CN116098951A - A multiple oil-fat emulsion injection containing tea oil - Google Patents
A multiple oil-fat emulsion injection containing tea oil Download PDFInfo
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- CN116098951A CN116098951A CN202310158022.XA CN202310158022A CN116098951A CN 116098951 A CN116098951 A CN 116098951A CN 202310158022 A CN202310158022 A CN 202310158022A CN 116098951 A CN116098951 A CN 116098951A
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- oil
- tea
- fat emulsion
- injection
- tea oil
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- 239000010495 camellia oil Substances 0.000 title claims abstract description 76
- 238000002347 injection Methods 0.000 title claims abstract description 53
- 239000007924 injection Substances 0.000 title claims abstract description 53
- 239000002960 lipid emulsion Substances 0.000 title claims abstract description 36
- 239000003921 oil Substances 0.000 claims abstract description 60
- 235000019198 oils Nutrition 0.000 claims abstract description 49
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 39
- 239000003995 emulsifying agent Substances 0.000 claims abstract description 36
- 239000012071 phase Substances 0.000 claims abstract description 26
- 238000010008 shearing Methods 0.000 claims abstract description 22
- 239000004006 olive oil Substances 0.000 claims abstract description 19
- 235000008390 olive oil Nutrition 0.000 claims abstract description 19
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 18
- 238000002156 mixing Methods 0.000 claims abstract description 17
- 238000002360 preparation method Methods 0.000 claims abstract description 17
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims abstract description 16
- 210000003022 colostrum Anatomy 0.000 claims abstract description 16
- 235000021277 colostrum Nutrition 0.000 claims abstract description 16
- 239000008215 water for injection Substances 0.000 claims abstract description 12
- 239000003814 drug Substances 0.000 claims abstract description 10
- 239000002245 particle Substances 0.000 claims abstract description 10
- 239000002994 raw material Substances 0.000 claims abstract description 8
- BCKXLBQYZLBQEK-KVVVOXFISA-M Sodium oleate Chemical compound [Na+].CCCCCCCC\C=C/CCCCCCCC([O-])=O BCKXLBQYZLBQEK-KVVVOXFISA-M 0.000 claims abstract description 7
- 239000008346 aqueous phase Substances 0.000 claims abstract description 6
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims abstract description 6
- 239000000839 emulsion Substances 0.000 claims abstract description 6
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 claims description 25
- 238000006243 chemical reaction Methods 0.000 claims description 16
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 15
- 238000010438 heat treatment Methods 0.000 claims description 11
- 238000003756 stirring Methods 0.000 claims description 11
- 235000007164 Oryza sativa Nutrition 0.000 claims description 9
- GUJOJGAPFQRJSV-UHFFFAOYSA-N dialuminum;dioxosilane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[O-2].[Al+3].[Al+3].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O GUJOJGAPFQRJSV-UHFFFAOYSA-N 0.000 claims description 9
- 229910052901 montmorillonite Inorganic materials 0.000 claims description 9
- 235000009566 rice Nutrition 0.000 claims description 9
- 238000007792 addition Methods 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 6
- 235000018597 common camellia Nutrition 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- 238000001291 vacuum drying Methods 0.000 claims description 6
- JQWAHKMIYCERGA-UHFFFAOYSA-N (2-nonanoyloxy-3-octadeca-9,12-dienoyloxypropoxy)-[2-(trimethylazaniumyl)ethyl]phosphinate Chemical compound CCCCCCCCC(=O)OC(COP([O-])(=O)CC[N+](C)(C)C)COC(=O)CCCCCCCC=CCC=CCCCCC JQWAHKMIYCERGA-UHFFFAOYSA-N 0.000 claims description 5
- 239000007853 buffer solution Substances 0.000 claims description 5
- 238000001816 cooling Methods 0.000 claims description 5
- 230000001804 emulsifying effect Effects 0.000 claims description 5
- 235000011187 glycerol Nutrition 0.000 claims description 5
- 239000008055 phosphate buffer solution Substances 0.000 claims description 5
- 239000010779 crude oil Substances 0.000 claims description 4
