Tibetan medicine for treating haemorrhoids as well as preparation method and application of Tibetan medicine

Abstract

The invention discloses a Tibetan medicine for treating haemorrhoids as well as a preparation method and application thereof, and relates to the technical field of Tibetan medicines. The Tibetan medicine for treating haemorrhoids is prepared from the following raw materials in parts by weight: 8 to 10 parts of ferula asafetida, 7 to 9 parts of tween-80, 90 to 110 parts of glycerol, 35 to 45 parts of peppermint oil, 3 to 5 parts of potassium sorbate, 8 to 10 parts of carbomer 940, 70 to 90 parts of extract, 0.1 to 0.2 part of musk, 6 to 7 parts of triethanolamine and 500 to 600 parts of deionized water, and the extract is extract of embelia laeta, fructus violae, fructus piperis longi and rhizoma zingiberis. According to the invention, the formula and dosage form of the Tibetan medicine are innovated, the gel-type external-use haemorrhoids Tibetan ointment is developed, the defects of poor bioavailability, inconvenience for patients to use and the like of pill treatment are overcome, and the effective components of the external-use haemorrhoids treatment gel can be quickly absorbed during use, so that the bioavailability is improved, the curative effect is enhanced, and the curative effect is improved. And the paste body is convenient to carry and is more easily accepted by the majority of patients.

Description

Technical Field

[0001] The invention relates to the technical field of Tibetan medicine preparations, and in particular to a Tibetan medicine for treating hemorrhoids and a preparation method and application thereof. Background Art

[0002] Hemorrhoids are a common chronic anorectal disease with an incidence rate of 55-75%. Long-term or intermittent symptoms such as blood in the stool, anal swelling, and pain seriously affect the patient's normal life. A variety of reasons can cause hemorrhoids. Currently, the treatment methods for hemorrhoids include surgery, oral or topical medications. Surgery is prone to recurrence and oral medications have many adverse reactions. Topical medications (especially traditional Chinese medicine) are increasingly gaining attention for the treatment of hemorrhoids because they are simple and easy to use with fewer adverse reactions. Summary of the invention

[0003] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a Tibetan medicine for external use in treating hemorrhoids and a preparation method and application thereof.

[0004] The objective of the present invention is achieved through the following technical solutions: A Tibetan medicine for treating hemorrhoids. The raw materials include, by weight: 8-10 parts of asafoetida, 7-9 parts of Tween-80, 90-110 parts of glycerol, 35-45 parts of peppermint oil, 3-5 parts of potassium sorbate, 8-10 parts of carbomer 940, 70-90 parts of extracts, 0.1-0.2 parts of musk, 6-7 parts of triethanolamine, and 500-600 parts of deionized water.

[0005] The extract is an extract of sour vine fruit, purple elm fruit, piper longum and dried ginger.

[0006] The Tibetan medicine is an external gel.

[0007] The preparation method of the Tibetan medicine for treating hemorrhoids comprises the following steps: evenly sprinkling Carbomer 940 on the surface of deionized water, standing to swell into a gel matrix; adding asafoetida, musk, Tween-80, potassium sorbate and triethanolamine into deionized water to prepare a suspension; sequentially adding glycerin, peppermint oil, the suspension and the extract into the gel matrix, stirring evenly each time a reagent is added before adding the next reagent, and finally slowly adding deionized water to make the volume 800 parts, stirring evenly, and preparing the Tibetan medicine for treating hemorrhoids.

[0008] The preparation method of the extract is as follows: taking sour vine fruit, purple lily, longan and dried ginger, grinding them into powder and then sieving them to obtain powder; using ethanol heating reflux method to extract the powder to obtain an extract as the extract.

[0009] The specific steps of heating and reflux of ethanol are as follows: add 10 times the amount of 60% ethanol to the powdered material, reflux and extract at 55°C twice, each time for 0.5 h, combine the filtrates and concentrate until each gram of extract contains 3 grams of medicinal materials.

[0010] The mass ratio of the extract raw materials, namely, sour vine fruit, purple schisandra chinensis, piper longum and dried ginger, is 4:2:2:1.

[0011] The third aspect of the present invention provides the use of the above Tibetan medicine for treating hemorrhoids in treating hemorrhoids.

[0012] The beneficial effects of the present invention are: The present application innovates the Tibetan medicine formula and dosage form, and develops a gel-type external Tibetan medicine ointment for hemorrhoids, which overcomes the shortcomings of poor bioavailability of pill treatment and inconvenience for patients. The external-use gel for treating hemorrhoids of the present application can be quickly absorbed by the active ingredients of the drug during use, thereby improving bioavailability and enhancing efficacy. The ointment is easy to carry and is more easily accepted by the majority of patients. It lays a foundation for the next step of the development and transformation of Tibetan medicine dosage forms for the treatment of hemorrhoids, and also provides a new drug for the treatment of hemorrhoids, contributing to the promotion of the local economy. DETAILED DESCRIPTION

[0013] The technical solution of the present invention will be clearly and completely described below in conjunction with the embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of the present invention.

