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

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a pharmaceutical composition for treating haemorrhoids as well as a preparation method and application thereof. The composition is prepared from the following raw materials: fructus forsythiae, radix et rhizoma rhei, herba violae, herba taraxaci, fructus gardeniae, radix scutellariae, radix scrophulariae and cortex dictamni. The traditional Chinese medicine composition disclosed by the invention is few in medicine flavor and remarkable in curative effect. Experiments show that the traditional Chinese medicine composition can achieve the treatment effect on haemorrhoids by relieving anus swelling, improving capillary permeability, eliminating inflammation, astringing ulcer wounds and accelerating wound healing, and has obvious advantages compared with an existing formula and a control group formula replacing medicine flavors.

Description

Technical Field

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

[0002] Hemorrhoids are a common and frequent disease in clinical practice. They can occur in men, women, old and young, and are more common in adults over 20 years old. The incidence rate gradually increases with age. The main clinical symptoms are repeated bleeding, prolapse and pain. There are many ways to treat hemorrhoids, which can be generally divided into traditional Chinese medicine and Western medicine. Among them, traditional Chinese medicine has unique advantages in the treatment of hemorrhoids, and is simple, convenient and inexpensive.

[0003] Surgical treatment of hemorrhoids has become the first choice of recommended and treatment options for clinicians. The complications caused by surgery have shifted the attention of clinical workers to the neglected traditional Chinese medicine treatment. Traditional Chinese medicine treatment of hemorrhoids has a long history, many methods, and significant efficacy. Compared with other therapies, it has the advantages of simple operation, low cost, less pain for patients, and low incidence of complications. Although with the development of science in recent years, the treatment of hemorrhoids has increasingly tended to surgical treatment, traditional Chinese medicine treatment still has its irreplaceable role, and there is a lot of room for development in both treatment methods and medication.

[0004] At present, Chinese patent medicines for treating hemorrhoids include Musk Hemorrhoid Suppositories, Sophora japonica Pills, etc. Authorization Publication No. CN106822354B discloses a medicine for treating hemorrhoids, which is composed of 13 medicinal materials including Angelica sinensis, Saposhnikovia divaricata, Scutellaria baicalensis, Honeysuckle, Chrysanthemum, Fructus Aurantii Immaturus, Fructus Cannabis, Rhubarb, Peony Root, Rehmannia glutinosa, Taraxacum mongolicum, Licorice, and Forsythia suspensa. All of the above medicines have the problems of complex formula and many medicinal flavors. It is clinically necessary to provide a formula with less medicinal flavor and good efficacy. Summary of the invention

[0005] In view of this, the present invention provides a Chinese medicine composition for treating hemorrhoids, which has less medicinal taste and significant curative effect.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] A traditional Chinese medicine composition for treating hemorrhoids, the raw materials of which include forsythia, rhubarb, viola yedoensis, dandelion, gardenia, scutellaria, scrophularia and dittany.

[0008] In the present invention, the weight parts of each raw material are as follows:

[0009] 6-10 parts of rhubarb, 5-8 parts of Scrophularia, 5-8 parts of Forsythia, 5-8 parts of Gardenia, 5-8 parts of Viola yedoensis, 5-8 parts of Taraxacum, 5-8 parts of Scutellaria, and 5-8 parts of Dictamni.

[0010] In the formula, rhubarb cools blood and detoxifies, is bitter and cold in nature, can purge downwards, and can both purge heat and promote bowel movements, cool blood and detoxify, disperse blood stasis and reduce swelling, so it is the main medicine; Forsythia suspensa, Taraxacum mongolicum, and Viola yedoensis are cold in nature, clearing away heat and detoxifying, dispersing nodules and eliminating carbuncles, and are good at treating heat toxic sores, so they are the ministerial medicines; Scrophularia ningpoensis, Scutellaria baicalensis, and Gardenia jasminoides are bitter and cold, clearing away, salty and soft, and are good at clearing heat and cooling blood, dispersing nodules and detoxifying, and nourishing yin and promoting bowel movements, so they are all adjuvants; Dictamni cortex is bitter and cold, clearing away, clearing away heat and dampness, dispelling wind and detoxifying, and can both clear away heat and detoxify, and promote water vapor in the small intestine, so it is the guiding medicine; the above 8 ingredients are used together to clear heat and cool blood, disperse nodules and reduce swelling, dispel wind and detoxify.

