Refreshing and antidiarrheal composition

Abstract

The invention discloses a heat-clearing and antidiarrheal composition, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 13 to 17 parts of herba pteridis multifidae, 8 to 12 parts of herba euphorbiae humifusae, 8 to 12 parts of fructus psoraleae, 1 to 5 parts of rhizoma coptidis, 4 to 8 parts of roasted radix aucklandiae, 4 to 5 parts of baked ginger, 8 to 12 parts of parched white peony root, 8 to 12 parts of radix saposhnikoviae, 8 to 12 parts of rhizoma atractylodis, 8 to 12 parts of roasted rhizoma atractylodis macrocephalae, 9 to 11 parts of herba agrimoniae and 9 to 11 parts of herba cayratiae japonicae, the weight part ratio of the hairyvein agrimony to the cayratia japonica is 1: 1. The traditional Chinese medicine has the advantages that the traditional Chinese medicine has the effects of replenishing qi to invigorate the spleen, soothing the liver, regulating qi, relieving pain, clearing heat and eliminating dampness, and the effect on diarrhea-type irritable bowel syndrome is remarkably improved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a clearing and antidiarrhea composition. Background Art

[0002] The aforementioned Qinghua antidiarrhea composition is mainly used to treat spleen and stomach damp-heat type diarrhea irritable bowel syndrome. Irritable bowel syndrome is one of the common intestinal dysfunction diseases in clinical practice, which is mainly divided into diarrhea type, constipation type and mixed type. Among the above three types, diarrhea type irritable bowel syndrome (English abbreviation: IBS-D) is the most common type. Up to now, its pathogenesis has not been fully explained, but it can be basically determined that: gastrointestinal tract dysfunction, visceral hypersensitivity, psychological and social factors, autonomic dysfunction, mucosal immune activation and genetic susceptibility are the causes of individual disorders of varying degrees. From the perspective of Western medicine treatment, anticholinergic drugs (such as mebeverine hydrochloride, dicycline, cimetropium bromide, etc.), acebutolol hydrochloride, calcium channel blockers (such as nifedipine, verapamil, etc.), and opioid antidiarrheal drugs (such as loperamide, etc.) are usually used. Because Western medicine not only has certain side effects, but also has relatively large dependence and is prone to recurrence and cannot achieve the purpose of curing the root cause, the Chinese people prefer traditional Chinese medicine treatment.

[0003] In the published Chinese patent literature, technical information on Chinese herbal medicine compositions related to the treatment of diarrhea can be found, such as the "Chinese herbal medicine composition for the treatment of chronic diarrhea of ​​spleen and stomach deficiency and its preparation" recommended in CN106492095B, ​​whose formula is calculated by weight: 4-6 parts of costus root, 6-8 parts of nard, 4-6 parts of cardamom, 10-15 parts of yam, 6-8 parts of lentils, 3-5 parts of jujube, 2-4 parts of poria, and 2-4 parts of ginseng. , 1-3 parts of lotus seeds, 4-6 parts of licorice, 2-3 parts of cyperus, 2-3 parts of bergamot and 1-2 parts of perilla; for example, CN109718352A provides "a Chinese medicine composition for treating indigestion and watery diarrhea", which is composed of 10 parts of ginseng, 10 parts of yam, 10 parts of atractylodes, 10 parts of poria, 20 parts of coix seeds, 10 parts of lentils, 10 parts of lotus seeds, 10 parts of platycodon, 10 parts of amomum and 10 parts of licorice. Not limited to the above-mentioned patents, which do not have comprehensive efficacy for the three types of irritable bowel syndrome mentioned above by the applicant, namely diarrhea type, constipation type and mixed type, there is a need to improve the synergy of clearing heat, promoting dampness and detoxification, clearing heat and removing dampness, etc. The technical solution to be introduced below is produced under this background. Summary of the invention

[0004] The task of the present invention is to provide a clearing and antidiarrhea composition which helps to play the role of invigorating qi and strengthening spleen, soothing liver and regulating qi to relieve pain, clearing away heat and removing dampness, so as to significantly improve the effect on diarrhea-type irritable bowel syndrome.