- 238000009874 alkali refining Methods 0.000 claims description 3
- 239000007864 aqueous solution Substances 0.000 claims description 3
- 239000008367 deionised water Substances 0.000 claims description 3
- 229910021641 deionized water Inorganic materials 0.000 claims description 3
- 238000005406 washing Methods 0.000 claims description 3
- 238000005303 weighing Methods 0.000 claims description 3
- 239000003712 decolorant Substances 0.000 claims description 2
- 240000007594 Oryza sativa Species 0.000 claims 2
- 241000209507 Camellia Species 0.000 claims 1
- 239000007957 coemulsifier Substances 0.000 claims 1
- 239000003607 modifier Substances 0.000 claims 1
- 235000013336 milk Nutrition 0.000 abstract description 6
- 239000008267 milk Substances 0.000 abstract description 6
- 210000004080 milk Anatomy 0.000 abstract description 6
- 238000000034 method Methods 0.000 abstract description 3
- 239000000872 buffer Substances 0.000 abstract description 2
- 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 abstract 1
- 239000000787 lecithin Substances 0.000 abstract 1
- 229940067606 lecithin Drugs 0.000 abstract 1
- 235000010445 lecithin Nutrition 0.000 abstract 1
- 241000209094 Oryza Species 0.000 description 7
- 240000001548 Camellia japonica Species 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 description 3
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 description 3
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 description 3
- 239000005642 Oleic acid Substances 0.000 description 3
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 description 3
- 230000009286 beneficial effect Effects 0.000 description 3
- 235000004626 essential fatty acids Nutrition 0.000 description 3
- 235000019197 fats Nutrition 0.000 description 3
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 description 3
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 3
- 150000003626 triacylglycerols Chemical class 0.000 description 3
- 235000015112 vegetable and seed oil Nutrition 0.000 description 3
- OYHQOLUKZRVURQ-NTGFUMLPSA-N (9Z,12Z)-9,10,12,13-tetratritiooctadeca-9,12-dienoic acid Chemical compound C(CCCCCCC\C(=C(/C\C(=C(/CCCCC)\[3H])\[3H])\[3H])\[3H])(=O)O OYHQOLUKZRVURQ-NTGFUMLPSA-N 0.000 description 2
- 239000003513 alkali Substances 0.000 description 2
- 235000020661 alpha-linolenic acid Nutrition 0.000 description 2
- DTOSIQBPPRVQHS-PDBXOOCHSA-N alpha-linolenic acid Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC(O)=O DTOSIQBPPRVQHS-PDBXOOCHSA-N 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 239000004519 grease Substances 0.000 description 2
- 230000036737 immune function Effects 0.000 description 2
- 229960004488 linolenic acid Drugs 0.000 description 2
- KQQKGWQCNNTQJW-UHFFFAOYSA-N linolenic acid Natural products CC=CCCC=CCC=CCCCCCCCC(O)=O KQQKGWQCNNTQJW-UHFFFAOYSA-N 0.000 description 2
- 229940057917 medium chain triglycerides Drugs 0.000 description 2
- 239000011022 opal Substances 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 238000001179 sorption measurement Methods 0.000 description 2
- 235000012424 soybean oil Nutrition 0.000 description 2
- 239000003549 soybean oil Substances 0.000 description 2
- PHIQHXFUZVPYII-ZCFIWIBFSA-O (R)-carnitinium Chemical compound C[N+](C)(C)C[C@H](O)CC(O)=O PHIQHXFUZVPYII-ZCFIWIBFSA-O 0.000 description 1
- 208000010444 Acidosis Diseases 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 235000006467 Camellia japonica Nutrition 0.000 description 1
- 241000526900 Camellia oleifera Species 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010058892 Carnitine deficiency Diseases 0.000 description 1
- 208000028399 Critical Illness Diseases 0.000 description 1
- 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 1
- 206010027417 Metabolic acidosis Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- BPQQTUXANYXVAA-UHFFFAOYSA-N Orthosilicate Chemical compound [O-][Si]([O-])([O-])[O-] BPQQTUXANYXVAA-UHFFFAOYSA-N 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 241001122767 Theaceae Species 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229960004203 carnitine Drugs 0.000 description 1
- 235000012000 cholesterol Nutrition 0.000 description 1
