CN116421791A - Medical cavity lubricating composition and preparation method and application thereof - Google Patents
Medical cavity lubricating composition and preparation method and application thereof Download PDFInfo
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- CN116421791A CN116421791A CN202111637920.0A CN202111637920A CN116421791A CN 116421791 A CN116421791 A CN 116421791A CN 202111637920 A CN202111637920 A CN 202111637920A CN 116421791 A CN116421791 A CN 116421791A
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- medical
- lubricating composition
- salt
- lubricating
- hyaluronic acid
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- 230000001050 lubricating effect Effects 0.000 title claims abstract description 83
- 239000000203 mixture Substances 0.000 title claims abstract description 46
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims abstract description 22
- 229920002674 hyaluronan Polymers 0.000 claims abstract description 22
- 229960003160 hyaluronic acid Drugs 0.000 claims abstract description 22
- 230000003444 anaesthetic effect Effects 0.000 claims abstract description 17
- 150000003839 salts Chemical class 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 11
- 230000003204 osmotic effect Effects 0.000 claims description 9
- 229960004393 lidocaine hydrochloride Drugs 0.000 claims description 7
- YECIFGHRMFEPJK-UHFFFAOYSA-N lidocaine hydrochloride monohydrate Chemical compound O.[Cl-].CC[NH+](CC)CC(=O)NC1=C(C)C=CC=C1C YECIFGHRMFEPJK-UHFFFAOYSA-N 0.000 claims description 7
- 238000000034 method Methods 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 5
- WCDDVEOXEIYWFB-VXORFPGASA-N (2s,3s,4r,5r,6r)-3-[(2s,3r,5s,6r)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C(O)=O)O[C@@H](O)[C@H](O)[C@H]1O WCDDVEOXEIYWFB-VXORFPGASA-N 0.000 claims description 2
- PPWHTZKZQNXVAE-UHFFFAOYSA-N Tetracaine hydrochloride Chemical compound Cl.CCCCNC1=CC=C(C(=O)OCCN(C)C)C=C1 PPWHTZKZQNXVAE-UHFFFAOYSA-N 0.000 claims description 2
- 159000000007 calcium salts Chemical class 0.000 claims description 2
- KNZADIMHVBBPOA-UHFFFAOYSA-N dyclonine hydrochloride Chemical compound [Cl-].C1=CC(OCCCC)=CC=C1C(=O)CC[NH+]1CCCCC1 KNZADIMHVBBPOA-UHFFFAOYSA-N 0.000 claims description 2
- 229960003462 dyclonine hydrochloride Drugs 0.000 claims description 2
- 239000003995 emulsifying agent Substances 0.000 claims description 2
- 239000000796 flavoring agent Substances 0.000 claims description 2
- 235000013355 food flavoring agent Nutrition 0.000 claims description 2
- 229940014041 hyaluronate Drugs 0.000 claims description 2
- 159000000003 magnesium salts Chemical class 0.000 claims description 2
- 239000000463 material Substances 0.000 claims description 2
- -1 pH regulator Substances 0.000 claims description 2
- XAEFZNCEHLXOMS-UHFFFAOYSA-M potassium benzoate Chemical compound [K+].[O-]C(=O)C1=CC=CC=C1 XAEFZNCEHLXOMS-UHFFFAOYSA-M 0.000 claims description 2
- MFDFERRIHVXMIY-UHFFFAOYSA-N procaine Chemical compound CCN(CC)CCOC(=O)C1=CC=C(N)C=C1 MFDFERRIHVXMIY-UHFFFAOYSA-N 0.000 claims description 2
- 229960001309 procaine hydrochloride Drugs 0.000 claims description 2
- 159000000000 sodium salts Chemical class 0.000 claims description 2
- SDKPSXWGRWWLKR-UHFFFAOYSA-M sodium;9,10-dioxoanthracene-1-sulfonate Chemical compound [Na+].O=C1C2=CC=CC=C2C(=O)C2=C1C=CC=C2S(=O)(=O)[O-] SDKPSXWGRWWLKR-UHFFFAOYSA-M 0.000 claims description 2
- GGCZERPQGJTIQP-UHFFFAOYSA-N sodium;9,10-dioxoanthracene-2-sulfonic acid Chemical compound [Na+].C1=CC=C2C(=O)C3=CC(S(=O)(=O)O)=CC=C3C(=O)C2=C1 GGCZERPQGJTIQP-UHFFFAOYSA-N 0.000 claims description 2
- 229960002494 tetracaine hydrochloride Drugs 0.000 claims description 2
- 150000003751 zinc Chemical class 0.000 claims description 2
- 239000013583 drug formulation Substances 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000002335 preservative effect Effects 0.000 claims 1
- 239000002562 thickening agent Substances 0.000 claims 1
- 210000004400 mucous membrane Anatomy 0.000 abstract description 5
- 238000003860 storage Methods 0.000 abstract description 5
- 150000005846 sugar alcohols Polymers 0.000 abstract description 4
- 230000000638 stimulation Effects 0.000 abstract description 3
- 239000000499 gel Substances 0.000 description 28
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 21
- 239000000047 product Substances 0.000 description 18
- 239000000314 lubricant Substances 0.000 description 14
- 238000005461 lubrication Methods 0.000 description 11