[0005] The task of the present invention is accomplished in this way. A clearing and antidiarrheal composition, the raw materials of which include, by weight: 13-17 parts of pteris viridis, 8-12 parts of euphorbia pulex, 8-12 parts of psoralea corylifolia, 1-5 parts of coptis chinensis, 4-8 parts of stewed costusroot, 4-5 parts of roasted ginger, 8-12 parts of stir-fried white peony root, 8-12 parts of siler, 8-12 parts of atractylodes, 8-12 parts of stir-fried atractylodes, 9-11 parts of agrimony and 9-11 parts of blackberry, wherein the weight ratio of the euphorbia pulex, psoralea corylifolia, stir-fried white peony root, siler, atractylodes and stir-fried atractylodes is 1:1:1:1:1:1:1, and the weight ratio of the agrimony and blackberry is 1:1.

[0006] In a specific embodiment of the present invention, a clearing and antidiarrheal composition, the raw materials of which include by weight: 15 parts of pteris vicifolia, 12 parts of euphorbia pulex, 12 parts of psoralea corylifolia, 1 part of coptis chinensis, 4 parts of stewed costusroot, 5 parts of roasted ginger, 12 parts of stir-fried white peony root, 12 parts of siler, 12 parts of atractylodes, 12 parts of stir-fried atractylodes, 9 parts of agrimony and 9 parts of blackberry.

[0007] In another specific embodiment of the present invention, a clearing and antidiarrheal composition, the raw materials of which include by weight: 13 parts of phoenix tail grass, 8 parts of ground ivy, 8 parts of psoralea corylifolia, 3 parts of coptis chinensis, 6 parts of stewed costusroot, 4 parts of roasted ginger, 8 parts of stir-fried white peony root, 8 parts of siler, 8 parts of atractylodes, 8 parts of stir-fried white atractylodes, 10 parts of herb agrimony and 10 parts of blackberry.

[0008] In another specific embodiment of the present invention, a clearing and antidiarrheal composition, the raw materials of which include by weight: 17 parts of pteris vicifolia, 10 parts of euphorbia pulex, 10 parts of psoralea corylifolia, 5 parts of coptis chinensis, 8 parts of stewed costusroot, 4 parts of roasted ginger, 10 parts of stir-fried white peony root, 10 parts of siler, 10 parts of atractylodes, 10 parts of stir-fried atractylodes, 11 parts of herba agrimonii and 11 parts of raspberry.

[0009] In another specific embodiment of the present invention, a clearing and antidiarrheal composition, the raw materials of which include by weight: 16 parts of pteris vicifolia, 11 parts of euphorbia pulex, 11 parts of psoralea corylifolia, 4 parts of coptis chinensis, 7 parts of stewed costusroot, 4.5 parts of roasted ginger, 11 parts of stir-fried white peony root, 11 parts of siler, 11 parts of atractylodes, 11 parts of stir-fried atractylodes, 10.5 parts of agrimony and 10.5 parts of blackberry.

[0010] In another specific embodiment of the present invention, a clearing and antidiarrheal composition is provided, wherein the raw materials include, by weight: 14 parts of phoenix tail grass, 9 parts of ground ivy, 9 parts of psoralea corylifolia, 3.5 parts of coptis chinensis, 5 parts of stewed costusroot, 5 parts of roasted ginger, 9 parts of stir-fried white peony root, 9 parts of siler, 9 parts of atractylodes, 9 parts of stir-fried white atractylodes, 9.5 parts of agrimony and 9.5 parts of blackberry.

[0011] The technical effect of the technical scheme provided by the present invention is that the herb of agrimony, stir-fried atractylodes and atractylodes in the formula invigorate the spleen and dry dampness to consolidate the body, coptis root, phoenix tail grass and euphorbia pulex are the main ingredients, which have the effects of clearing away heat, removing dampness and detoxifying, stewed costus root has the effects of promoting qi and removing dampness, regulating qi and relieving pain, and cooperates with stir-fried atractylodes and atractylodes to invigorate the spleen and regulate qi, psoralea corylifolia and roasted ginger warm and tonify the spleen and kidney, and the bitter and cold products (coptis root, phoenix tail grass and euphorbia pulex) are used to injure the spleen and stomach, stir-fried white peony root and siler yin are used to soothe the liver and drive away wind, relieve acute abdominal pain, siler yin has the effects of dispelling wind and relieving exterior symptoms, overcoming dampness and relieving pain and stopping spasm, and black mulberry clears heat and removes dampness, detoxifies and clears swelling, and is conducive to removing rheumatism in the body. The whole prescription is matched, and has the effects of invigorating qi and invigorating the spleen, soothing the liver and regulating qi and relieving pain, clearing heat and removing dampness, and treating chronic diarrhea and obtaining good results. Preliminary clinical studies have shown that the Qinghua antidiarrheal composition improves abdominal pain and diarrhea-related symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D), with significant clinical efficacy of up to 93.3%, and can improve and reverse the high expression of inflammatory cytokines at the same time. DETAILED DESCRIPTION

