CN113082050A - Temperature-sensitive gel for gynecology and preparation method thereof - Google Patents
Temperature-sensitive gel for gynecology and preparation method thereof Download PDFInfo
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- CN113082050A CN113082050A CN202110453466.7A CN202110453466A CN113082050A CN 113082050 A CN113082050 A CN 113082050A CN 202110453466 A CN202110453466 A CN 202110453466A CN 113082050 A CN113082050 A CN 113082050A
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- solution
- temperature
- gynecology
- sensitive gel
- hypochlorite
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- 238000002360 preparation method Methods 0.000 title claims abstract description 18
- WQYVRQLZKVEZGA-UHFFFAOYSA-N hypochlorite Chemical compound Cl[O-] WQYVRQLZKVEZGA-UHFFFAOYSA-N 0.000 claims abstract description 28
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 claims abstract description 23
- 229920002125 Sokalan® Polymers 0.000 claims abstract description 23
- 229960001631 carbomer Drugs 0.000 claims abstract description 23
- 238000003756 stirring Methods 0.000 claims abstract description 21
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims abstract description 18
- 229920001983 poloxamer Polymers 0.000 claims abstract description 14
- 229960000502 poloxamer Drugs 0.000 claims abstract description 14
- 239000002994 raw material Substances 0.000 claims abstract description 12
- 238000000034 method Methods 0.000 claims abstract description 4
- 230000001105 regulatory effect Effects 0.000 claims abstract description 3
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 20
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 14
- VTAJIXDZFCRWBR-UHFFFAOYSA-N Licoricesaponin B2 Natural products C1C(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2)C(O)=O)C)(C)CC2)(C)C2C(C)(C)CC1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O VTAJIXDZFCRWBR-UHFFFAOYSA-N 0.000 claims description 10
- 239000005708 Sodium hypochlorite Substances 0.000 claims description 10
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 10
- LPLVUJXQOOQHMX-UHFFFAOYSA-N glycyrrhetinic acid glycoside Natural products C1CC(C2C(C3(CCC4(C)CCC(C)(CC4C3=CC2=O)C(O)=O)C)(C)CC2)(C)C2C(C)(C)C1OC1OC(C(O)=O)C(O)C(O)C1OC1OC(C(O)=O)C(O)C(O)C1O LPLVUJXQOOQHMX-UHFFFAOYSA-N 0.000 claims description 10
- 229960004949 glycyrrhizic acid Drugs 0.000 claims description 10
- UYRUBYNTXSDKQT-UHFFFAOYSA-N glycyrrhizic acid Natural products CC1(C)C(CCC2(C)C1CCC3(C)C2C(=O)C=C4C5CC(C)(CCC5(C)CCC34C)C(=O)O)OC6OC(C(O)C(O)C6OC7OC(O)C(O)C(O)C7C(=O)O)C(=O)O UYRUBYNTXSDKQT-UHFFFAOYSA-N 0.000 claims description 10
- 239000001685 glycyrrhizic acid Substances 0.000 claims description 10
- 235000019410 glycyrrhizin Nutrition 0.000 claims description 10
- LPLVUJXQOOQHMX-QWBHMCJMSA-N glycyrrhizinic acid Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@@H]1C([C@H]2[C@]([C@@H]3[C@@]([C@@]4(CC[C@@]5(C)CC[C@@](C)(C[C@H]5C4=CC3=O)C(O)=O)C)(C)CC2)(C)CC1)(C)C)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O LPLVUJXQOOQHMX-QWBHMCJMSA-N 0.000 claims description 10
- SUKJFIGYRHOWBL-UHFFFAOYSA-N sodium hypochlorite Chemical compound [Na+].Cl[O-] SUKJFIGYRHOWBL-UHFFFAOYSA-N 0.000 claims description 10
- SATVIFGJTRRDQU-UHFFFAOYSA-N potassium hypochlorite Chemical compound [K+].Cl[O-] SATVIFGJTRRDQU-UHFFFAOYSA-N 0.000 claims description 8
- ZKQDCIXGCQPQNV-UHFFFAOYSA-N Calcium hypochlorite Chemical compound [Ca+2].Cl[O-].Cl[O-] ZKQDCIXGCQPQNV-UHFFFAOYSA-N 0.000 claims description 7
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 7
- 229920001542 oligosaccharide Polymers 0.000 claims description 5
- QWPPOHNGKGFGJK-UHFFFAOYSA-N hypochlorous acid Chemical class ClO QWPPOHNGKGFGJK-UHFFFAOYSA-N 0.000 claims description 4
- 239000003973 paint Substances 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 13
- 230000001954 sterilising effect Effects 0.000 abstract description 11
- 230000009471 action Effects 0.000 abstract description 4
- 239000003814 drug Substances 0.000 abstract description 4
- 229940079593 drug Drugs 0.000 abstract description 3
- 239000002085 irritant Substances 0.000 abstract description 3