[0014] Preparation of Tibetan ointment for external use on hemorrhoids: (1) Raw material pretreatment: Take the slices of Sour Ganoderma lucidum, Sour Ganoderma chinensis, Sour Ganoderma longituba and Dried Ginger, grind them into powder and pass through a No. 5 sieve for later use. The mass ratio of the slices of Sour Ganoderma lucidum, Sour Ganoderma chinensis, Sour Ganoderma longituba and Dried Ginger is 4:2:2:1.

[0015] (2) Preparation of extracts: Add 10 times the amount of 60% alcohol to the mixed powder obtained after pretreatment by ethanol heating and reflux method, and extract at 55°C for 2 times, each time for 0.5 h. Combine the filtrates and concentrate to 3 g of medicinal material per gram of extract. Cool and store in a 4°C refrigerator for later use.

[0016] (3) Preparation of Tibetan medicinal ointment for external use on hemorrhoids: Weigh 1.125 g of asafoetida, 12.5 mg of musk, 1 g of Tween-80, glycerol, 5 g of peppermint oil, 0.5 g of potassium sorbate, 0.8 g of triethanolamine, 1.2 g of carbomer 940, 10 g of extract and deionized water; sprinkle carbomer 940 evenly on the surface of 50 g of deionized water and let it swell for 24 h to obtain a gel matrix; add asafoetida, musk, Tween-80, potassium sorbate and triethanolamine to 30 g of deionized water to prepare a suspension for use; add glycerol, peppermint oil, suspension and extract to the gel matrix in sequence, stirring each reagent with a mixer before adding the next reagent, and finally slowly add the remaining deionized water to 100 g and stir evenly to obtain a Tibetan medicinal ointment for external use on hemorrhoids.

[0017] test: A total of 25 male SD rats were used for the test, with a body weight of 200±20g, an age of 6-8 weeks, and no specific pathogens. They were provided by Sibeifu (Beijing) Biotechnology Co., Ltd., and the animal production license number is SCXK (Beijing) 2024-0001. All rats were cultured for 7 days under the conditions of temperature (22±3)℃, humidity 50%±6%, and 12h light and dark cycle.

[0018] Main drugs and reagents Pyridine, ether, croton oil, and Mayinglong Musk Hemorrhoid Ointment were purchased from Wuhan Mayinglong Pharmaceutical Group Co., Ltd.; rat interleukin IL-1β, IL-6, and tumor necrosis factor-α enzyme-linked immunosorbent assay kits were purchased from Wuhan Gene Beauty Biotechnology Co., Ltd. The Tibetan ointment for external use of hemorrhoids prepared in this application.

[0019] Twenty-five SD rats were randomly divided into control group, model group, low-dose Tibetan ointment for external use for hemorrhoids group, high-dose Tibetan ointment for external use for hemorrhoids group and Mayinglong Musk Hemorrhoid Ointment group, with 5 rats in each group. The model was established after 7 days of adaptive feeding of rats. The rats were fasted for 12 hours before treatment. The model was established by inserting a sterile cotton swab (4.0 mm in diameter) soaked with 0.16 mL of croton oil suspension (distilled water, ether, pyridine and 6% croton oil mixed in a ratio of 1:5:4:10) into the rat anus (20 mm from the anus) and leaving it there for 30 seconds. This procedure was repeated for 3 days, once a day. All rats developed edema on the third day, indicating that the hemorrhoid model was successfully established. Rats in the blank control group received the same procedure, using cotton swabs soaked in deionized water instead of croton oil preparations. 24 hours after the end of the croton oil preparation induction, all experimental groups received drug treatment, rectally administered once a day for 3 consecutive days. The positive control group used Mayinglong Musk Hemorrhoid Ointment (1g / kg); the low-dose group of Tibetan medicinal ointment for hemorrhoids used 0.5g / kg Tibetan medicinal ointment for hemorrhoids; the high-dose group of Tibetan medicinal ointment for hemorrhoids used 1.0g / kg Tibetan medicinal ointment for hemorrhoids; at the same time, the blank control group and the hemorrhoid model group were given an equal amount of deionized water.