[0012] Embodiment 1:

[0013] The raw materials include, by weight: 15 parts of phoenix tail grass, 12 parts of ground ivy, 12 parts of psoralea corylifolia, 1 part of coptis chinensis, 4 parts of stewed costusroot, 5 parts of roasted ginger, 12 parts of fried white peony root, 12 parts of siler, 12 parts of atractylodes, 12 parts of fried atractylodes, 9 parts of agrimony and 9 parts of blackberry.

[0014] Embodiment 2:

[0015] The raw materials include, by weight: 13 parts of phoenix tail grass, 8 parts of ground ivy, 8 parts of psoralea corylifolia, 3 parts of coptis chinensis, 6 parts of stewed costusroot, 4 parts of roasted ginger, 8 parts of fried white peony root, 8 parts of siler, 8 parts of atractylodes, 8 parts of fried atractylodes, 10 parts of agrimony and 10 parts of blackberry.

[0016] Embodiment 3:

[0017] 17 parts of Herba Pteris Coptidis, 10 parts of Herba Euphorbiae Ichthyophthirius, 10 parts of Psoralea Corylifoliae, 5 parts of Rhizoma Coptidis, 8 parts of Radix Aucklandiae, 4 parts of Rhizoma Zingiberis Preparata, 10 parts of Stir-fried White Peony Root, 10 parts of Saposhnikovia Divaricata, 10 parts of Atractylodes Lanceolata, 10 parts of Stir-fried Atractylodes Macrocephalae, 11 parts of Herba Agrimoniae and 11 parts of Rhizoma Cibotii.

[0018] Embodiment 4:

[0019] The raw materials include, by weight: 16 parts of phoenix tail grass, 11 parts of ground ivy, 11 parts of psoralea corylifolia, 4 parts of coptis chinensis, 7 parts of stewed costusroot, 4.5 parts of roasted ginger, 11 parts of fried white peony root, 11 parts of siler, 11 parts of atractylodes, 11 parts of fried atractylodes, 10.5 parts of agrimony and 10.5 parts of blackberry.

[0020] Embodiment 5:

[0021] The raw materials include, by weight: 14 parts of phoenix tail grass, 9 parts of ground ivy, 9 parts of psoralea corylifolia, 3.5 parts of coptis chinensis, 5 parts of stewed costusroot, 5 parts of roasted ginger, 9 parts of stir-fried white peony root, 9 parts of siler, 9 parts of atractylodes, 9 parts of stir-fried white atractylodes, 9.5 parts of agrimony and 9.5 parts of blackberry.

[0022] The control group was given 50 mg of Pinaverium Bromide Tablets (Registration No. I120160396), 3 times a day, 1 tablet each time, for a course of 7 days.

[0023] The Qinghua antidiarrhea composition obtained in Examples 1 to 5 was prepared into a decoction piece, one dose per day, decocted twice with water to obtain 200-220 ml of the juice, and taken twice a day with warm water in the morning and evening. The treatment was continued for one month. The subjects who took the Qinghua antidiarrhea composition of the present invention were referred to as the treatment group.

[0024] The therapeutic effects of the above treatment group and the control group are shown in the following table:

[0025] Comparison table of therapeutic effects between the treatment group and the control group

[0026]

[0027] Compared with the control group, *P<0.05

[0028] The control group included 60 cases, including 31 males and 29 females, aged 24-70 years old, with an average age of (44.18±2.06) years old, and the course of disease ranged from 8 months to 5.3 years, with an average of (3.14±0.17) years old. There was no significant difference in general data between the two groups (P>0.05), and they were comparable. The treatment group included 60 cases, including 29 males and 31 females, aged 21-65 years old, with an average age of (41.4±1.65) years old, and the course of disease ranged from 6 months to 5 years, with an average of (2.81±0.16) years.

