阅读说明：本技术 一种含氧化还原酶的女性生殖道修复凝胶及其制备方法 (Oxidoreductase-containing gel for repairing female genital tract and preparation method thereof ) 是由 陈云明 易江 丁龙 于 2021-08-11 设计创作，主要内容包括：本发明公开了一种含氧化还原酶的女性生殖道修复凝胶,涉及妇科卫生技术领域,所述修复凝胶包括下列原料：氧化还原酶、溶菌酶、醋酸氯己定、三乙醇胺、白油、卡波姆、壳聚糖、胶原蛋白、云南白药。本发明的女性生殖道修复凝胶中的氧化还原酶具有特殊的生理活性,是生物体内清除自由基的首要物质。氧化还原酶起到清除氧自由基,抗衰老等作用。用于女性生殖道,主要是抑制金黄色葡萄球菌、大肠杆菌、白色念珠菌等常见细菌感染。适用于女性日常常规护理,抑菌清洁,祛味止痒,修复损伤和粘膜屏障；抑制引发妇科疾病的细菌、真菌,巩固和提高女性生殖系统的抵抗力。(The invention discloses a female genital tract repair gel containing oxidoreductase, relating to the technical field of gynecological hygiene, and the repair gel comprises the following raw materials: oxidoreductase, lysozyme, chlorhexidine acetate, triethanolamine, white oil, carbomer, chitosan, collagen, and Yunnan white drug powder. The oxidoreductase in the female genital tract repair gel has special physiological activity and is the primary substance for scavenging free radicals in organisms. The oxidoreductase has the functions of scavenging oxygen free radicals, resisting aging and the like. Can be used for female genital tract to inhibit common bacterial infection such as Staphylococcus aureus, Escherichia coli, Candida albicans, etc. Is suitable for female daily routine nursing, bacteriostasis and cleaning, removing odor and relieving itching, and repairing injury and mucosa barrier; inhibiting bacteria and fungi causing gynecological diseases, and consolidating and improving female reproductive system resistance.)

1. The gel containing oxidoreductase for repairing the female genital tract is characterized by comprising the following components in parts by weight: 50-150 parts of oxidoreductase, 50-150 parts of lysozyme, 2-15 parts of chlorhexidine acetate, 1-12 parts of triethanolamine, 10-30 parts of white oil, 5-20 parts of carbomer, 20-40 parts of chitosan, 20-40 parts of collagen and 3-12 parts of Yunnan white drug powder.

2. The oxidoreductase-containing gel for repairing the female genital tract as claimed in claim 1, which comprises the following components in parts by weight: 70-130 parts of oxidoreductase, 70-130 parts of lysozyme, 5-12 parts of chlorhexidine acetate, 5-8 parts of triethanolamine, 15-25 parts of white oil, 10-15 parts of carbomer, 25-35 parts of chitosan, 25-35 parts of collagen and 5-10 parts of Yunnan white drug powder.

3. The oxidoreductase-containing gel for repairing the female genital tract as claimed in claim 1, which comprises the following components in parts by weight: 100 parts of oxidoreductase, 100 parts of lysozyme, 8 parts of chlorhexidine acetate, 6 parts of triethanolamine, 20 parts of white oil, 12 parts of carbomer, 30 parts of chitosan, 30 parts of collagen and 8 parts of Yunnan white drug powder.

4. The oxidoreductase-containing gel for repairing female genital tract as claimed in claim 1, wherein the concentration of said oxidoreductase is 300u/g to 2000u/g and the concentration of lysozyme is 1000u/g to 5000 u/g.

5. The oxidoreductase-containing female genital tract repair gel of claim 1 wherein said repair gel has a pH of 4 to 8.

6. A method of preparing an oxidoreductase-containing gel for the repair of the female genital tract as claimed in any one of claims 1 to 5, comprising the steps of:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder, and adding pure water to dissolve the components to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the products subjected to code spraying by using a packaging machine, and sending the packaged products into a warehouse for storage after the packaging is finished.

7. The method of preparing an oxidoreductase-containing gel for repairing the female genital tract as claimed in claim 6, wherein the steps one, two, three and four are performed in a clean area of hundred thousand grade.

8. The method for preparing an oxidoreductase-containing gel for repairing female genital tract as claimed in claim 6, wherein a vacuum homogenizer is used for emulsification in the second step, and the emulsification time is 6 hours.

9. The method for preparing an oxidoreductase-containing gel for repairing female genital tract as claimed in claim 6, wherein in the seventh step, the product is placed in a constant temperature incubator after packaging is completed, and then is stored.

Technical Field

The invention relates to the technical field of gynecological hygiene, in particular to a female genital tract repair gel containing oxidoreductase and a preparation method thereof.

