A traditional Chinese medicine preparation for treating sepsis and a preparation method thereof
By rationally combining Chinese herbal ingredients such as Camptotheca acuminata fruit, this traditional Chinese medicine preparation has solved the problem of poor efficacy of existing treatments for sepsis, improved the survival rate of sepsis patients, reduced the level of inflammatory factors in serum, and achieved better treatment results.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- DONGZHIMEN HOSPITAL OF BEIJING UNIV OF CHINESE MEDICINE
- Filing Date
- 2025-11-21
- Publication Date
- 2026-06-26
AI Technical Summary
Existing treatments for sepsis suffer from limitations such as a limited spectrum of antibiotics, unsatisfactory therapeutic effects, and the inability of a single treatment method to meet the needs of patients with significant individual differences. Traditional Chinese medicine preparations also have shortcomings in terms of preparation process and efficacy, which have not yet been effectively addressed by current technologies.
This invention provides a traditional Chinese medicine preparation composed of Camptotheca acuminata fruit, peach kernel, Trichosanthes kirilowii peel, Sedum sarmentosum, Cynanchum paniculatum root, Codonopsis pilosula, Adenophora stricta, bitter almond, and licorice. Through rational formulation, the principal, assistant, adjuvant, and guide herbs complement each other to achieve the effects of promoting blood circulation, removing blood stasis, clearing heat and detoxifying, and tonifying the middle and replenishing qi. It is prepared into oral dosage forms such as decoction, honey pills, water pills, granules, and capsules for the treatment of sepsis.
It significantly improved the survival rate of sepsis patients, reduced the levels of inflammatory factors and classic sepsis markers in serum, and enhanced the therapeutic effect.
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Abstract
Description
Technical Field
[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine preparation for treating sepsis and its preparation method. Background Technology
[0002] Sepsis is a systemic inflammatory response syndrome caused by infection. It can trigger a wide range of infections, and there is no gold standard for diagnosis. It is a leading cause of critical illness and livestock mortality worldwide, affecting nearly 20 million people annually with a mortality rate exceeding 25%. Researching the pathogenesis of sepsis and developing related treatments has become a key focus. During the pathogenesis of sepsis, elevated levels of high-burden antigens and pro-inflammatory cytokines (such as IL-6 and TNF-α) weaken the body's innate and adaptive immune responses, preventing the production of an effective anti-infective immune response and ultimately leading to immune paralysis and even death.
[0003] Currently, the main treatments for sepsis include anti-infective therapy, fluid resuscitation, and symptomatic supportive care. However, existing treatment methods have some significant limitations. First, regarding anti-infective therapy, antibiotics have a limited antibacterial spectrum, making infection difficult to control and resulting in unsatisfactory treatment outcomes. Second, sepsis patients exhibit significant individual differences, and a single treatment method often cannot meet the needs of all patients. Therefore, emphasizing comprehensive treatment and combining multiple treatment approaches to improve therapeutic efficacy is particularly important.
[0004] In recent years, traditional Chinese medicine (TCM) treatment for sepsis has gradually gained attention. TCM believes that sepsis is related to factors such as internal heat and toxicity, damage to the blood vessels, acute deficiency syndromes, and abdominal obstruction. Targeting these causes, TCM treatments include clearing heat and detoxifying, promoting blood circulation and removing blood stasis, strengthening the body's resistance, and purging the abdomen. For example, TCM formulas such as Xianfang Huoming Yin, Buyang Huanwu Tang, Bazhen Tang, and Da Chengqi Tang have shown some efficacy in treating sepsis. In addition, TCM preparations such as Angong Niuhuang Wan and Centella asiatica cream ointment are also widely used in the treatment of sepsis, improving symptoms such as fever and weakness, and reducing the severity of the disease.
[0005] Although traditional Chinese medicine (TCM) has achieved certain results in treating sepsis, existing TCM preparations still need further improvement in terms of preparation technology, drug components, and therapeutic effects. Therefore, this application provides a TCM preparation for treating sepsis and its preparation method. Summary of the Invention
[0006] The primary objective of this invention is to provide a traditional Chinese medicine preparation for treating sepsis, comprising the following raw materials in parts by weight: 10-25 parts of Camptotheca acuminata fruit, 5-20 parts of peach kernel, 25-35 parts of Trichosanthes kirilowii peel, 2-15 parts of Sedum sarmentosum, 5-15 parts of Cynanchum paniculatum root, 26-35 parts of Codonopsis pilosula, 5-15 parts of bitter almond, 2-10 parts of Adenophora stricta, and 25-40 parts of licorice.