[0029] The above observation indicators and methods for the treatment group and the control group are as follows: ① Comparison of the efficacy of the two groups. ② Comparison of the changes in the TCM syndrome scores before and after treatment between the two groups. Referring to the quantitative grading standard of spleen and stomach damp-heat syndrome in the "Consensus of Experts on TCM Diagnosis and Treatment of Irritable Bowel Syndrome (2017)", the main symptoms were recorded as 0, 2, 4, and 6 points according to the symptoms of no, mild, moderate, and severe; the secondary symptoms were recorded as 0, 1, 2, and 3 points according to the symptoms of no, mild, moderate, and severe. ③ The self-rating anxiety scale (SAS) and the self-rating depression scale (SDS) were used to evaluate the negative emotions of the two groups of patients before and after treatment. Both SAS and SDS have 20 test items, and each item is scored from 1 to 4 levels, 1 point: no occurrence, 2 points: less occurrence, 3 points: more occurrence, 4 points: most of the time or always appear, and 5 of the items are scored in reverse. When the total score of SAS is greater than 50 points, it indicates that the patient has anxiety, and when the total score of SDS is greater than 53 points, it indicates that the patient has depression symptoms. ④ 5 mL of fasting cubital venous blood was collected from the two groups of patients in the morning before and after treatment, and the supernatant was obtained after centrifugation and stored at -20°C. The levels of interleukin 1β (IL-1β), interleukin 6 (IL-6), and tumor necrosis factor α (TNF-α) were detected by enzyme-linked immunosorbent assay (ELISA). The kit was provided by Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. and the instructions of the kit were followed. ⑤ The expression of TLR4, MyD88, and NF-κB p65 related proteins of the TLR4 / MyD88 / NF-κB signaling pathway in the two groups before and after treatment was detected by ELISA. The kit was provided by Nanjing Jiancheng Bioengineering Research Institute Co., Ltd. and the instructions of the kit were followed.

[0030] Efficacy criteria: The efficacy was evaluated by the nimodipine method based on the total score of TCM syndrome. Clinical cure: clinical symptoms almost disappeared, and the total score of TCM syndrome decreased by ≥95%; marked effect: clinical symptoms were alleviated, and the total score of TCM syndrome decreased by 70%≤<95%; effective: clinical symptoms were alleviated, but the total score of TCM syndrome decreased by 30%≤<70%; ineffective: clinical symptoms did not improve or even worsened, and the total score of TCM syndrome decreased by <30%. The total effective was calculated by clinical cure + marked effect + effective.

[0031] Statistical methods: SPSS 22.0 statistical software was used for statistical analysis, and the measurement data were expressed as mean ± standard deviation. The t test was used to express the data, and the x test was used to compare the counting data rates. 2 P<0.05 was considered statistically significant.

[0032] The results can be confirmed from the above table that the therapeutic effect of the treatment group is significantly better than that of the control group.

[0033] The comparison of TCM syndrome scores of the treatment group and the control group before and after treatment is shown in the following table:

[0034] Comparison of TCM syndrome scores between the two groups before and after treatment.

[0035] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, △P<0.05.

[0036] As can be seen from the above table, after treatment, the scores of each TCM syndrome and the total score of the two groups were lower than those before treatment (P < 0.05), and the reduction in the treatment group was more obvious (P < 0.05).

[0037] The comparison of SAS scores and SDS scores before and after treatment between the treatment group and the control group is shown in the following table:

[0038] Comparison of SAS and SDS scores between the two groups before and after treatment.

[0039] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, △P<0.05.

[0040] As can be seen from the table above, the SAS scores and SDS scores of the two groups after treatment were lower than those before treatment (P < 0.05), and the reduction in the treatment group was more obvious (P < 0.05).

[0041] The comparison of serum IL-1β, IL-6 and TNF-α levels between the above treatment group and the control group before and after treatment is shown in the following table:

[0042] Comparison of serum IL-1β, IL-6 and TNF-α levels between the two groups before and after treatment (ng / L),

[0043] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, △P<0.05.

[0044] As can be seen from the table above, the levels of serum IL-1β, IL-6 and TNF-α in the two groups after treatment were lower than those before treatment (P < 0.05), and the decrease in the treatment group was more obvious (P < 0.05).

[0045] The comparison of serum TLR4, MyD88 and NF-κB p65 expression levels between the two groups before and after treatment is shown in the following table:

[0046] Comparison of serum TLR4, MyD88 and NF-κB p65 expression levels between the above treatment group and the control group before and after treatment (ng / L),

[0047] Compared with the group before treatment, *P<0.05; compared with the control group after treatment, △P<0.05.

