CN109289095B - Enteroscope gel containing lidocaine hydrochloride and preparation method thereof - Google Patents
Enteroscope gel containing lidocaine hydrochloride and preparation method thereof Download PDFInfo
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- CN109289095B CN109289095B CN201811404995.2A CN201811404995A CN109289095B CN 109289095 B CN109289095 B CN 109289095B CN 201811404995 A CN201811404995 A CN 201811404995A CN 109289095 B CN109289095 B CN 109289095B
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Abstract
The invention provides an enteroscope gel, which consists of lidocaine hydrochloride, sodium carboxymethylcellulose, glycerol, propylene glycol, carbomer, tragacanth, triethanolamine, sorbic acid and purified water, and is prepared into a gel with uniform content and good stability by high-pressure homogenization. The sodium carboxymethylcellulose, the carbomer and the tragacanth in the gel are used in a matched manner, so that the stability of the gel can be synergistically increased, a large number of micelles and flocculent precipitates are avoided, good stability can be maintained even if the gel is stored for a long time, and the safety and the effectiveness are effectively guaranteed.
Description
Technical Field
The invention relates to medical enteroscope gel and a preparation method thereof, in particular to enteroscope gel containing lidocaine hydrochloride and a preparation method thereof
Background
With the increase of the incidence of colorectal and anal diseases, more and more patients need enteroscopy in clinic, but pain caused by enteroscopy and mechanical damage to human bodies cause pain to the patients. The use of the lubricant can reduce the pain of the patient and reduce the damage to the body tissues and mucous membranes to the maximum extent. The main components of the enteroscope lubricant, namely tetracaine hydrochloride and lidocaine hydrochloride, are local anesthetics, enter an intestinal cavity along with an enteroscope, and are quickly absorbed through an intestinal epidermal mucous membrane, so that the local anesthetic effect is achieved, the pain of a patient caused by the fact that an enteroscope instrument enters the intestinal cavity is further relieved, and the compliance of the patient is improved.
However, the lubricant used in clinical enteroscopy is comparatively disordered, and the medical apparatus registered in the name of enteroscopy lubrication in the domestic market at present is only Zheng Zhou Rui kang Da Biotechnology Co., Ltd, and the registered product name is enteroscopy lubrication mucilage which consists of sodium carboxymethylcellulose and PPE polyether defoaming agent. In addition, the body cavity introduction antibacterial lubricating liquid of Dongguan Jinfang biological medicine incubator GmbH mainly comprises glycerol, xanthan gum, glyceryl behenate and purified water, and is suitable for lubrication of the cavities of urethra, digestive tract, vagina, respiratory tract, anus, rectum and the like and for insertion tube lubrication introduction. In the above-mentioned product, it is unstable often to appear the system, and patient's absorption effect is relatively poor after using, and a large amount of micelles and flocculent precipitate appear often in the storage process, seriously influence result of use and security.
The gel is a mucosa drug delivery carrier with strong solubilization and excellent permeation promoting effect. The domestic authoritative report about the lubrication of the enteroscope starts from an endoscope lubricating gel recorded in a preparation handbook of Shanghai municipal hospitals, which consists of cartin hydrochloride, glycerol, tragacanth, p-hydroxybenzoate and distilled water, but the product has larger viscosity and is inconvenient to use in clinical application reaction, and tetracaine hydrochloride is not quantitatively specified. Patent application CN201310309351A discloses a preparation method of medical gastroscope gel, which specifically comprises the following steps: controlling the water temperature to 35 ℃, adding sorbic acid, aspartame and saccharin sodium into the water while stirring for dissolving, adding glycerol and hydroxypropyl methyl cellulose fully wetted by polyethylene glycol, sieving the obtained solution with a 100-mesh sieve, adding a micro-emulsion solution of pepper essential oil and simethicone and an emulsifying essence, and stirring uniformly to obtain the product. The gel prepared by the conventional method has poor stability of a mixed system, can be changed after being stored for a long time, and has improved safety and effectiveness. Therefore, there is a need for a safer and more effective formulation that overcomes the above-mentioned drawbacks to address the need for lubrication and pain relief during enteroscopy in clinical patients.
