Poloxamer hydrogel for treating haemorrhoids
By using poloxamer hydrogel, combined with specific formula ingredients and preparation methods, the problems of limited effects and side effects of existing hemorrhoid treatment methods are solved, and the effect of significantly improving symptoms and signs is achieved, and it is safe and convenient to use.
Patent Information
- Application Number
- CN202510521755.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-04-24
- Publication Date
- 2025-06-17
AI Technical Summary
Among the existing hemorrhoid treatment methods, non-surgical treatment has limited effect, surgical treatment has side effects and inconvenience, and the existing external gels are inactivated in multiple links in the body, reducing the efficacy of the drug.
Poloxamer hydrogel is used as a topical drug for treating hemorrhoids. The main ingredients are poloxamer and purified water, combined with carbomer, glycerol, disodium edeate, triethanolamine and hydroxybenzene, and gel is formed by specific preparation methods.
Poloxamer hydrogel significantly improves the clinical symptoms and signs of hemorrhoid patients, reduces anal pain and swelling, promotes the dissipation of inflammation, improves local blood and lymph circulation, and is safe to use and easy to carry, with better results than traditional methods.
Smart Images
Figure SMS_1 
Figure SMS_14
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of medicine and relates to a poloxamer hydrogel for the treatment of hemorrhoids. Background Art
[0002] Hemorrhoids refer to a chronic disease in which varices form in the venous plexus at the bottom of the anorectum and the anal mucosa, resulting in one or more soft venous masses. Hemorrhoids are a common anorectal disease, which is mostly related to factors such as defecation habits, sitting or standing for a long time, constipation, obesity, and eating habits. Generally, hemorrhoids are divided into internal hemorrhoids, external hemorrhoids, and mixed hemorrhoids. Internal hemorrhoids are located inside the anus and usually do not cause pain. The main symptoms are bleeding during defecation and / or anal moistness and itching. External hemorrhoids are located outside the anus and usually cause pain, swelling, and itching of the skin around the anus, making defecation difficult. Mixed hemorrhoids show the coexistence of internal hemorrhoids and external hemorrhoids, and have the symptoms of both internal and external hemorrhoids.
[0003] In modern medicine, the treatment of hemorrhoids focuses on eliminating and alleviating symptoms. Doctors usually give priority to non-surgical therapies. For some surgical therapies targeting the hemorrhoid nucleus itself and relieving the cause, they are only considered when non-surgical therapies are ineffective. Anal topical medications can directly act on the wound surface, and the drug efficacy can reach the affected area, enabling absorption to play a preventive and therapeutic role. It can avoid the inactivation effect of the drug in multiple links in the body, reduce the drug efficacy, and at the same time avoid certain side effects of the drug. It is the preferred administration plan for the treatment of anal diseases such as hemorrhoids. Through clinical observation, it is found that hemorrhoid gel can improve the clinical symptoms and signs of hemorrhoid patients, relieve the anal pain and a sense of swelling of patients, promote the dissipation of body inflammation, improve local blood circulation and lymphatic circulation, and the use method of hemorrhoid gel is simple, easy to carry, and safe to use, and it is easily accepted by the majority of patients. Due to the wide use of topical medications for the treatment of hemorrhoids, studying a hemorrhoid topical gel with reliable efficacy and low irritation has high clinical significance. Summary of the Invention
[0004] The present invention provides a poloxamer hydrogel for the treatment of hemorrhoids with remarkable efficacy and low irritation.
[0005] The main components of the poloxamer hydrogel for the treatment of hemorrhoids provided by the present invention are: poloxamer and purified water.
[0006] Preferably, the poloxamer is poloxamer 407 or poloxamer 188.
[0007] Preferably, the dosage of the poloxamer is 2.5 - 3.5%, and more preferably, the dosage of the poloxamer is 3.0%.
[0008] Preferably, the poloxamer hydrogel for the treatment of hemorrhoids provided by the present invention further contains carbomer, and preferably, the carbomer is carbomer homopolymer type C.
[0009] Preferably, the poloxamer hydrogel for treating hemorrhoids provided by the present invention further contains glycerol, disodium edetate, triethanolamine and methylparaben.