- 229920005862 polyol Polymers 0.000 description 11
- 150000003077 polyols Chemical class 0.000 description 11
- 230000000052 comparative effect Effects 0.000 description 9
- 235000011187 glycerol Nutrition 0.000 description 8
- 210000001035 gastrointestinal tract Anatomy 0.000 description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 6
- 229920002385 Sodium hyaluronate Polymers 0.000 description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 6
- 229940010747 sodium hyaluronate Drugs 0.000 description 6
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 6
- 230000001070 adhesive effect Effects 0.000 description 4
- 239000011521 glass Substances 0.000 description 4
- 230000007794 irritation Effects 0.000 description 4
- 210000001215 vagina Anatomy 0.000 description 4
- 208000002193 Pain Diseases 0.000 description 3
- 239000013065 commercial product Substances 0.000 description 3
- 238000011049 filling Methods 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 210000002345 respiratory system Anatomy 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 210000003708 urethra Anatomy 0.000 description 3
- NIXOWILDQLNWCW-UHFFFAOYSA-N Acrylic acid Chemical compound OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 2
- 206010013082 Discomfort Diseases 0.000 description 2
- 239000004909 Moisturizer Substances 0.000 description 2
- 229920002125 Sokalan® Polymers 0.000 description 2
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 229960001631 carbomer Drugs 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- AMTWCFIAVKBGOD-UHFFFAOYSA-N dioxosilane;methoxy-dimethyl-trimethylsilyloxysilane Chemical compound O=[Si]=O.CO[Si](C)(C)O[Si](C)(C)C AMTWCFIAVKBGOD-UHFFFAOYSA-N 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 230000001333 moisturizer Effects 0.000 description 2
- 230000035699 permeability Effects 0.000 description 2
- 239000002985 plastic film Substances 0.000 description 2
- 229940083037 simethicone Drugs 0.000 description 2
- 210000004872 soft tissue Anatomy 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000001502 supplementing effect Effects 0.000 description 2
- 239000000230 xanthan gum Substances 0.000 description 2
- 229920001285 xanthan gum Polymers 0.000 description 2
- 229940082509 xanthan gum Drugs 0.000 description 2
- 235000010493 xanthan gum Nutrition 0.000 description 2
- 206010006784 Burning sensation Diseases 0.000 description 1
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 description 1
- 229920002683 Glycosaminoglycan Polymers 0.000 description 1
- OVRNDRQMDRJTHS-UHFFFAOYSA-N N-acelyl-D-glucosamine Natural products CC(=O)NC1C(O)OC(CO)C(O)C1O OVRNDRQMDRJTHS-UHFFFAOYSA-N 0.000 description 1
- MBLBDJOUHNCFQT-LXGUWJNJSA-N N-acetylglucosamine Natural products CC(=O)N[C@@H](C=O)[C@@H](O)[C@H](O)[C@H](O)CO MBLBDJOUHNCFQT-LXGUWJNJSA-N 0.000 description 1
- 230000002378 acidificating effect Effects 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- AEMOLEFTQBMNLQ-WAXACMCWSA-N alpha-D-glucuronic acid Chemical compound O[C@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O AEMOLEFTQBMNLQ-WAXACMCWSA-N 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 238000000237 capillary viscometry Methods 0.000 description 1
- 239000004568 cement Substances 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000035606 childbirth Effects 0.000 description 1
- 238000003759 clinical diagnosis Methods 0.000 description 1
- 238000013329 compounding Methods 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 230000003013 cytotoxicity Effects 0.000 description 1
- 231100000135 cytotoxicity Toxicity 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 239000003193 general anesthetic agent Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 210000004877 mucosa Anatomy 0.000 description 1
- 229950006780 n-acetylglucosamine Drugs 0.000 description 1
- 230000008520 organization Effects 0.000 description 1
- 238000011056 performance test Methods 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000000451 tissue damage Effects 0.000 description 1
- 231100000827 tissue damage Toxicity 0.000 description 1
- 238000002627 tracheal intubation Methods 0.000 description 1
- 238000012795 verification Methods 0.000 description 1
- 238000000196 viscometry Methods 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/042—Polysaccharides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/145—Hydrogels or hydrocolloids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
