Medical dressing for treating constipation

Abstract

The invention provides a medical constipation dressing which is characterized by comprising the following components in percentage by mass: 1%-2% of carbomer, 5% of glycerol, 1%-2% of isomaltooligosacharide, 0.5%-0.7% of sodium alginate, 0.3%-0.5% of ethyl p-hydroxybenzoate and the balance of purified water. The medical constipation dressing can avoid harm caused by long-term medicine taking, the components are matched to achieve the moisturizing, lubricating and anti-inflammation effects, and the medical constipation dressing is suitable for various people suffering from postpartum constipation, adult constipation, pregnant woman and child constipation, old people habitual constipation and the like.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and particularly to a medical constipation dressing. Background Art

[0002] The methods for treating constipation include drug treatment, biofeedback therapy, and surgical treatment. For constipation caused by rectal and anal as well as pelvic floor muscle dysfunction, biofeedback therapy can be used for treatment, and severe intractable constipation can be considered for surgical treatment. In less severe cases, the general approach is drug treatment, and appropriate drugs need to be selected according to the condition. Commonly used drugs are bulk laxatives, osmotic laxatives, and lubricating laxatives. Some lubricating laxative dressings on the market have the defect of insufficiently ideal moisturizing performance; in addition, some also have the problem of poor stability. After the medicament is opened and used, if it is not used up within a short time, the remaining medicament is prone to deterioration. Summary of the Invention

[0003] In order to solve the above problems, the present invention aims to provide a medical constipation dressing with better moisturizing, lubricating, and anti-inflammatory properties.

[0004] To achieve the above object, the present invention adopts the following technical solutions:

[0005] The present invention provides a medical constipation dressing, which is characterized by consisting of the following components in mass percentages: carbomer 1% - 2%, glycerol 5%, isomaltooligosaccharide 1% - 2%, sodium alginate 0.5% - 0.7%, ethyl p-hydroxybenzoate 0.3% - 0.5%, and the balance being purified water.

[0006] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: the medical constipation dressing is prepared by the following method: Step 1: Weigh the raw materials of each component and divide the purified water into three parts; Step 2: Take the first part of the purified water, sprinkle the weighed carbomer into the purified water, and continuously stir until a uniform colloidal solution is formed; Step 3: Add the weighed glycerol and isomaltooligosaccharide to the colloidal solution obtained in Step 2 and stir evenly; Step 4: Add the weighed sodium alginate to the colloidal solution obtained in Step 3 and stir evenly; Step 5: Heat the second part of the purified water, then add ethyl p-hydroxybenzoate thereto, and after ethyl p-hydroxybenzoate is completely dissolved in the purified water, add the obtained dissolved solution to the colloidal solution obtained in Step 3 and stir evenly; Step 6: Add the third part of the purified water to the mixed solution, stir while adding, and after the purified water is added, stir evenly again to obtain the medical constipation dressing.

[0007] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: the first part of purified water is 20% - 30% of the total amount of purified water, the second part of purified water is greater than or equal to the amount that can completely dissolve ethyl p-hydroxybenzoate, and the third part of purified water is the remaining purified water.

[0008] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: the second part of purified water is heated to 40°C - 50°C.

[0009] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: during the preparation process of the medical constipation dressing, the environmental temperature is controlled below 28°C.

[0010] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: during the preparation process of the medical constipation dressing, the environmental humidity in winter is controlled at 30% - 50%, and the environmental humidity in summer is controlled at 50% - 70%.

[0011] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: the medical constipation dressing obtained in step six is gel-like, and then the medical constipation dressing is filled into low-density polyethylene bottles, and after filling and sealing, it is irradiated and sterilized.

[0012] Further, in the medical constipation dressing provided by the present invention, it may also have the following characteristics: the pH value of the medical constipation dressing is 4.0 - 7.0.

[0013] Advantages of the present invention:

[0014] In the medical constipation dressing provided by the present invention, glycerol has the functions of moisturizing and lubricating. In the gel, after being applied to the skin or mucous membrane surface, it will form a protective film to reduce the irritation of external factors to the local area; isomaltooligosaccharide and sodium alginate are lubricants, which play the roles of moisturizing and lubricating, and cooperate with glycerol to further prevent skin dryness and promote intestinal peristalsis; in addition, isomaltooligosaccharide is also a prebiotic, which can provide certain nutritional components for the skin and promote skin health; sodium alginate can quickly form a gel when encountering divalent cations (such as calcium ions), and this property enables it to form a stable gel-like protective film on the wound surface, providing a moist healing environment for the wound, isolating external bacteria and other pollutants, and at the same time allowing oxygen and water vapor to exchange; ethylparaben, as a preservative, can effectively inhibit the growth and reproduction of microorganisms (such as bacteria, fungi, etc.), prevent the liquid dressing from deteriorating during storage, extend the shelf life of the product, and ensure the safety and effectiveness of the product within the validity period; carbomer plays the roles of thickening and emulsifying in the gel, and can make the gel have good rheological properties, such as appropriate viscosity and elasticity.