- 231100000021 irritant Toxicity 0.000 abstract description 3
- 231100000252 nontoxic Toxicity 0.000 abstract description 2
- 230000003000 nontoxic effect Effects 0.000 abstract description 2
- 239000000243 solution Substances 0.000 description 44
- 238000012360 testing method Methods 0.000 description 24
- 230000002147 killing effect Effects 0.000 description 9
- 210000001215 vagina Anatomy 0.000 description 8
- 241000222122 Candida albicans Species 0.000 description 7
- 241000191967 Staphylococcus aureus Species 0.000 description 7
- 229940095731 candida albicans Drugs 0.000 description 7
- 230000000694 effects Effects 0.000 description 7
- 241000588724 Escherichia coli Species 0.000 description 6
- 241001465754 Metazoa Species 0.000 description 6
- 230000001580 bacterial effect Effects 0.000 description 6
- 238000001514 detection method Methods 0.000 description 6
- 210000004877 mucosa Anatomy 0.000 description 6
- 230000000638 stimulation Effects 0.000 description 6
- 230000000844 anti-bacterial effect Effects 0.000 description 5
- 239000000725 suspension Substances 0.000 description 5
- 241000894006 Bacteria Species 0.000 description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 4
- 239000000645 desinfectant Substances 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 239000008103 glucose Substances 0.000 description 4
- -1 glucose oligosaccharide Chemical class 0.000 description 4
- 239000013642 negative control Substances 0.000 description 4
- 230000003472 neutralizing effect Effects 0.000 description 4
- 229920001992 poloxamer 407 Polymers 0.000 description 4
- 229940044476 poloxamer 407 Drugs 0.000 description 4
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 3
- 230000003110 anti-inflammatory effect Effects 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 238000013095 identification testing Methods 0.000 description 3
- 235000010445 lecithin Nutrition 0.000 description 3
- 239000000787 lecithin Substances 0.000 description 3
- 229940067606 lecithin Drugs 0.000 description 3
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 3
- 229920000053 polysorbate 80 Polymers 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- WSFSSNUMVMOOMR-UHFFFAOYSA-N Formaldehyde Chemical compound O=C WSFSSNUMVMOOMR-UHFFFAOYSA-N 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- 241000283973 Oryctolagus cuniculus Species 0.000 description 2
- 208000027418 Wounds and injury Diseases 0.000 description 2
- 238000010171 animal model Methods 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 230000007794 irritation Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 238000011056 performance test Methods 0.000 description 2
- 230000008439 repair process Effects 0.000 description 2
- 239000011550 stock solution Substances 0.000 description 2
- 239000012085 test solution Substances 0.000 description 2
- 206010001526 Air embolism Diseases 0.000 description 1
- 229920001661 Chitosan Polymers 0.000 description 1
- 201000004624 Dermatitis Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 206010040880 Skin irritation Diseases 0.000 description 1
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000003385 bacteriostatic effect Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
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- 239000003085 diluting agent Substances 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 210000004996 female reproductive system Anatomy 0.000 description 1
- 210000005002 female reproductive tract Anatomy 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000011010 flushing procedure Methods 0.000 description 1
- 239000000499 gel Substances 0.000 description 1
- 239000001963 growth medium Substances 0.000 description 1
- 238000007490 hematoxylin and eosin (H&E) staining Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 238000002350 laparotomy Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002609 medium Substances 0.000 description 1
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- 238000011587 new zealand white rabbit Methods 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 210000002640 perineum Anatomy 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000002633 protecting effect Effects 0.000 description 1