[0011] In a specific embodiment of the present invention, the weight parts of each raw material are:

[0012] 8 parts of Rheum officinale, 6 parts of Scrophularia ningpoensis, 6 parts of Fructus Forsythiae, 6 parts of Gardenia jasminoides, 6 parts of Viola yedoensis, 6 parts of Herba Taraxaci, 6 parts of Scutellariae baicalensis and 6 parts of Cortex Dictamni.

[0013] In some other specific embodiments, the weight parts of each raw material are:

[0014] 6 parts of Rheum officinale, 5 parts of Scrophularia ningpoensis, 8 parts of Fructus Forsythiae, 8 parts of Gardenia jasminoides, 8 parts of Viola yedoensis, 8 parts of Taraxacum officinale, 8 parts of Scutellaria baicalensis and 8 parts of Dictamni; or

[0015] In some other specific embodiments, the weight parts of each raw material are:

[0016] 10 parts of Rhei Radix, 8 parts of Scrophulariae, 5 parts of Fructus Forsythiae, 5 parts of Gardeniae, 5 parts of Viola yedoensis, 5 parts of Herba Taraxaci, 5 parts of Radix Scutellariae and 5 parts of Cortex Dictamni.

[0017] The present invention also provides a method for preparing the Chinese medicine composition, which is characterized by comprising:

[0018] (1) Crush rhubarb and Scrophularia ningpoensis to obtain fine powder;

[0019] (2) crushing the forsythia suspensa and gardenia jasminoides, mixing them with viola yedoensis, dandelion, scutellaria baicalensis, and diffusa odorata, and extracting with water; collecting the water extract and concentrating it to obtain an extract;

[0020] (3) The fine powder is mixed with the extract, dried, and crushed to obtain the traditional Chinese medicine composition.

[0021] In the preparation method of the present invention, the water extraction is as follows: adding 10 to 12 times the amount of water, soaking for 0.5 to 1 hour, extracting for 1.5 to 2 hours, adding water for the second time for 8 to 10 times the total weight of each raw material drug, extracting for 1 to 1.5 hours, filtering the water extract, combining the filtrate, and concentrating to obtain an extract.

[0022] The 10-fold amount of water refers to the amount of water added being 10 times the total weight of each raw material.

[0023] In some specific embodiments, the water extraction is: adding 10 times the amount of water, soaking for 1 hour, adding water to extract twice, adding 10 times the amount of water for the second extraction, filtering the water extract, combining the filtrate, and concentrating to obtain an extract.

[0024] In the preparation method of the present invention, the drying is carried out under reduced pressure at 60° C. to 70° C.

[0025] In some specific embodiments, the drying temperature is 60°C, 65°C or 70°C.

[0026] The present invention also provides application of the Chinese medicine composition or the Chinese medicine composition prepared by the preparation method in preparing medicine for treating hemorrhoids.

[0027] Wherein, the treatment includes at least one of the following: reducing rectal swelling rate, improving capillary permeability, reducing inflammatory factor levels and accelerating ulcer healing.

[0028] Furthermore, the inflammatory factors include IL-6 and / or TNF-α.

[0029] The present invention also provides a product for preventing, improving and / or treating hemorrhoids, comprising the Chinese medicine composition of the present invention or the Chinese medicine composition prepared by the preparation method.

