CN107952108B

CN107952108B - Liquid gel dressing for resisting infection and contraception and preparation method thereof

Info

Publication number: CN107952108B
Application number: CN201711114130.8A
Authority: CN
Inventors: 吴浪浪
Original assignee: Guangxi Daqing Biological Science & Technology Co ltd
Current assignee: Guangxi Daqing Biological Science & Technology Co ltd
Priority date: 2017-11-13
Filing date: 2017-11-13
Publication date: 2021-05-28
Anticipated expiration: 2037-11-13
Also published as: CN107952108A

Abstract

The invention relates to an anti-infection and contraception liquid gel dressing and a preparation method thereof. The liquid gel dressing is prepared from N-isopropyl acrylamide, glycerol, polyethylene glycol, dimethyl silicone oil, nonoxynol-9, didecyl dimethyl ammonium chloride, coptis chinensis, polygonum cuspidatum, gallnut, hairyvein agrimony, Chinese pulsatilla root, clove and the like. The liquid gel dressing can prevent infection such as vaginitis and prevent unintended pregnancy.

Description

Liquid gel dressing for resisting infection and contraception and preparation method thereof

Technical Field

The invention relates to the technical field of medical supplies, in particular to an anti-infection and contraception liquid gel dressing and a preparation method thereof.

Background

Venereal diseases are diseases mainly transmitted through sexual behaviors, and in recent years, various venereal diseases are rapidly spread in China, and the incidence rate of the venereal diseases is increased at a rate of 20% -30% every year and tends to rise year by year. According to official statistics in China in 2005, 70 thousands of people infected with venereal diseases in China become one of five infectious diseases. Bacterial vaginitis is a syndrome of bacteriology manifested as a decrease in the number of normal flora and an increase in the number of anaerobic flora in the genital tract. It is a disease determined to be related to sexual transmission, is a common disease and frequently encountered disease of vast women and accounts for 30 to 50 percent of vulvar-vaginal infection. BV is mainly caused by the increase of ascending infection, the infection rate of genital organs in the pelvic cavity is increased along with the ascending infection rate, and ectopic pregnancy and infertility are caused. The clinical manifestations include increased leucorrhea and peculiar smell. Whether clinical symptoms exist or not, the traditional Chinese medicine composition can cause various complications such as premature birth, premature rupture of fetal membranes, chorioamnionitis, puerperal infection, low-weight newborn, cervical cancer, cervical epidermal dysplasia and the like, and can increase susceptibility of AIDS. BV seriously affects the quality of life and work efficiency of women, and the prevention and effective treatment of various bacterial vaginosis become one of the most concerned problems for the majority of clinicians and women. Clinically, the bacterial vaginitis is treated by two modes of oral administration and vaginal local administration. The oral antibiotic therapy is systemic administration, is absorbed by oral administration, is distributed to tissues of the whole body, achieves lower concentration of local parts of the vagina, is difficult to achieve effective antibacterial effect, and generates toxic and side effects on the whole body by the antibiotic and metabolites thereof. The vaginal local administration, such as vaginal effervescent tablets or suppositories containing metronidazole and 2% clindamycin vaginal agent, is superior to oral administration, and has high local concentration, good antibacterial effect and low toxic and side effects. So far, no antibiotic can kill the pathogenic bacteria simultaneously in oral administration or local administration, and clinical combined administration is needed, so that the combined administration has the disadvantages of large side effect, inconvenient administration and high cost, and the antibiotic generates drug resistance, and is effective in a short time during treatment but easy to relapse after stopping administration.

In a large family of modern contraceptive devices, barrier contraception is widely used by people because of its dual functions of contraception and prevention of Sexually Transmitted Diseases (STDs). The exercise of safety behaviors advocated by people, adherence to condoms and reduction in the number of sexual partners, in a sense prevents STD transmission, but the literature shows that its effect can only be shown in global epidemiology when the range of safety behaviors is very wide.

The exercise of safety behaviors advocated by people, adherence to condoms and reduction in the number of sexual partners, in a sense prevents STD transmission, but the literature shows that its effect can only be shown in global epidemiology when the range of safety behaviors is very wide. When the condom is used, the pleasure, the comfort and the satisfaction of the male are reduced, and the male has stronger rejection. Clinically, the bacterial vaginitis is treated by two modes of oral administration and vaginal local administration. The oral antibiotic therapy is systemic administration, is absorbed by oral administration, is distributed to tissues of the whole body, achieves lower concentration of local parts of the vagina, is difficult to achieve effective antibacterial effect, and generates toxic and side effects on the whole body by the antibiotic and metabolites thereof. Local administration is superior to oral administration, local concentration is high, an antibacterial effect is good, toxic and side effects are low, but gels are directly administered in a semisolid form, administration is inconvenient, the gel needs to enter the deep part of a vagina through an administration device and melt or soften in the deep part, and patient compliance is poor.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide an anti-infection and contraceptive liquid gel dressing;

it is another object of the present invention to provide a method for preparing an anti-infective and contraceptive liquid gel dressing.