- 230000001603 reducing effect Effects 0.000 description 1
- 230000036556 skin irritation Effects 0.000 description 1
- 231100000475 skin irritation Toxicity 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
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- 238000012422 test repetition Methods 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/20—Elemental chlorine; Inorganic compounds releasing chlorine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
- A61K31/77—Polymers containing oxygen of oxiranes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/74—Synthetic polymeric materials
- A61K31/765—Polymers containing oxygen
- A61K31/78—Polymers containing oxygen of acrylic acid or derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
Abstract
The invention discloses a temperature-sensitive gel for gynecology and a preparation method thereof, relating to the technical field of gynecology medication, wherein the raw materials for preparing the temperature-sensitive gel comprise hypochlorite, a pH regulator, carbomer, poloxamer and water, and the method for preparing the temperature-sensitive gel comprises the following steps: firstly, hypochlorite is added into a proper amount of water to be dissolved, then a pH regulator is added, and the pH value of the solution is regulated to 3-6 to obtain a solution I; adding carbomer into the rest water, stirring to dissolve carbomer, adding poloxamer, stirring, standing until the solution is clear to obtain solution II, and slowly adding solution I into solution II, and slowly stirring to mix well. The temperature-sensitive gel disclosed by the invention is non-toxic and non-irritant, and has the advantages of good sterilization performance, long action time and high comfort level.
Description
Technical Field
The invention relates to the technical field of gynecological medicines, in particular to a temperature-sensitive gel for gynecology and a preparation method thereof.
Background
Gynecological inflammation becomes a common frequently-occurring disease of women, has various clinical manifestations and complex etiology, is often accompanied by various serious complications, and has great influence on the life and work of women. Some current pharmaceutical preparations cannot completely meet the clinical and market requirements in terms of curative effect, and some chemical medicines have anti-inflammatory and antibacterial effects but do not consider the problem of skin irritation. The main products used in the current gynecological inflammation or postoperative repair are chitosan, the main dosage forms comprise suppository, gel, powder, liquid and the like, and the products have antibacterial and repair effects, but the antibacterial activity of the products is weak, the treatment effect is not obvious, and even the acid-base balance of the female reproductive system can be destroyed, so that the female reproductive tract is polluted. The raw materials of some common flushing fluids comprise traditional Chinese medicines and disinfectants, and the products are easy to pollute clothes of patients when in use and are inconvenient to clean after being polluted.
Disclosure of Invention
The invention aims to: in order to solve the problems, the temperature-sensitive gel for the gynecology department has good sterilization effect, no stimulation and long action time and the preparation method thereof.
The technical scheme adopted by the invention is as follows:
a temperature-sensitive gel for gynecology comprises the following raw materials in parts by weight:
hypochlorite salt: 0.1-1 part;
pH regulator: 0.01-1 part;
carbomer: 0.01-0.5 part;
poloxamer: 0.01-1 part;
water: 100 parts.
Further, the gel also comprises glycyrrhizic acid, and the weight portion of the glycyrrhizic acid is 0.01-0.3; glycyrrhizic acid has anti-inflammatory effect and can prevent skin allergy.
Further, the gel also comprises 0.01-1 part by weight of glucose oligosaccharide; the glucose oligosaccharide can be decomposed by beneficial bacteria of skin to absorb nutrition, and is helpful for skin biological balance.
