Traditional Chinese medicine composition with effect of treating ulcerative colitis and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine composition as well as a preparation method and application thereof, in particular to a traditional Chinese medicine composition for treating ulcerative colitis and a preparation method thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials: 10-50g of pseudo-ginseng and 10-50g of cuttlebone, wherein the mass ratio of the pseudo-ginseng to the cuttlebone is 1: (1-10). The composition can be a composition obtained by directly mixing the raw material medicines, and can also be an extract obtained by combining the raw materials and extracting the combined raw materials according to a conventional method. The composition disclosed by the invention not only has an obvious improvement effect on ulcerative colitis, but also has an obvious improvement effect on chronic gastritis combined ulcerative colitis.

Description

Technical Field

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

[0002] Ulcerative colitis (UC) is a chronic nonspecific intestinal inflammatory disease. Clinical manifestations include intermittent diarrhea, bloody stools with mucus, abdominal pain, and tenesmus. The cause of the disease is not yet clear, but it is currently believed to be caused by the interaction of multiple factors. The disease is difficult to cure, has a high recurrence rate, and has a high rate of canceration, which is closely related to the incidence of colon cancer.

[0003] At present, the western medicines used in clinical practice mainly include sulfasalazine salicylic acid preparations (such as Aidisha, mesalazine), corticosteroids (such as prednisone or dexamethasone), but these drugs have adverse reactions, and such drugs are expensive, and the treatment time is long, and the body will gradually develop drug resistance, and most of them are enema or intravenous injection, which will cause great pressure on life and economy for ordinary patients. Ulcerative colitis belongs to the category of dysentery in traditional Chinese medicine. Commonly used traditional Chinese medicine treatment prescriptions include Baitouweng Decoction, Shaoyao Decoction, Zhuche Pills, etc., which are not only complicated in composition, but also have uncertain efficacy. Therefore, it is necessary to find a Chinese medicine composition with simple composition and definite efficacy, so as to expand the application of traditional Chinese medicine in the preparation of drugs for the treatment of ulcerative colitis. Summary of the invention

[0004] The first object of the present invention is to provide a Chinese medicine composition for treating ulcerative colitis.

[0005] The objective of the present invention is achieved through the following technical solutions:

[0006] A traditional Chinese medicine composition having the effect of treating ulcerative colitis is prepared from the following raw materials: Panax notoginseng and cuttlebone.

[0007] Furthermore, the Chinese medicine composition is prepared from the following raw materials: 10-50g of Panax notoginseng and 10-50g of cuttlebone.

[0008] Furthermore, the mass ratio of Panax notoginseng to cuttlebone is: 1:(1-10).

[0009] Preferably, the mass ratio of Panax notoginseng to cuttlebone is: 1:(1-3).

[0010] More preferably, the mass ratio of Panax notoginseng to cuttlebone is 1:1.

[0011] The second object of the present invention is to provide a method for preparing the Chinese medicine composition.

[0012] In some embodiments, the composition of the present invention can be a composition obtained by directly mixing the above-mentioned raw materials; the composition can be made into a health product or a medicine through conventional processes.

[0013] In some embodiments, it can also be an extract obtained by conventional extraction after combining the raw materials, or an effective part obtained by further refining and purifying the extract; it can also be a composition formed by combining the extracts obtained by conventional extraction of the raw materials separately or the effective parts obtained by further refining and purifying the extracts. Among them, the conventional extraction method includes immersion extraction, decoction extraction, reflux extraction, percolation extraction, ultrasonic extraction, etc.; the extraction solvent includes water, 20-95% ethanol solution; the refining and purification process includes alcohol precipitation, extraction, silica gel column separation, macroporous resin column separation, etc.

[0014] In some embodiments, the composition of the present invention can be prepared into conventional oral dosage forms according to conventional preparation processes; such as decoctions, teas, pills (pills, honey pills, water pills, paste pills, wax pills, concentrated pills), powders, wines, syrups, extracts, dews, cakes, tablets, bags, oral liquids, granules, capsules, sustained release, nano preparations, etc.

[0015] In some embodiments, conventional excipients in the field of formulations may be added, including fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, bases, etc. Fillers include starch, pregelatinized starch, lactose, mannitol, chitin, microcrystalline cellulose, sucrose, etc.; disintegrants include starch, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch, cross-linked polyvinyl pyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, etc.; lubricants include magnesium stearate, sodium lauryl sulfate, talc, silicon dioxide, etc.; suspending agents include polyvinyl pyrrolidone, microcrystalline cellulose, sucrose, agar, hydroxypropyl methylcellulose, etc.; binders include starch slurry, polyvinyl pyrrolidone, hydroxypropyl methylcellulose, etc.