- 230000002301 combined effect Effects 0.000 description 1
- 229910052906 cristobalite Inorganic materials 0.000 description 1
- 238000004042 decolorization Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 235000021323 fish oil Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 230000007365 immunoregulation Effects 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 230000028709 inflammatory response Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 238000002386 leaching Methods 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 235000016709 nutrition Nutrition 0.000 description 1
- 230000035764 nutrition Effects 0.000 description 1
- 235000021313 oleic acid Nutrition 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 230000004783 oxidative metabolism Effects 0.000 description 1
- 235000016236 parenteral nutrition Nutrition 0.000 description 1
- 230000036961 partial effect Effects 0.000 description 1
- 150000002978 peroxides Chemical class 0.000 description 1
- 235000020777 polyunsaturated fatty acids Nutrition 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 150000004671 saturated fatty acids Chemical class 0.000 description 1
- 229910052604 silicate mineral Inorganic materials 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 208000016505 systemic primary carnitine deficiency disease Diseases 0.000 description 1
- 230000017423 tissue regeneration Effects 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 229910052905 tridymite Inorganic materials 0.000 description 1
- 230000029663 wound healing Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/82—Theaceae (Tea family), e.g. camellia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/32—Burseraceae (Frankincense family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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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
- A61K9/08—Solutions
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- Animal Behavior & Ethology (AREA)
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- Bioinformatics & Cheminformatics (AREA)
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Abstract
The invention discloses a tea oil-containing multiple oil fat emulsion injection, which comprises the following raw materials by weight per 100ml of injection: 10g-20g of main medicine components, 12g-15g of emulsifying agent, 0.03-0.05g of auxiliary emulsifying agent, 1.95-2.35g of isotonic regulator and the balance of water for injection, wherein the pH value is adjusted to 5.6-8.5; the preparation method comprises the following steps: an oil phase: high-speed shearing to dissolve lecithin and sodium oleate in olive oil, tea oil and structural oil; aqueous phase: mixing glycerol and appropriate amount of water for injection, and adjusting pH with disodium hydrogen phosphate and citric acid buffer; then, preparing the colostrum by an online shearing method to ensure that milk particles are distributed more uniformly; finally homogenizing under high pressure and 8000-10000psi to make the milk particles distributed uniformly; the prepared multi-oil fat emulsion injection containing tea oil has uniform emulsion particles and good stability.
Description
Technical Field
The invention relates to a fat emulsion injection, in particular to a multi-oil fat emulsion injection containing tea oil.
Background
Tea seed oil is also called camellia oil, camellia seed oil and camellia seed oil. Camellia japonica is a special local product of Dabieshan, fujian, jiangxi, hunan (Chang Ning) and the like in China, and high-quality camellia oil, namely tea seed oil, can be extracted from fruits. Is obtained by squeezing or leaching fat-rich seeds produced by camellia oleifera or small She Youcha. The tea seed oil mainly comprises oleic acid, linoleic acid, linolenic acid and partial saturated fatty acid, wherein the oleic acid content in the tea oil can reach more than 75%, polyunsaturated fatty acids such as linoleic acid, linolenic acid and the like account for about 10%, and the oleic acid is safe fatty acid, is very beneficial to the health of a human body, and has the effects of reducing cholesterol in blood, preventing cardiovascular diseases and inhibiting tumors.