Further, the hypochlorite includes at least one of sodium hypochlorite, calcium hypochlorite, and potassium hypochlorite.
Further, the pH regulator comprises at least one of hydrochloric acid, phosphoric acid and sulfuric acid.
The preparation method of the temperature-sensitive gel for gynecology comprises the following steps:
step 1: adding hypochlorite into a proper amount of water for dissolving, adding a pH regulator, and regulating the pH value of the solution to 3-6 to obtain a solution I;
step 2: adding carbomer into the rest water, stirring to dissolve carbomer, adding poloxamer, stirring, standing until the solution is clear to obtain a second solution;
and step 3: and slowly adding the solution I into the solution II, and slowly stirring until the solution I and the solution II are uniformly mixed to obtain the water-based paint.
Further, the preparation environment of the step 2 is 2-6 ℃.
Further, in the step 2, the standing time is 6-24 hours.
Further, in the step 2, when poloxamer is added, glycyrrhizic acid is also added.
Further, in the step 3, when the first solution and the second solution are mixed, the glucose oligosaccharide is also added.
In summary, due to the adoption of the technical scheme, the invention has the beneficial effects that:
the main effective components of the temperature-sensitive gel are hypochlorous acid, carbomer and poloxamer, the hypochlorous acid has a high-efficiency sterilization effect, is non-toxic, non-irritant, residue-free and safe, can quickly kill bacteria on a wound surface, has a sterilization effect on bacteria, mold and spores, and can promote wound healing while sterilizing; carbomer has antiinflammatory, antibacterial, viscosity reducing, neutralizing and protecting effects, and can reduce irritation and injury to skin; poloxamer has effects of promoting absorption, dispersing solid, and stabilizing; when the temperature-sensitive gel is used, the temperature-sensitive gel has no stimulation to the affected part of a patient, the contact time and the action time of the medicine and the affected part of the patient are as long as 24 hours, the affected part of the patient and clothes are not polluted, and the comfort level is high.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments.
Example one
The embodiment provides a temperature-sensitive gel for gynecology, which comprises the following raw materials in parts by weight: 0.1 part of hypochlorite; 0.01 part of pH regulator; 0.01 part of carbomer; 0.01 part of poloxamer; 100 parts of water. Wherein hypochlorite is sodium hypochlorite, and pH regulator is hydrochloric acid.
According to the weight parts of the raw materials, the preparation method of the temperature-sensitive gel for gynecology of the embodiment comprises the following steps:
step 1: under the normal temperature environment, 0.1% sodium hypochlorite is added into 60 parts of water for dissolving, hydrochloric acid is added, and the pH value of the solution is adjusted to 3 to obtain a solution I.
Step 2: and (2) adding 0.02-0.2% of carbomer into the residual water at 4 ℃, continuously stirring until the carbomer is dissolved, adding 0.05-2% of poloxamer 407, stirring uniformly, and standing at 4 ℃ for 6 hours until the solution is clear to obtain a second solution.
And step 3: and slowly adding the solution I into the solution II under the normal temperature environment, and slowly stirring until the solution I and the solution II are uniformly mixed to obtain the water-based paint.
Example two
The embodiment provides a temperature-sensitive gel for gynecology, which comprises the following raw materials in parts by weight: hypochlorite 0.5 parts; 0.4 part of pH regulator; 0.3 part of carbomer; 0.45 part of poloxamer; 0.01 part of glycyrrhizic acid; 100 parts of water. Wherein, the hypochlorite adopts calcium hypochlorite, and the pH regulator adopts phosphoric acid.
According to the weight parts of the raw materials, the preparation method of the temperature-sensitive gel for gynecology of the embodiment comprises the following steps:
step 1: under normal temperature environment, 0.1% calcium hypochlorite is added into 65 parts of water for dissolution, phosphoric acid is added, and the pH value of the solution is adjusted to 4.5 to obtain a first solution.