[0015] The pH value range of the medical constipation dressing provided by the present invention is 4.0 - 7.0, which is close to the human body's pH level. The medical constipation dressing of the present invention can avoid the harm caused by long-term medication, and the combination of its components plays a role in moisturizing, lubricating, and anti-inflammatory. The medical constipation dressing of the present invention is produced under sterile conditions to protect the balance of the anorectal flora. This medical constipation dressing has a relatively high comfort level, is small and portable, has no drug resistance, takes effect quickly, and is applicable to various groups such as postpartum constipation, adult constipation, constipation in pregnant women and children, and habitual constipation in the elderly. Description of the Drawings

[0016] Figure 1 It is a schematic diagram of the production process of the medical constipation dressing in the embodiment of the present invention;

[0017] Figure 2 It is the finished product of the medical constipation dressing in the embodiment of the present invention. Detailed Embodiments

[0018] In order to make the technical means, creative features, achieved purposes, and effects of the present invention easy to understand, the technical solutions of the present invention will be clearly and completely described below in conjunction with the drawings. Obviously, the described embodiments are only preferred embodiments of the present invention. Based on the technical solutions of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the scope of protection of the present invention.

[0019] <Example>

[0020] First, weigh the raw materials of each component according to the following quality: accurately weigh 0.5 g of glycerol, 0.5 g of ethylparaben, 2 g of isomaltooligosaccharide, 0.5 g of sodium alginate, 1 g of carbomer, and measure 91 mL of purified water.

[0021] Divide the weighed purified water into three parts: The first part of the purified water is 20% of the total amount of purified water; the second part of the purified water is a very small amount, just enough to completely dissolve ethylparaben; the remaining purified water is used as the third part of the purified water.

[0022] Step 1: Take the first part of the purified water, sprinkle the weighed carbomer into the purified water, and stir continuously until a uniform colloidal solution is formed.

[0023] Step 2: Add the weighed glycerol and isomaltooligosaccharide to the colloidal solution obtained in Step 2, and stir evenly.

[0024] Step 3: Add the weighed glycerol and isomaltooligosaccharide to the colloidal solution obtained in Step 2, and stir evenly.

[0025] Step 4: Add the weighed sodium alginate to the colloidal solution obtained in Step 3 and stir evenly;

[0026] Step 5: Heat the second part of the purified water to 40°C, then add ethyl p-hydroxybenzoate to it. After the ethyl p-hydroxybenzoate is completely dissolved in the purified water, add the resulting solution to the colloidal solution obtained in Step 3 and stir evenly.

[0027] Step 6: Add the third part of the purified water to the mixed solution while stirring. After the addition of the purified water is complete, stir evenly to obtain the medical constipation dressing.

[0028] Perform appearance and pH tests on the prepared medical constipation dressing product, and then fill it into low-density polyethylene bottles. Then, perform irradiation sterilization on the filled and sealed product. Finally, perform outer packaging and finished product inspection and store in the warehouse.

[0029] <Comparative Example 1>

[0030] First, weigh each component raw material according to the following quality: accurately weigh 0.5 g of glycerol, 0.5 g of ethylparaben, 0.5 g of sodium alginate, 1 g of carbomer, and measure 93 mL of purified water.

[0031] Divide the weighed purified water into three parts: The first part of the purified water is 20% of the total amount of purified water; the second part of the purified water is a very small amount, just enough to completely dissolve the ethyl p-hydroxybenzoate; the remaining purified water is used as the third part of the purified water.

[0032] The preparation steps of the medical dressing in Comparative Example 1 are the same as those in the Example, and will not be elaborated in detail here.

[0033] <Comparative Example 2>

[0034] First, weigh each component raw material according to the following quality: accurately weigh 0.5 g of glycerol, 0.5 g of ethylparaben, 2 g of isomaltooligosaccharide, 1 g of carbomer, and measure 91.5 mL of purified water.

[0035] Divide the weighed purified water into three parts: The first part of the purified water is 20% of the total amount of purified water; the second part of the purified water is a very small amount, just enough to completely dissolve the ethyl p-hydroxybenzoate; the remaining purified water is used as the third part of the purified water.

[0036] The preparation steps of the medical dressing in Comparative Example 1 are the same as those in the Example, and will not be elaborated in detail here.

[0037] <Appearance Test>

[0038] Perform appearance tests on the dressings of the Example, Comparative Example 1, and Comparative Example 2: The dressings of the Example, Comparative Example 1, and Comparative Example 2 are all transparent, with uniform texture and a small amount of bubbles.