[0010] Preferably, the dosage of carbomer is 0.6-1.0%, more preferably, the dosage of carbomer is 0.8%; the dosage of glycerol is 2.0%; the dosage of disodium edetate is 0.05%; the dosage of triethanolamine is 0.5%; the dosage of methylparaben is 0.1%.
[0011] The present invention also provides a preparation method of the above poloxamer hydrogel, which includes the following steps:
[0012] (1) Weigh poloxamer and add it to purified water, quickly stir and homogenize for 5 min, keep it at 85 °C for 20 min, stir evenly, cool to room temperature, add purified water to 1000 ml, and stir evenly.
[0013] (2) Fill the gel obtained in step (1) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0014] Preferably, the homogenization parameter in step (1) is 40 HZ.
[0015] When the formula contains carbomer, glycerol, triethanolamine, disodium edetate, and methylparaben, the preparation method of the above poloxamer hydrogel includes the following steps:
[0016] (1) Take an appropriate amount of purified water, add triethanolamine to a container and stir evenly to obtain a pre-solution.
[0017] (2) Weigh glycerol and an appropriate amount of purified water in a batching tank, start stirring, heat up to 85 °C, add disodium edetate and methylparaben, and stir until completely dissolved.
[0018] (3) Weigh carbomer and poloxamer and add them, quickly stir and homogenize for 5 min, keep it at 85 °C for 20 min, and stir evenly.
[0019] (4) Add the triethanolamine pre-solution to the batching tank, add purified water to the full volume, and stir evenly.
[0020] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0021] Preferably, the homogenization parameter in step (3) is 40 HZ.
[0022] In the prior art, carbomer is commonly used to make hemorrhoid gels. The present invention uses a specific proportion of poloxamer as the ingredient for treating hemorrhoids, and has achieved unexpected technical effects. Detailed Embodiments
[0023] Example 1 Preparation of Poloxamer Hydrogel
[0024] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0025] (2) Take 700 ml of purified water and add it to a batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0026] (3) Weigh 6 g of Carbomer homopolymer C type and 25 g of Poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0027] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0028] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0029] Example 2 Preparation of Poloxamer Hydrogel
[0030] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0031] (2) Take 700 ml of purified water and add it to a batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0032] (3) Weigh 10 g of Carbomer homopolymer C type and 35 g of Poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0033] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0034] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0035] Example 3 Preparation of Poloxamer Hydrogel
[0036] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0037] (2) Take 700 ml of purified water and add it to the batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0038] (3) Weigh 8 g of carbomer homopolymer type C and 30 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0039] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0040] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0041] Example 4 Preparation of Poloxamer Hydrogel
[0042] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution.
[0043] (2) Take 700 ml of purified water and add it to the batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0044] (3) Weigh 8 g of carbomer homopolymer type B and 30 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0045] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0046] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0047] Example 5 Preparation of Poloxamer Hydrogel
[0048] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution.
[0049] (2) Take 700 ml of purified water and add it to the batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0050] (3) Weigh 8 g of carbomer homopolymer type C and 30 g of poloxamer 188, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0051] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0052] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0053] Example 6 Preparation of Poloxamer Hydrogel
[0054] (1) Weigh 30 g of poloxamer 407, add it to 700 ml of purified water, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, stir evenly, cool to room temperature, add purified water to 1000 ml, and stir evenly.
[0055] (2) Fill the gel obtained in step (1) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0056] Example 7 Preparation of Poloxamer Hydrogel
[0057] (1) Weigh 24 g of poloxamer 407, add it to 700 ml of purified water, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, stir evenly, cool to room temperature, add purified water to 1000 ml, and stir evenly.
[0058] (2) Fill the gel obtained in step (1) into an aluminum-plastic tube to obtain the poloxamer hydrogel
[0059] Example 8 Preparation of Poloxamer Hydrogel
[0060] (1) Weigh 36 g of poloxamer 407, add it to 700 ml of purified water, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, stir evenly, cool to room temperature, add purified water to 1000 ml, and stir evenly.
