Traditional Chinese medicine composition for treating asymptomatic gallstone as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating asymptomatic gallstone as well as a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating the asymptomatic gallstone comprises the following components: curcuma zedoary, salvia chinensis, sculellaria barbata, lysimachia christinae hance, radix curcumae, endothelium corneum gigeriae galli, walnuts, pericarpium citri reticulatae, radix paeoniae rubra, radix paeoniae alba, liquorice, semen cannabis, quassia, serrate rabdosia herb and lalang grass rhizome. Walnuts are independently prepared into powder, and then the powder and water extracts of other medicines are combined for taking, so that the synergistic effect of different medicines is successfully exerted. Experiments prove that the medicine provided by the invention can remarkably promote dissolution and discharge of gallstone, the total effective rate is as high as 93.33%, the occurrence of gallstone symptoms and complications can be reduced, the content of serum cholesterol is reduced, and the recurrence of gallstone is inhibited. The medicine disclosed by the invention can be used for effectively treating asymptomatic gallstone and has a wide application prospect.

Description

Technical Field

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

[0002] B-ultrasound, X-ray or cholecystography confirms that there are gallstones in the gallbladder, but there has never been any symptom of gallstones, no obvious biliary colic or complications such as obstructive jaundice, biliary pancreatitis, etc., and no stones are found in the intrahepatic and extrahepatic bile ducts. This is called asymptomatic gallstones. The formation of gallstones is related to the increase in the cholesterol saturation index in bile and is negatively correlated with the bile salt concentration. According to the composition of the stones, they can be divided into cholesterol stones (37%-86%), bile pigment stones (2%-27%) and other stones (4%-16%). At present, the factors that can be determined to cause the formation of gallstones include: factors that lead to bile cholesterol supersaturation; factors that lead to cholesterol precipitation and crystal formation; factors that damage the basic functions of the gallbladder (contraction, absorption, secretion, etc.); factors that damage the enterohepatic circulation of bile acids.

[0003] Although most patients with gallstones can be asymptomatic for life, many patients are still hospitalized for complications of gallstones (such as biliary pancreatitis, etc.), so more active intervention plans need to be taken for high-risk patients. At present, conservative treatments for gallstones mainly include extracorporeal shock wave lithotripsy (ESWL), drug lithotripsy, gallbladder stone removal, and Chinese medicine stone removal. In traditional Chinese medicine internal medicine, gallstones belong to the categories of "bile distension", "jaundice", "flank pain", and "abdominal pain". Traditional Chinese medicine believes that dietary damage, exogenous dampness and heat, and emotional frustration are the main causes of gallstone formation, and its clinical syndromes are mostly qi stagnation, blood stasis, dampness and heat, yin deficiency, and yang deficiency. At present, there are studies on taking Chinese medicine to increase bile secretion and then remove stones, but there are defects such as long cycle, high cost, and incomplete stone removal. Therefore, it is urgent to prepare a Chinese medicine composition that is efficient in stone removal and inhibits the formation of gallstones. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for treating asymptomatic gallstones, and a preparation method and application thereof, so as to solve the problems existing in the above-mentioned prior art. The Chinese medicine composition of the present invention can efficiently expel stones and inhibit the formation of gallstones, and can be used to treat asymptomatic gallstones.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] The invention provides a traditional Chinese medicine composition for treating asymptomatic gallbladder stones. The traditional Chinese medicine composition comprises the following components by weight: 9-16 parts of zedoaria, 12-17 parts of celery, 18-24 parts of scutellaria barbata, 28-33 parts of desmodium strychnine, 8-15 parts of curcuma, 27-32 parts of chicken's gizzard lining, 30 parts of walnut, 8-14 parts of tangerine peel, 11-18 parts of red peony root, 12-17 parts of white peony root, 5-8 parts of liquorice, 9-14 parts of hemp seed, 10-18 parts of quassinus, 10-15 parts of cyperus rotundus and 17-22 parts of Imperata root.