Fat emulsion injections have been used in parenteral nutrition in the 60 s of the 20 th century and together with glucose provide energy. Fat emulsions are widely used in surgery and critically ill patients for the purpose of providing energy as well as essential fatty acids, promoting wound healing and tissue repair. The fat emulsion injection is characterized in that the main component is grease, so that emulsion particles are not uniform and are easy to separate, and the stability is not ensured.
Disclosure of Invention
The invention aims to provide a multi-oil fat emulsion injection with low tea oil content.
The aim of the invention can be achieved by the following technical scheme:
a multi-oil fat emulsion injection containing tea oil comprises the following raw materials by weight per 100ml of injection: 10g-20g of main medicine components, 12g-15g of emulsifying agent, 0.03 g-0.05 g of auxiliary emulsifying agent, 1.95 g-2.35 g of isotonic regulator and the balance of water for injection, wherein the pH value is adjusted to 5.6-8.5.
Further, the main medicine component is a combination of tea oil and any other grease, for example, the tea oil comprises: the oil and fat such as soybean oil and fish oil are used in combination.
Further, the weight ratio of the raw materials in the main medicine components is olive oil: tea oil: structured oil=3-6 g:4-8g:3-6g; the structural oil is a structural triglyceride, and the structural triglyceride contains 70% -80% of medium-long chain mixed triglyceride, 5% -10% of long-chain triglyceride and 12% -27% of medium-chain triglyceride.
Structural triglycerides can maintain long chain triglycerides to provide essential fatty acids and energy, while being independent of carnitine transport, and have slow oxidative metabolism. The method has the characteristic of better water solubility of medium-chain triglycerides, provides energy through rapid oxidation, is not easy to accumulate in the liver, and is certainly beneficial to critical patients and newborns suffering from carnitine deficiency. Structural triglycerides also avoid metabolic acidosis and nervous system side effects caused by medium chain triglycerides.
Further, the preparation method of the tea oil comprises the following steps:
(1) Alkali refining deacidification
Heating the crude oil of camellia seed to 40-45 ℃, adding 10-12% sodium hydroxide aqueous solution with mass fraction, stirring and mixing uniformly, heating to 75-85 ℃, preserving heat and stirring for 1-1.5h, naturally cooling to room temperature after the reaction is finished, centrifugally separating, adding 50-60 ℃ deionized water into the centrifugally separated product for washing, and centrifugally separating again to obtain deacidified camellia oil;
(2) Decoloring (decoloring)
Weighing 100g of the deacidified tea oil prepared in the step (1), adding the deacidified tea oil into a reaction bottle, placing the reaction bottle into a water bath kettle with the water bath temperature of 35-40 ℃, standing for 10-15min for preheating, vacuumizing for 10-15min, transferring the vacuumized reaction bottle into an oscillating water bath kettle with the water bath temperature of 80-85 ℃, adding 3-5g of mixed decolorant, preserving heat, oscillating for 30-40min, and naturally cooling to room temperature after the reaction is finished to obtain the decolored tea oil;
(3) Drying
And (3) carrying out vacuum drying on the tea oil decolorized in the step (2) to obtain the tea oil for injection.
Further, the preparation method of the mixed decoloring agent comprises the following steps: respectively placing montmorillonite and rice hull ash in a drying oven, vacuum drying at 55-60deg.C for 3-5h, and mixing the dried montmorillonite and rice hull ash according to mass ratio=3-5: 1, and uniformly mixing the components to obtain the mixed decoloring agent.
Further, the emulsifier is refined egg yolk lecithin.
Further, the auxiliary emulsifier is sodium oleate.
Further, the isotonic regulator is glycerol.
Further, the pH is adjusted to 6.0-8.5.