[0061] (2) Fill the gel obtained in step (1) into an aluminum-plastic tube to obtain the poloxamer hydrogel
[0062] Example 9 Preparation of Poloxamer Hydrogel
[0063] (1) Take 100 ml of purified water and add it to a container, add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0064] (2) Take 700 ml of purified water and add it to the batching tank, add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0065] (3) Weigh and add 30 g of poloxamer 407, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0066] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0067] Comparative Example 1 Preparation of poloxamer hydrogel
[0068] (1) Take 100 ml of purified water and add it to a container, add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0069] (2) Take 700 ml of purified water and add it to the batching tank, add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0070] (3) Weigh and add 5 g of carbomer homopolymer C type and 30 g of poloxamer 407, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0071] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0072] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0073] Comparative Example 2 Preparation of poloxamer hydrogel
[0074] (1) Take 100 ml of purified water and add it to a container, add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0075] (2) Take 700 ml of purified water and add it to the batching tank, add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0076] (3) Weigh and add 8 g of carbomer homopolymer C type and 23 g of poloxamer 407, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0077] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0078] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0079] Comparative Example 3 Preparation of Poloxamer Hydrogel
[0080] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0081] (2) Take 700 ml of purified water and add it to a batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0082] (3) Weigh 11 g of Carbomer homopolymer C type and 30 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0083] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0084] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0085] Comparative Example 4 Preparation of Poloxamer Hydrogel
[0086] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0087] (2) Take 700 ml of purified water and add it to a batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0088] (3) Weigh 8 g of Carbomer homopolymer C type and 36 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0089] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0090] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0091] Comparative Example 5 Preparation of Poloxamer Hydrogel
[0092] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0093] (2) Take 700 ml of purified water and add it to the batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0094] (3) Weigh 11 g of carbomer homopolymer type C and 36 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0095] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0096] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0097] Comparative Example 6 Preparation of Poloxamer Hydrogel
[0098] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution.
[0099] (2) Take 700 ml of purified water and add it to the batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0100] (3) Weigh 5 g of carbomer homopolymer type C and 24 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0101] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0102] (5) Fill the gel obtained in step (4) into an aluminum-plastic tube to obtain the poloxamer hydrogel.
[0103] Comparative Example 7 Preparation of Carbomer Hydrogel
[0104] (1) Take 100 ml of purified water and add it to a container. Add 5 g of triethanolamine and stir evenly to obtain a pre-solution.
[0105] (2) Take 700 ml of purified water and add it to the batching tank. Add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0106] (3) Weigh 8 g of carbomer homopolymer type C, add it, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0107] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly.
[0108] (5) Pour the gel obtained in step (4) into an aluminum-plastic tube to obtain the hydrogel.
[0109] Comparative Example 8 Preparation of poloxamer hydrogel
[0110] (1) Take 100 ml of purified water and add it to a container, add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0111] (2) Take 700 ml of purified water and add it to the batching tank, add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0112] (3) Weigh 8 g of carbomer homopolymer type C and 30 g of poloxamer 407, add them, stir rapidly and homogenize at 30 HZ for 5 min, keep warm at 85 °C for 20 min, and stir evenly.
[0113] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly, but the gel does not form.
[0114] Comparative Example 9 Preparation of poloxamer hydrogel
[0115] (1) Take 100 ml of purified water and add it to a container, add 5 g of triethanolamine and stir evenly to obtain a pre-solution;
[0116] (2) Take 700 ml of purified water and add it to the batching tank, add 20 g of glycerol, start stirring, heat up to 85 °C, add 0.5 g of disodium edetate and 1 g of methylparaben, and stir until completely dissolved.
[0117] (3) Weigh 8 g of carbomer homopolymer type C and 30 g of poloxamer 407, add them, stir rapidly and homogenize at 40 HZ for 5 min, keep warm at 75 °C for 20 min, and stir evenly.
[0118] (4) Add the triethanolamine pre-solution prepared in step (1) to the batching tank, add purified water to 1000 ml, and stir evenly, but the gel does not form.