The purpose of the invention is realized by the following technical scheme:

an anti-infection and contraception liquid gel dressing is prepared from the following raw materials in parts by weight:

1-3 parts of N-isopropyl acrylamide, 0.0159-0.228 part of didecyl dimethyl ammonium chloride, 92-4 parts of nonoxynol and 5-10 parts of compound traditional Chinese medicine extract;

the compound traditional Chinese medicine extract is prepared from coptis chinensis, giant knotweed rhizome, clove, Chinese gall, hairyvein agrimony and Chinese pulsatilla root, wherein the weight ratio of each component is as follows: coptis chinensis: giant knotweed rhizome: clove: gallnut: agrimony: chinese pulsatilla root = 5-10: 3-8: 3-8: 3-8: 3-8: 3-8 parts.

The compound traditional Chinese medicine extract is prepared by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and pulsatilla chinensis.

The preparation method of the compound traditional Chinese medicine extract comprises the following steps:

weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to weight ratio, soaking in 6-8 times of water for 0.5-1 hr, boiling, stirring for 1-2 hr, and filtering while hot; decocting the residue with water twice, each for 0.5-1h, filtering, mixing filtrates, concentrating the filtrate at 50-70 deg.C under reduced pressure to obtain extract with relative density of 1.10-1.20 at room temperature, standing to room temperature, adding 95% ethanol to make ethanol content reach 60-70%, stirring while precipitating impurities, standing for 18-36h, filtering, concentrating the filtrate at 50-70 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.10-1.20.

An anti-infection and contraception liquid gel dressing is prepared from the following raw materials and auxiliary materials in parts by weight:

1-3 parts of N-isopropyl acrylamide, 1-3 parts of glycerol, 1-3 parts of polyethylene glycol, 1-3 parts of simethicone, 0.03-0.3 part of didecyl dimethyl ammonium chloride, 92-4 parts of nonoxynol, 4-10 parts of compound traditional Chinese medicine extract and 74-90 parts of purified water;

Preferably, the feed additive is prepared from the following raw materials and auxiliary materials in parts by weight:

1-2 parts of N-isopropyl acrylamide, 1-2 parts of glycerol, 1-2 parts of polyethylene glycol, 1-2 parts of simethicone, 0.1-0.2 part of didecyl dimethyl ammonium chloride, 92-3 parts of nonoxynol, 5-8 parts of traditional Chinese medicine extract and 81-89 parts of purified water.

The traditional Chinese medicine extract is prepared from coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight ratio of each component is as follows: coptis chinensis: giant knotweed rhizome: clove: gallnut: agrimony: chinese pulsatilla root = 5-8: 4-6: 4-6: 4-6: 4-6: 4-6 parts.

The compound traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and pulsatilla.

The following are the medicinal material sources of the traditional Chinese medicine raw materials:

coptidis rhizoma, dried rhizome of Coptis chinensis Franch of Ranunculaceae, Coptis deltoidea C.Y. Cheng et Hsiao or Coptis Teeta wall. Bitter and cold. It enters heart, spleen, stomach, liver, gallbladder and large intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity. Can be used for treating damp-heat distention, fullness, emesis, acid regurgitation, dysentery, jaundice, hyperpyrexia, coma, excessive heart-fire, vexation, insomnia, hematemesis, hemorrhage, conjunctival congestion, toothache, diabetes, carbuncle, furuncle, etc.; it is used externally to treat eczema, eczema and purulent ear canal. Huang Lian (Chinese goldthread) processed with wine is good at clearing heat in upper energizer. It can be used for treating conjunctival congestion and aphtha. Jiang Huang Lian can clear stomach, harmonize stomach and stop vomiting. Can be used for treating cold and heat accumulation, damp-heat obstruction, fullness and emesis. Yu Huang Lian soothes liver, harmonizes stomach and stops vomiting. Can be used for treating liver and stomach disharmony, emesis and acid regurgitation.