Step 2: adding 0.02-0.2% of carbomer into the residual water at 2 ℃, continuously stirring until the carbomer is dissolved, adding 0.05-2% of poloxamer 407 and glycyrrhizic acid, stirring uniformly, and standing at 2 ℃ for 8 hours until the solution is clear to obtain a second solution.
And step 3: and slowly adding the solution I into the solution II under the normal temperature environment, and slowly stirring until the solution I and the solution II are uniformly mixed to obtain the water-based paint.
EXAMPLE III
The embodiment provides a temperature-sensitive gel for gynecology, which comprises the following raw materials in parts by weight: hypochlorite 0.75 parts; 0.6 part of pH regulator; 0.4 part of carbomer; 0.6 part of poloxamer; 0.01 part of glucooligosaccharides; 100 parts of water. Wherein, hypochlorite adopts sodium hypochlorite and potassium hypochlorite, the addition amount of the sodium hypochlorite and the potassium hypochlorite is 0.45 part and 0.3 part respectively, pH regulator adopts hydrochloric acid and phosphoric acid, and the addition amount of the hydrochloric acid and the phosphoric acid is 0.3 part and 0.3 part respectively.
According to the weight parts of the raw materials, the preparation method of the temperature-sensitive gel for gynecology of the embodiment comprises the following steps:
step 1: under the normal temperature environment, 0.1% of sodium hypochlorite and potassium hypochlorite are added into 65 parts of water for dissolving, hydrochloric acid and phosphoric acid are added, and the pH value of the solution is adjusted to 5 to obtain a solution I.
Step 2: and (2) adding 0.02-0.2% of carbomer into the residual water at 2 ℃, continuously stirring until the carbomer is dissolved, adding 0.05-2% of poloxamer 407, stirring uniformly, and standing at 2 ℃ for 12 hours until the solution is clear to obtain a second solution.
And step 3: and slowly adding the solution I into the solution II under a normal temperature environment, adding the glucooligosaccharide, and slowly stirring until the mixture is uniformly mixed to obtain the compound.
Example four
The embodiment provides a temperature-sensitive gel for gynecology, which comprises the following raw materials in parts by weight: 1 part of hypochlorite; 1 part of pH regulator; 0.5 part of carbomer; 1 part of poloxamer; 0.3 part of glycyrrhizic acid; 1 part of glucose oligosaccharide; 100 parts of water. Wherein, hypochlorite adopts sodium hypochlorite, calcium hypochlorite and potassium hypochlorite, the addition amounts of the sodium hypochlorite, the calcium hypochlorite and the potassium hypochlorite are respectively 0.5 part, 0.3 part and 0.2 part, pH regulator adopts hydrochloric acid and sulfuric acid, and the addition amounts of the hydrochloric acid and the sulfuric acid are respectively 0.7 part and 0.3 part.
According to the weight parts of the raw materials, the preparation method of the temperature-sensitive gel for gynecology of the embodiment comprises the following steps:
step 1: under the normal temperature environment, 0.1% of sodium hypochlorite, calcium hypochlorite and potassium hypochlorite are added into 70 parts of water for dissolving, hydrochloric acid and sulfuric acid are added, and the pH value of the solution is adjusted to 6 to obtain a solution I.
Step 2: adding 0.02-0.2% of carbomer into the residual water at 6 ℃, continuously stirring until the carbomer is dissolved, adding 0.05-2% of poloxamer 407 and glycyrrhizic acid, stirring uniformly, and standing at 6 ℃ for 24 hours until the solution is clear to obtain a second solution.
And step 3: and slowly adding the solution I into the solution II under a normal temperature environment, adding the glucooligosaccharide, and slowly stirring until the mixture is uniformly mixed to obtain the compound.
The following are the samples prepared in example four for the bactericidal test and toxicity test:
first, vagina mucosa irritation test
Preparation of the test:
experimental animals: 6 common-grade New Zealand white rabbits, female, with the weight of 2.0 kg-2.5 kg, were purchased from the Dongxin Hua laboratory animal farm in the Huadu district of Guangzhou City.