[0007] Preferably, the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 18 parts of Camptotheca acuminata fruit, 14 parts of peach kernel, 30 parts of Trichosanthes kirilowii peel, 8 parts of Sedum sarmentosum, 10 parts of Cynanchum paniculatum root, 30 parts of Codonopsis pilosula, 12 parts of bitter almond, 8 parts of Adenophora stricta, and 32 parts of licorice.
[0008] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine preparation for treating sepsis as described in the first objective. The raw materials are weighed according to the specified weight proportions, pulverized and sieved, then soaked in water, and decocted twice. Each time, after boiling over high heat, the decoction is simmered over low heat. After turning off the heat, the mixture is filtered, the filtrates are combined, and pharmaceutically acceptable excipients are added to prepare the corresponding dosage form.
[0009] Preferably, the amount of water used is 6-8 times the total mass of the raw material.
[0010] Preferably, the soaking time is 1-2 hours.
[0011] Preferably, the simmering time is 0.5-1 h.
[0012] Preferably, the dosage form is an oral dosage form.
[0013] Preferably, the dosage form is a decoction, honey pills, water-honey pills, water pills, granules, capsules, tablets, oral liquids, or syrups.
[0014] The pharmacological and pharmacodynamic analyses of the active pharmaceutical ingredient used in this invention are as follows:
[0015] Camptotheca acuminata fruit: bitter and pungent in taste, cold in nature, enters the spleen, stomach and liver meridians, and has the functions of clearing heat and detoxifying, dispersing nodules and eliminating masses.
[0016] Peach kernels: They taste bitter and sweet, and are neutral in nature. They enter the heart, liver, and large intestine meridians and have the functions of promoting blood circulation, removing blood stasis, moistening the intestines, and relieving constipation.
[0017] Trichosanthes peel: sweet in taste, cold in nature, enters the lung and stomach meridians, clears away heat and phlegm, promotes qi circulation, relieves chest congestion and dissipates nodules.
[0018] Sedum sarmentosum: It is sweet, bland, slightly sour, and cool in nature, and has the effects of clearing heat and dampness, inhibiting bacteria and reducing swelling.
[0019] Baiwei root: It tastes bitter, salty, and cold. It enters the liver and stomach meridians and has the functions of clearing heat, cooling blood, detoxifying, and healing sores.
[0020] Codonopsis pilosula: It has a sweet taste and a neutral nature. According to the Chinese Pharmacopoeia, it enters the spleen and lung meridians and has the functions of tonifying the middle energizer, replenishing qi, nourishing blood and promoting body fluid production.
[0021] Nan Sha Shen: It has a sweet taste and slightly cold nature. It enters the lung and stomach meridians and has the functions of nourishing yin and clearing the lungs, benefiting the stomach and promoting body fluids, resolving phlegm and benefiting qi.
[0022] Bitter almonds: The Compendium of Materia Medica records that they kill insects, treat various sores and scabies, reduce swelling, and remove wind-related rashes and blisters from the head and face.
[0023] Licorice: Sweet in taste, neutral in nature, and enters the spleen, stomach, heart, and lung meridians. It harmonizes the middle jiao (digestive system), relieves spasms, moistens the lungs, clears heat and detoxifies, and harmonizes the effects of other herbs. It is primarily used to treat shortness of breath, fatigue, poor appetite, loose stools, cough, asthma, and sore throat. The *Shennong Bencao Jing* records that it treats cold and heat pathogens in the five internal organs and six bowels, strengthens tendons and bones, promotes muscle growth, increases strength, treats wounds and swelling, and detoxifies.
