External ointment for treating haemorrhoids and hemorrhoid leakage tube and preparation method of external ointment

Abstract

The invention discloses an external ointment for treating haemorrhoids and hemorrhoid leakage tubes and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine external preparations. The ointment is prepared from the following components in percentage by weight: 60% of pogonatherum indicum, 20% of triminium, 10% of yellow lead, 10% of cinnabar and a proper amount of excipient Vaseline. The preparation method comprises the following steps: respectively crushing and sieving the raw materials, mixing, uniformly stirring with molten vaseline, and cooling. According to the monarch, minister, assistant and guide theory of traditional Chinese medicine, the paris polyphylla plays a monarch drug role in drawing out poison and diminishing inflammation, the triminium serves as a minister drug to assist in diminishing inflammation and promoting tissue regeneration, the yellow lead and the silver cinnabar serve as assistant and guide drugs to enhance the anti-inflammation effect, and the whole formula synergistically achieves the effects of drawing out poison, expelling pus, promoting tissue regeneration and relieving swelling and pain.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of external preparation of traditional Chinese medicine, in particular to an external ointment for treating hemorrhoids and hemorrhoid fistula and a preparation method thereof. BACKGROUND

[0002] Hemorrhoids is a common anorectal disease, including internal hemorrhoids, external hemorrhoids and mixed hemorrhoids, and its main symptoms are hematochezia, pain, swelling and prolapse, etc. Hemorrhoid fistula is a fistula formed by further development of hemorrhoids, often accompanied by symptoms such as pus and blood leakage and local infection, which seriously affects the quality of life of patients.

[0003] At present, the methods for treating hemorrhoids and hemorrhoid fistula mainly include surgical treatment and drug treatment. Although surgical treatment can solve the problem to some extent, it has the disadvantages of large trauma, slow postoperative recovery and easy recurrence, which brings great pain and economic burden to patients. In drug treatment, western medicine mainly focuses on anti-inflammatory and analgesic, which can only relieve symptoms and is difficult to cure completely, and long-term use can easily produce drug resistance and side effects. Traditional Chinese medicine preparations are various, but most of them have problems such as uncertain efficacy, slow effect and long treatment cycle.

[0004] Therefore, the present application provides an external preparation of traditional Chinese medicine which has significant effect, fast effect, high safety and can completely cure hemorrhoids and hemorrhoid fistula. SUMMARY

[0005] The present application aims to overcome the defects of poor efficacy and large side effects of existing drugs for treating hemorrhoids and hemorrhoid fistula, and provides an external ointment which has the effects of removing toxins and pus, promoting tissue regeneration, reducing swelling and relieving pain, can effectively treat various hemorrhoids and hemorrhoid fistula, and has high safety.

[0006] An external ointment for treating hemorrhoids and hemorrhoid fistula is prepared from the following raw materials in percentage by weight:

[0007] 60% of detoxification grass, 20% of Sanxian Dan, 10% of yellow dan, 10% of silver red, and an appropriate amount of excipient vaseline.

[0008] Preferably, the detoxification grass is a powder-like substance treated by drying and crushing, and the particle size is 80-120 mesh.

[0009] Preferably, the Sanxian Dan is a product treated by purification, and the purity is not less than 98%.

[0010] Preferably, the yellow dan and the silver red are powders treated by fine grinding, and the particle size is 100-150 mesh.

[0011] A preparation method of an external ointment for treating hemorrhoids and hemorrhoid fistula includes the following steps:

[0012] (1) Take out the poisonous grass, three immortal pills, yellow Dan, silver red by weight percentage, respectively, crushing, screening treatment, ready for use;

[0013] (2) The out poisonous grass, three immortal pills, yellow Dan, silver red mixed evenly after step (1) treatment, get mixed medicine powder;

[0014] (3) The vaseline is heated to the melting state, then add the mixed medicine powder obtained in step (2), stir evenly, cool to room temperature, the external use hemorrhoids ointment is obtained.

[0015] As preferred, in step (3), the mass ratio of vaseline and mixed medicine powder is 1:1-2:1.

[0016] As preferred, in step (3), the stirring speed is 300-500r / min, and the stirring time is 15-30min.