Further, the preparation method of the tea oil-containing multiple oil fat emulsion injection comprises the following steps:
firstly, preparing an oil phase: adding olive oil, tea oil and structural oil into a high-speed shearing machine, adding an emulsifying agent and an auxiliary emulsifying agent, and shearing for 10-15min at the rotating speed of 600-1000r/min to dissolve the emulsifying agent and the auxiliary emulsifying agent into the olive oil, the tea oil and the structural oil;
secondly, preparing an aqueous phase: mixing and stirring the isotonic regulator and water for injection for 20-25min, uniformly mixing, and then adopting a disodium hydrogen phosphate buffer solution with the mass fraction of 10-15% and a citric acid buffer solution with the mass fraction of 5-10% to adjust the pH value to 6.0-8.5;
thirdly, preparing the colostrum: heating the oil phase and the water phase to 70-80 ℃ respectively, firstly adding the heated water phase into a high-speed shearing machine, slowly adding the heated oil phase at the rotating speed of 300-400r/min, adjusting the rotating speed to 1400-1500r/min after the addition, and maintaining high-speed shearing and emulsifying for 5-7min to obtain the colostrum;
fourth, injection preparation: adding the colostrum prepared in the fourth step into a high-pressure homogenizer, homogenizing for 3-5 times under 8000-10000psi to make the emulsion particles distributed uniformly, and obtaining fat emulsion injection.
The invention has the beneficial effects that:
the invention provides a multi-oil fat emulsion injection containing tea oil, which has uniform emulsion particles and good stability, and the tea oil and olive oil in the formula have anti-inflammatory effect and improve the immune function of patients; the invention mainly combines tea oil and olive oil for use, thereby enhancing anti-inflammatory effect and better improving immune function of patients; plays an important auxiliary role in inflammatory response, immunoregulation, improvement of intestinal nutrition, reduction of hospitalization time and the like of severe patients and organ transplantation patients; in addition, the olive oil and the soybean oil provide essential fatty acids;
the product uses sodium oleate as auxiliary emulsifier and buffer pair to regulate pH value, and has stable milk granule and stable quality in long-term storage process. Reduces injection pain and adverse reaction of clinical use.
Of course, it is not necessary for any one product to practice the invention to achieve all of the advantages set forth above at the same time.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described, and it is obvious that the described embodiments are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the following examples, the preparation method of tea oil is as follows:
(1) Alkali refining deacidification
Heating oil tea seed crude oil (acid value of 0.40-0.43 mgKOH/g) to 40deg.C, adding 10% sodium hydroxide aqueous solution (calculated by adding alkali amount, D= [ (7.13×10) -4 *AV+B)/C]* E, D is the actual alkali consumption, av=degummed oil acid value, B is the excess sodium hydroxide consumption of 0.16%, C is the solution percentage concentration of sodium hydroxide, E is the weight of the crude oil of camellia seed), stirring and mixing uniformly, then heating to 80 ℃, preserving heat and stirring for reaction for 1h, after the reaction is finished, naturally cooling to room temperature, centrifugally separating, adding deionized water with the temperature of 60 ℃ into the centrifuged product for water washing, centrifugally separating again, and obtaining deacidified tea oil, wherein the acid value of the deacidified tea oil is 0.0596mgKOH/g according to the measurement according to the GB/T5530-2005 standard;
(2) Decoloring (decoloring)
Weighing 100g of the deacidified tea oil prepared in the step (1), adding the deacidified tea oil into a reaction bottle, placing the reaction bottle into a water bath kettle with the water bath temperature of 35-40 ℃, standing for 10min for preheating, vacuumizing for 10-15min, transferring the vacuumized reaction bottle into an oscillating water bath kettle with the water bath temperature of 85 ℃, adding 4g of a mixed decoloring agent, and carrying out heat preservation oscillation reaction for 30min with the decoloring rate of 93.154%; the decolorization effect is good, and the decolorized camellia seed oil has stable color and is not easy to return color;
the preparation method of the mixed decoloring agent comprises the following steps: respectively placing montmorillonite and rice hull ash in a drying oven, vacuum drying at 60 ℃ for 5 hours, and mixing the dried montmorillonite and rice hull ash according to the mass ratio of = 3.5:1, and uniformly mixing the components to obtain the mixed decoloring agent.