[0016] The third object of the present invention is to provide the use of the traditional Chinese medicine composition in the preparation of medicines or health products for treating ulcerative colitis.

[0017] Furthermore, the present invention provides the use of the traditional Chinese medicine composition in the preparation of medicines or health products for treating chronic gastritis combined with ulcerative colitis.

[0018] Technical effects of the present invention:

[0019] The present invention uses Panax notoginseng and cuttlebone in combination for treating ulcerative colitis, has a definite therapeutic effect and has no toxic or side effects.

[0020] Panax notoginseng is the dried root and rhizome of Panax notoginseng, a plant of the Araliaceae family. It tastes sweet and slightly bitter, is warm in nature, and enters the liver and stomach meridians. It has the effects of dispersing blood stasis and stopping bleeding, and relieving swelling and pain. Panax notoginseng has both walking and guarding effects, and can both purge and replenish the body. It has strong hemostatic and stasis-removing effects, and can also replenish the body. It has the advantages of stopping bleeding without leaving blood stasis, and activating blood circulation without consuming qi. It is effective for both internal and external use, and can be used for bleeding and swelling. "Compendium of Materia Medica" records that "Sanqi can stop bleeding, disperse blood, and relieve pain. For those who have bleeding from sword wounds, arrow wounds, falls, or cane sores, chew it and apply it, or grind it into powder and mix it with the medicine to stop the bleeding. It also treats vomiting blood, nosebleed, bleeding, bloody diarrhea, metrorrhagia, continuous menstruation, postpartum blood retention, blood circulation, blood pain, red eyes, carbuncle, tiger bite, snake bite and other diseases." Modern research has also found that Sanqi mainly contains tetracyclic triterpenoid ingredients such as ginsenosides, notoginseng saponins, and escin, as well as substances such as notoginseng, quercetin and polysaccharides, which have anti-aging, antioxidant, immune regulation, increased coronary blood flow, reduced oxygen consumption, liver protection, sedation and tranquilization effects.

[0021] Cuttlebone is the dried inner shell of the Sepiidae animal, the needleless squid or the golden squid. It tastes salty, astringent, warm, and enters the spleen and kidney meridians. It has the effects of astringing and stopping bleeding, astringing semen and stopping leukorrhea, relieving acid and relieving pain, and astringing moisture and healing sores. "Compendium of Materia Medica" states: "Cuttlefish bone is a medicine for the Jueyin blood. It has a strong taste and can move blood. Therefore, blood deficiency and emaciation, amenorrhea, metrorrhagia, dysentery and malnutrition are Jueyin diseases; cold and heat, malaria, deafness and impotence, lower abdominal pain, and genital pain are Jueyin meridian diseases; eye opacity and tearing are Jueyin orifice diseases. Jueyin belongs to the liver, and the liver governs blood, so all blood diseases can be cured by it." Modern research shows that the content of calcium carbonate in cuttlefish is about 80% to 85%, shell keratin is 6% to 7%, mucus is 10% to 15%, and it contains a small amount of sodium chloride, calcium phosphate, magnesium salts, etc. It has a significant effect on stomach pain, heartburn and bleeding caused by gastric and duodenal ulcers. It can also be used to treat bedsores and malaria in the shallow ulcer stage.

[0022] After long-term clinical observation and experimental research, the composition of the present invention has a significant improvement effect on the symptoms of ulcerative colitis and chronic gastritis combined with ulcerative colitis. When the ratio of Panax notoginseng to cuttlebone is greater than 1:1, its efficacy in treating ulcerative colitis is not obvious. When the ratio of Panax notoginseng to cuttlebone is 3:1, its effective rate in treating ulcerative colitis is less than 50%, and its inflammatory index is close to the index before taking the medicine. When the ratio of Panax notoginseng to cuttlebone is less than or equal to 1:1, its efficacy in treating ulcerative colitis is obvious. When the ratio of Panax notoginseng to cuttlebone is 1:1-1:3, its effective rate in treating ulcerative colitis is greater than or equal to 50%. In particular, when the ratio of the two is 1:1, its effective rate is more than 90%, and it will not cause toxic side effects, which greatly improves the patient's quality of life and long-term prognosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The effect of samples 1-3 on DAI scores of DSS-induced UC mice;

[0024] Compared with the normal group, ##P<0.01; compared with the model group, *P<0.05, **P<0.01.