[0007] Preferably, the following components are included by weight: 12 parts of Curcuma zedoaria, 15 parts of Lithospermum officinale, 20 parts of Scutellaria barbata, 30 parts of Herba Lysimachiae, 12 parts of Curcumae aromatica, 30 parts of Chicken's gizzard lining, 30 parts of walnuts, 12 parts of dried tangerine peel, 15 parts of red peony root, 15 parts of white peony root, 6 parts of liquorice, 12 parts of Semen Hemp, 15 parts of Quassinus, 12 parts of Herba Imperatae and 20 parts of Imperatae rhizome.

[0008] The invention provides application of the traditional Chinese medicine composition in preparing medicine for treating asymptomatic gallstones.

[0009] The present invention also provides a medicine for treating asymptomatic gallbladder stones, wherein the only effective ingredient of the medicine is the above-mentioned traditional Chinese medicine composition.

[0010] Preferably, a pharmaceutically acceptable excipient is also included.

[0011] Preferably, the dosage form of the drug includes decoction, powder, paste, pills and granules.

[0012] The present invention also provides a method for preparing the drug, comprising the following steps:

[0013] Weigh the corresponding mass of the drug raw material according to the formula of the composition;

[0014] Wetting the walnuts, steaming and frying them, and crushing them to obtain walnut powder;

[0015] Mix zedoaria, lily bulb, scutellaria barbata, limonia odorata, curcuma, chicken's gizzard lining, dried orange peel, red peony root, white peony root, liquorice, sesame seed, quassia, cyperus rotundus and Imperata cylindrica, grind and sieve to obtain drug powder;

[0016] The drug powder is mixed with water, heated, condensed and refluxed for 2 hours, filtered, and concentrated to obtain an extract;

[0017] The extract is cooled to room temperature, and the walnut powder is added to obtain the product.

[0018] Preferably, the steaming and frying temperature is 130-140° C. and the time is 15-25 min.

[0019] Preferably, the sieving is through a 60-mesh sieve.

[0020] Preferably, the mass ratio of the drug micropowder to water is 1:10.

[0021] The present invention discloses the following technical effects:

[0022] The present invention prepares water extracts from Curcuma zedoaria, Lithospermum officinale, Scutellaria barbata, Herba Lysimachiae, Curcumae Radix, Galliformis gizzardii, Pericarpium Citri Reticulatae, Paeonia lactiflora, Radix Glycyrrhizae, Semen Semen Semen, Quassiae, Herba Imperatae and Rhizoma Imperatae into aqueous extracts, prepares walnut into powders separately, and then combines and takes, successfully exerting the synergistic effect between different medicaments. Experiments have shown that the medicine provided by the present invention can significantly promote the dissolution and discharge of gallstones, with a total effective rate of up to 93.3%, and can also reduce the occurrence of gallstone symptoms and complications, reduce serum cholesterol content, and inhibit gallstones from recurring. The medicine of the present invention can effectively treat asymptomatic gallstones and has broad application prospects. DETAILED DESCRIPTION

[0023] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as limiting the present invention, but should be understood as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0024] It should be understood that the terms described in the present invention are only for describing a particular embodiment and are not intended to limit the present invention. In addition, for the numerical range in the present invention, it should be understood that each intermediate value between the upper and lower limits of the scope is also specifically disclosed. The intermediate value in any stated value or stated range, and each smaller range between any other stated value or intermediate value in the described range is also included in the present invention. The upper and lower limits of these smaller ranges can be independently included or excluded in the scope.

[0025] Unless otherwise indicated, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Although the present invention describes only preferred methods and materials, any methods and materials similar or equivalent to those described herein may also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials associated with the documents. In the event of a conflict with any incorporated document, the content of this specification shall prevail.

[0026] It will be apparent to those skilled in the art that various modifications and variations may be made to the specific embodiments of the present invention description without departing from the scope or spirit of the present invention. Other embodiments derived from the present invention description will be apparent to those skilled in the art. The present invention description and examples are exemplary only.

[0027] The words “include,” “including,” “have,” “contain,” etc. used in this document are open-ended terms, meaning including but not limited to.