[0030] In some embodiments, the product provided by the present invention is a drug, and the drug also includes an excipient acceptable in pharmacy, such as fatty acid glyceride, dextrin, corn starch, magnesium stearate, sucrose, etc. Those skilled in the art can select the appropriate type of excipients as needed, and prepare the desired dosage form according to the conventional preparation method in pharmacy. The dosage form includes but is not limited to tablets, pills, granules, suppositories or ointments.

[0031] The Chinese medicine composition of the present invention comprises forsythia, rhubarb, viola yedoensis, dandelion, gardenia, scutellaria, scrophularia and dactylic acid. The composition has the effects of clearing away heat and detoxicating, promoting blood circulation and removing blood stasis, promoting dampness and reducing swelling, and stopping bleeding and relieving pain. Pharmacodynamic related tests show that the therapeutic effect of the composition on hemorrhoids is significantly better than that of the existing prescription and the comparative prescription (the control sample replacing one or two of the ingredients of the present invention), indicating that the components in the composition are reasonably matched, synergistically effective, and indispensable. DETAILED DESCRIPTION

[0032] The present invention provides a Chinese medicine composition for treating hemorrhoids. Those skilled in the art can refer to the content of this article and appropriately improve the process parameters to achieve it. It is particularly important to point out that all similar replacements and modifications are obvious to those skilled in the art, and they are all considered to be included in the present invention. The method and application of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the method and application of this article without departing from the content, spirit and scope of the present invention to realize and apply the technology of the present invention.

[0033] The test materials used in the present invention are all common commercial products and can be purchased in the market.

[0034] The present invention will be further described below in conjunction with embodiments:

[0035] Example 1 Preparation of the composition of the present invention

[0036] Prescription: 8 parts of rhubarb, 6 parts of Scrophularia, 6 parts of Forsythia, 6 parts of Gardenia, 6 parts of Viola yedoensis, 6 parts of Taraxacum, 6 parts of Scutellaria, and 6 parts of Dictamni.

[0037] Preparation method:

[0038] (1) Take 8 parts of rhubarb and 6 parts of Scrophularia ningpoensis, grind them into fine powder, mix them evenly, and obtain fine powder 1, which is set aside.

[0039] (2) Take 6 parts of Forsythia suspensa and 6 parts of Gardenia jasminoides, crush them, add 6 parts of Viola yedoensis, 6 parts of Taraxacum officinale, 6 parts of Scutellaria baicalensis, and 6 parts of Dictamni cortex, soak them in 10 times the amount of water for 1 hour, add water to extract twice, each time for 2 hours, filter the water extract, combine the filtrate, and concentrate to obtain an extract.

[0040] (3) The fine powder 1 is mixed with the extract, dried under reduced pressure at 60°C to 70°C, and crushed to obtain a mixed powder.

[0041] (4) Take the mixed powder from step (3) and add an appropriate amount of sucrose to prepare granules.

[0042] Example 2 Preparation of the composition of the present invention

[0043] Prescription: 6 parts of rhubarb, 5 parts of Scrophularia, 8 parts of Forsythia, 8 parts of Gardenia, 8 parts of Viola yedoensis, 8 parts of Taraxacum, 8 parts of Scutellaria, and 8 parts of Dictamni.

[0044] Preparation method:

[0045] (1) Take 6 parts of rhubarb and 5 parts of Scrophularia, grind them into fine powder, mix them evenly, and set aside.

[0046] (2) Take 8 parts of Forsythia suspensa and 8 parts of Gardenia jasminoides, crush them, add 8 parts of Viola yedoensis, 8 parts of Taraxacum officinale, 8 parts of Scutellaria baicalensis, and 8 parts of Dictamni cortex, soak them in 12 times the amount of water, extract for 1 hour, add 10 times the amount of water for the second time, extract for 1 hour, filter the water extract, combine the filtrate, and concentrate to obtain an extract.

[0047] (3) The fine powder 1 is mixed with the extract, dried under reduced pressure at 60°C to 70°C, and crushed to obtain a mixed powder.