[0039] <pH Value Test of the Example>

[0040] The pH value change of the medical dressing in the examples was detected at different storage temperatures, and the initial pH value was 5.6.

[0041] The following is the table of pH value changes of the samples in the examples after being stored at different temperatures for different times:

[0042] Storage time (days) pH value at 4°C pH value at 25°C pH value at 40°C 0 5.6 5.6 5.6 7 5.5 5.5 5.5 14 5.5 5.5 5.4 21 5.4 5.4 5.4 28 5.4 5.4 5.4

[0043] The pH value of the medical constipation dressing in the examples of the present invention is weakly acidic, close to the human body's pH value, and can maintain the pH value stability for a long time at different storage temperatures.

[0044] <Stability test experiment of the example>

[0045] Take the dressing in the example and put it into a transparent glass bottle and seal it. The glass bottle is placed in a specific temperature environment, and observe and record whether the liquid dressing shows phenomena such as stratification, precipitation, discoloration, etc. within a certain time.

[0046] Table of appearance changes of the samples in the examples after being stored at different temperatures for different times:

[0047]

[0048] The medical constipation dressing in the examples of the present invention shows good stability at 4°C and 25°C, and can be maintained for one week at a high temperature of 40°C. The medical constipation dressing needs to be used up as soon as possible after being opened at high temperatures in summer.

[0049] <Antibacterial test experiment of the example>

[0050] 1. Bacteria strains for verification

[0051] Staphylococcus aureus (CMCC(B)26003), Escherichia coli (CMCC(B)44102), Bacillus subtilis (CMCC(B)63501), Candida albicans (CMCC(F)98001), Aspergillus niger (CMCC(B)98003).

[0052] Note: They are common bacteria strains causing inflammation in clinic.

[0053] 2. Bacterial liquid preparation:

[0054] Take 1 ml of the nutrient broth liquid culture of Staphylococcus aureus cultured at 30 - 35°C for 18 - 24 hours and add it to 9 ml of sodium chloride solution with a concentration of 0.9%, and dilute it 10 times to 10 -5 ~10 -7 not greater than 100 cfu / ml for standby.

[0055] Take 1 ml of the Escherichia coli nutrient broth liquid culture incubated at 30 - 35°C for 18 - 24 hours and add it to 9 ml of a 0.9% sodium chloride solution, then dilute it 10-fold to 10 -5 ~10 -7 for use as a stock solution with no more than 100 cfu / ml.

[0056] Take 1 ml of the Bacillus subtilis nutrient broth liquid culture incubated at 30 - 35°C for 18 - 24 hours and add it to 9 ml of a 0.9% sodium chloride solution, then dilute it 10-fold to 10 -5 ~10 -7 for use as a stock solution with no more than 100 cfu / ml.

[0057] Take 1 ml of the Candida albicans liquid culture incubated at 20 - 25°C for 2 - 3 days, add it to 9 ml of a 0.9% sodium chloride solution, and dilute it 10-fold to 10 -5 for use as a stock solution with no more than 100 cfu / ml.

[0058] Inoculate the fresh culture on the Aspergillus niger slant onto Sabouraud dextrose agar slant medium and incubate at 20 - 25°C for 5 - 7 days to allow a large number of spores to mature. Add 3 - 5 ml of a 0.9% sodium chloride solution containing 0.05 (ml / ml) polysorbate 80 to elute the spores. Then aspirate the spore suspension and dilute it in a 0.9% sodium chloride solution to prepare a spore suspension with less than 100 cfu of spores per 1 ml for use as a stock solution.

[0059] 2. Preparation of the test solution

[0060] Take 10 g of the medical dressing from the example, add 100 ml of sterile sodium chloride - peptone buffer with a pH of 7.0 to prepare a 1:10 test solution.

[0061] 3. Aerobic bacteria, mold, and yeast counting (plate method)

[0062] Test group: Take 5 sets of the test solution, 9.9 ml for each set, and add 0.1 ml of one of the above-mentioned bacterial solutions to each set and mix well. Then, aspirate 1 ml and inject it into a petri dish, immediately pour 15 - 20 ml of tryptic soy agar medium, mix well, solidify, and incubate for 5 days to count the colony number. Prepare two parallel plates for each group.

[0063] Bacterial solution group: Take 1 ml of each of the above five bacterial solutions, immediately pour 15 - 20 ml of tryptic soy agar medium, mix well, solidify, and incubate for 5 days to count the colony number. Prepare two parallel plates for each group.

[0064] Test solution control group: Take 5 sets of the test solution, 1 ml for each set, immediately pour 15 - 20 ml of tryptic soy agar medium, mix well, solidify, and incubate for 5 days to count the colony number. Prepare two parallel plates for each group.

