Traditional Chinese medicine composition for treating ulcerative colitis and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating ulcerative colitis and a preparation method, and belongs to the field of traditional Chinese medicine treatment. The traditional Chinese medicine composition comprises 60-80 parts of clove, 60-80 parts of kaki calyx, 20-40 parts of ginseng and 80-100 parts of ginger. The preparation method comprises the following steps: decocting the raw materials twice, and combining filtrates. The traditional Chinese medicine composition is derived from traditional Chinese medicine classical famous prescription clove and kaki calyx powder, can effectively treat ulcerative colitis, can help patients to recover body weight, relieve hematochezia and diarrhea symptoms, increase colon length, reduce spleen index and the like, has a curative effect superior to that of part of existing medicines, has the advantages of stable curative effect, low recurrence rate, few adverse reactions, low cost and the like, and is worthy of popularization and application. The application prospect is wide.

Description

Technical Field

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

[0002] Ulcerative colitis (UC) is one of the main subtypes of inflammatory bowel disease (IBD). It is a lifelong, chronic, relapsing inflammatory bowel disease characterized by diffuse inflammatory damage to the colonic mucosa. Clinical manifestations include abdominal pain, diarrhea, mucus, pus, and blood in the stool, which seriously affect the health of patients.

[0003] The cause of UC is still unclear. Current treatments mainly rely on aminosalicylic acid, glucocorticoids, and biological agents. However, these treatments have limitations, such as large individual differences in efficacy, and long-term use can easily lead to infection and metabolic disorders. In addition, the disease course is prolonged, and the complications and disability rates are high. Safe and effective alternative therapies are urgently needed.

[0004] In Traditional Chinese Medicine (TCM), UC is classified as "intestinal diarrhea" (diarrhea). Its core pathogenesis is "spleen deficiency leading to dysfunctional function, a mixture of cold and heat, and qi stagnation and dampness." Spleen deficiency leads to internal dampness and qi stagnation, which in turn triggers intestinal pathology. Clove and Persimmon Calyx Powder (DXSDS), a classic Chinese prescription from the Zheng Yin Mai Zhi (Syndrome, Causes, and Pulse Treatments), consists of cloves, persimmon calyx, ginseng, and ginger. It boasts the effects of "warming the middle, relieving adverse effects, and invigorating qi and harmonizing the stomach." Its combination closely aligns with UC's underlying pathogenesis of spleen deficiency and dampness and qi stagnation: ginseng invigorates qi and strengthens the spleen, replenishing the underlying spleen deficiency; cloves and ginger warm and neutralize dampness, aiding the spleen and stomach in digestion; persimmon calyx and cloves regulate qi and relieve intestinal congestion, addressing the connection between the spleen, stomach, and large intestine, providing a targeted treatment for UC. Summary of the Invention

[0005] In order to solve the above technical problems, the present invention proposes a Chinese medicine composition for treating ulcerative colitis and a preparation method, so as to solve the problems of large individual differences in efficacy of existing drugs for treating ulcerative colitis, infection and metabolic disorders caused by long-term use.

[0006] The traditional Chinese medicine composition for treating ulcerative colitis of the present invention is derived from the classic prescription Clove Persimmon Calyx Powder and comprises 60-80 parts of cloves, 60-80 parts of persimmon calyx, 20-40 parts of ginseng and 80-100 parts of ginger.

[0007] Preferably, the traditional Chinese medicine composition comprises 60 parts of cloves, 60 parts of persimmon calyx, 30 parts of ginseng and 90 parts of ginger.

[0008] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition, comprising the following steps:

[0009] Cloves, persimmon calyx, ginseng, and ginger are decocted with water, and a filtrate is collected to obtain a traditional Chinese medicine composition. The decocting comprises: mixing the above raw materials with water and performing a first decoction to obtain a first filter residue and a first filtrate; mixing the first filter residue with water and performing a second decoction to obtain a second filter residue and a second filtrate; and combining the first filtrate and the second filtrate to obtain the traditional Chinese medicine composition.

[0010] Preferably, in the first decoction, the mass ratio of all raw materials to water is 1:10; and the decoction time is 0.9-1.1 h.

[0011] Preferably, in the second decoction, the mass ratio of the first filter residue to water is 1:10; and the second decoction time is 0.9-1.1 h.

[0012] The beneficial effects of the present invention are:

[0013] Compared to existing technologies, the Chinese medicine composition provided by the present invention is based on Traditional Chinese Medicine theory and utilizes cloves, persimmon calyx, ginseng, and ginger in combination. Together, they achieve the effects of warming the middle and relieving adverse reactions, invigorating qi and soothing the stomach, effectively treating ulcerative colitis. Experimental validation has shown that this Chinese medicine composition can help ulcerative colitis model mice regain weight, alleviate symptoms of bloody stools and diarrhea, increase colon length, and reduce spleen index, among other benefits. Furthermore, it outperforms the positive-acting drug cyclosporine in several aspects. Furthermore, Traditional Chinese Medicine treatment offers advantages such as stable efficacy, low recurrence rate, low incidence of adverse reactions, and relatively low treatment costs, thus possessing broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments.