[0024] Compared with the prior art, the main advantages of the present invention are as follows:
[0025] This invention provides a traditional Chinese medicine preparation for sepsis. The prescription is rationally formulated, with the principal, assistant, and adjuvant herbs working synergistically. The principal herbs are Camptotheca acuminata fruit and Prunus persica kernel, which together promote blood circulation and remove blood stasis. The assistant herbs are Trichosanthes kirilowii peel, Sedum sarmentosum, and Cynanchum atratum root, which together clear heat, promote diuresis, inhibit bacteria, and reduce swelling. Combined with the principal herbs, they enhance the effects of promoting blood circulation and removing blood stasis while also clearing heat and detoxifying. The adjuvant herbs are Codonopsis pilosula, Adenophora stricta, and Prunus armeniaca, which tonify the middle energizer, replenish qi, nourish blood, and generate fluids, assisting the principal and assistant herbs and enhancing their efficacy. The adjuvant herb is Glycyrrhiza uralensis, which harmonizes the other herbs, guides them to the appropriate meridians, and works together to expel pathogens. The entire formula is rationally formulated and has a good therapeutic effect on sepsis. Detailed Implementation
[0026] The technical solution of the present invention will be further explained below with reference to specific embodiments, comparative examples, and test examples.
[0027] Unless otherwise specified, the raw materials and preparation methods used in the following examples, comparative examples, and experimental cases are all conventional materials and techniques in the art. Example 1
[0028] A traditional Chinese medicine preparation for treating sepsis comprises the following raw materials in parts by weight: 22 parts of Camptotheca acuminata fruit, 18 parts of peach kernel, 12 parts of Trichosanthes kirilowii peel, 14 parts of Sedum sarmentosum, 12 parts of Cynanchum paniculatum root, 8 parts of Codonopsis pilosula, 8 parts of bitter almond, 8 parts of Adenophora stricta, and 5 parts of licorice.
[0029] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating sepsis, including the following steps:
[0030] Weigh each raw material according to the above-mentioned weight proportions, crush and sieve, add 7 times the total weight of the raw materials in water and soak for 1 hour, bring to a boil over high heat and then simmer over low heat for 0.5 hours, turn off the heat and filter, add 7 times the total weight of the raw materials in water to the residue and simmer again in the same way, combine the filtrates and concentrate to an extract with a relative density of 1.15, add sucrose and sodium benzoate to the extract and prepare an oral liquid using conventional methods. Example 2
[0031] A traditional Chinese medicine preparation for treating sepsis includes the following raw materials in parts by weight: 20 parts of Camptotheca acuminata fruit, 15 parts of peach kernel, 10 parts of Trichosanthes kirilowii peel, 12 parts of Sedum sarmentosum, 10 parts of Cynanchum paniculatum root, 6 parts of Codonopsis pilosula, 5 parts of bitter almond, 6 parts of Adenophora stricta, and 4 parts of licorice.
[0032] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating sepsis, including the following steps:
[0033] Weigh each raw material according to the above-mentioned weight proportions, crush and sieve, add 6 times the total weight of the raw materials in water and soak for 1.5 hours. Bring to a boil over high heat, then simmer over low heat for 0.5 hours. After turning off the heat, filter. Add 6 times the total weight of the raw materials in water to the residue and simmer again using the same method. Combine the filtrates and concentrate to an extract with a relative density of 1.02. Dry the extract and crush it to fill the capsules with the powder to obtain the capsule preparation. Example 3
[0034] A traditional Chinese medicine preparation for treating sepsis comprises the following raw materials in parts by weight: 25 parts of Camptotheca acuminata fruit, 20 parts of peach kernel, 15 parts of Trichosanthes kirilowii peel, 15 parts of Sedum sarmentosum, 15 parts of Cynanchum paniculatum root, 10 parts of Codonopsis pilosula, 10 parts of bitter almond, 10 parts of Adenophora stricta, and 8 parts of licorice.
[0035] This embodiment also provides a method for preparing the above-mentioned traditional Chinese medicine preparation for treating sepsis, including the following steps:
[0036] Weigh each raw material according to the above-mentioned weight proportions, crush and sieve, add 8 times the total weight of the raw materials in water and soak for 2 hours, bring to a boil over high heat and then simmer over low heat for 1 hour, turn off the heat and filter, add 8 times the total weight of the raw materials in water to the residue and simmer again in the same way, combine the filtrates and concentrate to an extract with a relative density of 1.15, add sucrose to the extract and make granules using conventional methods.
[0037] Comparative Example 1
[0038] Comparative Example 1 is basically the same as Example 1, except that the traditional Chinese medicine preparation includes the following raw materials in parts by weight: 22 parts of Camptotheca acuminata fruit, 18 parts of peach kernel, 12 parts of Trichosanthes kirilowii peel, 12 parts of Cynanchum paniculatum root, 8 parts of Codonopsis pilosula, 8 parts of bitter almond, 8 parts of Adenophora stricta, and 5 parts of licorice.