Polygonum cuspidatum is dried rhizome and root of Polygonum cuspidatum Sieb. et Zucc. Slightly bitter and slightly cold. It enters liver, gallbladder and lung meridians. Dispel wind and remove dampness, dissipate blood stasis and relieve pain, relieve cough and resolve phlegm. Can be used for treating arthralgia, jaundice due to damp-heat pathogen, amenorrhea, abdominal mass, scald due to hot water or fire, traumatic injury, carbuncle, swelling, sore, and cough with excessive phlegm.

Clove, a dried bud of Eugenia caryophyllata Thunb, a plant of Myrtaceae. Pungent and warm. It enters spleen, stomach, lung and kidney meridians. To warm the middle-jiao and descend the adverse flow of qi, tonify the kidney and strengthen yang. Can be used for treating deficiency-cold of spleen and stomach, singultus emesis, anorexia vomiting and diarrhea, psychroalgia of heart and abdomen, and sexual impotence due to kidney deficiency.

Gallnut, a gall on leaves of Rhus chinensis Mill, Rhus potaninii Maxim, or Rhus chinensis pun-jabensis Stew.var.sina (Diels) Red et Wils, a plant of the family Anacardiaceae, formed mainly by parasitization of the gall aphid Melaphosis chinensis (Bell) Baker. Sour, astringent and cold. It enters lung, large intestine and kidney meridians. Astringe lung to reduce fire, astringe intestine to check diarrhea, astringe sweat to stop bleeding, astringe dampness to heal wound. Can be used for treating chronic cough due to lung deficiency, chronic diarrhea, night sweat, diabetes, hemafecia, hemorrhoid, traumatic hemorrhage, carbuncle, sore, and skin ulcer.

Herba et Gemma Agrimoniae is dried aerial part of Agrimonia pilosa Ledeb of Rosaceae. Bitter, astringent and mild. It enters heart and liver meridians. Astringe to stop bleeding, check malaria, stop dysentery and remove toxicity. Can be used for treating hemoptysis, hematemesis, metrorrhagia, malaria, dysentery with bloody stool, overstrain wound, carbuncle, sore, pruritus vulvae, and leukorrhagia.

Pulsatilla chinensis, dried root of Pulsatilla chinensis (Bge.) Regel of Ranunculaceae. Bitter and cold. It enters stomach and large intestine meridians. Clear heat and remove toxicity, cool blood and stop dysentery. Can be used for treating dysentery with heat-toxin and blood, pudendal pruritus, leukorrhagia, and amebic dysentery.

In another aspect, the invention provides a method of preparing an anti-infective and contraceptive liquid gel dressing of the invention, comprising the steps of:

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to weight ratio, soaking in 6-8 times of water for 0.5-1 hr, boiling, stirring for 1-2 hr, and filtering while hot; decocting the residue with water twice, each for 0.5-1h, filtering, mixing filtrates, concentrating the filtrate at 50-70 deg.C under reduced pressure to obtain extract with relative density of 1.10-1.20 at room temperature, standing to room temperature, adding 95% ethanol to make ethanol content reach 60-70%, stirring while precipitating impurities, standing for 18-36h, filtering, concentrating the filtrate at 50-70 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.10-1.20;

(2) weighing the didecyl dimethyl ammonium chloride in the formula proportion, adding the didecyl dimethyl ammonium chloride into the purified water in the formula proportion, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, cooling the solution to room temperature for later use, wherein one part is 20% of the total amount of the solution containing the didecyl dimethyl ammonium chloride, and the other part is 80% of the total amount of the solution containing the didecyl dimethyl ammonium chloride, and cooling the solution to 10 ℃ for later use;

(3) taking 20% of the total amount of the aqueous solution of the didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, dimethyl silicone oil and nonoxynol-9 according to the weight part ratio, weighing the extract A according to the weight part ratio, adding the extract A, and stirring at room temperature for 1-2 hours to obtain a solution B;

(4) weighing N-isopropylacrylamide according to the weight part ratio, slowly adding the N-isopropylacrylamide into the aqueous solution of the didodecyldimethylammonium chloride with the balance of 10 ℃ under stirring to obtain a solution C, standing overnight at the temperature of 4 ℃, adding the solution B cooled to room temperature in the next day, uniformly stirring, and stirring for 1-2 hours to obtain the anti-infection and contraception liquid gel dressing for the vagina.