The test method comprises the following steps:
(1) the inspection basis is as follows: the technical specification of disinfection (2002 edition) and the hygienic standard of disposable sanitary products GB 15979-2002.
(2) The detection method comprises the following steps:
the 6 animals were divided into 3 animals each for the sample group and the control group, and the animals were fixed on their backs to expose perineum and vaginal opening. After the syringe connected with the blunt hose sucks the test solution, the syringe is gently inserted into the vagina of the rabbit for 4-5 cm, and 2ml of the test solution is slowly injected to complete the contamination. Control animals were treated with saline in the same manner. And (3) killing the animals by adopting an air embolism method after 24 hours, carrying out laparotomy, taking out a complete vagina, longitudinally cutting, carrying out visual observation on whether congestion, edema and other manifestations exist or not for reference when pathological materials are obtained, then putting the vagina into a 10% formalin solution for fixing for more than 24 hours, selecting tissues at two ends and the center of the vagina for flaking, carrying out histopathological examination under a microscope after HE staining, and grading according to a vaginal mucosa reaction grading standard.
The test results are shown in the table below, and the test vagina mucosa stimulation index is 0 and is non-irritant according to the evaluation of vagina mucosa stimulation intensity grading in disinfection technical specification (2002 edition) by pathological detection.
Second, kill test for Staphylococcus aureus and Escherichia coli
Preparation of the test:
(1) test strains: staphylococcus aureus ATCC 6538, Escherichia coli 8099. The generation numbers of the above strains are all 4 th generation, and 0.03mol/LPBS is used for preparing bacterial liquid.
(2) Neutralizing agent: 0.5% lecithin, 1% tween 80 in PBS.
(3) Graduated pipettes (0.1mL, 1.0mL, 5.0mL, 10.0mL), and the like.
The test method comprises the following steps:
(1) the detection basis is as follows: a method for testing the sterilization performance, the bacteriostatic performance and the stability of a product in appendix C of hygienic standard GB15979-2002 of disposable hygienic products.
(2) And (3) identification test of a neutralizer: the test bacterium is staphylococcus aureus. The test groups are: firstly, disinfectant and bacterial suspension; ② the neutralizer is added to the (disinfectant and bacterial suspension); ③ neutralizing agent and bacterial suspension; fourthly, adding (disinfectant and neutralizer) and bacterial suspension; fifth, PBS solution + bacterial suspension; sixthly, PBS solution of the same batch; seventhly, neutralizing agent in the same batch; and culture medium in the same batch. Diluent + neutralizer + medium. The samples were allowed to act for 5 min. The experiment was repeated 3 times. The test environment temperature is 20 ℃.
(3) And (3) killing performance test: the action time of the sample is 5min, 10min, 15min and 20min, and the test is repeated for 3 times. The test environment temperature is 20 ℃.
The test results are as follows:
1. neutralizer identification test
3 times of repeated experiments prove that the average number of growing colonies in the 1 st group is aseptically grown, and the average number of growing colonies in the 2 nd group is 1.04X 102CFU/mL, similar average number of growing colonies in groups 3, 4, and 5, and sterile growth in groups 6, 7, and 8, the results are shown in the following table:
note: negative control was grown aseptically.
2. Killing effect on staphylococcus aureus and escherichia coli
Repeated experiments for 3 times prove that the sample acts for 5min, the killing rate of staphylococcus aureus and escherichia coli can reach 90 percent, and the results are as follows:
note: negative control was grown aseptically.
Third, killing test for Candida albicans
In the test preparation and test method for the killing effect of the test sample on the candida albicans, except that the test strains and the detection basis are different from the killing effect of the test sample on the staphylococcus aureus and escherichia coli, the rest are the same, and the description of the same parts is omitted. The test strain for examining the killing effect of the sample on candida albicans was candida albicans ATCC 10231.