[0025] Figure 2 Effects of samples 1-3 on colon length in DSS-induced UC mice;

[0026] Compared with the normal group, ##P<0.01; compared with the model group, **P<0.01. DETAILED DESCRIPTION

[0027] Example 1 Preparation of Composition 1 (1:1)

[0028] Ingredients: Panax notoginseng 10g, Cuttlebone 10g

[0029] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400ml of 60℃ warm water to dissolve. Usage and Dosage: Drink a total of 400ml per day, twice a day.

[0030] Example 2 Preparation of Composition 2 (1:10)

[0031] Composition: Panax notoginseng 1.82g, Cuttlebone 18.18g

[0032] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400ml of 60℃ warm water to dissolve. Usage and Dosage: Drink a total of 400ml per day, twice a day.

[0033] Example 3 Preparation of Composition 3 (1:3)

[0034] Ingredients: Panax notoginseng 5g, Cuttlebone 15g

[0035] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400ml of 60℃ warm water to dissolve. Usage and Dosage: Drink a total of 400ml per day, twice a day.

[0036] Example 4 Preparation of Composition 4 (3:1)

[0037] Ingredients: Panax notoginseng 15g, Cuttlebone 5g

[0038] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400ml of 60℃ warm water to dissolve. Usage and Dosage: Drink a total of 400ml per day, twice a day.

[0039] Example 5 Preparation of Composition 5

[0040] Ingredients: Panax notoginseng 10g, Cuttlebone 10g, Bletilla striata 10g

[0041] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400ml of 60℃ warm water to dissolve. Usage and Dosage: Drink a total of 400ml per day, twice a day.

[0042] Example 6 Preparation of Composition 6

[0043] Ingredients: Panax notoginseng 10g, Cuttlebone 10g, Bletilla striata 10g, Vinegar-cooked Corydalis 6g

[0044] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400ml of 60℃ warm water to dissolve. Usage and Dosage: Drink a total of 400ml per day, twice a day.

[0045] Example 7 Preparation of compositions prepared by different preparation methods:

[0046] (1) Direct mixing of powders (composition 1)

[0047] Ingredients: Panax notoginseng 10g, Cuttlebone 10g

[0048] Preparation: Weigh the raw material powders according to the proportion, mix, and add 400 ml of 60°C warm water to dissolve. (2) Extraction after mixing (composition 7)

[0049] Ingredients: Panax notoginseng 10g, Cuttlebone 10g

[0050] Preparation: Weigh the raw material powders according to the proportion, mix them, add 10-8-8 times 60℃ double distilled water, ultrasonically extract three times, each time for 40 minutes, concentrate, and dry at -80℃.

[0051] (3) Extraction and mixing (composition 8)

[0052] Ingredients: Panax notoginseng 10g, Cuttlebone 10g

[0053] Preparation: Weigh the raw material powders according to the proportion, add 10-8-8 times 60℃ double distilled water and ultrasonically extract three times, each time for 40 minutes, mix the extracts of the two drugs, concentrate, and dry at -80℃.

[0054] Experimental Example 1 Study on the clinical effect of treating ulcerative colitis

[0055] 84 patients were enrolled, all of whom were diagnosed with ulcerative colitis, either primary or chronic recurrent, and had not received any relevant systemic treatment in the past month. The corresponding composition was taken orally, twice a day, for 4 consecutive weeks.

[0056] Table 1 Comparison of clinical efficacy of different compositions [n / case (%)]

[0057]

[0058] Note: Treatment effectiveness rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0059] Cured: The patient's clinical symptoms and signs disappear, defecation becomes normal, the pathological changes of intestinal mucosa return to normal, and scars are formed on colon ulcers; Significantly effective: The patient's clinical symptoms and signs are significantly relieved, defecation becomes basically normal, and the pathological changes of intestinal mucosa are basically restored, with a little inflammation;

[0060] Effective: The patient's clinical symptoms and signs were alleviated, bowel movements were occasionally abnormal, and local intestinal mucosa inflammation and polyp formation still occurred; Ineffective: The patient's clinical symptoms, intestinal mucosal lesions and serological indicators did not improve or even worsened.

[0061] Conclusion: When the mass ratio of Panax notoginseng to cuttlebone is 3:1, the effective rate is less than 50%, and when the mass ratio of Panax notoginseng to cuttlebone is 1:1-1:3, the effective rate is greater than 50%. The highest effective rate is obtained when Panax notoginseng and cuttlebone powder are mixed or the two are mixed and then extracted with conventional water. It can be seen that the combination of Panax notoginseng and cuttlebone has a synergistic effect, thereby improving the efficacy.