The liquid gel dressing formula provided by the invention comprises the following components:

1. the product utilizes the temperature-sensitive film-forming slow-release capability of N-isopropylacrylamide to control and release drug effect, adopts a liquid state direct injection administration mode to improve the compliance of patients, forms gel in vivo, and plays roles of isolation protection and slow-release drug effect;

2. the Chinese herbal medicine compound of the combination of the coptis, the giant knotweed, the clove, the gallnut, the hairyvein agrimony and the Chinese pulsatilla root has the effects of inhibiting or killing candida albicans, gonococcus and trichomonas vaginalis, inhibiting bacteria in the vagina, diminishing inflammation and resisting infection; can be combined with nonoxynol-9 to prevent infection such as vaginitis and contraception;

3. the polyethylene glycol, the glycerol and the dimethyl silicone oil are used in a matching way, so that the water and moisture can be preserved, and the vagina lubricating effect can be achieved;

4. the ammonium didecyl dimethyl chloride has antibacterial property, can inhibit bacteria, kill bacteria, prevent infection, maintain the stability of the liquid and prolong the shelf life.

The invention has the beneficial effects that:

1. the anti-infective and contraceptive liquid gel dressing is administered by direct injection in a liquid state,

the defect that the applicator causes discomfort or secondary injury when entering the vagina is overcome, the administration compliance of a patient is improved, the liquid dressing enters the body, the liquidity of the liquid dressing is exerted, the vagina is uniformly covered, the vagina is lubricated and moistened, semisolid gel is quickly formed due to the rise of the temperature, and the drug effect is slowly released, so that the long-lasting prevention is achieved; the components are reasonably matched, supplement each other, have no conflict, and have good slow release, antibacterial, anti-inflammatory, moisturizing, lubricating and contraceptive effects.

2. The defect that in the prior art, when a condom is used, the pleasure, the comfort and the satisfaction of the male are reduced, and the male has strong rejection to the condom is overcome. The nonoxynol-9 and the Chinese herbal medicine compound are combined and added into a temperature sensitive material matrix N-isopropyl acrylamide, so that the infection such as vaginitis and the like can be prevented and involuntary pregnancy can be avoided at the same time, and a female controlled contraception method is provided.

3. The preparation process adopted by the invention comprises the following steps: the compound Chinese medicinal extract A is prepared by extracting with water and precipitating with ethanol, boiling at high temperature for sterilizing, accelerating extraction of effective components of Chinese medicinal materials, precipitating with ethanol, and removing impurities; II, secondly: the method comprises the following steps of dissolving the didecyl dimethyl ammonium chloride into purified water in advance, dividing the purified water into two parts of aqueous solution containing the didecyl dimethyl ammonium chloride for preparing other raw materials, and effectively preventing the solution B and the solution C from being polluted by microorganisms in the preparation process; thirdly, the method comprises the following steps: the N-isopropylacrylamide has good temperature-sensitive characteristic, and can be changed into semisolid gel from a solution at 32 ℃, the solution C is placed at 4 ℃ overnight, and then the solution B at room temperature is added for stirring and preparation, so that the problem that the solution is changed into gel from phase change in the subsequent stirring and preparation process, and the influence on the uniform dispersion of the raw material in the N-isopropylacrylamide matrix is avoided.

Detailed Description

The invention is further illustrated by the following examples. It should be understood that the examples of the present invention are for illustrative purposes and not intended to limit the present invention. Simple modifications of the invention in accordance with its spirit fall within the scope of the claimed invention. Unless otherwise stated, the percentage of ethanol amount in the present invention is a volume percentage, v/v represents a volume ratio of the solution, and finally ethanol is recovered by reduced pressure rotary evaporation.

Example 1

An anti-infection and contraception liquid gel dressing is prepared from the following raw materials and auxiliary materials:

1g of N-isopropyl acrylamide, 1g of glycerol, 1g of polyethylene glycol, 1g of simethicone, 0.03g of didecyl dimethyl ammonium chloride, 92 g of nonoxynol, 4g of traditional Chinese medicine extract and 90g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 5g of coptis chinensis, 3g of giant knotweed, 3g of clove, 3g of gallnut, 3g of hairyvein agrimony and 3g of Chinese pulsatilla root.

An anti-infective and contraceptive liquid gel dressing is prepared by the following steps:

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 120g water for 0.5h, heating to boil, stirring for 1h, and filtering while hot; decocting the residue with water twice, each for 0.5 hr, filtering, mixing filtrates, concentrating the filtrate at 50 deg.C under reduced pressure to obtain extract with relative density of 1.10 at room temperature, standing at room temperature, adding 95% ethanol to make ethanol content reach 60%, stirring while precipitating impurities, standing for 36 hr, filtering, concentrating the filtrate at 50 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.10;

(2) weighing 0.03g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 90g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely one part of the solution containing 18g of didecyl dimethyl ammonium chloride, cooling the solution to room temperature for later use, and cooling 72g of the solution containing one part of didecyl dimethyl ammonium chloride to 10 ℃ for later use;

(3) taking 18g of ammonium didecyl dimethyl chloride aqueous solution, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 into the solution according to the formula, adding the extract A cooled to room temperature, and stirring the mixture for 1 hour at room temperature to obtain solution B;

(4) weighing N-isopropyl acrylamide according to the formula, slowly adding the N-isopropyl acrylamide into 72g of didecyl dimethyl ammonium chloride aqueous solution at the temperature of 10 ℃ under stirring to obtain solution C, standing overnight at the temperature of 4 ℃, adding the solution B cooled to room temperature in the next day, uniformly stirring, and stirring for 1 hour.