[0020] After the administration period, the rats were fasted for 12 h, and blood was collected after sodium pentobarbital anesthesia. The blood was kept at room temperature for 2 h, and then centrifuged at 4°C and 3500 r / min for 30 min to collect serum. The levels of IL-1β, IL-6, and TNF-α in serum were detected strictly according to the rat ELISA kit method.

[0021] Compared with the blank control group, the serum IL-1β, IL-6 and TNF-α levels in the hemorrhoids model group were increased (P<0.05); compared with the hemorrhoids model group, the serum IL-1β, IL-6 and TNF-α levels in the positive control group, low-dose and high-dose Tibetan ointment groups for hemorrhoids were decreased (P<0.05); the serum IL-1β, IL-6 and TNF-α levels in the high-dose Tibetan ointment group for hemorrhoids were lower than those in the low-dose Tibetan ointment group for hemorrhoids (P<0.05); there were no statistically significant changes in the serum IL-1β, IL-6 and TNF-α levels in the positive control group and high-dose Tibetan ointment group for hemorrhoids (P>0.05).

[0022] Anorectal coefficient analysis The rats were killed, and the anorectal tissues were collected and weighed after being rinsed with normal saline. The anorectal coefficient was expressed as the ratio of the anorectal tissue mass (mg) to the rat body mass (g).

[0023] Compared with the blank control group, the anorectal coefficient of rats in the hemorrhoids model group was increased (P<0.05); compared with the hemorrhoids model group, the anorectal coefficients of rats in the positive control group and the low- and high-dose groups of external Tibetan ointment for hemorrhoids were decreased (P<0.05); the anorectal coefficient of rats in the high-dose group of external Tibetan ointment for hemorrhoids was lower than that in the low-dose group of external Tibetan ointment for hemorrhoids (P<0.05); there was no statistically significant change in the anorectal coefficients of rats in the positive control group and the high-dose group of external Tibetan ointment for hemorrhoids (P>0.05).

[0024] It can be seen from the above two groups of data that the Tibetan ointment for external use of hemorrhoids prepared in the present application can treat hemorrhoidal rats.

[0025] The above is only a preferred embodiment of the present invention. It should be understood that the present invention is not limited to the form disclosed herein, and should not be regarded as excluding other embodiments, but can be used in various other combinations, modifications and environments, and can be modified within the scope of the concept described herein through the above teachings or the technology or knowledge of the relevant field. The changes and modifications made by those skilled in the art shall not deviate from the spirit and scope of the present invention, and shall be within the scope of protection of the claims attached to the present invention.

Claims

1. A Tibetan medicine for treating hemorrhoids, characterized in that: The raw materials include, by weight: 8-10 parts of asafoetida, 7-9 parts of Tween-80, 90-110 parts of glycerin, 35-45 parts of peppermint oil, 3-5 parts of potassium sorbate, 8-10 parts of carbomer 940, 70-90 parts of extracts, 0.1-0.2 parts of musk, 6-7 parts of triethanolamine, and 500-600 parts of deionized water; the extracts are extracts of sour vine fruit, purple mulberry fruit, piper longum and dried ginger.

2. The Tibetan medicine for treating hemorrhoids according to claim 1, characterized in that: The Tibetan medicine is an external gel.

3. A method for preparing a Tibetan medicine for treating hemorrhoids according to any of claims 1 to 2, characterized in that: The following steps are involved: Carbomer 940 is evenly sprinkled on the surface of deionized water, and allowed to stand to swell into a gel matrix; asafoetida, musk, Tween-80, potassium sorbate, and triethanolamine are added to deionized water to prepare a suspension; glycerin, peppermint oil, the suspension, and the extract are sequentially added to the gel matrix, each time a reagent is added, the mixture is stirred evenly before adding the next reagent, and finally deionized water is slowly added to make the volume 800 parts, and the mixture is stirred evenly to prepare a Tibetan medicine for treating hemorrhoids.

4. The preparation method according to claim 3, characterized in that: The preparation method of the extract comprises the following steps: taking sour vine fruit, purple lily, longan and dried ginger, grinding them into powder and then sieving them to obtain powder; extracting the powder by heating and refluxing ethanol to obtain an extract as the extract.

5. The preparation method according to claim 3, characterized in that: The ethanol heating reflux method is specifically as follows: adding 10 times the amount of 60% ethanol to the powdered material, reflux extraction at 55° C. for 2 times, each time for 0.5 h, combining the filtrates and concentrating until each gram of extract contains 3 grams of medicinal materials.

6. The preparation method according to claim 4, characterized in that: The mass ratio of the sour vine fruit, purple schisandra fruit, piper longum and dried ginger is 4:2:2:

1.

7. Use of the Tibetan medicine for treating hemorrhoids as claimed in claims 1 to 2 in treating hemorrhoids.