[0119] The present invention provides the following test and comparison results:
[0120] Gel mucosal irritation test:
[0121] Negative control: physiological saline;
[0122] Positive control: The gels prepared in the examples and control examples;
[0123] Test animals: New Zealand rabbits, weighing about 3.0 kg, 4 rabbits in each group, 2 males and 2 females.
[0124] Test method: The New Zealand rabbits in each group were observed for 1 week for adaptation. There were no abnormalities in activities, feeding, defecation, etc. Then, rectal administration was started by injecting through the anus. The blank control group was given normal saline, and the positive control group was given the gels prepared in the examples and comparative examples. The drug was administered once in the morning and once in the evening, 2 g each time, and each contact lasted for 6 h. The drug administration continued for 7 days. After the last drug administration, half of the animals were sacrificed, and the rectum was taken to observe any changes such as hyperemia, bleeding, ulceration, etc. of the mucosa. Immediately after that, it was fixed with 10% formalin and then subjected to pathological histological examination and compared with the blank control group. The remaining animals were continuously observed daily and sacrificed on the 7th day to observe the rectal changes.
[0125] Result evaluation: Using pathological examination and gross morphology as indicators, observe whether there is a stimulating effect on the rectal mucosa of each group of gels.
[0126] Test results:
[0127] The results of both pathological examination and gross morphology examination showed that compared with the negative control group, Examples 3, 4, 5, 6, 7, 8, and 9 did not show mucosal irritation. The pathological examination results showed that the mucosal layer was intact, and there was no hyperemia in the submucosa and serosa layers; in Examples 1 and 2 and Comparative Examples 1-6, there was mild to moderate hyperemia in the submucosa and serosa layers, indicating a mild stimulating effect on the rectal mucosa of rabbits; in Comparative Example 7, there was a small amount of shedding on the mucosal surface, and the submucosa and serosa layers were significantly hyperemic, indicating an obvious stimulating effect on the rectal mucosa of rabbits.
[0128] The above mucosal irritation test showed that poloxamer has no irritating effect on the mucosa. The combined use of poloxamer and carbomer can relieve the mucosal irritation of carbomer when preparing hydrogels, especially when the dosage of poloxamer is 2.5-3.5% and the dosage of carbomer is 0.6-1.0%, the effect is the best.
[0129] II. Effect of the gel on croton oil-induced anal swelling in rats
[0130] Take experimental mice, weighing 330 - 340 g, 12 - 13 weeks old, with an equal number of males and females. Prepare an inflammatory agent by mixing 1 part of distilled water, 4 parts of pyridine, 5 parts of ether, and 10 parts of 6% croton oil ether solution. Fast the mice for 12 h before treatment. Insert a sterile cotton swab (4.00 mm in diameter) adsorbed with 200 μL of croton oil preparation into the anus of the rats (20 mm from the anus) and place it for 25 s, once a day for 4 consecutive days. Severe edema, leukocyte infiltration, degeneration and necrosis of glandular epithelium, mucosal layer and submucosal layer occurred in the anorectal tissues of the rats, and the mucosa in the inflammatory area was thickened and edematous, with severe blood vessel dilation, simulating the symptoms of human anorectal hemorrhoids. Select mice for grouping according to the degree of swelling. Five mice were used in each group for the examples, comparative examples, and blank examples (i.e., the non-drug group) for the experiment. Administer the drug rectally once a day, 0.6 g each time, for 7 consecutive days. On the 8th day, sacrifice the mice, collect the anorectal tissues, and examine the pathological changes of the tissues. The specific results are shown in Table 1:
[0131] Table 1 Effects of the gel on croton oil-induced anal swelling in rats
[0132]
[0133] The results of the croton oil-induced anal swelling test in rats in Table 1 above show that poloxamer has a positive effect on the treatment of hemorrhoids. The combined use of poloxamer and carbomer has a better effect on the treatment of hemorrhoids when the dosage of poloxamer is 2.5 - 3.5% and the dosage of carbomer is 0.6 - 1.0%. In particular, the effect is the best when the dosage of poloxamer is 3.0% and the dosage of carbomer is 0.8%.