[0048] (4) Take the mixed powder of step (3), add appropriate amount of dextrin and corn starch, mix evenly, make granules, add appropriate amount of magnesium stearate, mix evenly, and press into tablets to make tablets.

[0049] Example 3 Preparation of the composition of the present invention

[0050] Prescription: 10 parts of rhubarb, 8 parts of Scrophularia, 5 parts of Forsythia, 5 parts of Gardenia, 5 parts of Viola yedoensis, 5 parts of Taraxacum, 5 parts of Scutellaria, and 5 parts of Dictamni.

[0051] Preparation method:

[0052] (1) Take 10 parts of rhubarb and 8 parts of Scrophularia ningpoensis, grind them into fine powder, mix them evenly, and obtain fine powder 1, which is set aside.

[0053] (2) Take 5 parts of Forsythia suspensa and 5 parts of Gardenia jasminoides, crush them, add 5 parts of Viola yedoensis, 5 parts of Taraxacum officinale, 5 parts of Scutellaria baicalensis, and 5 parts of Dictamni cortex, soak them in 10 times the amount of water for 1 hour, extract for 2 hours, add 8 times the amount of water for the second time, extract for 1.5 hours, filter the water extract, combine the filtrate, and concentrate to obtain an extract.

[0054] (3) The fine powder 1 is mixed with the extract, dried under reduced pressure at 60°C to 70°C, and crushed to obtain a mixed powder.

[0055] (4) Take the mixed fatty acid glyceride and dimethyl sulfoxide, heat and melt, add the mixed powder of step (3) when the temperature is 60-70°C, stir evenly, pour into a suppository mold, cool and make a suppository.

[0056] Test Case

[0057] (I) Grouping and sample preparation for groups 1 to 2 of each comparative sample

[0058] Composition group 1: a pharmaceutical composition (granules) prepared according to Example 1 of the present invention;

[0059] Composition Group 2: a pharmaceutical composition (tablet) prepared according to Example 2 of the present invention.

[0060] Composition group 3: a pharmaceutical composition (suppository) prepared according to Example 3 of the present invention.

[0061] Comparative sample group 1: prepared according to the formula and method of the specific implementation method of the specification of authorization publication number CN106822354B.

[0062] Comparison sample 2 groups:

[0063] Prescription: 7 parts of rhubarb, 6 parts of Scrophularia, 4 parts of Forsythia, 4 parts of Gardenia, 4 parts of Viola yedoensis, 4 parts of Taraxacum, 4 parts of Scutellaria, and 4 parts of Dictamni.

[0064] Preparation method:

[0065] (1) Take 7 parts of rhubarb and 6 parts of Scrophularia ningpoensis, grind them into fine powder, mix them evenly, and obtain fine powder 1, which is set aside.

[0066] (2) Take 4 parts of Forsythia suspensa and 4 parts of Gardenia jasminoides, crush them, add 4 parts of Viola yedoensis, 4 parts of Taraxacum officinale, 4 parts of Scutellaria baicalensis, and 4 parts of Dictamni cortex, soak them in 10 times the amount of water for 1 hour, add water to extract twice, each time for 2 hours, filter the water extract, combine the filtrate, and concentrate to obtain an extract.

[0067] (3) The fine powder 1 is mixed with the extract, dried under reduced pressure at 60°C to 70°C, and crushed to obtain a mixed powder.

[0068] (4) Take the mixed fatty acid glyceride and dimethyl sulfoxide, heat and melt, add the mixed powder of step (3) when the temperature is 60-70°C, stir evenly, pour into a suppository mold, cool and make a suppository.

[0069] (II) Instruments and reagents

[0070] SMP500-18272-LSIO microplate reader: Manufactured in China Designed in California USA; LD5-2A low-speed centrifuge: Beijing Medical Centrifuge Factory; JA1103N electronic balance: Shanghai Minqiao Precision Scientific Instrument Co., Ltd.; IL-6 and TNF-α kits, Nanjing Jiancheng Bioengineering Institute.