- A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/402—Anaestetics, analgesics, e.g. lidocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/10—Materials for lubricating medical devices
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention discloses a medical cavity lubricating composition, a preparation method and application thereof. The lubricating gel has the characteristics of simple components, no stimulation to mucous membrane and excellent lubricating performance, and the molecular weight, the concentration of hyaluronic acid and the addition of anesthetic of the hyaluronic acid are screened, so that the lubricating performance of the composition is better, the thermal stability is good, and the use of excessive polyhydric alcohol is avoided. And, through the design of special preparation process, further improve the storage stability and lubricating property of the composition.
Description
Technical Field
The invention relates to a medical lubricating composition for providing lubrication when medical equipment enters a natural cavity of a human body, a preparation method and application thereof, in particular to a cavity lubricating composition containing hyaluronic acid or salt thereof and an anesthetic, and a preparation method and application thereof, belonging to the technical field of medical supplies.
Background
The medical cavity lubricant is water-soluble or oil-soluble adhesive cement or liquid for providing lubrication for various medical instruments such as gastroscope, enteroscope, colposcope, ureteroscope, catheter and the like in the clinical diagnosis, treatment or operation process, and is mainly used for lubricating the intubation of natural cavities of upper digestive tract, respiratory tract, urethra, vagina, intestinal tract or various endoscopes and other medical equipment.
Currently, medical lubricants on the market are largely classified into oily lubricants and water-soluble lubricants. The oily lubricant has the defects of corrosion damage to medical instruments made of high polymer materials, irritation to mucous membranes of the cavity, poor lubricating effect and the like, so the lubricant is gradually replaced by a water-soluble lubricant. The water-soluble lubricant provided in the market at present contains more complex components, a large amount of polyol is almost contained in the formula besides water-soluble polymer components, the purpose of the water-soluble lubricant is to improve the lubricity of the product, 25% of propylene glycol or glycerol is contained in a patent CN102949755B, 30% -38% of glycerol is contained in a patent CN104958788B, 10% -30% of polyol is contained in a patent CN109200345B, and glycerol is almost contained in a cavity lubricating product retrieved from the national drug administration. The addition of high concentrations of polyols in the formulation directly results in a product with an osmotic pressure of up to 2000mOsm/kg or more, even up to 5000mOsm/kg or more, and according to the prior studies (Vaginal lubricants and moisturizers: a review into use, efficacy, and safety. Clinical 2020:29:1-6.), moderate high permeability (about 2000 mOsm/kg) causes mild or moderate irritation to the mucous membrane, very high permeability (about 5000 mOsm/kg) causes severe irritation, tissue damage, cytotoxicity, and the world health organization recommends an osmotic pressure of not more than 380mOsm/kg for the lubricant for the lumen. The high concentration of polyalcohol substances can cause high osmotic pressure of the product, and can cause burning sensation and stinging sensation to patients, and can interfere microorganisms such as vagina and intestinal tract to influence microecological balance.
Hyaluronic acid is a natural macromolecular acidic mucopolysaccharide composed of D-glucuronic acid and N-acetylglucosamine disaccharide units, has excellent functions of water retention and storage, lubrication, soft tissue volume support and the like, and has been widely used in the aspects of skin care, joint lubrication, soft tissue filling, ophthalmic surgery and the like. In the aspect of lubrication of hyaluronic acid, besides intra-articular cavity lubrication, the lubricating agent is also gradually used for human body lubrication and medical cavity lubrication in recent years, and the performance advantages of the lubricating product containing hyaluronic acid are increasingly outstanding from the feedback of application of a user.