1. Neutralizer identification test
3 times of repeated experiments prove that the average number of growing colonies in the 1 st group is aseptic growth, and the average number of growing colonies in the 2 nd group is 1.05 multiplied by 102CFU/mL, similar average number of growing colonies in groups 3, 4, and 5, and sterile growth in groups 6, 7, and 8, the results are shown in the following table:
note: negative control was grown aseptically.
2. Killing effect on Candida albicans
3 times of repeated tests prove that the sterilization rate of the samples on Candida albicans can reach 90% after the samples act for 5min, and the results are as follows:
note: negative control was grown aseptically.
Fourth, stability test
Detection conditions are as follows: the samples were placed in a 37 ℃ incubator for 3 months, and the sterilization performance test was performed while maintaining a relative humidity of 78%. The number of test repetitions: 2 times, the results are given in the following table:
the detection conclusion is as follows:
1. and (3) vagina mucosa stimulation test: the result of the test of the stimulation of the sample to the vaginal mucosa of the rabbit is nonirritant, and meets the requirements of 'disinfection technical specification' (2002 edition).
2. The PBS solution containing 0.5 percent of lecithin and 1 percent of Tween 80 is used as a neutralizer, and after the sample stock solution acts for 5min, the sterilization rate on staphylococcus aureus, escherichia coli and pseudomonas aeruginosa can reach 90 percent, thereby meeting the requirements of the hygienic standard GB15979-2002 for disposable sanitary products.
3. The PBS solution containing 0.5 percent of lecithin and 1 percent of Tween 80 is used as a neutralizer, and after the sample stock solution acts for 5min, the sterilization rate of Candida albicans can reach 90 percent, thereby meeting the requirements of hygienic standard GB15979-2002 for disposable hygienic products.
4. After the sample is stored for 90 days at 37 ℃, the sterilization rate can reach more than 90 percent, and the requirement of the hygienic standard GB15979-2002 of disposable hygienic products is met.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.
Claims (9)
1. The temperature-sensitive gel for gynecology is characterized by comprising the following raw materials in parts by weight:
hypochlorite salt: 0.1-1 part;
pH regulator: 0.01-1 part;
carbomer: 0.01-0.5 part;
poloxamer: 0.01-1 part;
water: 100 parts.
2. The temperature-sensitive gel for gynecology according to claim 1, wherein the gel further comprises glycyrrhizic acid in an amount of 0.01 to 0.3 parts by weight.
3. The temperature-sensitive gel for gynecology as claimed in claim 1, wherein the gel further comprises 0.01-1 part by weight of gluco-oligosaccharide.
4. The temperature-sensitive gel for gynecology of claim 1, wherein the hypochlorite comprises at least one of sodium hypochlorite, calcium hypochlorite and potassium hypochlorite.
5. The temperature-sensitive gel for gynecology of claim 1, wherein the pH regulator comprises at least one of hydrochloric acid, phosphoric acid and sulfuric acid.
6. The preparation method of the temperature-sensitive gel for gynecology is characterized by comprising the following steps:
step 1: adding hypochlorite into a proper amount of water for dissolving, adding a pH regulator, and regulating the pH value of the solution to 3-6 to obtain a solution I;
step 2: adding carbomer into the rest water, stirring to dissolve carbomer, adding poloxamer, stirring, standing until the solution is clear to obtain a second solution;
and step 3: and slowly adding the solution I into the solution II, and slowly stirring until the solution I and the solution II are uniformly mixed to obtain the water-based paint.
7. The preparation method of the temperature-sensitive gel for gynecology according to claim 6, wherein the preparation environment of the step 2 is 2-6 ℃, and the standing time is 6-24 hours.
8. The method for preparing a temperature-sensitive gel for gynecology according to claim 6, wherein in the step 2, glycyrrhizic acid is further added when poloxamer is added.
9. The preparation method of the temperature-sensitive gel for gynecology as claimed in claim 6, wherein in the step 3, when the first solution and the second solution are mixed, a glucooligosaccharide is further added.
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