[0071] Experimental Animals:

[0072] Wistar rats, SPF grade, 180–220 g were purchased from Changchun Yisi Laboratory Animal Technology Co., Ltd., license number SCXK(Ji)-2020-0002.

[0073] (III) Experimental methods and results analysis

[0074] The above samples were used to conduct comparative studies on drug efficacy, and the methods and results are as follows:

[0075] 1. Effect of the drug composition on the hemorrhoid model of rats induced by croton oil

[0076] 1.1 Model establishment and drug administration

[0077] Distilled water, pyridine, ether and 6% croton oil ether solution were prepared in a ratio of 1:4:5:10 and mixed evenly to obtain a croton oil mixture. 70 male Wistar rats in good health were randomly divided into 7 groups: blank control group, model control group, comparison sample group 1, comparison sample group 2, combination group 1, combination group 2, and combination group 3. There were 10 rats in each group. The blank control group and the model control group were given purified water, the combination group 1, the combination group 2, and the comparison sample group 1 were given 10ml / kg of the corresponding drugs by gavage, and the combination group 3 and the control group 2 were given 0.2ml / rat of the corresponding drugs, and the drugs were administered anally. After each group was given the drugs, the croton oil mixture was injected into the anus of all rats except the blank control group, 0.15mL / rat, causing edema of the rat rectal mucosa to create an anal swelling model, and the swelling reached the peak after 6h of contact with croton oil. The drugs were administered again according to the dose 4h after modeling.

[0078] 1.2 Detection indicators

[0079] 1.2.1 Calculation and comparison of swelling rate Rats in each group were killed 2 hours after the second administration, and the rectum with a length of 15 mm from the anus was taken. The anus was cut from the edge of the fur, and the anus fur and connective tissue around the rectum were trimmed and weighed to obtain the rectal wet weight; the taken rectum was placed in a constant temperature drying oven at 80°C and dried for 16 hours, and weighed to obtain the rectal dry weight. The anal swelling rate was calculated according to the following formula, and the swelling rate was statistically analyzed. Rectal anal swelling rate (%) = (rectal wet weight - rectal dry weight) / rectal wet weight × 100%.

[0080] 1.2.2 Calculation and comparison of vascular permeability 30 minutes before the most obvious time of rectal edema formation (5.5 hours after the rectum was exposed to croton oil), 0.9% sodium chloride solution containing 1% Evans blue was injected into the tail vein at a dose of 20 mg / kg. The rats were killed 30 minutes later, and a 15 mm long rectum was taken from the edge of the anus fur and placed in 0.5 mL formamide solution for standby use. After 72 hours of constant temperature water bath at 45°C, the weight was weighed, and the OD value of the formamide solution in which the sample was immersed was measured at a wavelength of 620 nm using an enzyme marker. According to the Evans blue standard curve, the weight of Evans blue contained in each sample was calculated, and the rectal vascular permeability of each group of rats was calculated by the following formula, and statistical analysis was performed. Vascular permeability = Evans blue weight (μg) / rectum weight (g).

[0081] 1.3 Experimental Results

[0082] Compared with the blank control group, the rectal swelling rate in the model group was significantly increased (P < 0.001), and the vascular permeability was significantly reduced (P < 0.001). Compared with the model group, the rectal swelling rate was significantly reduced in the control sample groups 1 and 2, and the combined groups 1, 2, and 3, and the vascular permeability was significantly improved (P < 0.05, P < 0.01, P < 0.001). Compared with the control sample group 1, the combined group 3 reduced the rectal swelling rate, and the combined groups 1, 2, and 3 improved the vascular permeability, which was statistically significant (P < 0.05, P < 0.01). Compared with the control sample group 2, the combined groups 2 and 3 improved the vascular permeability. The results are shown in Table 1.