The gel formed by combining hyaluronic acid and anesthetic is used for lubricating the cavity, no commercial product exists in the market at present, and although related patents such as CN102949755B, CN102580104A refer to a preparation method of lubricating gel by mixing substances containing hyaluronic acid, anesthetic and the like, the patents are not used for solving the lubricating property of the gel and the stability of the gel.
Disclosure of Invention
Aiming at adverse effects of excessive use of polyol on human body and pain caused by medical instruments entering the human body, the invention provides a medical cavity lubricating composition which does not use or uses polyol with lower concentration, has the characteristics of low osmotic pressure or equal osmotic pressure, avoids various discomforts and irritation caused by excessive polyol on the human body, and ensures that the composition has excellent lubricating property and adhesive property and the obtained lubricating gel has good stability and safety through screening of molecular weight of hyaluronic acid or salt thereof and proportion of each component.
In the research process, the medical lubricating product formula with simple components and no or little polyol is developed, the formula components are simple and safe, and finally, the creative labor discovery that the use of hyaluronic acid or the salt thereof and anesthetic for compounding can solve the uncomfortable feeling brought by medical equipment when entering a human body, and the medical lubricating product formula has unexpected lubricating performance and can achieve similar or better lubricating effect as the addition of the excessive polyol.
The medical cavity lubricating composition comprises hyaluronic acid or salt thereof and anesthetic.
Further, the molecular weight of the hyaluronic acid or the salt thereof is 80-300 kilodaltons, preferably 150-250 kilodaltons.
Further, the hyaluronate may be one or more selected from sodium salt, potassium salt, calcium salt, magnesium salt, zinc salt, silver salt and gold salt thereof.
Further, the anesthetic is lidocaine hydrochloride, tetracaine hydrochloride, procaine or dyclonine hydrochloride, preferably lidocaine hydrochloride.
Furthermore, the medical cavity lubricating composition is in a gel state, and besides the hyaluronic acid or the salt thereof and the anesthetic component, the medical cavity lubricating composition also contains pharmaceutically acceptable antibacterial and antibacterial agents, flavoring agents, pH regulators, emulsifying agents, moisturizers, water and the like, wherein the components can be only one or two or more.
Further, the medical cavity lubricating composition does not contain polyol or contains a small amount of polyol, and the content of the polyol is less than or equal to 1wt%.
Further, in the medical cavity lubricating composition, the concentration of hyaluronic acid or a salt thereof is 20 mg/mL-40 mg/mL, preferably 22 mg/mL-35 mg/mL.
Further, in the medical cavity lubricating composition, the concentration of the anesthetic is 5 mg/mL-25 mg/mL, preferably 10 mg/mL-20 mg/mL.
Further, the medical channel lubricating composition has an osmotic pressure of less than 380mOsm/kg.
Preferably, the medical cavity lubricating composition is obtained by uniformly mixing all the components and then performing high-temperature treatment, and the high-temperature treatment mode is as follows: the medical channel lubricating composition is treated at 105-125 ℃ for 3-30 minutes, preferably 115-122 ℃ for 5-10 minutes. After high-temperature treatment, the medical cavity lubricating composition has better heat-resistant stability and better lubricating performance.
Furthermore, the medical cavity lubricating composition can be uniformly mixed only by adopting a simple physical mixing mode, so that the gel lubricating composition can be obtained. In addition, the invention also discovers a preferable preparation method, which can obtain a product with better performance and comprises the following steps:
(1) Uniformly mixing the components;
(2) And (5) carrying out high-temperature treatment on the uniformly mixed materials.
Further, the high temperature treatment temperature is 105-125 ℃ and the time is 3-30 minutes. Preferably, the high temperature treatment temperature is 115-122 ℃ and the time is 5-10 minutes.
The invention also provides application of the medical cavity lubricating composition in preparation of medical medicinal preparations or medical instruments.
The invention also provides a medical medicinal preparation, and the components of the preparation comprise the medical cavity lubricating composition.
The invention also provides a medical appliance, the medical appliance is provided with the medical cavity lubricating composition, and the part of the medical appliance entering the natural cavity is provided with the medical cavity lubricating composition, and the natural cavity comprises the respiratory tract, the upper digestive tract, the urethra, the lower digestive tract, the vagina and the like.