[0017] The beneficial effects of the present application are:

[0018] The external ointment of the present application takes the out poisonous grass as the monarch drug, which has a strong detoxification and anti-inflammatory effect, and can effectively remove toxins and inflammatory factors at the lesion site;

[0019] The three immortal pills are used as the minister drug, which assists the monarch drug to play the anti-inflammatory effect, and has the effect of promoting the repair and regeneration of damaged tissues at the same time;

[0020] The yellow Dan and silver red are used as the auxiliary drug, which further enhances the anti-inflammatory effect and plays a synergistic role with the monarch drug and the minister drug. The whole prescription is reasonably matched, and has the effects of detoxification, pus removal, tissue regeneration, swelling reduction and pain relief.

[0021] The preparation method of the present application is simple and easy to operate, the production cost is low, and it is suitable for large-scale production. The hemorrhoids ointment is an external preparation, which directly acts on the lesion, has a rapid effect, can quickly relieve the pain, swelling and other symptoms of the patient, promotes the automatic discharge of pus and blood in the fistula, accelerates the healing of hemorrhoids and hemorrhoids fistula, and has high safety and no obvious side effects. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical scheme and advantages of the embodiments of the present application more clear, the technical scheme of the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are part of the embodiments of the present application, not all. The components of the embodiments of the present application described and shown herein can be arranged and designed in various different configurations.

[0023] An external ointment for treating hemorrhoids and hemorrhoids fistula and a preparation method thereof

[0024] 1.1 Raw material preparation

[0025] Radix Rubi parvifolii: select dry, no impurities Radix Rubi parvifolii, use a pulverizer to crush and pass through a 100 mesh sieve, and reserve.

[0026] Sanxian Dan: purchase Sanxian Dan with a purity of 99%, and reserve.

[0027] Huangdan: select high-quality Huangdan, grind into powder using a fine grinder, and pass through a 120 mesh sieve, and reserve.

[0028] Yinshu: select high-quality Yinshu, grind into powder using a fine grinder, and pass through a 120 mesh sieve, and reserve.

[0029] Vaseline: select medical grade Vaseline, and reserve.

[0030] 1.2 Preparation of hemorrhoids and fistula ointment

[0031] According to the weight percentage, weigh 60 g of Radix Rubi parvifolii, 20 g of Sanxian Dan, 10 g of Huangdan, and 10 g of Yinshu, and mix the above raw materials uniformly to obtain a mixed medicinal powder. Weigh 500 g of Vaseline, heat to 60-70°C to melt it, then add the mixed medicinal powder, and stir at a stirring speed of 400 r / min for 20 min. After mixing uniformly, cool to room temperature, and then add 1% of borneol to melt it to enhance the anti-inflammatory and heat-clearing effects, and thus the external use hemorrhoids and fistula ointment is obtained.

[0032] 1.3 Method of use

[0033] Wash the affected area with warm water, dry it, and then take an appropriate amount of the external use hemorrhoids and fistula ointment of the present application, and evenly apply it to the hemorrhoid and hemorrhoid fistula affected area, 2-3 times a day.

[0034] 2. Experimental verification

[0035] 2.1 Animal experiment

[0036] 2.1.1 Purpose of experiment

[0037] Observe the treatment effect of the external use hemorrhoids and fistula ointment of the present application on the hemorrhoid model animals.

[0038] 2.1.2 Experimental materials

[0039] Experimental animals: select 60 healthy male SD rats with a body weight of 200-220 g, which are provided by a certain experimental animal center.

[0040] Test drugs: the external use hemorrhoids and fistula ointment prepared in the present application; positive control drug: a certain brand of hemorrhoids ointment on the market.

[0041] Experimental reagents: formaldehyde solution, physiological saline, etc.

[0042] 2.1.3 Experimental method

[0043] Establishment of hemorrhoid model: 60 SD rats were randomly divided into blank control group, model control group, low-dose group of the application, middle-dose group of the application, high-dose group of the application and positive control group, 10 rats in each group. Except the blank control group, the rest of the rats were injected with formaldehyde solution around the anus to establish the hemorrhoid model, and the specific operation was as follows: after the rats were anesthetized, 5% formaldehyde solution 0.1 ml / rat was injected subcutaneously around the anus to induce perianal inflammation, swelling and form a hemorrhoid model.