Background

Hormone or antibiotic ingredients are often added into the gel of a plurality of female genital tracts in the market, and the gel has the advantages of quick effect, large side effect and large vaginal irritation. Some products are traditional Chinese medicine components, and have slow efficacy and long treatment course. Some medicines also need to be blended and washed, and the using process is troublesome and embarrassing.

Disclosure of Invention

The invention provides a female genital tract repair gel containing oxidoreductase and a preparation method thereof, which solve the problems in the background technology.

In order to achieve the purpose, the invention provides the following technical scheme:

the female genital tract repair gel containing oxidoreductase comprises the following components in parts by weight: 50-150 parts of oxidoreductase, 50-150 parts of lysozyme, 2-15 parts of chlorhexidine acetate, 1-12 parts of triethanolamine, 10-30 parts of white oil, 5-20 parts of carbomer, 20-40 parts of chitosan, 20-40 parts of collagen and 3-12 parts of Yunnan white drug powder.

As a preferred technical scheme of the invention, the composition comprises the following components in parts by weight: 70-130 parts of oxidoreductase, 70-130 parts of lysozyme, 5-12 parts of chlorhexidine acetate, 5-8 parts of triethanolamine, 15-25 parts of white oil, 10-15 parts of carbomer, 25-35 parts of chitosan, 25-35 parts of collagen and 5-10 parts of Yunnan white drug powder.

As a preferred technical scheme of the invention, the composition comprises the following components in parts by weight: 100 parts of oxidoreductase, 100 parts of lysozyme, 8 parts of chlorhexidine acetate, 6 parts of triethanolamine, 20 parts of white oil, 12 parts of carbomer, 30 parts of chitosan, 30 parts of collagen and 8 parts of Yunnan white drug powder.

As a preferable technical scheme of the invention, the concentration of the oxidoreductase is 300-2000 u/g, and the concentration of the lysozyme is 1000-5000 u/g.

As a preferable technical scheme of the invention, the pH value of the repairing gel is 4-8.

A preparation method of a female genital tract repair gel containing oxidoreductase comprises the following steps:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder, and adding pure water to dissolve the components to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the products subjected to code spraying by using a packaging machine, and sending the packaged products into a warehouse for storage after the packaging is finished.

As a preferred technical scheme of the invention, the operations of the step one, the step two, the step three and the step four are all carried out in a hundred thousand grade clean area.

And as a preferable technical scheme of the invention, a vacuum homogenizing emulsifying machine is adopted for emulsification in the second step, and the emulsification time is 6 hours.

In the seventh step, after the packaging is finished, the product is placed in a constant temperature incubator and then stored.

The invention has the following advantages: the oxidoreductase in the female genital tract repair gel has special physiological activity and is the primary substance for scavenging free radicals in organisms. The oxidoreductase has the functions of scavenging oxygen free radicals, resisting aging and the like. Can be used for female genital tract to inhibit common bacterial infection such as Staphylococcus aureus, Escherichia coli, Candida albicans, etc. Is suitable for female daily routine nursing, bacteriostasis and cleaning, removing odor and relieving itching, and repairing injury and mucosa barrier; inhibiting bacteria and fungi causing gynecological diseases, and consolidating and improving female reproductive system resistance.

Detailed Description

The following description of the preferred embodiments of the present invention is provided for the purpose of illustration and description, and is in no way intended to limit the invention.

Example 1

An oxidoreductase-containing, female reproductive tract repair gel comprising the following components:

50 parts of oxidoreductase, 50 parts of lysozyme, 2 parts of chlorhexidine acetate, 1 part of triethanolamine, 10 parts of white oil, 5 parts of carbomer, 20 parts of chitosan, 20 parts of collagen and 3 parts of Yunnan white drug powder.

The oxidoreductase concentration was 2000u/g and the lysozyme concentration was 5000 u/g.

The invention also provides a preparation method of the gel containing the oxidoreductase for repairing the female genital tract, which comprises the following steps:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving and preparing, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white yam, adding pure water, dissolving and emulsifying the components by using a vacuum homogenizing emulsifying machine, and emulsifying for 6 hours to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the code-sprayed product by using a packaging machine, placing the product in a constant-temperature incubator after the packaging is finished, and then sending the product into a warehouse for storage.

The first step, the second step, the third step and the fourth step are all operated in a hundred thousand grade clean area.

Example 2

An oxidoreductase-containing gel for repairing the female genital tract, which comprises the following components:

150 parts of oxidoreductase, 150 parts of lysozyme, 15 parts of chlorhexidine acetate, 12 parts of triethanolamine, 30 parts of white oil, 20 parts of carbomer, 40 parts of chitosan, 40 parts of collagen and 12 parts of Yunnan white drug powder.

The concentration of the oxidoreductase was 300u/g and the concentration of the lysozyme was 1000 u/g.