[0039] Comparative Example 2
[0040] Comparative Example 2 is basically the same as Example 1, except that the traditional Chinese medicine preparation includes the following raw materials in parts by weight: 22 parts of Camptotheca acuminata fruit, 18 parts of peach kernel, 12 parts of Trichosanthes kirilowii peel, 14 parts of Sedum sarmentosum, 8 parts of Codonopsis pilosula, 8 parts of bitter almond, 8 parts of Adenophora stricta, and 5 parts of licorice.
[0041] Comparative Example 3
[0042] Comparative Example 3 is basically the same as Example 1, except that the traditional Chinese medicine preparation includes the following raw materials in parts by weight: 22 parts of Camptotheca acuminata fruit, 18 parts of peach kernel, 12 parts of Trichosanthes kirilowii peel, 26 parts of Cynanchum paniculatum root, 8 parts of Codonopsis pilosula, 8 parts of bitter almond, 8 parts of Adenophora stricta, and 5 parts of licorice.
[0043] Comparative Example 4
[0044] Comparative Example 4 is basically the same as Example 1, except that the traditional Chinese medicine preparation includes the following raw materials in parts by weight: 22 parts of Camptotheca acuminata fruit, 18 parts of peach kernel, 12 parts of Trichosanthes kirilowii peel, 26 parts of Sedum sarmentosum, 8 parts of Codonopsis pilosula, 8 parts of bitter almond, 8 parts of Adenophora stricta, and 5 parts of licorice.
[0045] Comparative Example 5
[0046] Comparative Example 4 is basically the same as Example 1, except that the traditional Chinese medicine preparation includes the following raw materials in parts by weight: 22 parts of Camptotheca acuminata fruit, 18 parts of peach kernel, 12 parts of Trichosanthes kirilowii peel, 14 parts of Sedum sarmentosum, 12 parts of Paeonia suffruticosa bark, 8 parts of Codonopsis pilosula, 8 parts of bitter almond, 8 parts of Adenophora stricta, and 5 parts of licorice.
[0047] Experimental Example 1
[0048] (1) Experimental animals
[0049] SPF-grade male BALB / c mice weighing 18-20 g at 6-8 weeks of age were selected. Before the experiment, all mice were allowed free access to water and food at 25±2℃ and 55-65% humidity, with a 12h / 12h light-dark cycle for one week. They were fasted for 12 hours before the experiment but allowed free access to water.
[0050] (2) Trial grouping and dosing regimen
[0051] A sepsis mouse model was established using cecal ligation and perforation in 180 mice. Another 20 mice were selected as the control group, but without cecal ligation and perforation, and operated identically to the model group. The 180 CLP mouse models were then randomly divided into 9 groups: the high-dose group of Example 1, the medium-dose group of Example 1, the low-dose group of Example 1, the groups of Examples 2-3, the comparative examples 1-5, and the model group. Post-surgery, mice in the high-dose group of Example 1 were administered the traditional Chinese medicine preparation of Example 1 by gavage at a concentration of 12 mg / kg body weight; mice in the medium-dose group of Example 1 were administered the traditional Chinese medicine preparation of Example 1 by gavage at a concentration of 6 mg / kg body weight; mice in the low-dose group of Example 1 were administered the traditional Chinese medicine preparation of Example 1 by gavage at a concentration of 3 mg / kg body weight; mice in the groups of Examples 2-3 and the comparative examples 1-5 were administered the traditional Chinese medicine preparations of Examples 2-3 and 1-5 by gavage at a concentration of 12 mg / kg body weight; the control group and the model group were given an equal volume of physiological saline once every 12 hours for a total of 5 days.
[0052] (3) Test methods
[0053] Five days after drug administration, the survival rate of mice in each group was recorded, and the results are shown in Table 1. After anesthetizing the surviving mice in each group, blood was collected by enucleation, and serum was separated. The levels of inflammatory factors (TNF-α, TNF-β, and IL-6) and classic biomarkers of sepsis (CRP and PCT) in the serum were measured using the corresponding ELISA kits, and the results are shown in Tables 2 and 3.