[0015] Figure 1 The effect of DXSDS on body weight changes in UC model mice (n=8), where Control is the control group, Model is the model group, CsA is the cyclosporine positive control group, and DXSDS-L / M / H are DXSDS low / medium / high dose groups.

[0016] Figure 2 The effect of DXSDS on the DAI score of UC model mice (n=8), where Control is the control group, Model is the model group, CsA is the cyclosporine positive control group, and DXSDS-L / M / H are DXSDS low / medium / high dose groups.

[0017] Figure 3 The effect of DXSDS on the colon length of UC model mice (n=8), where Control is the control group, Model is the model group, CsA is the cyclosporine positive control group, and DXSDS-L / M / H are the DXSDS low / medium / high dose groups.

[0018] Figure 4 The effect of DXSDS on the spleen index of UC model mice (n=8), where Control is the control group, Model is the model group, CsA is the cyclosporine positive control group, and DXSDS-L / M / H are DXSDS low / medium / high dose groups. DETAILED DESCRIPTION

[0019] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments.

[0020] Example 1

[0021] The traditional Chinese medicine composition consists of 60 parts of cloves, 60 parts of persimmon calyx, 30 parts of ginseng and 90 parts of ginger.

[0022] Example 2

[0023] The traditional Chinese medicine composition consists of 70 parts of cloves, 70 parts of persimmon calyx, 30 parts of ginseng and 100 parts of ginger.

[0024] Example 3

[0025] The traditional Chinese medicine composition consists of 80 parts of cloves, 80 parts of persimmon calyx, 40 parts of ginseng and 100 parts of ginger.

[0026] Example 4

[0027] The traditional Chinese medicine composition consists of 65 parts of cloves, 75 parts of persimmon calyx, 25 parts of ginseng and 85 parts of ginger.

[0028] Example 5

[0029] The traditional Chinese medicine composition consists of 75 parts of cloves, 65 parts of persimmon calyx, 35 parts of ginseng and 95 parts of ginger.

[0030] The preparation methods of the Chinese medicine compositions of Examples 1-5 are all as follows: mixing the raw materials in proportion, adding 10 times the total mass of water to perform a first decoction for 1 hour, and filtering to obtain a first residue and a first filtrate; adding 10 times the mass of water to perform a second decoction for 1 hour, and filtering to obtain a second residue and a second filtrate; combining the first filtrate and the second filtrate to obtain the Chinese medicine composition. The patient is to take 150-200 ml twice a day.

[0031] Experimental data proving efficacy

[0032] 1. Validation of the efficacy of Dingxiang Shidi Powder in a mouse model of ulcerative colitis

[0033] Animal model establishment

[0034] DSS-induced UC mouse model: After 6 days of adaptive feeding, mice in the model and treatment groups were given free access to 2% DSS solution for 6 consecutive days, followed by 2.5% DSS solution for 2 days. The normal control group was given normal water throughout the entire feeding period.

[0035] Grouping and drug administration

[0036] The normal control group received an equal volume of saline by gavage; the model group received an equal volume of saline by gavage; the low-, medium-, and high-dose groups received an aqueous extract of Clove and Persimmon Codonopsis Powder (3.48, 4.52, and 5.65 g of herb / kg / day) by gavage; the positive control group received 60 mg / kg / day by gavage. Dosing cycle: 8 consecutive days from the start of DSS induction.

[0037] Efficacy evaluation

[0038] a) Disease Activity Index Score

[0039] During the experiment, the weight of each group of mice was recorded daily. Starting on the third day of the experiment, the viscosity and blood content of feces were monitored and recorded. The disease activity index (DAI) was calculated. The DAI score mainly includes the changes in the mice's weight, fecal characteristics, and blood in the stool. The specific scoring criteria are as follows:

[0040] Scoring of weight changes: compared with the original body weight, a weight loss of 0% was scored as 0 points, a weight loss of 1-5% was scored as 1 point, a weight loss of 5-10% was scored as 2 points, a weight loss of 10-20% was scored as 3 points, and a weight loss of more than 20% was scored as 4 points.

[0041] Fecal characteristics scoring: normal mouse feces were scored as 0 points, loose and soft feces were scored as 1 point, mucous feces were scored as 2 points, semi-loose feces were scored as 3 points, and loose or watery feces were scored as 4 points.

[0042] Scoring of blood in stool: negative is scored as 0 points, no visible blood in stool and positive fecal occult blood test kit is scored as 2 points, and obvious blood in stool or anal bleeding is scored as 4 points.

[0043] The scores of various indicators were summarized and the DAI score was calculated according to the following formula: DAI = (weight change score + stool characteristics score + blood in stool score) / 3.