The invention has the following beneficial effects:
1. the cavity lubricating composition disclosed by the invention takes hyaluronic acid or salt thereof and anesthetic as active ingredients, the lubricating property and stability of the composition are improved by controlling the consumption of the anesthetic and the hyaluronic acid and the molecular weight of the hyaluronic acid, and compared with products using polyalcohols such as glycerol, propylene glycol and the like, the cavity lubricating composition has the advantages of simple components and no stimulation to mucous membrane, various discomforts and stimulation caused by adding excessive polyalcohols are avoided, the pain of a patient is relieved by adding the anesthetic, and the compliance of the patient is improved; also ensures the lubricating performance of the product.
2. The invention carries out high-temperature treatment on the composition during preparation, and the stability and the lubricating performance of the treated composition are further improved after long-time storage and high-temperature storage.
3. The medical cavity lubricating composition has excellent lubricating and adhesive properties, wide application range and various application modes, and can be used for lubricating the medical instruments such as an endoscope, a catheter and the like entering a natural cavity, wherein the natural cavity comprises a respiratory tract, an upper digestive tract, a urethra, a lower digestive tract and a vagina; the condom can also be used as human body lubrication, and can be used singly or matched with a condom; it can also be used for birth canal lubrication during childbirth.
Detailed Description
In order to better illustrate the technical solution and advantages of the present invention, the present invention will be further explained and illustrated with reference to the following specific examples. It should be noted that, the process parameters, process steps, etc. not specifically described in the present invention are all performed according to conventional technical means in the art.
In the following examples, hyaluronic acid or a salt thereof was used from Hua Xi Biotech Co.Ltd.
Example 1
950mL of water was added to a glass beaker, followed by adding 20g of sodium hyaluronate having a molecular weight of 80 kilodaltons and 20g of lidocaine hydrochloride with stirring to dissolve completely, then adjusting pH to 6.5 with 0.5M sodium hydroxide solution, supplementing water to 1000mL, then filtering through a 10 μm filter membrane, filling into a glass vessel, performing high temperature treatment at 115℃for 10 minutes, and cooling to obtain a medical channel lubricating gel having an osmotic pressure lower than 380mOsm/kg.
Example 2-example 21
Adding 900mL of water into a glass beaker, adding sodium hyaluronate and anesthetic agent under stirring, stirring to dissolve completely, adjusting the pH value to 6.5 with 0.5M sodium hydroxide solution, supplementing water to 1000mL, filtering with a 10-micrometer filter membrane, filling into a glass container, performing high-temperature treatment, and cooling to obtain the medical channel lubricating gel.
The molecular weight of sodium hyaluronate, the concentration of anesthetic, the temperature and time of high temperature treatment in each medical channel lubricating gel are shown in the following table 1, and the osmotic pressure of each medical channel lubricating gel is lower than 380mOsm/kg.
Comparative example 1
A medical channel lubricating gel was prepared as in example 14, except that: the molecular weight of sodium hyaluronate is 40 kilodaltons.
Comparative example 2
A medical channel lubricating gel was prepared as in example 14, except that: the concentration of sodium hyaluronate was 12 mg/ml and the concentration of lidocaine hydrochloride was 30 mg/ml.
Comparative example 3
A medical channel lubricating gel was prepared as in example 14, except that: no high temperature treatment was performed.
Comparative example 4
A medical channel lubricating gel was prepared as in example 14, except that: the high temperature treatment temperature is 90 ℃ and the treatment time is 40min.
Comparative example 5
A medical channel lubricating gel was prepared as in example 14, except that: the concentration of sodium hyaluronate was 42 mg/ml without the addition of the anesthetic lidocaine hydrochloride.
Verification example
To verify the lubricating properties and stability of the lubricating gel of the present invention, the following tests were performed:
1. lubrication performance test
The dynamic friction coefficients of the lubricating gels obtained in each example and comparative example were measured by the method in the measurement of friction coefficients of plastic films and sheets of GB 10006-2021, while the lubricating gels (content 25 wt.%) of commercially available products, i.e., glycerin (content 18 wt.%), triethanolamine, carbomer, water, etc.), and the endoscope lubricants (components were glycerin (content 18 wt.%), simethicone, xanthan gum, water, etc.), were compared, and the results are shown in Table 2 below.
Stability study
The lubricating gels of each example and comparative example were placed at 60℃for 10 days, sampled on days 0, 5 and 10, and the samples placed on days 0, 5 and 10 were diluted 5 times with water, and then the viscosity of each lubricating gel was measured at 25℃by the first method Ping Shi capillary viscometry of the four parts 0633 viscometry of the "Chinese pharmacopoeia" 2020 edition, and the stability of the lubricating gel was evaluated by the viscosity reduction rate of each lubricating gel, as shown in Table 3 below.