Disclosure of Invention
Based on the defects of the prior art, the invention provides the enteroscope gel containing lidocaine, which is characterized in that the stability of the gel is obviously improved by matching the sodium carboxymethyl cellulose, the carbomer and the tragacanth, and the microemulsion is more thorough in the preparation process by a high-pressure homogenization mode, so that the stability of the product is further improved.
The invention provides an enteroscope gel containing lidocaine, which consists of lidocaine hydrochloride, sodium carboxymethylcellulose, glycerol, propylene glycol, carbomer, tragacanth, triethanolamine, sorbic acid and purified water.
Further, the gel agent comprises 1.0-3.0% of lidocaine hydrochloride, 0.5-2.0% of sodium carboxymethylcellulose, 8.0-15.0% of glycerol, 1.2-2.2% of propylene glycol, 0.1-1.0% of carbomer, 0.1-1.0% of tragacanth, 1.0-2.0% of triethanolamine, 0.05-0.5% of sorbic acid and the balance of purified water in percentage by weight.
Furthermore, the gel agent comprises 1.5-2.5% of lidocaine hydrochloride, 0.8-1.5% of sodium carboxymethylcellulose, 9.0-12.0% of glycerol, 1.4-2.0% of propylene glycol, 0.3-0.8% of carbomer, 0.3-0.8% of tragacanth, 1.3-1.8% of triethanolamine, 0.08-0.2% of sorbic acid and the balance of purified water in percentage by weight.
Still further, the gel agent is composed of 2.0% of lidocaine hydrochloride, 1.0% of sodium carboxymethylcellulose, 10.0% of glycerol, 1.7% of propylene glycol, 0.5% of carbomer, 0.5% of tragacanth, 1.5% of triethanolamine, 0.1% of sorbic acid and the balance of purified water in percentage by weight.
Further, the carbomer is carbomer 974.
The invention also provides a preparation method of the enteroscope gel, which is characterized by comprising the following steps:
(1) adding part of purified water into lidocaine hydrochloride and triethanolamine, and mixing uniformly to obtain a mixed solution A;
(2) adding purified water into carbomer, sodium carboxymethylcellulose and tragacanth, swelling, adding glycerol and propylene glycol, wetting, and adding sorbic acid to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and homogenizing under high pressure.
Further, the temperature in the step (1) is controlled to be 30-40 ℃.
Further, purified water is added while stirring in the step (1).
Further, in the step (2), purified water is added into carbomer, sodium carboxymethylcellulose and tragacanth gum for swelling for 10-15 h.
Further, after glycerol and propylene glycol are added in the step (2), the obtained solution is filtered through a 90-110 mesh screen, and then sorbic acid is added while stirring.
Further, the pressure of the high-pressure homogenization in the step (3) is 200-1500bar, and the circulation homogenization is carried out for 2-8 times.
Furthermore, the pressure for high-pressure homogenization in the step (3) is 500-1000bar, and the circulation homogenization is carried out for 4-6 times.
The invention has the beneficial effects that:
(1) according to the invention, sodium carboxymethylcellulose, carbomer and tragacanth are used in a matching manner, so that the stability of the gel is obviously improved, wherein the sodium carboxymethylcellulose can be stored for a long time and has the characteristic of a protective colloid, and the tragacanth has the effects of solubilization and emulsification but insufficient emulsification strength, and can be matched with the sodium carboxymethylcellulose and the carbomer to synergistically improve the stability of the gel.
(2) The gel property of the carbomer is easily influenced by pH, the aqueous solution is acidic, after the mixing in the step 3, the pH of the mixed solution can be adjusted to a neutral range due to the triethanolamine contained in the mixed solution A, the viscosity of the hydrogel formed by the carbomer is the largest at the moment, the lubricating effect of the product is obviously improved, and the stability is also improved.
(3) According to the invention, under a proper high-pressure homogenization condition, lidocaine hydrochloride, sodium carboxymethylcellulose, carbomer, tragacanth and the like are prepared into a stable microemulsion solution, so that the dispersibility of the lidocaine hydrochloride is improved, the medicine is prevented from being unevenly distributed, and the stability of the product is obviously improved.
(4) The propylene glycol added in the invention has good effect of promoting transdermal absorption and can promote the absorption of human body to lidocaine hydrochloride.