[0044] 2. Experimental Results

[0045] like Figure 1As shown in the figure, compared with the normal group, the model group had a significant decrease in body weight (P<0.0001). Compared with the model group, the low dose of Dingxiang Shidi Powder showed some improvement, but there was no significant difference. The high dose had a significant improvement (P<0.05), and the medium dose had an even more significant improvement (P<0.01).

[0046] Figure 2 The results showed that compared with the blank group, the model group mice had a poor mental state, decreased activity, and a significantly increased DAI score (P<0.0001). Compared with the model group, the low-dose Dingxiang Shidi San had a certain improvement in the score of mice (P<0.01), but the therapeutic effect was more significant in the medium and high-dose groups (P<0.001).

[0047] Figure 3 Data showed that compared with the normal group, the colon length of the model group mice was significantly shortened (P<0.0001). Compared with the model group, the low, medium, and high doses of Dingxiang Shidi Powder all showed some improvement, with the low dose of Dingxiang Shidi Powder showing some improvement (P<0.01), and the medium and high doses of Dingxiang Shidi Powder showing more significant improvement (P<0.0001).

[0048] Figure 4 The results showed that compared with the normal group, the spleen index of the model group mice was significantly increased (P<0.0001). Compared with the model group mice, the low, medium, and high doses of Dingxiang Shidi Powder all had some improvement on the spleen index of the mice. Among them, the low dose of Dingxiang Shidi Powder had a slight improvement effect (P<0.05), the medium dose of Dingxiang Shidi Powder had a significant improvement effect (P<0.01), and the high dose of Dingxiang Shidi Powder had the most significant improvement effect (P<0.0001).

[0049] Conclusion and Significance

[0050] The experimental results show that Dingxiang Shidi San effectively reduces DSS-induced ulcerative colitis symptoms in mice, with the effect being dose-dependent. Dingxiang Shidi San can help mice regain weight, alleviate bloody diarrhea, increase colon length, and reduce spleen index. Dingxiang Shidi San even has a more pronounced effect than the active drug cyclosporine in terms of body weight, DAI score, colon length, and spleen index.

[0051] Traditional Chinese Medicine (TCM) offers unique advantages in the treatment of ulcerative colitis (UC): stable efficacy, low relapse rates, low incidence of adverse reactions, and relatively low treatment costs. In recent years, TCM has gained increasing attention for the treatment of UC. As a traditional resource in my country, TCM has been widely used in the prevention and treatment of chronic diseases due to its multiple targets, minimal side effects, and lack of dependency. The "Guidelines for the Diagnosis and Treatment of Ulcerative Colitis with Integrated Traditional Chinese and Western Medicine" emphasizes the substitutability and complementarity of TCM and Western medicine in the treatment of mild to moderate active UC, and affirms the value of TCM as an adjunctive therapy in managing severe UC. The "Guidelines for the Diagnosis and Treatment of Ulcerative Colitis with TCM" also emphasizes the advantages of TCM in treating UC in terms of stabilizing the disease, improving symptoms, preventing relapses, and improving patients' quality of life. Mild and moderate UC can be treated with TCM alone, while severe UC can also be treated with TCM in combination to shorten the time to induction of clinical remission and reduce the incidence of adverse reactions. This demonstrates the crucial importance of TCM in the treatment of UC.

[0052] The preferred embodiments of the present invention disclosed above are intended only to help illustrate the present invention. The preferred embodiments do not exhaustively describe all details, nor do they limit the invention to the specific embodiments described. Obviously, many modifications and variations are possible based on the content of this specification.

Claims

1. A Chinese medicine composition for treating ulcerative colitis, characterized in that: The invention comprises 60-80 parts of cloves, 60-80 parts of persimmon calyx, 20-40 parts of ginseng and 80-100 parts of ginger.

2. The Chinese medicine composition for treating ulcerative colitis according to claim 1, wherein The traditional Chinese medicine composition comprises 60 parts of cloves, 60 parts of persimmon calyx, 30 parts of ginseng and 90 parts of ginger.

3. A method for preparing a traditional Chinese medicine composition for treating ulcerative colitis, characterized in that: The following steps are involved: The raw materials of clove, persimmon calyx, ginseng and ginger are decocted with water, and the filtrate is collected to obtain a Chinese medicine composition; the decocting comprises: mixing the raw materials with water for a first decocting to obtain a first filter residue and a first filtrate; The first filter residue is mixed with water and then decocted for the second time to obtain a second filter residue and a second filtrate; the first filtrate and the second filtrate are combined to obtain a traditional Chinese medicine composition.

4. The method for preparing the Chinese medicine composition for treating ulcerative colitis according to claim 3, wherein: In the first decoction, the mass ratio of all raw materials to water is 1:10; and the decoction time is 0.9-1.1 hours.

5. The method for preparing the Chinese medicine composition for treating ulcerative colitis according to claim 4, wherein: In the second decoction, the mass ratio of the first filter residue to water is 1:10; and the second decoction time is 0.9-1.1 h.

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