[0028] Example 1

[0029] Take 30g of walnuts, moisten them, steam and fry them at 130℃ for 25min, and crush them to obtain walnut powder;

[0030] Take 9g of Curcuma, 17g of Lithospermum officinale, 24g of Scutellaria barbata, 28g of Lysimachia chinensis, 8g of Curcuma aromatica, 27g of Gallus gallus domestica, 8g of Tangerine peel, 18g of Red Peony Root, 12g of White Peony Root, 8g of Licorice, 14g of Semen Semen, 18g of Quassima, 10g of Herba Imperatae, and 22g of Imperatae Rhizome, mix well, grind, pass through a 60-mesh sieve to obtain drug powder, add 2230mL of clean water, heat, condense and reflux for extraction for 2h, filter, and concentrate to obtain an extract;

[0031] Cool the extract to room temperature and add the above-mentioned walnut powder to obtain the product.

[0032] Example 2

[0033] Take 30g of walnuts, moisten them, steam and fry them at 140℃ for 20min, and crush them to obtain walnut powder;

[0034] Take 16g of Curcuma, 12g of Lithospermum officinale, 18g of Scutellaria barbata, 33g of Lysimachia chinensis, 15g of Curcuma aromatica, 32g of Gallus gallus domestica, 14g of Citrus reticulata, 11g of Red Peony Root, 17g of White Peony Root, 5g of Licorice, 9g of Semen Semen, 10g of Quassinus officinalis, 15g of Herba Imperatae, and 17g of Rhizoma Imperatae, mix well, grind, pass through a 60-mesh sieve to obtain drug powder, add 2240mL of clean water, heat, condense and reflux for extraction for 2h, filter, and concentrate to obtain an extract;

[0035] Cool the extract to room temperature and add the above-mentioned walnut powder to obtain the product.

[0036] Example 3

[0037] Take 30g of walnuts, moisten them, steam and fry them at 135℃ for 25min, and crush them to obtain walnut powder;

[0038] Take 14g of Curcuma, 13g of Lithospermum officinale, 21g of Scutellaria barbata, 32g of Lysimachia chinensis, 10g of Curcuma aromatica, 28g of Gallus gallus domestica, 10g of Tangerine peel, 16g of Red Peony Root, 14g of White Peony Root, 7g of Licorice, 11g of Semen Semen, 12g of Quassima, 13g of Herba Imperatae, and 18g of Imperatae Rhizoma, mix them, grind them, pass through a 60-mesh sieve to obtain drug powder, add 2190mL of clean water, heat, condense and reflux for extraction for 2h, filter, and concentrate to obtain an extract;

[0039] Cool the extract to room temperature and add the above-mentioned walnut powder to obtain the product.

[0040] Example 4

[0041] Take 30g of walnuts, moisten them, steam and fry them at 137℃ for 20min, and crush them to obtain walnut powder;

[0042] Take 12g of Curcuma, 15g of Lithospermum officinale, 20g of Scutellaria barbata, 30g of Lysimachia chinensis, 12g of Curcuma aromatica, 30g of Gallus gallus domestica, 12g of Tangerine peel, 15g of Red Peony Root, 15g of White Peony Root, 6g of Licorice, 12g of Semen Semen, 15g of Quassima, 12g of Herba Imperatae, and 20g of Imperatae Rhizome, mix well, grind, pass through a 60-mesh sieve to obtain drug powder, add 2260mL of clean water, heat, condense and reflux for extraction for 2h, filter, and concentrate to obtain an extract;

[0043] Cool the extract to room temperature and add the above-mentioned walnut powder to obtain the product.

[0044] Comparative Example 1

[0045] Take 12g of Curcuma, 15g of Lithospermum officinale, 20g of Scutellaria barbata, 30g of Lysimachia chinensis, 12g of Curcuma aromatica, 30g of Chicken's gizzard lining, 30g of Walnut, 12g of Tangerine peel, 15g of Red Peony Root, 15g of White Peony Root, 6g of Licorice, 12g of Semen Semen, 15g of Quassinus, 12g of Cyperus rotundus and 20g of Imperata root, mix well, grind, pass through a 60-mesh sieve to obtain drug powder, add 2560mL of clean water, heat, condense and reflux for extraction for 2h, filter, and concentrate to obtain an extract.

