therefore, the present application provides a traditional Chinese medicine preparation for treating sepsis and a preparation method thereof. SUMMARY

[0006] The first object of the present application is to provide a traditional Chinese medicine preparation for treating sepsis, which comprises the following raw materials in parts by weight: Fructus camptothecae 10-25 parts, Semen persicae 5-20 parts, Pericarpium trichosanthis 25-35 parts, Sedum lineare 2-15 parts, Radix baiyuan 5-15 parts, Radix codonopsis 26-35 parts, Semen amygdali 5-15 parts, Radix notoginseng 2-10 parts, and Radix glycyrrhizae 25-40 parts.

[0007] Preferably, the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: Fructus camptothecae 18 parts, Semen persicae 14 parts, Pericarpium trichosanthis 30 parts, Sedum lineare 8 parts, Radix baiyuan 10 parts, Radix codonopsis 30 parts, Semen amygdali 12 parts, Radix notoginseng 8 parts, and Radix glycyrrhizae 32 parts.

[0008] The second object of the present application is to provide a preparation method of the traditional Chinese medicine preparation for treating sepsis as described in the first object, which comprises the following steps: taking each raw material according to the weight parts, crushing and sieving, then soaking in water, decocting twice, each time boiling with strong fire and then decocting with gentle fire, filtering after turning off the fire, combining the filtrates, adding pharmaceutically acceptable adjuvants, and preparing into corresponding dosage forms.

[0009] Preferably, the amount of water is 6-8 times the total mass of the raw materials.

[0010] Preferably, the soaking time is 1-2 h.

[0011] Preferably, the gentle decocting time is 0.5-1 h.

[0012] Preferably, the dosage form is an oral dosage form.

[0013] Preferably, the dosage form is a water decoction, a honeyed pill, a water-honeyed pill, a water pill, a granule, a capsule, a tablet, an oral liquid, or a syrup.

[0014] The pharmacological properties of the raw materials used in the present application are as follows: Fructus camptothecae: bitter and pungent in taste, cold in nature, and meridian entry into spleen, stomach, and liver, with the functions of clearing heat and resolving toxins, and resolving masses and relieving symptoms.

[0015] Semen persicae: bitter and sweet in taste, and neutral in nature, with meridian entry into heart, liver, and large intestine, and the functions of activating blood and resolving stasis, and moistening the intestines and promoting defecation.

[0016] Pericarpium trichosanthis: sweet in taste, cold in nature, and meridian entry into lung and stomach, with the functions of clearing heat and resolving phlegm, and promoting qi and relieving chest and resolving masses.

[0017] Sedum lineare: sweet, mild, slightly sour, and cool, with the functions of clearing heat and dampness, inhibiting bacteria, and relieving swelling.

[0018] Radix baiyuan: bitter and salty in taste, and cold in nature, with meridian entry into liver and stomach, and the functions of clearing heat and cooling blood, and detoxifying and treating sores.

[0019] Radix codonopsis: sweet in taste, and neutral in nature, with meridian entry into spleen and lung, and the functions of tonifying the center, benefiting qi, nourishing blood, and producing fluid, etc.

[0020] Radix Adenophorae: sweet, slightly cold, lung and stomach meridians, nourishing yin, clearing lung, benefiting stomach and producing saliva, reducing phlegm and tonifying qi.

[0021] Bitter apricot kernel: Bencao Gangmu records that it can kill insects, treat sores and scabies, reduce swelling, and treat various facial wind and pimple.

[0022] Glycyrrhiza: sweet, flat, spleen, stomach, heart and lung meridians. It can relieve acute and chronic conditions, moisten the lungs, clear heat and detoxify, and harmonize various drugs. It is used to treat shortness of breath, lack of energy, poor appetite, loose stools, coughing and wheezing, sore throat, etc. Benjing records that it can treat cold and heat evil of five zang organs and six fu organs, strengthen bones and muscles, increase strength, treat swollen wounds, and detoxify.