[0048] As can be seen from the table above, the expression levels of TLR4, MyD88, and NF-κB p65 in the two groups after treatment were lower than those before treatment (P < 0.05), and the decrease in the treatment group was more obvious (P < 0.05).

[0049] In addition, the inventors of the present application also established an IBS-D rat model based on the classic senna leaf gavage + restraint method to evaluate the effects and possible mechanisms of the Qinghua Zhixie recipe. The results showed that the Qinghua Zhixie recipe can reverse the decrease in AWR threshold and the increase in Bristol score of D-IBS rats, and relieve intestinal inflammatory cell infiltration. The mechanism may be that it inhibits the levels of inflammatory factors interleukin 6 (IL-6), interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α) and interferon-γ (IFN-γ), thereby inhibiting the intestinal immune inflammatory response, alleviating visceral hypersensitivity, and thus improving diarrhea and abdominal pain.

[0050] In summary, the technical solution provided by the present invention makes up for the shortcomings of the existing technology, successfully completes the invention task, and faithfully realizes the technical effects stated by the applicant in the technical effect column above.

Claims

1. A composition for clearing and stopping diarrhea, characterized in that: The raw materials include, by weight, 13-17 parts of phoenix tail grass, 8-12 parts of euphorbia pulex, 8-12 parts of psoralea corylifolia, 1-5 parts of coptis chinensis, 4-8 parts of stewed costusroot, 4-5 parts of roasted ginger, 8-12 parts of stir-fried white peony root, 8-12 parts of siler, 8-12 parts of atractylodes, 8-12 parts of stir-fried atractylodes, 9-11 parts of agrimony and 9-11 parts of scutellaria baicalensis, wherein the weight ratio of the euphorbia pulex, psoralea corylifolia, stir-fried white peony root, siler, atractylodes and stir-fried atractylodes is 1:1:1:1:1:1:1, and the weight ratio of agrimony and scutellaria baicalensis is 1:

1.

2. A detoxifying and antidiarrheal composition according to claim 1, characterized in that: The raw materials include, by weight: 15 parts of phoenix tail grass, 12 parts of ground ivy, 12 parts of psoralea corylifolia, 1 part of coptis root, 4 parts of stewed costusroot, 5 parts of roasted ginger, 12 parts of stir-fried white peony root, 12 parts of siler, 12 parts of atractylodes, 12 parts of stir-fried white atractylodes, 9 parts of agrimony and 9 parts of blackberry.

3. A clearing and antidiarrhea composition according to claim 1, characterized in that: The raw materials include, by weight: 13 parts of phoenix tail grass, 8 parts of ground ivy, 8 parts of psoralea corylifolia, 3 parts of coptis chinensis, 6 parts of stewed costusroot, 4 parts of roasted ginger, 8 parts of stir-fried white peony root, 8 parts of siler, 8 parts of atractylodes, 8 parts of stir-fried white atractylodes, 10 parts of agrimony and 10 parts of blackberry.

4. The antidiarrheal composition according to claim 1, characterized in that: The raw materials include, by weight: 17 parts of phoenix tail grass, 10 parts of ground ivy, 10 parts of psoralea corylifolia, 5 parts of coptis chinensis, 8 parts of stewed costusroot, 4 parts of roasted ginger, 10 parts of stir-fried white peony root, 10 parts of siler, 10 parts of atractylodes, 10 parts of stir-fried white atractylodes, 11 parts of agrimony and 11 parts of blackberry.

5. The antidiarrheal composition according to claim 1, characterized in that: The raw materials include, by weight, 16 parts of phoenix tail grass, 11 parts of ground ivy, 11 parts of psoralea corylifolia, 4 parts of coptis chinensis, 7 parts of stewed costusroot, 4.5 parts of roasted ginger, 11 parts of stir-fried white peony root, 11 parts of siler, 11 parts of atractylodes, 11 parts of stir-fried white atractylodes, 10.5 parts of agrimony and 10.5 parts of blackberry.

6. The antidiarrheal composition according to claim 1, characterized in that: The raw materials include, by weight: 14 parts of phoenix tail grass, 9 parts of ground ivy, 9 parts of psoralea corylifolia, 3.5 parts of coptis root, 5 parts of stewed costusroot, 5 parts of roasted ginger, 9 parts of stir-fried white peony root, 9 parts of siler, 9 parts of atractylodes, 9 parts of stir-fried white atractylodes, 9.5 parts of agrimony and 9.5 parts of blackberry.

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