[0046] The extract is cooled to room temperature.

[0047] Effect verification example

[0048] 1. Patient information

[0049] Patients with asymptomatic gallstones diagnosed among the people who visited the outpatient and inpatient departments of Linyi People's Hospital from February 2023 to August 2023 were selected.

[0050] Inclusion criteria: patients aged 20-65 years diagnosed with asymptomatic gallstones by routine imaging examinations such as B-ultrasound or X-ray.

[0051] Exclusion criteria: patients with symptoms of gallstones such as upper abdominal pain, nausea, and vomiting were excluded; patients with gallbladder polyps, diagnosed gallbladder cancer, or highly suspected gallbladder cancer were excluded; patients with related organic lesions of the heart, liver, kidney, and brain were excluded; patients with acute pancreatitis, acute peptic ulcer with perforation, acute alcoholic and viral hepatitis, etc. were excluded; pregnant and lactating women were excluded.

[0052] 2. Experimental Methods

[0053] 2.1 Basic treatment

[0054] Patients with asymptomatic gallstones were randomly divided into 6 groups (including 4 experimental groups, 1 control group, and 1 blank control group), and appropriate adjustments were made to ensure that there were no statistically significant differences in basic data such as gender, age, weight, and height among the groups.

[0055] The patients in the six groups were restricted in their daily diet, eating less high-fat, high-calorie, and spicy foods, and quitting smoking and drinking. The patients were made to have a regular work and rest schedule and maintain a healthy mentality and mood.

[0056] 2.2 Drug treatment

[0057] The extract prepared in Examples 1-4 of the present invention was concentrated to 1500 mL, and the patients in the experimental groups 1-4 took the medicine three times a day, 500 mL each time, and 10 g of walnut powder was added to the concentrated extract before taking it. The extract prepared in Comparative Example 1 was concentrated to 1500 mL, and the patients in the control group took the medicine three times a day, 500 mL each time. The patients in the blank control group drank 500 mL of normal temperature water after three meals a day.

[0058] 2.3 Detection methods

[0059] Before the experiment, all patients underwent B-ultrasound examination, and the number and volume of stones were recorded, and serum cholesterol levels were tested. The patients were re-examined with B-ultrasound and cholesterol every 3 months, and the treatment cycle was 12 months. According to the patient's main complaint, the occurrence of gallstone symptoms such as biliary colic or complications such as acute cholecystitis, bile duct obstruction, and pancreatitis in each group of patients was recorded.

[0060] 2.4 Evaluation Criteria

[0061] The disappearance of gallstones was considered cured; the reduction in stone size by >4mm or the number of stones by >1 / 2 was considered markedly effective; the reduction in stone size by <4mm or the number of stones by <1 / 2 was considered effective; and the absence of a reduction in stone size or number was considered ineffective. The total effective rate of the drug was calculated according to the following formula.

[0062] Total effective rate = (1-number of ineffective patients in the group / total number of patients in the group) × 100%.

[0063] 3. Experimental results

[0064] According to the inclusion and exclusion criteria of the present invention, at the beginning of the experiment, a total of 180 patients with asymptomatic gallstones were treated, and at the end of the experiment, a total of 180 patients finally completed the treatment and had complete result records. The efficacy records and clinical symptoms are shown in Tables 1 and 2.

[0065] Table 16 Clinical efficacy statistics of patients with asymptomatic gallstones

[0066]

[0067] Note: * indicates P<0.01 compared with the blank control group; # indicates P<0.05 compared with the control group.

[0068] Table 2 Comparison of complications during treatment in 6 groups of patients with asymptomatic gallstones

[0069]

[0070] Note: * indicates P<0.05 compared with the blank control group; ** indicates P<0.01 compared with the blank control group; # indicates P<0.05 compared with the control group.

[0071] Table 36 Statistics of cholesterol test before and after treatment of patients with asymptomatic gallstones

[0072]

[0073] Note: * indicates P<0.01 compared with the blank control group; # indicates P<0.01 compared with the control group.