Montmorillonite is a layered silicate mineral, has low cost, large specific surface area and strong adsorption performance, and has good filtration assisting effect; rice hull ash is a silicon-rich material containing a large amount of cristobalite and tridymite, and has a structure of opal glass, and the opal glass is composed of a mixture of silicon dioxide and silicate, and also has good adsorption effect. The montmorillonite and the rice hull ash have synergistic effect, so that the filter speed and the filter efficiency are good, and the decolored tea oil is stable in color and is not easy to return color due to the combined effect of the montmorillonite and the rice hull ash.
(3) Drying
And (3) carrying out vacuum drying on the tea oil decolorized in the step (2) to obtain the tea oil for injection. The prepared tea oil for injection is detected:
| detecting items | Detection result |
| Acid value mgKOH/g | 0.06 |
| Absorbance at 270nm | 0.015 |
| Color (Luowei colorimeter 133.4 groove) | Y0,R0 |
| Peroxide value mmol/kg | 1.05 |
| Unsaponifiable matter value% | 0.37 |
| Moisture and volatile matter% | 0.02 |
| Heavy metal limiting mg/kg | ＜1.8 |
Meets the quality standard of the oil for injection in Chinese pharmacopoeia (2010 edition).
Example 1
A multi-oil fat emulsion injection containing tea oil comprises the following raw materials by weight per 100ml of injection: the main medicine components (olive oil: tea oil: structural oil=3g:8g:6g, wherein the structural oil is structural triglyceride, the structural triglyceride contains 77% of medium-long chain mixed triglyceride, 6% of long-chain triglyceride and 17% of medium-chain triglyceride) 17g, the emulsifier is refined egg yolk lecithin 14g, the auxiliary emulsifier sodium oleate 0.03g, the isoosmotic regulator glycerin 2.25g, the balance of water for injection and the pH value is regulated to 6.5.
The preparation method of the tea oil-containing multiple oil fat emulsion injection comprises the following steps:
firstly, preparing an oil phase: adding olive oil, tea oil and structural oil into a high-speed shearing machine, adding an emulsifying agent and an auxiliary emulsifying agent, and shearing for 15min at the rotating speed of 600r/min to dissolve the emulsifying agent and the auxiliary emulsifying agent into the olive oil, the tea oil and the structural oil;
secondly, preparing an aqueous phase: mixing and stirring the isotonic regulator and water for injection for 20min, and then adopting a disodium hydrogen phosphate buffer solution with the mass fraction of 12% and a citric acid buffer solution with the mass fraction of 6% to adjust the pH value to 6.5;
thirdly, preparing the colostrum: heating the oil phase and the water phase to 70 ℃ respectively, firstly adding the heated water phase into a high-speed shearing machine, slowly adding the heated oil phase at the rotating speed of 350r/min, adjusting the rotating speed to 1400r/min after the addition, and maintaining high-speed shearing and emulsifying for 5min to obtain the colostrum;
fourth, injection preparation: adding the colostrum prepared in the fourth step into a high-pressure homogenizer, homogenizing for 3 times under 10000psi to uniformly distribute milk particles, and obtaining the fat emulsion injection.
Example 2
A multi-oil fat emulsion injection containing tea oil comprises the following raw materials by weight per 100ml of injection: the main medicine components (olive oil: tea oil: structural oil=6g:8g:6g, wherein the structural oil is structural triglyceride, the structural triglyceride contains 72% of medium-long chain mixed triglyceride, 9% of long-chain triglyceride and 19% of medium-chain triglyceride), 20g of emulsifier refined egg yolk lecithin 12g, 0.05g of auxiliary emulsifier sodium oleate, 1.99g of isotonic regulator glycerol, the balance of water for injection and the pH value is regulated to 7.9.