The invention also provides a preparation method of the gel containing the oxidoreductase for repairing the female genital tract, which comprises the following steps:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving and preparing, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white yam, adding pure water, dissolving and emulsifying the components by using a vacuum homogenizing emulsifying machine, and emulsifying for 6 hours to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the code-sprayed product by using a packaging machine, placing the product in a constant-temperature incubator after the packaging is finished, and then sending the product into a warehouse for storage.

The first step, the second step, the third step and the fourth step are all operated in a hundred thousand grade clean area.

Example 3

An oxidoreductase-containing gel for repairing the female genital tract, which comprises the following components:

70 parts of oxidoreductase, 70 parts of lysozyme, 5 parts of chlorhexidine acetate, 5 parts of triethanolamine, 15 parts of white oil, 10 parts of carbomer, 25 parts of chitosan, 25 parts of collagen and 5 parts of Yunnan white drug powder.

The concentration of the oxidoreductase was 1250u/g and the concentration of the lysozyme was 3000 u/g.

The invention also provides a preparation method of the gel containing the oxidoreductase for repairing the female genital tract, which comprises the following steps:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving and preparing, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white yam, adding pure water, dissolving and emulsifying the components by using a vacuum homogenizing emulsifying machine, and emulsifying for 6 hours to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the code-sprayed product by using a packaging machine, placing the product in a constant-temperature incubator after the packaging is finished, and then sending the product into a warehouse for storage.

The first step, the second step, the third step and the fourth step are all operated in a hundred thousand grade clean area.

Example 4

An oxidoreductase-containing gel for repairing the female genital tract, which comprises the following components:

130 parts of oxidoreductase, 130 parts of lysozyme, 12 parts of chlorhexidine acetate, 8 parts of triethanolamine, 25 parts of white oil, 15 parts of carbomer, 35 parts of chitosan, 35 parts of collagen and 10 parts of Yunnan white drug powder.

The concentration of the oxidoreductase was 1250u/g and the concentration of the lysozyme was 3000 u/g.

The invention also provides a preparation method of the gel containing the oxidoreductase for repairing the female genital tract, which comprises the following steps:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving and preparing, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white yam, adding pure water, dissolving and emulsifying the components by using a vacuum homogenizing emulsifying machine, and emulsifying for 6 hours to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the code-sprayed product by using a packaging machine, placing the product in a constant-temperature incubator after the packaging is finished, and then sending the product into a warehouse for storage.

The first step, the second step, the third step and the fourth step are all operated in a hundred thousand grade clean area.

Example 5

An oxidoreductase-containing gel for repairing the female genital tract, which comprises the following components: 100 parts of oxidoreductase, 100 parts of lysozyme, 8 parts of chlorhexidine acetate, 6 parts of triethanolamine, 20 parts of white oil, 12 parts of carbomer, 30 parts of chitosan, 30 parts of collagen and 8 parts of Yunnan white drug powder.

The concentration of the oxidoreductase was 1250u/g and the concentration of the lysozyme was 3000 u/g.

The invention also provides a preparation method of the gel containing the oxidoreductase for repairing the female genital tract, which comprises the following steps:

the method comprises the following steps: weighing, namely weighing oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white drug powder in sequence according to the mass parts by using a balance;

step two: dissolving and preparing, namely mixing the weighed oxidoreductase, lysozyme, chlorhexidine acetate, carbomer, triethanolamine, white oil, chitosan, collagen and Yunnan white yam, adding pure water, dissolving and emulsifying the components by using a vacuum homogenizing emulsifying machine, and emulsifying for 6 hours to obtain a mixture;

step three: filling, namely filling the mixture obtained after dissolution by adopting a filling machine to be matched with a packaging bag;

step four: sealing the cover, namely sealing the filled packaging bag by adopting an automatic plastic film continuous sealing machine;

step five: detecting leakage, namely detecting the packaging bag in a mechanical inspection or manual quality inspection mode, and removing products with incomplete sealing or missed sealing;

step six: code spraying, namely sequentially putting the products subjected to leak detection into a production line, and sequentially spraying codes on the products by adopting a code spraying machine;

step seven: and packaging and warehousing, packaging the code-sprayed product by using a packaging machine, placing the product in a constant-temperature incubator after the packaging is finished, and then sending the product into a warehouse for storage.

The first step, the second step, the third step and the fourth step are all operated in a hundred thousand grade clean area.

The comparative advantages of the oxidoreductase-containing gel for the repair of the female genital tract of the invention with other lotions or gels are shown in the following table:

the invention carries out a plurality of times of vagina mucosa stimulation tests, and the contents are as follows:

firstly, experimental materials:

1. the test substance:

sample properties: colorless transparent jelly

2. Experimental animals: the weight is 2.4-3.0 kg. Standard GB14924.1-2001 was performed 2w was adapted in the animal house environment prior to the test.