[0065] Calculation formula: Recovery rate of bacteria count in the test group = [(Bacteria count in the test group - Bacteria count in the control solution of the test solution) / Bacteria count in the bacterial solution] × 100%

[0066] Judgment criterion: The recovery rate is not less than 90%.

[0067] The test results of the plate method are as follows in the table (unit: cfu / plate):

[0068]

[0069] 4. Verification of the test method for controlled bacteria

[0070] Test group: Take 10 ml of the test solution and add it to a 100 ml bottled casein soya peptone liquid medium.

[0071] Positive control group: Take 10 ml of the test solution and add it to a 100 ml bottled casein soya peptone liquid medium, and add 1 ml of bacterial solution (here, Escherichia coli bacterial solution is used).

[0072] Negative control group: Take 10 ml of sterile sodium chloride - peptone buffer solution and add it to a 100 ml bottled casein soya peptone liquid medium.

[0073] Take 1 ml of each of the above cultures, inoculate it into 100 ml of MacConkey liquid medium and culture it at 42 - 44 °C for 24 - 48 hours. Take the MacConkey liquid culture and streak it on a MacConkey agar plate, and culture it at 30 - 35 °C for 18 - 72 hours.

[0074] The test results are as follows in the table:

[0075]

[0076] Through the above antibacterial test experiment, it is verified that the medical constipation dressing of the embodiment of the present invention has the effect of inhibiting inflammatory bacteria. Therefore, it can play an anti - inflammatory role when used by constipation patients.

[0077] <Moisture retention test experiment of the embodiment and comparative examples>

[0078] Prepare several cover glasses of the same specification, and mark the embodiment, comparative example 1, comparative example 2 and the control group respectively. Apply the corresponding dressings on the cover glasses of the embodiment, comparative example 1 and comparative example 2, and apply an equal amount of water on the control group. Place the cover glasses in a constant temperature and humidity chamber (temperature set at 60 °C, humidity set at 60%), and observe and record the dryness of the samples on the cover glasses at regular intervals (such as 1 h, 2 h, 4 h, 6 h, 8 h).

[0079] The change table of dryness is as follows:

[0080]

[0081]

[0082] From the results of the above moisture retention test experiments, it can be seen that the medical constipation dressing of the embodiment of the present invention has good moisture retention effect, and its moisture retention effect is better than that of Comparative Example 1 and Comparative Example 2.

Claims

1. A medical constipation dressing, characterized in that: The invention is composed of the following components in percentage by mass: 1% to 2% of carbomer, 5% of glycerol, 1% to 2% of isomaltooligosaccharide, 0.5% to 0.7% of sodium alginate, 0.3% to 0.5% of ethyl p-hydroxybenzoate and the balance of purified water.

2. The medical constipation dressing according to claim 1, characterized in that: The medical constipation dressing is prepared by the following method: Step 1: Weigh the raw materials of each component and divide the purified water into three parts; Step 2: Take the first portion of purified water, sprinkle the weighed carbomer into the purified water, and stir until a uniform colloidal liquid is formed; Step 3: Add the weighed glycerol and isomaltooligosaccharide to the colloidal liquid obtained in step 2 and stir evenly; Step 4: Add the weighed sodium alginate into the colloid obtained in step 3 and stir evenly; Step 5: Heat the second portion of purified water, then add ethyl p-hydroxybenzoate thereto, and after ethyl p-hydroxybenzoate is completely dissolved in the purified water, add the resulting solution to the colloidal solution obtained in step 3, and stir evenly; Step 6: Add the third portion of purified water to the mixed solution, stirring while adding, and after the purified water is added, stir evenly to obtain the medical constipation dressing.

3. The medical constipation dressing according to claim 2, characterized in that: in, The first portion of purified water is 20% to 30% of the total amount of purified water, the second portion of purified water is greater than or equal to the amount that completely dissolves ethyl parahydroxybenzoate, and the third portion of purified water is the remaining purified water.

4. The medical constipation dressing according to claim 3, characterized in that: in, The second portion of purified water is heated to 40°C to 50°C.

5. The medical constipation dressing according to claim 2, characterized in that: in, During the preparation of the medical constipation dressing, the ambient temperature is controlled below 28°C.

6. The medical constipation dressing according to claim 2, characterized in that: in, During the preparation of the medical constipation dressing, the environmental humidity is controlled at 30% to 50% in winter and at 50% to 70% in summer.

7. The medical constipation dressing according to claim 2, characterized in that: in, Step 6: The medical constipation dressing is obtained in a gel state, and then the medical constipation dressing is filled into a low-density polyethylene bottle, and then irradiated and sterilized after filling and sealing.

8. The medical constipation dressing according to claim 2, characterized in that: in, The pH value of the medical constipation dressing is 4.0-7.0.

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