[0062] Table 2 Effects of different compositions on inflammatory indicators in patient serum

[0063]

[0064] Note: Compared with combination 1 and 7 groups, *P<0.05, **P<0.01.

[0065] Conclusion: The higher the values ​​of CRP, PCT and IL-6 in human serum, the more obvious the inflammation in the body. The results of this clinical experiment show that the effective rate after administration of compositions 1 and 7 is the highest, and the various inflammatory indicators are the lowest, and the anti-inflammatory effect is the best. The CPR and PCT values ​​after administration of compositions 2, 3, and 4 are significantly greater than those of compositions 1 and 7, and the IL-6 values ​​after administration of compositions 2-6 are significantly greater than those of compositions 1 and 7.

[0066] The results show that different compositions of the present invention have different degrees of therapeutic effects on ulcerative colitis, among which compositions 1 and 7 have the best therapeutic effects on ulcerative colitis.

[0067] Experimental Example 2: Clinical Effect Study on the Treatment of Chronic Gastritis Combined with Ulcerative Colitis

[0068] 64 patients were enrolled, all of whom were diagnosed with chronic gastritis combined with ulcerative colitis, all of whom were primary or chronic recurrent. The experimental group was treated with conventional antibiotics, immunosuppressants and hormone drugs according to the patient's disease treatment needs, and took the corresponding combination twice a day for 4 consecutive weeks. The control group (sulfasalazine combined with hydrocortisone) was given enema according to the doctor's advice.

[0069] Table 2 Comparison of clinical efficacy [n / case (%)]

[0070]

[0071]

[0072] Note: Treatment effectiveness rate = (number of cured cases + number of markedly effective cases + number of effective cases) / total number of cases × 100%.

[0073] Recovery: The patient's clinical symptoms and signs disappear, and gastroscopy and colonoscopy show that the ulcer has healed, and mucosal erosion, bleeding, congestion, and edema have disappeared;

[0074] Markedly effective: The patient's clinical symptoms and signs were significantly relieved, and the ulcers were basically healed by gastroscopy and colonoscopy, and mucosal erosion, bleeding, congestion, and edema basically disappeared;

[0075] Effective: The patient's clinical symptoms and signs are alleviated, and the lesions are reduced by more than 1 / 2 according to gastroscopy and colonoscopy. Inflammation and polyp formation still exist in the intestinal and gastric mucosa.

[0076] Ineffectiveness: The patient's main clinical symptoms and gastroscopy, colonoscopy or barium enema examinations showed no significant changes or even worsened.

[0077] The results show that the composition of the present invention has obvious efficacy in treating chronic gastritis combined with ulcerative colitis, and its therapeutic effect is better than sulfasalazine combined with hydrocortisone, and better than conventional antibiotics, immunosuppressants and hormone drugs.

[0078] Experimental Example 2 Animal Experimental Research

[0079] 1 Experimental methods:

[0080] Sample preparation:

[0081] Sample 1: 80 g of Panax notoginseng, add 10-8-8 times 60℃ double distilled water, ultrasonic extraction three times, 40 minutes each time, and dilute to the required concentration of 2.5 mg / ml;

[0082] Sample 2: 80 g of cuttlebone, add 10-8-8 times 60℃ double distilled water and ultrasonically extract three times, 40 minutes each time, and dilute to the required concentration of 2.5 mg / ml;

[0083] Sample 3: 80g Panax notoginseng, 80g Cuttlebone, add 10-8-8 times 60℃ double distilled water, ultrasonically extract three times, 40 minutes each time, and dilute to the required concentration of 5mg / ml;

[0084] Animal experiment: C57BL / 6J mice were used, 12 mice in each group.

[0085] Grouping:

[0086] Group A: blank control group

[0087] Group B: UC model group (2.5% dextran sulfate sodium (DSS) was dissolved in drinking water and allowed to drink freely for 10 days to establish the UC model)

[0088] Group C: UC model group + sample 1 (1.25g / kg)

[0089] Group D: UC model group + sample 2 (1.25 g / kg)

[0090] Group E: UC model group + sample 3 (2.5g / kg)

[0091] The CE group was given the corresponding drugs by gavage every day, and the A and B groups were given the same amount of normal saline once a day for 10 consecutive days, with a dosage of 0.2 mL / 20 g. The body weight, fecal characteristics and degree of blood in the stool of the mice were recorded every day, and the disease activity index (DAI) was scored. The DAI score table is shown in Table 3.