Example 2

2g of N-isopropyl acrylamide, 2g of glycerol, 2g of polyethylene glycol, 2g of simethicone, 0.2g of didecyl dimethyl ammonium chloride, 93 g of nonoxynol, 7.6g of traditional Chinese medicine extract and 81g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 8g of coptis chinensis, 6g of giant knotweed, 6g of clove, 6g of gallnut, 6g of hairyvein agrimony and 6g of Chinese pulsatilla root.

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 250g water for 1 hr, heating to boil, stirring for 2 hr, and filtering while hot; decocting the residue with water twice, each for 1 hr, filtering, mixing filtrates, concentrating the filtrate at 70 deg.C under reduced pressure to obtain extract with relative density of 1.20 at room temperature, standing to room temperature, adding 95% ethanol to make ethanol content reach 70%, stirring while precipitating impurities, standing for 18 hr, filtering, concentrating the filtrate at 70 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.20;

(2) weighing 0.2g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 81g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely one part of the solution containing 16.24g of didecyl dimethyl ammonium chloride, cooling to room temperature for later use, and cooling one part of the solution containing 64.96g of didecyl dimethyl ammonium chloride to 10 ℃ for later use;

(3) taking 16.24g of aqueous solution of didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 according to the formula, adding the extract A cooled to room temperature, and stirring at room temperature for 2 hours to obtain solution B;

(4) weighing N-isopropyl acrylamide according to the formula, slowly adding the N-isopropyl acrylamide into 64.96g of aqueous solution of didecyl dimethyl ammonium chloride at the temperature of 10 ℃ under stirring to obtain solution C, standing overnight at the temperature of 4 ℃, adding the solution B cooled to room temperature the next day, uniformly stirring, and stirring for 2 hours.

Example 3

1g of N-isopropyl acrylamide, 1g of glycerol, 1g of polyethylene glycol, 1g of simethicone, 0.1g of didecyl dimethyl ammonium chloride, 92 g of nonoxynol, 5g of traditional Chinese medicine extract and 89g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 5g of coptis chinensis, 4g of giant knotweed, 4g of clove, 4g of gallnut, 4g of hairyvein agrimony and 4g of Chinese pulsatilla root.

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 200g water for 40min, heating to boil, stirring for 0.5h, and filtering while hot; decocting the residue with water twice, each for 0.5 hr, filtering, mixing filtrates, concentrating the filtrate at 60 deg.C under reduced pressure to obtain extract with relative density of 1.15 at room temperature, standing at room temperature, adding 95% ethanol to make ethanol content reach 65%, stirring while precipitating impurities, standing for 24 hr, filtering, concentrating the filtrate at 60 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.15;

(2) weighing 0.1g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 89g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely one part of the solution containing 17.82g of didecyl dimethyl ammonium chloride, cooling to room temperature for later use, and cooling one part of the solution containing 64.96g of didecyl dimethyl ammonium chloride to 10 ℃ for later use;

(3) taking 17.82 parts of aqueous solution of didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, dimethyl silicone oil and nonoxynol-9 according to the formula, adding the extract A cooled to room temperature, and stirring at room temperature for 1.5 hours to obtain solution B;

(4) according to the formula, N-isopropyl acrylamide is weighed and slowly added into 64.96g of aqueous solution of didecyl dimethyl ammonium chloride at 10 ℃ under stirring to obtain solution C, the solution C is placed at 4 ℃ overnight, the solution B cooled to room temperature is added in the next day, the mixture is uniformly stirred, and the mixture is stirred for 1.5 hours to prepare the N-isopropyl acrylamide aqueous solution.

Example 4

3g of N-isopropyl acrylamide, 3g of glycerol, 3g of polyethylene glycol, 3g of simethicone, 0.3g of didecyl dimethyl ammonium chloride, 94 g of nonoxynol, 10g of traditional Chinese medicine extract and 74g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 10g of coptis chinensis, 8g of giant knotweed, 8g of clove, 8g of gallnut, 8g of hairyvein agrimony and 8g of Chinese pulsatilla root.