Detailed Description
Example 1 enteroscopy gel and preparation method thereof
The gel comprises, by weight, 2.0% of lidocaine hydrochloride, 1.0% of sodium carboxymethylcellulose, 10.0% of glycerol, 1.7% of propylene glycol, 0.5% of carbomer 974, 0.5% of tragacanth, 1.5% of triethanolamine, 0.1% of sorbic acid and the balance of purified water.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride and triethanolamine in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature to be 35 ℃, uniformly mixing while adding, and observing that the system is changed into a uniform system to obtain a mixed solution A;
(2) adding appropriate amount of carbomer 974, sodium carboxymethylcellulose and tragacanth into water, swelling for 12 hr, adding glycerol and propylene glycol, wetting, dissolving, and filtering with 100 mesh screen; dissolving sorbic acid into the solution under the condition of stirring to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and circularly homogenizing for 5 times in a high-pressure homogenizer at 800 bar; transferring the obtained medical gastroscope gel liquid to a container for storage;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Example 2 enteroscopy gel and preparation method thereof
The gel comprises 1.5 percent of lidocaine hydrochloride, 0.8 percent of sodium carboxymethylcellulose, 9.0 percent of glycerol, 1.4 percent of propylene glycol, 0.3 percent of carbomer 974, 0.3 percent of tragacanth, 1.3 percent of triethanolamine, 0.08 percent of sorbic acid and the balance of purified water in percentage by weight.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride and triethanolamine in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature at 30 ℃, uniformly mixing while adding, and observing that the system is changed into a uniform system to obtain a mixed solution A;
(2) adding a proper amount of carbomer 974, sodium carboxymethylcellulose and tragacanth into a prescription dose, swelling for 10 hours, then adding glycerol and propylene glycol, fully wetting uniformly and dissolving uniformly, and filtering the obtained solution through a 90-mesh screen; dissolving sorbic acid into the solution under the condition of stirring to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and circularly homogenizing for 7 times in a high-pressure homogenizer at 500 bar; transferring the obtained medical gastroscope gel liquid to a container for storage;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Example 3 enteroscope gel and preparation method thereof
The gel comprises, by weight, 2.5% of lidocaine hydrochloride, 1.5% of sodium carboxymethylcellulose, 12.0% of glycerol, 2.0% of propylene glycol, 0.8% of carbomer 974, 0.8% of tragacanth, 1.8% of triethanolamine, 0.2% of sorbic acid and the balance of purified water.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride and triethanolamine in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature at 40 ℃, uniformly mixing while adding, and observing that the system is changed into a uniform system to obtain a mixed solution A;
(2) adding a proper amount of carbomer 974, sodium carboxymethylcellulose and tragacanth into a prescription dose, swelling for 15 hours, then adding glycerol and propylene glycol, fully wetting uniformly and dissolving uniformly, and filtering the obtained solution through a 140-mesh screen; dissolving sorbic acid into the solution under the condition of stirring to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and circularly homogenizing for 8 times in a high-pressure homogenizer at a pressure of 200 bar; transferring the obtained medical gastroscope gel liquid to a container for storage;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Example 4 enteroscopy gel formulation and preparation method thereof
The gel comprises 1.0 percent of lidocaine hydrochloride, 0.5 percent of sodium carboxymethylcellulose, 8.0 percent of glycerol, 1.2 percent of propylene glycol, 0.1 percent of carbomer 974, 0.1 percent of tragacanth, 1.0 percent of triethanolamine, 0.05 percent of sorbic acid and the balance of purified water in percentage by weight.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride and triethanolamine in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature at 32 ℃, uniformly mixing while adding, and observing that the system is changed into a uniform system to obtain a mixed solution A;
(2) adding a proper amount of carbomer 974, sodium carboxymethylcellulose and tragacanth into a prescription dose, swelling for 11 hours, adding glycerol and propylene glycol, fully wetting and uniformly dissolving, and filtering the obtained solution through a 100-mesh screen; dissolving sorbic acid into the solution under the condition of stirring to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and circularly homogenizing for 2 times in a high-pressure homogenizer at 1500 bar; transferring the obtained medical gastroscope gel liquid to a container for storage;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Example 5 enteroscope gel and preparation method thereof
The gel comprises, by weight, 3.0% of lidocaine hydrochloride, 2.0% of sodium carboxymethylcellulose, 15.0% of glycerol, 2.2% of propylene glycol, 1.0% of carbomer 974, 1.0% of tragacanth, 2.0% of triethanolamine, 0.5% of sorbic acid and the balance of purified water.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride and triethanolamine in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature at 38 ℃, uniformly mixing while adding, and observing that the system is changed into a uniform system to obtain a mixed solution A;
(2) adding appropriate amount of carbomer 974, sodium carboxymethylcellulose and tragacanth into water, swelling for 12 hr, adding glycerol and propylene glycol, wetting, dissolving, and filtering with 100 mesh screen; dissolving sorbic acid into the solution under the condition of stirring to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and circularly homogenizing for 4 times in a high-pressure homogenizer at 1000 bar; transferring the obtained medical gastroscope gel liquid to a container for storage;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Comparative example 1 enteroscopy gel without sodium carboxymethylcellulose and preparation thereof
The gel was the same as in example 1 except that the gel contained no sodium carboxymethylcellulose.