[0023] Compared with the prior art, the beneficial effects of the present application mainly lie in: The present application provides a traditional Chinese medicine preparation for treating sepsis. The prescription is reasonable, and the monarch, minister, and assistant drugs complement each other. Shihu fruit and peach kernel are used as monarch drugs, both of which have the function of promoting blood circulation and removing blood stasis. Gualoupi, shihozawa, and baishui root are used together as minister drugs, which can clear heat and dampness, inhibit bacteria and reduce swelling. When combined with the monarch drugs, they can enhance the effect of promoting blood circulation and removing blood stasis, and also have the function of clearing heat and detoxifying. Party, nansha and bitter apricot kernel are used as assistant drugs, which can tonify the center, benefit qi, nourish blood and produce saliva, and assist the monarch and minister drugs to enhance their efficacy. Glycyrrhiza is used as the servant drug, which can harmonize various drugs, guide drugs into channels, and expel evil together. The whole prescription is reasonably matched, and has good therapeutic effect on sepsis. DETAILED DESCRIPTION

[0024] The technical solutions of the present application are further explained and described below in combination with specific examples, comparative examples, and test examples.

[0025] In the following examples, comparative examples, and test examples, the raw materials and preparation methods used are conventional materials and techniques in the field unless otherwise specified. Example 1

[0026] A traditional Chinese medicine preparation for treating sepsis, comprising the following raw materials by weight: Shihu fruit 22 parts, peach kernel 18 parts, Gualoupi 12 parts, shihozawa 14 parts, baishui root 12 parts, party 8 parts, bitter apricot kernel 8 parts, nansha 8 parts, and glycyrrhiza 5 parts.

[0027] The present embodiment also provides a preparation method for the above-mentioned traditional Chinese medicine preparation for treating sepsis, comprising the following steps: The raw materials are weighed according to the above weight ratio, crushed and sieved, then soaked in water with 7 times the total mass of the raw materials for 1 hour. After boiling with a strong fire, it is transferred to a weak fire and boiled for 0.5 hours. After stopping the fire, the filtrate is filtered again, and the filtrate is added to the filtrate again with 7 times the total mass of the raw materials and boiled again with the same method. The filtrate is combined and concentrated to a relative density of 1.15. Cane sugar and sodium benzoate are added to the extract, and a conventional method is used to prepare an oral solution. Example 2

[0028] A traditional Chinese medicine preparation for treating sepsis, comprising the following raw materials in weight parts: 20 parts of fructus camptothecae, 15 parts of semen persicae, 10 parts of pericarpium trichosanthis, 12 parts of sedum lineare, 10 parts of radix baiyueren, 6 parts of radix codonopsitis, 5 parts of seminam amygdali amari, 6 parts of radix notoginseng, and 4 parts of radix glycyrrhizae.

[0029] The embodiment also provides a preparation method of the traditional Chinese medicine preparation for treating sepsis, comprising the following steps: The raw materials are weighed according to the above weight parts, crushed and sieved, then soaked in water with a water amount of 6 times the total mass of the raw materials for 1.5 hours, boiled with a strong fire, then boiled with a weak fire for 0.5 hours, filtered after the fire is turned off, the filter residue is soaked in water with a water amount of 6 times the total mass of the raw materials again, and boiled with the same method again, the filter liquids are combined, concentrated to an extract with a relative density of 1.02, the extract is dried and crushed, filled into capsules as capsule powder, and the capsule preparation is prepared. Example 3

[0030] A traditional Chinese medicine preparation for treating sepsis, comprising the following raw materials in weight parts: 25 parts of fructus camptothecae, 20 parts of semen persicae, 15 parts of pericarpium trichosanthis, 15 parts of sedum lineare, 15 parts of radix baiyueren, 10 parts of radix codonopsitis, 10 parts of seminam amygdali amari, 10 parts of radix notoginseng, and 8 parts of radix glycyrrhizae.

[0031] The embodiment also provides a preparation method of the traditional Chinese medicine preparation for treating sepsis, comprising the following steps: The raw materials are weighed according to the above weight parts, crushed and sieved, then soaked in water with a water amount of 8 times the total mass of the raw materials for 2 hours, boiled with a strong fire, then boiled with a weak fire for 1 hour, filtered after the fire is turned off, the filter residue is soaked in water with a water amount of 8 times the total mass of the raw materials again, and boiled with the same method again, the filter liquids are combined, concentrated to an extract with a relative density of 1.15, sucrose is added to the extract, and granules are prepared by a conventional method.