[0044] Method of administration: after the model was successfully established, the rats in the blank control group and the model control group were smeared with physiological saline around the anus, twice a day; the rats in the low-dose, middle-dose and high-dose groups of the application were smeared with 0.1 g, 0.2 g and 0.3 g of hemorrhoid and fistula ointment of the application around the anus, respectively, twice a day; the rats in the positive control group were smeared with 0.2 g of commercially available hemorrhoid ointment around the anus, twice a day. The administration was continuously performed for 7 days.

[0045] Observation index: the swelling degree of the rats in each group was observed at 1 day, 3 days, 5 days and 7 days after administration, and the swelling volume was measured; the pus and blood discharge and healing time of the rats in each group were recorded.

[0046] 2.1.4 Experimental results

[0047] The experimental results are shown in Table 1. As shown in Table 1, compared with the model control group, the swelling volume of the rats in each dose group of the application and the positive control group was significantly reduced (P<0.05), and the pus and blood discharge time and healing time were significantly shortened (P<0.05); and the effect of the middle-dose and high-dose groups of the application was better than that of the positive control group (P<0.05), and the effect of the high-dose group was better than that of the middle-dose group (P<0.05).

[0048] Table 1 Comparison of swelling volume, pus and blood discharge time and healing time of rats in each group (x±s)

[0049] Group Swollen volume (mm 3 )]]> Discharge time of pus and blood (days) Healing time (days) Blank control group 0.12±0.03 0 0 Model control group 2.85±0.31 5.62±0.58 8.75±0.72 Low-dose group of the application 1.86±0.25 4.15±0.42 6.52±0.61 Medium-dose group of the application 1.23±0.18 3.02±0.35 5.12±0.53 High-dose group of the application 0.85±0.12 2.15±0.28 4.05±0.41 Positive control group 1.56±0.21 3.86±0.40 6.02±0.58

[0050] 2.2 Clinical experiment

[0051] 2.2.1 Purpose of experiment

[0052] To observe the clinical treatment effect of the external use hemorrhoid and fistula ointment of the application on patients with hemorrhoids and hemorrhoid fistula.

[0053] 5.2.2 Experimental objects

[0054] Select 2023 January-2023 December in a hospital anorectal department of 120 cases of hemorrhoids and hemorrhoids fistula patients, including 70 cases of male, 50 cases of female, age 25-65 years old, 1-10 years of disease course. All patients meet the diagnostic criteria of hemorrhoids and hemorrhoids fistula, exclude severe liver and kidney dysfunction, pregnant and lactating women, etc. 120 patients were randomly divided into experimental group and control group, 60 cases in each group. The two groups of patients in gender, age, disease duration and other general information, the difference was not statistically significant (P>0.05), with comparable.

[0055] 2.2.3 treatment method

[0056] The experimental group used the external hemorrhoids ointment prepared by the application, 2-3 times a day, applied to the affected area; the control group used a certain brand of hemorrhoids ointment on the market, 2-3 times a day, applied to the affected area. Two groups of patients were treated for 4 weeks, during which spicy and irritating food was avoided, and the stool was kept unobstructed.

[0057] 2.2.4 curative effect judgment standard

[0058] Cure: hemorrhoids and hemorrhoids fistula symptoms completely disappeared, healing, no pain, swelling, pus and blood and other symptoms.

[0059] Markedly effective: hemorrhoids and hemorrhoids fistula symptoms improved significantly, pain and swelling were significantly reduced, and the amount of pus and blood in the fistula was significantly reduced.

[0060] Effective: hemorrhoids and hemorrhoids fistula symptoms improved, pain and swelling were reduced, and the amount of pus and blood in the fistula was reduced.

[0061] Invalid: hemorrhoids and hemorrhoids fistula symptoms were not improved, even worse.

[0062] Total effective rate=(cured cases+effective cases+effective cases) / total cases x 100%.