Viscosity decrease rate = (η) 0 -η n ）/η 0 ×100%
Wherein eta 0 Viscosity on day 0; η (eta) n For viscosity on day n, n=5 or 10.
From the above experimental results, the dynamic friction coefficients of examples 1-21 are smaller than those of comparative examples 1-5, which means that the gel samples of examples 1-21 have good lubricity, and the gel stability of examples 1-21 is higher than that of comparative examples, which means that the viscosity change of the product during storage and transportation is smaller, and the adhesive property of the product during clinical use is better exerted.
In addition, from the viscosity point of view, the product viscosity obtained in examples 1 to 21 was 20mm 2 /s to 80mm 2 As a result, the viscosity of the commercially available lubricating gel (glycerol (content: 25 wt%), triethanolamine, carbomer, purified water, etc.) was 6.3mm 2 Per s, the viscosity of the commercially available product endoscope lubricant (the components are glycerin (content 18 wt%), simethicone, xanthan gum, water and the like) is 6.2mm 2 And/s. From the data, the gel viscosity of the invention is far greater than that of the commercially available lubricating product, which indicates that the product has better adhesiveness and is more beneficial to being adhered to a catheter or a natural cavity mucosa.
Therefore, the gel sample provided by the invention has better lubricating performance than a commercial product, and has higher viscosity than the commercial product, so that the high viscosity is favorable for the lubricating product to be better adhered to the surfaces of a catheter and a mucous membrane.
Claims (10)
1. A medical lumen lubricating composition, which is characterized in that: comprising hyaluronic acid or a salt thereof and an anesthetic.
2. The medical channel lubricating composition of claim 1, wherein: the molecular weight of the hyaluronic acid or the salt thereof is 80-300 kilodaltons, preferably 150-250 kilodaltons; preferably, the hyaluronate is one or more of sodium salt, potassium salt, calcium salt, magnesium salt, zinc salt, silver salt and gold salt of hyaluronic acid.
3. The medical channel lubricating composition of claim 1, wherein: the anesthetic is lidocaine hydrochloride, tetracaine hydrochloride, procaine or dyclonine hydrochloride, preferably lidocaine hydrochloride.
4. A medical channel lubricating composition as claimed in claim 1, 2 or 3, characterised in that: the concentration of hyaluronic acid or a salt thereof is 20 mg/mL-40 mg/mL, preferably 22 mg/mL-35 mg/mL; preferably, the concentration of anesthetic is 5 mg/mL-25 mg/mL, preferably 10 mg/mL-20 mg/mL.
5. The medical channel lubricating composition of claim 1, wherein: also included are one or more of the following pharmaceutically acceptable ingredients: preservative, thickener, flavoring agent, pH regulator, emulsifier, and water.
6. The medical channel lubricating composition of claim 1, wherein: the medical cavity lubricating composition is in a gel state, and the osmotic pressure of the medical cavity lubricating composition is less than or equal to 380mOsm/kg.
7. A medical channel lubricating composition as claimed in claim 1, 2 or 3, characterised in that: the medical cavity lubricating composition is obtained by carrying out high-temperature treatment on the uniformly mixed components, wherein the high-temperature treatment mode is as follows: the homogeneously mixed components are treated at 105-125 deg.c for 3-30 min, preferably at 115-122 deg.c for 5-10 min.
8. A method of preparing a medical channel lubricating composition as claimed in any one of claims 1 to 7, characterised by comprising the steps of:
(1) Uniformly mixing the components;
(2) Carrying out high-temperature treatment on the uniformly mixed materials; preferably, the high temperature treatment temperature is 105-125 ℃ and the treatment time is 3-30 minutes; more preferably, the high temperature treatment temperature is 115 ℃ to 122 ℃ and the treatment time is 5 minutes to 10 minutes.
9. Use of the medical channel lubricating composition of any one of claims 1-7 in the manufacture of a medical drug formulation or medical device.
10. A medical drug formulation or medical device, characterized by: the components of the medical drug preparation comprise the medical channel lubricating composition of any one of claims 1-7, and the medical device is provided with the medical channel lubricating composition of any one of claims 1-7.
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