The preparation method of the tea oil-containing multiple oil fat emulsion injection comprises the following steps:
firstly, preparing an oil phase: adding olive oil, tea oil and structural oil into a high-speed shearing machine, adding an emulsifying agent and an auxiliary emulsifying agent, and shearing for 10min at the rotating speed of 800r/min to dissolve the emulsifying agent and the auxiliary emulsifying agent into the olive oil, the tea oil and the structural oil;
secondly, preparing an aqueous phase: mixing and stirring the isotonic regulator and water for injection for 25min, and then adopting a 10% disodium hydrogen phosphate buffer solution and a 10% citric acid buffer solution to adjust the pH to 7.9;
thirdly, preparing the colostrum: heating the oil phase and the water phase to 80 ℃ respectively, firstly adding the heated water phase into a high-speed shearing machine, slowly adding the heated oil phase at the rotating speed of 300r/min, adjusting the rotating speed to 1500r/min after the addition, and maintaining high-speed shearing and emulsifying for 5min to obtain the colostrum;
fourth, injection preparation: adding the colostrum prepared in the fourth step into a high-pressure homogenizer, homogenizing for 4 times under the pressure of 8000psi to uniformly distribute milk particles, and obtaining the fat emulsion injection.
Example 3
A multi-oil fat emulsion injection containing tea oil comprises the following raw materials by weight per 100ml of injection: the main medicine components (olive oil: tea oil: structural oil=5g:4g:3g, wherein the structural oil is structural triglyceride, the structural triglyceride contains 74% medium-long chain mixed triglyceride, 8% long-chain triglyceride and 18% medium-chain triglyceride) 12g, the emulsifier refined egg yolk lecithin 14g, the auxiliary emulsifier sodium oleate 0.03g, the isoosmotic regulator glycerol 2.33g, the balance of water for injection and the pH value is adjusted to 8.3.
The preparation method of the tea oil-containing multiple oil fat emulsion injection comprises the following steps:
firstly, preparing an oil phase: adding olive oil, tea oil and structural oil into a high-speed shearing machine, adding an emulsifying agent and an auxiliary emulsifying agent, and shearing for 10min at the rotating speed of 1000r/min to dissolve the emulsifying agent and the auxiliary emulsifying agent into the olive oil, the tea oil and the structural oil;
secondly, preparing an aqueous phase: mixing and stirring the isotonic regulator and water for injection for 20-25min, and then adopting 14% disodium hydrogen phosphate buffer solution and 8% citric acid buffer solution to adjust the pH to 8.3;
thirdly, preparing the colostrum: heating the oil phase and the water phase to 75 ℃ respectively, firstly adding the heated water phase into a high-speed shearing machine, slowly adding the heated oil phase at the rotating speed of 400r/min, adjusting the rotating speed to 1400r/min after the addition, and maintaining high-speed shearing and emulsifying for 7min to obtain the colostrum;
fourth, injection preparation: adding the colostrum prepared in the fourth step into a high-pressure homogenizer, homogenizing for 3 times under 10000psi to uniformly distribute milk particles, and obtaining the fat emulsion injection.
Stability test of the prepared fat emulsion injection
From the above table, the fat emulsion injection prepared by the invention has good stability.
The foregoing is merely illustrative and explanatory of the principles of the invention, as various modifications and additions may be made to the specific embodiments described, or similar thereto, by those skilled in the art, without departing from the principles of the invention or beyond the scope of the appended claims.
Claims (10)
1. A multi-oil fat emulsion injection containing tea oil is characterized by comprising the following raw materials by weight per 100ml of injection: 10g-20g of main medicine components, 12g-15g of emulsifying agent, 0.03 g-0.05 g of auxiliary emulsifying agent, 1.95 g-2.35 g of isotonic regulator and the balance of water for injection, wherein the pH value is adjusted to 5.6-8.5.
2. The multi-oil fat emulsion injection containing tea oil according to claim 1, wherein the main medicine component is a combination of tea oil and any other oil.
3. The tea oil-containing multiple oil fat emulsion injection according to claim 2, wherein the weight ratio of the raw materials in the main medicine components is olive oil: tea oil: structured oil=3-6 g:4-8g:3-6g; the structural oil is a structural triglyceride, and the structural triglyceride contains 70% -80% of medium-long chain mixed triglyceride, 5% -10% of long-chain triglyceride and 12% -27% of medium-chain triglyceride.