[0054] (4) Experimental results and analysis
[0055] The survival rates of mice in each group are shown in Table 1:
[0056] Table 1. Survival rate of mice in each group
[0057]
[0058] As shown in Table 1, after 5 days of treatment, all mice in the control group survived, while the survival rate of the model group was significantly lower than that of the control group. Compared with the model group, the survival rate of mice in Examples 1-3 was significantly improved. Compared with Example 1, the survival rate of mice in Comparative Examples 1-5 decreased. These results indicate that the traditional Chinese medicine preparations prepared in Examples 1-3 of this invention can significantly improve the survival rate of septic mice.
[0059] The levels of inflammatory factors (TNF-α and IL-6) and classic biomarkers of sepsis (CRP and PCT) in the serum of mice in each group are shown in Tables 2 and 3:
[0060] Table 2. Serum TNF-α and IL-6 levels in each group of mice
[0061]
[0062] Table 3. CRP and PCT levels in the serum of mice in each group
[0063]
[0064] As shown in Tables 2 and 3, compared with the control group, the serum levels of TNF-α, IL-6, CRP, and PCT in the model group mice were significantly increased; compared with the model group, the serum levels of two inflammatory factors and two classical biomarkers in the groups of Examples 1-3 mice were significantly decreased. The prescription composition of the traditional Chinese medicine preparations in Comparative Examples 1-5 was adjusted. Comparative Example 1 omitted one of the auxiliary herbs, *Sedum sarmentosum*; Comparative Example 2 omitted one of the auxiliary herbs, *Cynanchum paniculatum*; Comparative Example 3 omitted *Sedum sarmentosum* and adjusted the dosage of *Cynanchum paniculatum*; Comparative Example 4 omitted *Cynanchum paniculatum* and adjusted the dosage of *Sedum sarmentosum*; and Comparative Example 5 replaced *Cynanchum paniculatum* in the auxiliary herbs with *Paeonia suffruticosa*, which also has heat-clearing and blood-cooling properties. The results showed that the serum levels of TNF-α, IL-6, CRP, and PCT in Comparative Examples 1-5 mice were all lower than those in the Example 1 group, indicating that the ingredients in the prescription had a synergistic effect, especially the synergistic effect of *Sedum sarmentosum* and *Cynanchum paniculatum* in the auxiliary herbs, which could reduce the expression of inflammatory factors and classical biomarkers in mouse serum, thereby improving the survival rate of mice.
[0065] The above are merely preferred embodiments of the present invention and are not limited to the examples described above. Those skilled in the art will recognize that various modifications and variations can be made based on the principles of the present invention. Any modifications or improvements made should be considered within the scope of protection of the present invention.
Claims
1. A traditional Chinese medicine preparation for treating sepsis, characterized in that, It is composed of the following ingredients in parts by weight: 20-25 parts of Camptotheca acuminata fruit, 15-20 parts of peach kernel, 10-15 parts of Trichosanthes kirilowii peel, 12-15 parts of Sedum sarmentosum, 10-15 parts of Cynanchum paniculatum root, 6-10 parts of Codonopsis pilosula, 5-10 parts of bitter almond, 6-10 parts of Adenophora stricta, and 4-8 parts of licorice.
2. The traditional Chinese medicine preparation for treating sepsis according to claim 1, characterized in that, It is composed of the following ingredients in parts by weight: 22 parts Camptotheca acuminata fruit, 18 parts peach kernel, 12 parts Trichosanthes kirilowii peel, 14 parts Sedum sarmentosum, 12 parts Cynanchum paniculatum root, 8 parts Codonopsis pilosula, 8 parts bitter almond, 8 parts Adenophora stricta, and 5 parts licorice.
3. A method for preparing a traditional Chinese medicine preparation for treating sepsis as described in claim 1 or 2, characterized in that, Weigh each raw material according to the stated weight proportions, crush and sieve, soak in water, decoct twice, each time boiling over high heat and then simmering over low heat, filter after turning off the heat, combine the filtrates, add pharmaceutically acceptable excipients, and prepare the corresponding dosage form.
4. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The amount of water used is 6-8 times the total mass of the raw drug.
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 hours.
6. The method for preparing the traditional Chinese medicine preparation for treating sepsis according to claim 3, characterized in that, The simmering time 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 forms are decoctions, honey pills, water-honey pills, water pills, granules, capsules, tablets, oral liquids, or syrups.