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 350g water for 40min, heating to boil, stirring for 0.5h, and filtering while hot; decocting the residue with water twice, each for 0.5 hr, filtering, mixing filtrates, concentrating the filtrate at 60 deg.C under reduced pressure to obtain extract with relative density of 1.15 at room temperature, standing at room temperature, adding 95% ethanol to make ethanol content reach 65%, stirring while precipitating impurities, standing for 24 hr, filtering, concentrating the filtrate at 60 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.15;

(2) weighing 0.3g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 74g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely 14.86g of one part, cooling to room temperature for later use, and cooling 59.44g of one part to 10 ℃ for later use;

(3) taking 14.86g of aqueous solution of didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 according to the formula, adding the extract A cooled to room temperature, and stirring at room temperature for 1.5 hours to obtain solution B;

(4) according to the formula, N-isopropyl acrylamide is weighed and slowly added into 59.44g of aqueous solution of didecyl dimethyl ammonium chloride at 10 ℃ under stirring to obtain solution C, the solution C is placed at 4 ℃ overnight, the solution B cooled to room temperature is added in the next day, the mixture is uniformly stirred, and the mixture is stirred for 1.5 hours to prepare the N-isopropyl acrylamide aqueous solution.

Example 5

1.5g of N-isopropylacrylamide, 1.5g of glycerol, 1.5g of polyethylene glycol, 1.5g of simethicone, 0.05g of didecyl dimethyl ammonium chloride, 92.5 g of nonoxynol, 6.2g of traditional Chinese medicine extract and 85g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 6g of coptis chinensis, 5g of giant knotweed, 5g of clove, 5g of gallnut, 5g of hairyvein agrimony and 5g of Chinese pulsatilla root.

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 220g water for 50min, heating to boil, stirring for 1h, and filtering while hot; decocting the residue with water twice, each for 1 hr, filtering, mixing filtrates, concentrating the filtrate at 55 deg.C under reduced pressure to obtain extract with relative density of 1.15 at room temperature, standing to room temperature, adding 95% ethanol until the ethanol content reaches 65%, stirring while precipitating impurities, standing for 20 hr, filtering, concentrating the filtrate at 55 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.15;

(2) weighing 0.05g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 85g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely 17g of the solution, cooling the solution to room temperature for later use, and cooling 68g of the solution to 10 ℃ for later use;

(3) taking 17g of aqueous solution of didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 into the aqueous solution according to the formula, adding the extract A cooled to room temperature, and stirring the mixture for 1.2 hours at room temperature to obtain solution B;

(4) weighing N-isopropyl acrylamide according to the formula, slowly adding the N-isopropyl acrylamide into 68g of aqueous solution of didecyl dimethyl ammonium chloride at the temperature of 10 ℃ under stirring to obtain solution C, standing overnight at the temperature of 4 ℃, adding the solution B cooled to room temperature in the next day, uniformly stirring, and stirring for 1.2 hours to obtain the N-isopropyl acrylamide.

Example 6

1.2g of N-isopropylacrylamide, 1.2g of glycerol, 1.5g of polyethylene glycol, 1.5g of simethicone, 0.15g of didecyl dimethyl ammonium chloride, 92.5 g of nonoxynol, 8.4g of traditional Chinese medicine extract and 84g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 7g of coptis chinensis, 7g of giant knotweed, 7g of clove, 7g of gallnut, 7g of hairyvein agrimony and 7g of Chinese pulsatilla root.

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 270g water for 45min, heating to boil, stirring for 1.5 hr, and filtering while hot; decocting the residue with water twice, each for 0.5 hr, filtering, mixing filtrates, concentrating the filtrate at 65 deg.C under reduced pressure to obtain extract with relative density of 1.15 at room temperature, standing at room temperature, adding 95% ethanol to make ethanol content reach 60%, stirring while precipitating impurities, standing for 30 hr, filtering, concentrating the filtrate at 65 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.15;

(2) weighing 0.15g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 84g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely one part of the solution containing 16.83g of didecyl dimethyl ammonium chloride, cooling to room temperature for later use, and cooling to 10 ℃ for later use, wherein the other part of the solution containing 67.32g of didecyl dimethyl ammonium chloride is divided into two parts of the solution;

(3) taking 16.83g of aqueous solution of didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 according to the formula, adding the extract A cooled to room temperature, and stirring at room temperature for 1.2 hours to obtain solution B;

(4) according to the formula, N-isopropyl acrylamide is weighed and slowly added into 67.32g of aqueous solution of didecyl dimethyl ammonium chloride at 10 ℃ under stirring to obtain solution C, the solution C is placed at 4 ℃ overnight, the solution B cooled to room temperature is added in the next day, the mixture is uniformly stirred, and the mixture is stirred for 1.2 hours to obtain the N-isopropyl acrylamide aqueous solution.