The preparation method comprises the following steps: the preparation was carried out as in example 1.
Comparative example 2 enteroscopy gel without carbomer 974 and preparation thereof
The gel was the same as in example 1 except that carbomer 974 was not included.
The preparation method comprises the following steps: the preparation was carried out as in example 1.
Comparative example 3 enteroscopy gel without tragacanth gum and preparation thereof
The gel formulation is the same as in example 1 except that it does not contain tragacanth.
The preparation method comprises the following steps: the preparation was carried out as in example 1.
Comparative example 4 enteroscopy gel without propylene glycol and preparation thereof
The gel was the same as in example 1 except that it did not contain propylene glycol.
The preparation method comprises the following steps: the preparation was carried out as in example 1.
Comparative example 5 enteroscope gel preparation without high pressure homogenization and preparation thereof
The gel was the same as in example 1.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride and triethanolamine in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature to be 35 ℃, uniformly mixing while adding, and observing that the system is changed into a uniform system to obtain a mixed solution A;
(2) adding appropriate amount of carbomer 974, sodium carboxymethylcellulose and tragacanth into water, swelling for 12 hr, adding glycerol and propylene glycol, wetting, dissolving, and filtering with 100 mesh screen; dissolving sorbic acid into the solution under the condition of stirring to obtain a mixed solution B;
(3) mixing the mixed solution A and the mixed solution B for later use;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Comparative example 6 enteroscope gel prepared by different preparation methods and preparation thereof
The gel was the same as in example 1.
The preparation method comprises the following steps:
(1) putting lidocaine hydrochloride, triethanolamine and sorbic acid in a prescription amount into a container, adding a proper amount of purified water, controlling the water temperature at 35 ℃, uniformly mixing while adding, and observing that the system becomes a uniform system to obtain a mixed solution A;
(2) adding the formula amounts of carbomer 974, sodium carboxymethylcellulose and tragacanth into glycerol and propylene glycol, fully wetting and uniformly dissolving, and filtering the obtained solution through a 100-mesh screen to obtain a mixed solution B;
(3) mixing the mixed solution A and B, and circularly homogenizing for 5 times in a high-pressure homogenizer at 800 bar; transferring the obtained medical gastroscope gel liquid to a container for storage;
(4) the split charging and filling process and the material transfer are carried out according to the specified production rules, the solution is split charged into a plastic hose, the plastic hose is covered and sterilized, and after the plastic hose is qualified through lamp inspection and quality identification, the plastic hose is externally packaged.
The quality control of the production process and the quality control of the transmission process of the medical enteroscopy glue are carried out according to GMP (good manufacturing practice) specifications.
The loading amount of the 10 tubes of the hoses which are filled with the feed liquid are randomly checked at certain intervals so as to detect the difference of the loading amounts. The method comprises the following steps: the average loading capacity of the product is not less than 10ml at 20 +/-2 ℃. The maximum negative deviation should not exceed 0.5 ml.
Effect example 1 stability study of different enteroscopy gels
The gels prepared in the examples 1-5 and the comparative examples 1-6 are placed in an environment with the temperature of 40 +/-2 ℃ and the relative humidity of 75 +/-5% for accelerated experimental study, samples are taken at the 0 th month and the 6 th month, and the properties, the pH, the content of lidocaine hydrochloride and the like of the enteroscope gel are observed and measured.