[0083] Table 1 Changes in rectal swelling rate and vascular permeability of rats in each group ( n=10)

[0084]

[0085] Note: Compared with the blank group ### P<0.001; compared with the model group * P<0.05, ** P<0.01, *** P<0.001, compared with control group 1, △P<0.05, △△ P<0.01; compared with control group 2 □ P<0.05.

[0086] 2. Effect of the drug composition on the rat hemorrhoidal ulcer model

[0087] 2.1 Model establishment and drug administration

[0088] 80 Wistar rats, half male and half female, 10 rats were randomly selected as blank group; filter paper with inner diameter of 6mm fully soaked in 99.0% acetic acid solution was placed around the anus of another 70 rats, so that the filter paper was in close contact with the skin and mucosa around the anus, one filter paper was used each time, and the filter paper was replaced once at 0.5 and 1min for each rat; the degree of ulcer was observed on the second day, and the rats were adjusted and divided into 7 groups according to the difference in ulcer area and the principle of half male and half female, namely blank control group, model control group, comparison sample group 1, comparison sample group 2, combination group 1, combination group 2, and combination group 3. The blank control group was given purified water, and the model control group (wet compress with cotton wool dipped in the same volume of physiological saline); the corresponding drugs were given by gavage to group 1, group 2, and comparison sample group 1 at 10ml / kg, and the corresponding drugs were given to group 3 and group 2 of the control group at 0.2ml / rat, and the drugs were administered to the anus, covered with plastic wrap and fixed with adhesive tape after administration, and the dressing was removed after 1h, and the medication site was cleaned with physiological saline. The drug was administered once a day for 7 consecutive days.

[0089] 2.2 Detection indicators

[0090] The local healing of the ulcer was observed on the 2nd, 4th, 6th day of administration and 24 hours after the last administration, and the ulcer score was assessed (assessment criteria: 1 point for ulcer exudate; 2 points for a little ulcer exudate; 3 points for eschar and basic healing; 4 points for complete healing). The peripheral blood IL-6 and TNF-α levels were detected by kits.

[0091] 2.3 Experimental Results

[0092] Table 2 Ulcer healing scores of rats in each group at different times ( n=10)

[0093]

[0094] Note: Compared with the model control group * P<0.05, ** P<0.01; compared with control group 1 △ P<0.05, △△ P<0.01; compared with control group 2 □ P<0.05, □□ P<0.01, □□□ P<0.001.

[0095] The model control group had varying degrees of ulcers and exudation within 1 to 8 days of modeling. Compared with the model control group, the ulcer healing was significantly accelerated in the composition 1, 2, and 3 groups on the 2nd and 4th days (P<0.05, P<0.01); on the 6th day and 24 hours after the last administration, the ulcer healing was significantly accelerated in the control sample 1, 2, and the composition 1, 2, and 3 groups (P<0.05, P<0.01, P<0.001). Compared with the control sample group 1, the exudate was reduced and the healing was accelerated in the composition group 1 on the 2nd day, the 4th and 6th days, and the last 24 hours of the composition 1, 2, and 3 days (P<0.05, P<0.01). Compared with the control sample group 2, the exudate was reduced and the healing was accelerated in the composition group 1 on the 2nd day, the 4th and 6th days, and the last 24 hours of the composition 1, 2, and 3 days (P<0.05, P<0.01, P<0.001).

[0096] Table 3 Changes of inflammatory indexes in rats in each group ( n=10)

[0097]

[0098] Note: Compared with the blank control group ## P<0.01, ### P<0.001; compared with the model control group * P<0.05, ** P<0.01, ***P<0.001, compared with control sample 1, △ P<0.05; compared with control group 2 □ P<0.05, □□ P<0.01, □□□ P<0.001.