Example 7

2.5g of N-isopropylacrylamide, 1.5g of glycerol, 1.5g of polyethylene glycol, 2.5g of simethicone, 0.25g of didecyl dimethyl ammonium chloride, 93 g of nonoxynol, 6g of traditional Chinese medicine extract and 83g of purified water.

The traditional Chinese medicine extract is obtained by carrying out water extraction and alcohol precipitation on coptis chinensis, polygonum cuspidatum, clove, gallnut, agrimony and Chinese pulsatilla root, wherein the weight of each component is as follows: 6g of coptis chinensis, 5g of giant knotweed, 4g of clove, 6g of gallnut, 4g of hairyvein agrimony and 5g of Chinese pulsatilla root.

(1) weighing Coptidis rhizoma, rhizoma Polygoni Cuspidati, Galla chinensis, herba et Gemma Agrimoniae, radix Pulsatillae, and flos Caryophylli according to the above formula, soaking in 200g water for 0.5 hr, heating to boil, stirring for 1 hr, and filtering while hot; decocting the residue with water twice, each for 1 hr, filtering, mixing filtrates, concentrating the filtrate at 60 deg.C under reduced pressure to obtain extract with relative density of 1.20 at room temperature, standing to room temperature, adding 95% ethanol until the ethanol content reaches 60%, stirring while adding to precipitate impurities, standing for 32 hr, filtering, concentrating the filtrate at 60 deg.C under reduced pressure, and recovering ethanol to obtain extract A with relative density of 1.20;

(2) weighing 0.25g of didecyl dimethyl ammonium chloride according to the formula, adding the didecyl dimethyl ammonium chloride into 83g of purified water, uniformly stirring to obtain a solution containing the didecyl dimethyl ammonium chloride, dividing the solution into two parts, namely one part of the solution containing 16.65g of didecyl dimethyl ammonium chloride, cooling to room temperature for later use, and cooling one part of the solution containing 66.6g of didecyl dimethyl ammonium chloride to 10 ℃ for later use;

(3) taking 16.65g of aqueous solution of didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 according to the formula, adding the extract A cooled to room temperature, and stirring at room temperature for 1.5 hours to obtain solution B;

(4) according to the formula, N-isopropyl acrylamide is weighed and slowly added into 66.6g of aqueous solution of didecyl dimethyl ammonium chloride at the temperature of 10 ℃ under stirring to obtain solution C, the solution C is placed at the temperature of 4 ℃ overnight, the solution B cooled to room temperature is added in the next day, the mixture is uniformly stirred, and the mixture is stirred for 1.5 hours to prepare the N-isopropyl acrylamide aqueous solution.

Clinical trial 1

1 general data

60 patients with bacterial vaginitis were diagnosed. The age is 18-58 years. The main clinical manifestations are vaginal secretion increase and vulvar pruritus, sometimes burning, pain, dyspareunia and the like, the secretion is typically characterized by thin purulent property, yellow green, foamy and odorous, the inspection shows that the vaginal mucosa is congested, the serious patient has bleeding spots, part of cervix has blood spots, the posterior fornix has leucorrhea, and the vaginal secretion objective lens detects visible bacteria.

2 method of treatment

The inventive example 2 treatment was given 2 times daily for a treatment period of 5 days.

3 evaluation of therapeutic Effect

And (3) healing: itching and pain of vagina and external vagina disappear, and examination of vaginal secretion turns to normal. The integral is 0 point.

The effect is shown: the itching and pain of the vagina and the external vagina are obviously relieved, and the examination of the vaginal secretion is normal. The score decreased more than 2/3 after treatment than before treatment.

The method has the following advantages: the vaginal secretion is checked to be normal and other symptoms exist, or other symptoms disappear, are relieved and the vaginal secretion is checked to be abnormal. The score decreased more than 1/3 after treatment than before treatment.

And (4) invalidation: the examination and symptoms after treatment are the same as before treatment.

The total effective rate is the curative rate.

4 results

The results are shown in Table 1.