4. A multi-oil fat emulsion injection containing tea oil according to claim 2 or 3, wherein the preparation method of the tea oil is as follows:
(1) Alkali refining deacidification
Heating the crude oil of camellia seed to 40-45 ℃, adding 10-12% sodium hydroxide aqueous solution with mass fraction, stirring and mixing uniformly, heating to 75-85 ℃, preserving heat and stirring for 1-1.5h, naturally cooling to room temperature after the reaction is finished, centrifugally separating, adding 50-60 ℃ deionized water into the centrifugally separated product for washing, and centrifugally separating again to obtain deacidified camellia oil;
(2) Decoloring (decoloring)
Weighing 100g of the deacidified tea oil prepared in the step (1), adding the deacidified tea oil into a reaction bottle, placing the reaction bottle into a water bath kettle with the water bath temperature of 35-40 ℃, standing for 10-15min for preheating, vacuumizing for 10-15min, transferring the vacuumized reaction bottle into an oscillating water bath kettle with the water bath temperature of 80-85 ℃, adding 3-5g of mixed decolorant, preserving heat, oscillating for 30-40min, and naturally cooling to room temperature after the reaction is finished to obtain the decolored tea oil;
(3) Drying
And (3) carrying out vacuum drying on the tea oil decolorized in the step (2) to obtain the tea oil for injection.
5. The tea oil-containing multiple oil-fat emulsion injection according to claim 4, wherein the preparation method of the mixed decolorizer comprises the following steps: respectively placing montmorillonite and rice hull ash in a drying oven, vacuum drying at 55-60deg.C for 3-5h, and mixing the dried montmorillonite and rice hull ash according to mass ratio=3-5: 1, and uniformly mixing the components to obtain the mixed decoloring agent.
6. The tea oil-containing multiple oil fat emulsion injection according to claim 1, wherein the emulsifier is refined egg yolk lecithin.
7. The tea oil-containing multiple oil-fat emulsion injection according to claim 1, wherein the co-emulsifier is sodium oleate.
8. The tea oil-containing multiple oil-fat emulsion injection according to claim 1, wherein the isotonicity modifier is glycerin.
9. The tea oil-containing multiple oil-fat emulsion injection according to claim 1, wherein the pH is adjusted to 6.0-8.5.
10. The tea-oil-containing multiple oil-fat emulsion injection according to claim 1, wherein the preparation method of the tea-oil-containing multiple oil-fat emulsion injection comprises the following steps:
firstly, preparing an oil phase: olive oil: tea oil: adding the structural oil into a high-speed shearing machine, adding an emulsifying agent and an auxiliary emulsifying agent, and shearing for 10-15min at the rotating speed of 600-1000r/min to dissolve the emulsifying agent and the auxiliary emulsifying agent into the olive oil, the tea oil and the structural oil;
secondly, preparing an aqueous phase: mixing and stirring the isotonic regulator and water for injection for 20-25min, uniformly mixing, and then adopting a disodium hydrogen phosphate buffer solution with the mass fraction of 10-15% and a citric acid buffer solution with the mass fraction of 5-10% to adjust the pH value to 6.0-8.5;
thirdly, preparing the colostrum: heating the oil phase and the water phase to 70-80 ℃ respectively, firstly adding the heated water phase into a high-speed shearing machine, slowly adding the heated oil phase at the rotating speed of 300-400r/min, adjusting the rotating speed to 1400-1500r/min after the addition, and maintaining high-speed shearing and emulsifying for 5-7min to obtain the colostrum;
fourth, injection preparation: adding the colostrum prepared in the fourth step into a high-pressure homogenizer, homogenizing for 3-5 times under 8000-10000psi to make the emulsion particles distributed uniformly, and obtaining fat emulsion injection.
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