Wherein, the character uniformity observes the layering phenomenon, the clarity and the like of the gel;
the method for measuring the content of lidocaine hydrochloride comprises the following steps: according to the high performance liquid chromatography, the measurement is carried out in the Chinese pharmacopoeia 2010 edition (appendix V D), and the specific measurement is as follows:
octadecylsilane chemically bonded silica is used as a filler for chromatographic conditions and system applicability experiments; phosphate buffer (1.3 ml of 1mol/L sodium dihydrogen phosphate solution and 32.5ml of 0.5mol/L disodium hydrogen phosphate solution are taken, diluted to 1000ml with water and shaken up) -acetonitrile (50: 50) (pH value is adjusted to 8.0 by phosphoric acid) is taken as a mobile phase, and the detection wavelength is 254 nm. The theoretical plate number is not less than 2000 in terms of lidocaine peak.
The determination method comprises weighing 10g of the product, precisely weighing, adding 1L of 15% sodium chloride solution as solvent, and stirring thoroughly until the sample is completely dispersed or dissolved. Precisely transferring the solution into a volumetric flask of 2ml to 20ml, diluting the solution to a scale with a mobile phase, shaking up, precisely measuring 20ul of the solution, injecting the solution into a liquid chromatograph, and recording a chromatogram; and precisely weighing a proper amount of lidocaine hydrochloride reference substance, and measuring by the same method. Calculating according to the peak area by an external standard method to obtain the product.
TABLE 1 stability Studies of different gels
The data in Table 1 show that the enteroscope gel patch provided by the invention has good stability, the gel patches prepared in comparative examples 1-6 have relatively poor stability, and after 6-month accelerated test, the phenomena of turbidity and delamination appear, and the content of lidocaine hydrochloride is reduced.
Effect example 2 clinical application study of different gels
The enteroscope gel prepared in example 1 was applied to clinical studies, and compared with commercially available similar products (produced by boyuan biochemical medical products, llc, new market, No. 2013, No. 3221331, national food and drug administration apparatus), the examination success rate, the perianal discomfort of endoscope entrance, the effective rate of abdominal pain, and the examination time were examined when the gel (experimental group) and the commercially available lubricant (control group) of the present invention were used.
Subject: patients collected in Jiangsu province people hospital (center 1) and people hospital (center 2) in Liyuankang city.
The experimental process comprises the following steps:
the gel and the commercially available lubricant are coated on an enteroscope instrument.
The experimental results are as follows:
2.1 check success Rate Condition
TABLE 2 success rates of examination of different gel patches
Note: comparing the success rates, and testing with chi-square to obtain X statistic2Or by Fisher's exact test.
The two sets of comparisons summed, with extended Mantel-Haenzsel statistics taking into account the center effect, were CMHX2。
The test compositional power was 93.94%, and the control compositional power was 50.77%. Centrally layered CMHX2The results show that the success rate of the two groups of examination is compared, the difference has significant significance, and the test group is higher than the control group;
table 3 test success rate and efficacy test of different gel patches
Note: h0, T-C ≦ 0.30. 95% CI (T-C) (0.3038, + ∞).
And (3) carrying out the test on the effectiveness of the success rate of the two groups of tests, wherein the difference between the two groups has significant statistical significance, namely the effectiveness test is established, and the test group is superior to the control group.
2.2 perianal discomfort in endoscopic approach
TABLE 4 discomfort constitution of different gels around anus
When the endoscope is put in, the comparison between the test group and the control group of the perianal discomfort feeling of the subject among grades has statistical significance, and the mild proportion of the test group is higher than that of the control group
2.3 Abdominal pain response
TABLE 5 different Agents for treating abdominal pain
In the process of endoscope entering, the difference between the abdominal pain test group of the subject and the control group has statistical significance, and the mild proportion of the test group is higher than that of the control group.
2.4 check time-consuming
TABLE 6 examination of different gels takes time
The enteroscopy is time consuming, the difference is statistically significant between the test and control groups, and the test group is lower than the control group.
The above test results show that the power of the test composition is 93.94%, and the power of the control composition is 50.77%. Centrally layered CMHX2The results show that the success rate of the two groups of examination is compared, the difference has significant significance, and the test group is higher than the control group; and (3) carrying out the test on the effectiveness of the success rate of the two groups of tests, wherein the difference between the two groups has significant statistical significance, namely the effectiveness test is established, and the test group is superior to the control group.