TABLE 1 treatment results (example)

	Number of examples	Cure of disease	Show effect	Invalidation	Total effective	Total effective rate
							Therapeutic effect	60	54	5	1	59	98.3%

From the results, it can be seen that the total effective rate of the anti-infective and contraceptive liquid gel dressing of the present invention against bacterial vaginitis is 98.3%.

Clinical trial 2

1 general data

Experimental animals: adult healthy Wistar rats, 24 female rats, weighing 250 + -10 g, 12 male rats, weighing 300 + -10 g.

Grouping experiments: the female mice were completely randomized into 3 groups (1) blank matrix group: administering a blank matrix; (2) control group: administration of nonoxynol-9; (3) experimental groups: the anti-infective and contraceptive liquid gel dressing described in example 5 of this invention was administered at 0.5 g.

The medication method comprises the following steps: when the estrus is 9 days later, the medicine is administrated intravaginally once, the administration is closed with male mice, and when vaginal secretion is detected by microscopic examination in the next 9 days, the male mice are immediately raised in cages.

2 methods of observation and determination: on the 10 th day after the administration, the uterus is dissected by the conventional method after the anesthesia by 0.8 percent sodium pentobarbital, the number of live fetuses, the number of dead fetuses, the implantation points, the number of corpus luteum and the number of blastocysts in the left uterine horn and the right uterine horn of each mouse are counted by visual observation, if one implantation point exists, the pregnant mouse is calculated, then the fertility rate, the average live fetuses, the dead fetuses, the implantation points and the number of corpus luteum of each group are calculated, and the results of each group are compared.

3 results

The results are shown in Table 1.

TABLE 1 contraceptive effect of self-made liquid gel on rats (example)

Under the experimental condition, each group of the experiment has no dead fetus, the blank matrix group is completely pregnant, and the ovulation point of the rat in the self-made liquid gel group is compared with the blank matrix group and the nonoxynol-9 control group, so that no difference between the groups exists, and the ovulation function of the ovary of each rat is normal; the uterus implantation point of the self-made liquid gel group has very significant meaning compared with the blank matrix group (P is less than 0.01); the number of live births in the home-made liquid gel group was statistically significantly different (P < 0.01) from that in the blank matrix group.

From the results, it can be seen that the anti-infective and contraceptive liquid gel dressing of the present invention has an effective rate of contraceptive effect of 75% in rats.

Although the invention has been described in detail hereinabove by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that many modifications and improvements can be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims

1. The liquid gel dressing for resisting infection and contraception is characterized by being prepared from the following raw materials and auxiliary materials in parts by weight:

the compound traditional Chinese medicine extract is prepared from coptis chinensis, giant knotweed rhizome, clove, Chinese gall, hairyvein agrimony and Chinese pulsatilla root, wherein the weight ratio of each component is as follows: coptis chinensis: giant knotweed rhizome: clove: gallnut: agrimony: chinese pulsatilla root = 5-10: 3-8: 3-8: 3-8: 3-8: 3-8 parts;

the preparation method comprises the following steps:

(2) weighing the didecyl dimethyl ammonium chloride in the formula proportion, adding the didecyl dimethyl ammonium chloride into the purified water in the formula proportion, uniformly stirring to obtain a didecyl dimethyl ammonium chloride-containing aqueous solution, dividing the didecyl dimethyl ammonium chloride-containing aqueous solution into two parts, cooling the solution to room temperature for later use, and cooling 80% of the solution to 10 ℃ for later use;

(3) taking 20% of the total amount of the aqueous solution containing the didecyl dimethyl ammonium chloride, sequentially adding glycerol, polyethylene glycol, simethicone and nonoxynol-9 according to the weight part ratio, weighing the extract A according to the weight part ratio, adding the extract A, and stirring at room temperature for 1-2 hours to obtain a solution B;

(4) weighing N-isopropylacrylamide according to the weight part ratio, slowly adding the N-isopropylacrylamide into the aqueous solution of the didodecyldimethylammonium chloride with the balance of 10 ℃ under stirring to obtain a solution C, cooling to 4 ℃, standing overnight, adding the solution B cooled to room temperature the next day, uniformly stirring, and stirring for 1-2 hours to obtain the anti-infection and contraception liquid gel dressing for the vagina.

2. The anti-infective and contraceptive liquid gel dressing of claim 1, prepared from the following raw materials and adjuvants in parts by weight:

1-2 parts of N-isopropyl acrylamide, 1-2 parts of glycerol, 1-2 parts of polyethylene glycol, 1-2 parts of simethicone, 0.1-0.2 part of didecyl dimethyl ammonium chloride, 92-3 parts of nonoxynol, 5-8 parts of traditional Chinese medicine extract and 81-89 parts of purified water;