[0032] Comparative Example 1 Comparative Example 1 is basically the same as Example 1, except that the traditional Chinese medicine preparation comprises the following raw materials in weight parts: 22 parts of fructus camptothecae, 18 parts of semen persicae, 12 parts of pericarpium trichosanthis, 12 parts of radix baiyueren, 8 parts of radix codonopsitis, 8 parts of seminam amygdali amari, 8 parts of radix notoginseng, and 5 parts of radix glycyrrhizae.

[0033] Comparative Example 2 Comparative Example 2 is basically the same as Example 1, except that the traditional Chinese medicine preparation comprises the following raw materials in weight parts: 22 parts of fructus camptothecae, 18 parts of semen persicae, 12 parts of pericarpium trichosanthis, 14 parts of sedum lineare, 8 parts of radix codonopsitis, 8 parts of seminam amygdali amari, 8 parts of radix notoginseng, and 5 parts of radix glycyrrhizae.

[0034] Comparative Example 3 The comparative example 3 is basically the same as the example 1, except that the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: Fructus camptothecae 22 parts, Semen persicae 18 parts, Pericarpium trichosanthis 12 parts, Radix bupleuri 26 parts, Radix codonopsis 8 parts, Semen amygdali 8 parts, Radix notoginseng 8 parts, and Radix glycyrrhizae 5 parts.

[0035] Comparative example 4 The comparative example 4 is basically the same as the example 1, except that the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: Fructus camptothecae 22 parts, Semen persicae 18 parts, Pericarpium trichosanthis 12 parts, Herba sedum 26 parts, Radix codonopsis 8 parts, Semen amygdali 8 parts, Radix notoginseng 8 parts, and Radix glycyrrhizae 5 parts.

[0036] Comparative example 5 The comparative example 4 is basically the same as the example 1, except that the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: Fructus camptothecae 22 parts, Semen persicae 18 parts, Pericarpium trichosanthis 12 parts, Herba sedum 14 parts, Radix paeoniae 12 parts, Radix codonopsis 8 parts, Semen amygdali 8 parts, Radix notoginseng 8 parts, and Radix glycyrrhizae 5 parts.

[0037] Test example 1 (1) Test animals SPF level male BALB / c mice aged 6-8 weeks and weighing 18-20 g were selected, and all the mice were allowed to drink water and eat freely in an environment of 25±2℃ and humidity of 55-65% for one week before the experiment, and were raised in a light-dark cycle of 12h / 12. The mice were fasted for 12h but not watered before the experiment.

[0038] (2) Test grouping and administration scheme 180 mice were selected to establish a sepsis mouse model by cecal ligation and puncture, and another 20 mice were selected to be operated on in the same way as the model group, except that they were not subjected to cecal ligation and puncture, as a control group. The 180 CLP mouse models were randomly divided into 9 groups, namely, the example 1 high-dose group, the example 1 medium-dose group, the example 1 low-dose group, the example 2-3 groups, the comparative examples 1-5 groups, and the model group. After the operation, the mice in the example 1 high-dose group were administered with the traditional Chinese medicine preparation of the example 1 of the present application at a crude drug dosage of 12 mg / kg of body weight by gavage; the mice in the example 1 medium-dose group were administered with the traditional Chinese medicine preparation of the example 1 of the present application at a crude drug dosage of 6 mg / kg of body weight by gavage; the mice in the example 1 low-dose group were administered with the traditional Chinese medicine preparation of the example 1 of the present application at a crude drug dosage of 3 mg / kg of body weight by gavage, and the mice in the example 2-3 groups and the comparative examples 1-5 groups were administered with the traditional Chinese medicine preparations of the example 2-3 and the comparative examples 1-5 of the present application at a crude drug dosage of 12 mg / kg of body weight by gavage; the control group and the model group were both given an equal amount of normal saline, 1 time / 12 h, for a total of 5 days of treatment.

[0039] (3) Test method The survival rates of mice in each group were counted after 5 days of administration, and the results are shown in Table 1. The surviving mice in each group were anesthetized, and eyeball blood was taken to separate serum. The levels of inflammatory factors (TNF-α, TNF-β and IL-6) and sepsis classic markers (CRP and PCT) in the serum were determined using the corresponding ELISA kit, and the results are shown in Tables 2 and 3.