[0092] Table 3 DAI scoring criteria

[0093] Rating / points Body weight reduction% Stool characteristics Blood in the stool 0 0 normal normal 1 1-5 normal normal 2 5-10 Loose Hidden blood in stool 3 10-15 Loose Hidden blood in stool 4 ＞15 diarrhea Overt blood in stool

[0094] 2 Experimental results: See Figure 1-2 .

[0095] Compared with the normal group, the DAI score of the mice in the model group gradually increased with time (##P<0.01), and the colon length was shortened (##P<0.01); compared with the model group, the DAI scores of sample groups 2 and 3 gradually decreased with time (*P<0.05, **P<0.01), and the colon length of sample group 3 increased (**P<0.01). The effect of the combination of Panax notoginseng and cuttlebone on prolonging colon length in sample 3 was significantly better than the prolonging effect of Panax notoginseng or cuttlebone alone, and better than the sum of the prolonging effects of Panax notoginseng and cuttlebone alone. Therefore, the combination of Panax notoginseng and cuttlebone has a synergistic effect in the treatment of ulcerative colitis.

[0097] Example 1 Decoction

[0098] Prescription: Panax notoginseng 10g, cuttlebone 10g.

[0099] Preparation method: Weigh the raw materials in proportion and add 400 ml of 60°C warm water to dissolve.

[0100] Dosage and Administration: Daily consumption: 400ml, twice a day.

[0101] Example 2 Granules

[0102] Prescription: Panax notoginseng 10g, cuttlebone 10g.

[0103] Preparation method: Weigh each raw material in proportion, use 10-8 times the amount of 95% ethanol aqueous solution for ultrasonic extraction twice, each time for 1 hour, combine the extracts, concentrate under reduced pressure to obtain a dry paste, add appropriate conventional excipients (excipients, flavoring agents, etc.), make granules, and package according to the dosage to obtain granules.

[0104] Example 3 Capsules

[0105] Prescription: Panax notoginseng 10g, cuttlebone 10g.

[0106] Preparation method: Weigh each raw material in proportion, use 10-8 times the amount of 60℃ warm water for ultrasonic extraction twice, each time for 1 hour, combine the aqueous solutions, concentrate under reduced pressure to obtain a dry paste, add appropriate conventional excipients (excipients, flavoring agents, etc.), make granules, and pack them into capsules according to the dosage to obtain capsules.

[0107] Example 4 Oral Liquid

[0108] Prescription: Panax notoginseng 10g, cuttlebone 10g.

[0109] Preparation method: Weigh each raw material in proportion, use 10-8 times the amount of 60°C warm water for ultrasonic extraction twice, each time for 1 hour, combine the extracts, and concentrate under reduced pressure to obtain a concentrate of corresponding concentration, add suitable conventional excipients (flavor correctives, antibacterial agents, etc.), and package in containers of certain specifications according to the dosage to obtain a mixture (oral solution) or tincture.

[0110] Example 5 Tablets

[0111] Prescription: Panax notoginseng 10g, cuttlebone 10g.

[0112] Preparation method: Weigh each raw material in proportion, use 10-8 times the amount of 70% ethanol aqueous solution for ultrasonic extraction twice, each time for 40 minutes, combine the extracts, and concentrate under reduced pressure to obtain a concentrate of corresponding concentration, add suitable conventional excipients, make a soft material, and press and package to obtain tablets.

Claims

1. A Chinese medicine composition, characterized in that: It is prepared from the following raw materials: Panax notoginseng and cuttlebone.

2. The Chinese medicine composition according to claim 1, characterized in that Panax notoginseng 10-50g, cuttlebone 10-50g.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The mass ratio of Panax notoginseng and cuttlebone is: 1:(1-10).

4. The Chinese medicine composition according to claim 1 or 2, characterized in that: The mass ratio of Panax notoginseng and cuttlebone is: 1:(1-3).

5. The Chinese medicine composition according to claim 1 or 2, characterized in that: The mass ratio of Panax notoginseng and cuttlebone is 1:

1.

6. A pharmaceutical composition comprising the Chinese medicine composition according to any one of claims 1 to 5.

7. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: Weigh the raw material powders according to the proportion and mix them.

8. The method for preparing the Chinese medicine composition according to any one of claims 1 to 5, characterized in that: Weigh each raw material powder according to the proportion, mix them and then perform water extraction.

9. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the pharmaceutical composition according to claim 6 in the preparation of a medicine or health product for treating ulcerative colitis.

10. Use of the Chinese medicine composition according to any one of claims 1 to 5 or the pharmaceutical composition according to claim 6 in the preparation of medicines or health products for treating chronic gastritis combined with ulcerative colitis.

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