[0099] Compared with the blank control group, the levels of inflammatory indicators IL-6 and TNF-α in the model control group were significantly increased (P<0.01, P<0.001). Compared with the model control group, the control sample groups 1 and 2, and the combination groups 1, 2, and 3 could reduce the levels of IL-6 and TNF-α (P<0.05, P<0.01, P<0.001). Compared with the control sample group 1, the combination groups 1 and 3 could reduce the level of IL-6 (P<0.05), and the combination group 3 could reduce the level of TNF-α; compared with the control sample group 2, the combination groups 1, 2, and 3 could reduce the levels of IL-6 and TNF-α (P<0.05, P<0.001).

[0100] (IV) Conclusion

[0101] The Chinese medicine composition of the present invention can achieve the therapeutic effect on hemorrhoids by reducing anal swelling, improving capillary permeability, eliminating inflammation, astringing ulcer wounds, and accelerating wound healing, and the effect is significantly better than that of comparative samples 1 and 2.

[0102] The above are only preferred embodiments of the present invention. It should be pointed out that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating hemorrhoids, characterized in that: Its raw materials include rhubarb, Scrophularia, Forsythia, Viola yedoensis, Taraxacum, Gardenia, Scutellaria baicalensis and Dictamni.

2. The Chinese medicine composition according to claim 1, characterized in that: The weight parts of each raw material are as follows: 6-10 parts of rhubarb, 5-8 parts of Scrophularia, 5-8 parts of Forsythia, 5-8 parts of Gardenia, 5-8 parts of Viola yedoensis, 5-8 parts of Taraxacum, 5-8 parts of Scutellaria, and 5-8 parts of Dictamni.

3. The Chinese medicine composition according to claim 2, characterized in that: The weight parts of each raw material are: 8 parts of Radix Rhei, 6 parts of Scrophulariae, 6 parts of Fructus Forsythiae, 6 parts of Gardenia, 6 parts of Viola Yedoensis, 6 parts of Taraxacum Herba, 6 parts of Scutellariae Baicalensis and 6 parts of Cortex Dictamni; or 6 parts of Rheum officinale, 5 parts of Scrophularia ningpoensis, 8 parts of Fructus Forsythiae, 8 parts of Gardenia jasminoides, 8 parts of Viola yedoensis, 8 parts of Taraxacum officinale, 8 parts of Scutellaria baicalensis and 8 parts of Dictamni; or 10 parts of Rhei Radix, 8 parts of Scrophulariae, 5 parts of Fructus Forsythiae, 5 parts of Gardeniae, 5 parts of Viola yedoensis, 5 parts of Herba Taraxaci, 5 parts of Radix Scutellariae and 5 parts of Cortex Dictamni.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, characterized in that: include: (1) Crush rhubarb and Scrophularia ningpoensis to obtain fine powder; (2) crushing Forsythia suspensa and Gardenia jasminoides, mixing with Viola yedoensis, Taraxacum officinale, Scutellaria baicalensis, and Dictamni cortex, and extracting with water; Collect the water extract and concentrate it to obtain an extract; (3) The fine powder is mixed with the extract, dried, and crushed to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that: The water extraction is as follows: adding 10-12 times the amount of water, soaking for 0.5-1 hour, extracting for 1.5-2 hours, adding 8-10 times the amount of water for the second time, extracting for 1-1.5 hours, filtering the water extract, combining the filtrate, and concentrating to obtain an extract.

6. The preparation method according to claim 5, characterized in that: The drying is carried out under reduced pressure at 60°C to 70°C.

7. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 6 in the preparation of a medicament for treating hemorrhoids.

8. The use according to claim 7, characterized in that: The treatment includes at least one of the following: reducing rectal swelling rate, improving capillary permeability, reducing inflammatory factor levels and accelerating ulcer healing; The inflammatory factors include IL-6 and / or TNF-α.

9. A product for preventing, improving and / or treating hemorrhoids, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine composition prepared by the preparation method according to any one of claims 4 to 6.

10. The product according to claim 9, characterized in that The dosage forms include tablets, pills, granules, suppositories, sustained release agents, gels or ointments.

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