[0040] (4) Test results and analysis The survival rates of mice in each group are shown in Table 1. Table 1 Survival rates of mice in each group As can be seen from Table 1, after 5 days of treatment, all mice in the control group survived, and the survival rate of the model group was significantly lower than that of the control group. Compared with the model group, the survival rates of mice in Examples 1-3 were significantly improved. Compared with Example 1, the survival rates of mice in Comparative Examples 1-5 decreased. The above results show that the traditional Chinese medicine preparation prepared in Examples 1-3 can significantly improve the survival rate of sepsis mice.

[0041] The levels of inflammatory factors (TNF-α and IL-6) and sepsis classic markers (CRP and PCT) in the serum of mice in each group are shown in Tables 2 and 3. Table 2 Contents of TNF-α and IL-6 in the serum of mice in each group Table 3 Contents of CRP and PCT in the serum of mice in each group As can be seen from Tables 2 and 3, compared with the control group, the levels of TNF-α, IL-6, CRP and PCT in the serum of mice in the model group were significantly increased. Compared with the model group, the levels of two inflammatory factors and two classic markers in the serum of mice in Examples 1-3 were significantly reduced. The prescription composition of the traditional Chinese medicine preparation in Comparative Examples 1-5 was adjusted. Comparative Example 1 omitted one kind of vertical basin grass in the ministerial medicine, Comparative Example 2 omitted one kind of white willow root in the ministerial medicine, Comparative Example 3 omitted the vertical basin grass while adjusting the amount of white willow root, Comparative Example 4 omitted the white willow root while adjusting the amount of vertical basin grass, and Comparative Example 5 replaced the white willow root in the ministerial medicine with the same Danpi with heat-clearing and blood-cooling. The results showed that the levels of TNF-α, IL-6, CRP and PCT in the serum of mice in Comparative Examples 1-5 were lower than those in Example 1, indicating that the compatibility of each raw material in the prescription has a synergistic effect, especially the synergistic effect of vertical basin grass and white willow root in the ministerial medicine, which can reduce the expression of inflammatory factors and classic markers in the serum of mice, and further improve the survival rate of mice.

[0042] The above merely illustrates the preferred embodiments of the present application, and is not limited to the above examples. Any modification, improvement, etc. made by those skilled in the art under the principle of the present application shall be considered within the protection scope of the present application.

Claims

1. A traditional Chinese medicine preparation for treating sepsis, characterized in that, The raw materials include the following components in parts by weight: Fructus camptothecae 20-25 parts, Semen persicae 15-20 parts, Pericarpium trichosanthis 10-15 parts, Sedum lineare 12-15 parts, Radix baeckiae 10-15 parts, Radix codonopsis 6-10 parts, Semen amygdali 5-10 parts, Radix notoginseng 6-10 parts, and Radix glycyrrhizae 4-8 parts.

2. The traditional Chinese medicine preparation for treating sepsis according to claim 1, characterized in that, The raw materials include the following components in parts by weight: Fructus camptothecae 22 parts, Semen persicae 18 parts, Pericarpium trichosanthis 12 parts, Sedum lineare 14 parts, Radix baeckiae 12 parts, Radix codonopsis 8 parts, Semen amygdali 8 parts, Radix notoginseng 8 parts, and Radix glycyrrhizae 5 parts.

3. A method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 1 or 2, characterized in that, The raw materials are weighed according to the weight parts, and after being ground and sieved, they are soaked in water, decocted twice, each time after being boiled with a strong fire, the fire is turned to a weak fire for decoction, and after the fire is turned off, the filtrate is collected, pharmaceutically acceptable adjuvants are added, and the corresponding dosage forms are prepared.

4. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The amount of water is 6-8 times the total mass of the raw materials.

5. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The soaking time is 1-2 h.

6. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The time for decoction with a weak fire is 0.5-1 h.

7. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The dosage form is an oral dosage form.

8. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The dosage form is a water decoction, a honeyed pill, a water-honeyed pill, a water pill, a granule, a capsule, a tablet, an oral liquid, or a syrup.

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