[0063] 2.2.5 experimental results

[0064] After 4 weeks of treatment, the treatment effect of the two groups of patients is shown in Table 2. As shown in Table 2, the cure rate of the experimental group was 55.0%, the effective rate was 25.0%, the effective rate was 15.0%, the ineffective rate was 5.0%, and the total effective rate was 95.0%; The cure rate of the control group was 30.0%, the effective rate was 20.0%, the effective rate was 25.0%, the ineffective rate was 25.0%, and the total effective rate was 75.0%. The total effective rate of the experimental group was significantly higher than that of the control group (P<0.05), and the cure rate of the experimental group was significantly better than that of the control group (P<0.05).

[0065] Table 2 comparison of treatment effect of two groups of patients (cases, %)

[0066] Group Example Recovery Marked effect Effectiveness Ineffectiveness Total effective rate Experimental group 60 33(55.0) 15(25.0) 9(15.0) 3(5.0) 57(95.0) Control group 60 18(30.0) 12(20.0) 15(25.0) 15(25.0) 45(75.0)

[0067] At the same time, the symptom improvement time of the two groups of patients was counted, and the results showed that the pain relief time, swelling subsidence time and fistula closure time of the experimental group were significantly shorter than those of the control group (P<0.05), and the specific data are shown in Table 3.

[0068] Table 3 Comparison of symptom improvement time of two groups of patients (days, x ± s)

[0069] Group Pain relief time Swelling subsidence time Leakage closure time Experimental group 2.15±0.58 3.26±0.72 14.52±2.15 Control group 3.86±0.85 5.68±1.02 21.35±3.26

[0070] In addition, during the treatment process, no obvious adverse reactions occurred in the two groups of patients, indicating that the present application has high safety.

[0071] Conclusion

[0072] The external use ointment of the present application is prepared from pull-toxic grass, three immortal dan, yellow dan, silver red and vaseline, and has the effects of removing toxic pus, promoting tissue regeneration, reducing swelling and relieving pain through the synergistic effect of monarch, minister, assistant and messenger. Animal experiment and clinical experiment results show that the hemorrhoids and fistula ointment can effectively treat various hemorrhoids and hemorrhoids fistula, has fast effect, definite curative effect and high safety, and has broad clinical application prospect and market value.

[0073] The above only describes the preferred embodiments of the present application patent, and does not limit the present application patent, and any modification, equivalent replacement and improvement made within the spirit and principle of the present application patent should be included in the protection scope of the present application patent.

Claims

1. An external ointment for treating hemorrhoids and hemorrhoidal fistulae, characterized by: The following raw materials are prepared according to the percentage by weight: ​ Ba ducao 60%, Sanxian dan 20%, huangdan 10%, yinshu 10%, and an appropriate amount of excipient vaseline.

2. The ointment for treating hemorrhoids and hemorrhoidal fistula according to claim 1, characterized in that: The ba ducao is a powder after drying and crushing, with a particle size of 80-120 mesh.

3. The ointment for treating hemorrhoids and hemorrhoidal fistula according to claim 1, characterized in that: The Sanxian dan is a product after purification, with a purity of no less than 98%.

4. The ointment for treating hemorrhoids and hemorrhoidal fistula according to claim 1, characterized in that: The huangdan and yinshu are both powders after fine grinding, with a particle size of 100-150 mesh.

5. A method of preparing the external ointment for treating hemorrhoids and hemorrhoidal fistula according to any one of claims 1 to 4, characterized by, The method comprises the following steps: (1) ba ducao, Sanxian dan, huangdan, and yinshu are weighed according to the percentage by weight, and are respectively crushed and sieved for standby; (2) the ba ducao, Sanxian dan, huangdan, and yinshu after step (1) are mixed evenly to obtain a mixed medicine powder; (3) vaseline is heated to a molten state, then the mixed medicine powder obtained in step (2) is added, stirred evenly, and cooled to room temperature to obtain the external use hemorrhoid and fistula ointment.

6. A method of manufacture according to claim 5, wherein: In step (3), the mass ratio of vaseline to the mixed medicine powder is 1:1-2:

1.

7. The method of claim 5, wherein: In step (3), the stirring speed is 300-500 r / min, and the stirring time is 15-30 min.