[0134] III. Clinical use effect
[0135] To further illustrate the curative effect of the poloxamer hydrogel of the present invention on the treatment of hemorrhoids, the following presents the observational data on the clinical use effect of the poloxamer hemorrhoid gel on hemorrhoid patients.
[0136] Recruit 90 patients diagnosed with hemorrhoids in the outpatient clinic, and after screening, the hemorrhoid grades are respectively grade 30 cases, grade 30 cases, grade 30 cases; Divide the patients into 3 groups on average, namely the treatment group of Example 3, the treatment group of Example 6, and the control group treated with Musk Hemorrhoid Ointment (referred to as the control group). In the treatment group of Example 3, there are 16 males and 14 females, aged 42 - 55 years old, with an average age of 47 years old, grade, grade, grade 10 cases each; In the treatment group of Example 6, there are 15 males and 15 females, aged 39 - 58 years old, with an average age of 48 years old, grade, grade, There were 10 cases in each of the grade, grade, grade, with 10 cases in each group. There were no significant differences among the three groups of patients in terms of disease condition, gender, age, etc.
[0137] Treatment method:
[0138] Adopt the squatting position (or the supine position, with the legs bent in the supine position), and relax the body; according to the grade of hemorrhoids, apply the product to the affected area or squeeze the product into the anus; 2 g each time, twice a day; the usage period is 2 weeks. The clinical usage results are shown in the following table:
[0139] Table 2 Clinical usage results
[0140]
[0141] The results in Table 2 above show that poloxamer hydrogel has a positive effect on the treatment of hemorrhoids. The combined use of poloxamer and carbomer has a better therapeutic effect, and the cure rate and effective rate are better than those of the control group.
[0142] The above is the preferred implementation manner of the present invention. Of course, the scope of the rights of the present invention cannot be limited thereby. It should be pointed out that for those of ordinary skill in the art in this technical field, without departing from the principle of the present invention, several improvements and changes can still be made, and these improvements and changes are also regarded as the protection scope of the present invention.
Claims
1. A poloxamer hydrogel for treating hemorrhoids, characterized in that: The hydrogel consists of poloxamer and purified water.
2. The poloxamer hydrogel according to claim 1, wherein The poloxamer is poloxamer 407 or poloxamer 188.
3. The poloxamer hydrogel according to claim 1, characterized in that The dosage of the poloxamer is 2.5-3.5%.
4. The poloxamer hydrogel according to claim 3, characterized in that The dosage of the poloxamer is 3.0%.
5. The poloxamer hydrogel according to claim 1, characterized in that The poloxamer gel also contains 0.6-1.0% of carbomer, 0.05% of disodium edetate, 2.0% of glycerol, 0.5% of triethanolamine and 0.1% of methylparaben.
6. The poloxamer hydrogel according to claim 5, characterized in that The carbomer is carbomer homopolymer C type.
7. The poloxamer hydrogel according to claim 5, characterized in that The dosage of the carbomer is 0.8%.
8. The method for preparing the poloxamer hydrogel according to claim 1, comprising the following steps: (1) Weigh poloxamer and add purified water, stir rapidly and homogenize for 5 min, keep at 85°C for 20 min, stir evenly, cool to room temperature, add purified water to 1000 ml, and stir evenly; (2) The gel obtained in step (1) is filled into an aluminum-plastic tube to obtain a poloxamer hydrogel.
9. The method for preparing the poloxamer hydrogel according to claim 8, characterized in that: The homogenizing parameter is 40HZ.
10. The method for preparing the poloxamer hydrogel according to claim 5, comprising the following steps: (1) Take an appropriate amount of purified water, add triethanolamine into a container and stir evenly to obtain a pre-solution; (2) Weigh glycerin and an appropriate amount of purified water into a mixing tank and start stirring. Heat to 85°C, add disodium edetate and methylparaben, and stir until completely dissolved. (3) Weigh carbomer and poloxamer, add them, stir rapidly and homogenize at 40 Hz for 5 min, keep warm at 85°C for 20 min, and stir evenly; (4) Add triethanolamine pre-solution to the batching tank, add purified water to the full amount, and stir evenly; (5) The gel obtained in step (4) is filled into an aluminum-plastic tube to obtain a poloxamer hydrogel.