[0074] As shown in Tables 1 and 2, the effective rate of the treatment of patients treated with the drug of the present invention is significantly higher than that of the blank control group and the control group; it shows that after taking the drug of the present invention, the volume and number of gallstones are significantly reduced, and the drug provided by the present invention can effectively promote the dissolution and discharge of gallstones. At the same time, the drug provided by the present invention can also significantly reduce the symptoms and complications of gallstones, reduce the level of serum cholesterol, and inhibit the re-formation of gallstones. The control group treated with the drug of Comparative Example 1 also has a certain therapeutic effect on the elimination of gallstones and the reduction of cholesterol levels compared with the blank control group, but the therapeutic effects of experimental groups 1-4 are significantly better than those of the control group; this shows that walnuts are processed separately and taken in combination with other medicaments before taking the medicine, which plays a key role in the efficacy of the Chinese medicine composition of the present invention.

[0075] The embodiments described above are only descriptions of the preferred modes of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made to the technical solutions of the present invention by ordinary technicians in this field should all fall within the protection scope determined by the claims of the present invention.

Claims

1. A Chinese medicine composition for treating asymptomatic gallstones, characterized in that: The invention comprises the following components by weight: 9-16 parts of Curcuma zedoaria, 12-17 parts of Lithospermum officinale, 18-24 parts of Scutellaria barbata, 28-33 parts of Lysimachia chinensis, 8-15 parts of Curcuma aromatica, 27-32 parts of Chicken's gizzard lining, 30 parts of walnut, 8-14 parts of Tangerine peel, 11-18 parts of Red Peony Root, 12-17 parts of White Peony Root, 5-8 parts of Liquorice, 9-14 parts of Semen Hemp Seed, 10-18 parts of Quassinus officinalis, 10-15 parts of Cyperus rotundus and 17-22 parts of Imperata cylindrica.

2. The Chinese medicine composition according to claim 1, characterized in that The invention comprises the following components by weight: 12 parts of Curcuma zedoariae, 15 parts of Lithospermum officinale, 20 parts of Scutellaria barbata, 30 parts of Herba Lysimachiae, 12 parts of Curcumae aromatica, 30 parts of Chicken's gizzard lining, 30 parts of Walnut, 12 parts of Tangerine peel, 15 parts of Red Peony Root, 15 parts of White Peony Root, 6 parts of Liquorice, 12 parts of Semen Hemp Seed, 15 parts of Quassinus, 12 parts of Herba Imperatae and 20 parts of Imperatae Rhizoma.

3. Use of the Chinese medicine composition as claimed in claim 1 or 2 in the preparation of a medicine for treating asymptomatic gallstones.

4. A drug for treating asymptomatic gallstones, characterized in that: The only active ingredient of the medicine is the Chinese medicine composition according to claim 1 or 2.

5. The drug according to claim 4, characterized in that Pharmaceutically acceptable excipients are also included.

6. The drug according to claim 4, characterized in that The dosage forms of the medicine include decoction, powder, paste, pills and granules.

7. The method for preparing the drug according to claim 4, characterized in that: The following steps are involved: Weigh the corresponding mass of the drug raw material according to the formula of the composition; Wetting the walnuts, steaming and frying them, and crushing them to obtain walnut powder; Mix zedoaria, lily bulb, scutellaria barbata, limonia odorata, curcuma, chicken's gizzard lining, dried orange peel, red peony root, white peony root, liquorice, sesame seed, quassia, cyperus rotundus and Imperata cylindrica, grind and sieve to obtain drug powder; The drug powder is mixed with water, heated, condensed and refluxed for 2 hours, filtered, and concentrated to obtain an extract; The extract is cooled to room temperature, and the walnut powder is added to obtain the product.

8. The preparation method according to claim 7, characterized in that: The steaming and frying process is performed at a temperature of 130-140° C. and for a time of 15-25 minutes.

9. The preparation method according to claim 7, characterized in that: The sieving is through a 60-mesh sieve.

10. The preparation method according to claim 7, characterized in that: The mass ratio of the drug micropowder to water is 1:10.

Images