3. Detection conditions are as follows: the temperature range is 20-23 ℃, and the relative humidity range is 50-70%.

Second, method

1. The method selects 6 healthy and early-adult female New Zealand rabbits, and before the test, the vaginal orifice of the rabbit is checked to have secretion, congestion, edema and other injury conditions, and the rabbit is discarded by a person with inflammation or (and) injury. Experimental animals were randomly divided into experimental and control groups of 3 rabbits each.

2. A blunt tip soft catheter (No. 8 catheter) of 8cm length was connected to a 2mL syringe. The injector and the catheter are filled with the test substances for standby. The animal is fixed on its back to expose perineum and vaginal opening. The catheter was moistened with the test solution and gently inserted into the vagina (4-5cm) of the animal, and the syringe was slowly pushed into 2mL of the test substance, and the catheter was gently withdrawn to complete the contamination. According to the method, the infection is repeated every 24h for 5 days continuously. If there was any overflow, the solution was gently wiped with sterilized cotton. Control animals were treated with sterile saline as well.

3. 24h after infection, the animals are killed by an air embolism method, the whole vagina is taken out after laparotomy, the longitudinal incision is carried out, and whether congestion, edema and other manifestations exist or not is observed by naked eyes for reference when pathological materials are obtained. Then, the vaginal tissue specimen is put into 10% formalin solution for fixation for more than 48h, tissues at two ends and 3 parts in the center of the vagina are selected for flaking, and histopathological examination is carried out after HE staining. The histopathological examination results were scored for vaginal mucosal irritation response according to Disinfection Specification (2002 edition) 2.3.5.3.

4. And (4) evaluating the results: the stimulation response intensity is judged according to the stimulation intensity of the vaginal mucosa.

Thirdly, obtaining a result:

the visual observation shows that the vaginal wall of the animals in the test group is basically the same as that of the animals in the control group, and obvious hyperemia, edema and other manifestations are not seen. The results of the histopathological examination are shown in Table 1.

TABLE 1 test article rabbit vaginal mucosa irritation test response score

Note: the average integral is the sum of the stimulation response integrals of 3 sites of 3 animals/total observed number (animals x 3); stimulation index is the mean integral of the infected group-the mean integral of the negative control group.

Fourth, conclusion

The stimulation index of the sample to the rabbit vaginal mucosa is 0, and the stimulation response intensity of the vaginal mucosa is the stimulation of the vagina-free mucosa.

The invention carries out bacteriostatic ring test, which comprises the following steps:

first, equipment

1. Test strains: escherichia coli 8099, Staphylococcus aureus ATCC6538

2. Culture medium: nutrient agar

4. And others: vernier calipers, etc.

Second, method

1. The detection basis is as follows: ministry of health, fire protection Specification 2002 edition 2.1.8.2.

2. Detection conditions are as follows: incubate at 37 ℃ for 18 hours and repeat the experiment 3 times.

Three, result in

After 3 times of repeated tests, the results show that the diameters of the bacteriostatic rings of the test sample on escherichia coli and staphylococcus aureus are all larger than 7.00mm, and the table below shows.

Note: the bacteriostatic rings of various recessive controls are all less than 7.00 mm.

And (4) conclusion: the result of the antibacterial ring verification shows that the female genital tract repair gel containing the oxidoreductase has antibacterial effects on escherichia coli, staphylococcus aureus and candida albicans.

The invention carries out microorganism index test, and the content is as follows:

method and device

1. The detection basis is as follows: the hygienic standard GB15979-2002 of the disposable sanitary product.

2. Detecting the temperature: 19-21 ℃.

Second, result in

Results of microbial indicators are shown in the table below.

Thirdly, conclusion: the microbial index results of the oxidoreductase-containing female genital tract repair gel meet the requirements of the hygienic standard GB15979-2002 for disposable hygienic products.

For another female genital tract repair gel containing complex enzyme, the main components of the gel are antioxidant enzyme, lysozyme, chlorhexidine acetate, triethanolamine, glycerol and carbomer, and the gel has the beneficial effects that: pure biological enzyme components, no hormone or antibiotics, safe components and no side effect; is suitable for female daily routine nursing, bacteriostasis and cleaning, removing odor and relieving itching, and repairing injury and mucosa barrier; inhibiting bacteria and fungi causing gynecological diseases, and consolidating and improving female reproductive system resistance. Is suitable for a wide range of people including infants, the elderly, pregnant women and lying-in women. The use method is simple and does not need washing. The advantages of the gel for restoring the female genital tract containing the oxidoreductase and the gel for restoring the female genital tract containing the complex enzyme can be seen in the following table:

finally, it should be noted that: although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that changes may be made in the embodiments and/or equivalents thereof without departing from the spirit and scope of the invention. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.