When the endoscope is put in, the difference between the tested group and the control group has statistical significance when the tested group and the control group are compared among grades, and the mild proportion of the tested group is higher than that of the control group. In the process of endoscope entering, the difference between the abdominal pain test group of the subject and the control group has statistical significance, and the mild proportion of the test group is higher than that of the control group. The enteroscopy is time consuming, the difference is statistically significant between the test and control groups, and the test group is lower than the control group. Compared with the control product, the experimental product can reduce the perianal discomfort and the abdominal pain degree when the subject enters the endoscope, and shorten the examination time.
In addition, no adverse event occurs in the two groups in the test process, and in the aspect of safety, the enteroscope gel provided by the invention has no significant difference with the products sold on the market, and the difference has no statistical significance when the difference between the vital signs (body temperature, respiration and blood pressure) and the difference values before, after and before treatment is compared. The difference between the heart rate before treatment and the heart rate after treatment is statistically insignificant; compared with the treated groups, the differences have statistical significance, but are within the normal value range, and have no clinical significance.
In the test process, the satisfaction degrees of the test product and the control product are both 100%.
In conclusion, the enteroscope gel provided by the invention has better using effect, and improves the using feeling of patients and the safety of operations by improving the performances of lubricity and the like.
The above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.
Claims (9)
1. An enteroscopy gel is characterized by comprising, by weight, 1.0% -3.0% of lidocaine hydrochloride, 0.5% -2.0% of sodium carboxymethylcellulose, 8.0% -15.0% of glycerol, 1.2% -2.2% of propylene glycol, 0.1% -1.0% of carbomer, 0.1% -1.0% of tragacanth, 1.0% -2.0% of triethanolamine, 0.05% -0.5% of sorbic acid and the balance of purified water.
2. The enteroscopy gel of claim 1, consisting of 1.5-2.5% lidocaine hydrochloride, 0.8-1.5% sodium carboxymethylcellulose, 9.0-12.0% glycerol, 1.4-2.0% propylene glycol, 0.3-0.8% carbomer, 0.3-0.8% tragacanth, 1.3-1.8% triethanolamine, 0.08-0.2% sorbic acid, and the balance purified water, by weight.
3. The enteroscopic gel of claim 2, wherein the gel consists of, in weight percent, 2.0% lidocaine hydrochloride, 1.0% sodium carboxymethylcellulose, 10.0% glycerol, 1.7% propylene glycol, 0.5% carbomer, 0.5% tragacanth, 1.5% triethanolamine, 0.1% sorbic acid, and the balance purified water.
4. A process for the preparation of an enteroscopy gel according to any of claims 1 to 3, comprising the steps of:
(1) adding part of purified water into lidocaine hydrochloride and triethanolamine, and mixing uniformly to obtain a mixed solution A;
(2) adding purified water into carbomer, sodium carboxymethylcellulose and tragacanth, swelling, adding glycerol and propylene glycol, wetting, and adding sorbic acid to obtain a mixed solution B;
(3) and (3) uniformly mixing the mixed solution A and the mixed solution B, and homogenizing under high pressure to obtain the product.
5. The method according to claim 4, wherein the temperature in the step (1) is controlled to be 30 to 40 ℃.
6. The method according to claim 4, wherein purified water is added while stirring in the step (1).
7. The preparation method according to claim 4, wherein purified water is added to carbomer, sodium carboxymethylcellulose and tragacanth gum in the step (2) for swelling for 10-15 h.
8. The method according to claim 4, wherein the glycerin and propylene glycol are added in the step (2), the obtained solution is filtered through a 90-110 mesh screen, and then the sorbic acid is added while stirring.
9. The preparation method as claimed in claim 4, wherein the pressure for high-pressure homogenization in step (3) is 200-1500bar, and the cycle homogenization is performed 2-8 times.
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Address after: School of pharmacy, Huaihai Institute of technology, 59 Cangwu Road, Haizhou District, Lianyungang City, Jiangsu Province, 222005 Patentee after: Jiangsu Ocean University Address before: School of pharmacy, Huaihai Institute of technology, 59 Cangwu Road, Haizhou District, Lianyungang City, Jiangsu Province, 222005 Patentee before: HUAIHAI INSTITUTE OF TECHNOLOGY |
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