CN105616710A - Tea-seed oil fat emulsion injection and preparing method and application thereof - Google Patents
Tea-seed oil fat emulsion injection and preparing method and application thereof Download PDFInfo
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- CN105616710A CN105616710A CN201511033998.6A CN201511033998A CN105616710A CN 105616710 A CN105616710 A CN 105616710A CN 201511033998 A CN201511033998 A CN 201511033998A CN 105616710 A CN105616710 A CN 105616710A
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- 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
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- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- 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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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Abstract
The invention discloses tea-seed oil fat emulsion injection and a preparing method and application thereof. Each liter of injection water of the tea-seed oil fat emulsion injection is prepared from following components: 0.01-30kg of tea-seed oil, 0.01-20kg of injection long chain oil, 0.5-10kg of emulsifier, 0.1-15kg of isoosmotic adjusting agent and 0-0.50kg of antioxygen and an adjusted pH is 5.5-9.50. By reducing the proportion of omega-6 polyunsaturated fatty acids while increasing the proportion of omega-3 polyunsaturated fatty acids, compatibility of various fats is optimized, a lipid metabolism level is accelerated, and organism material metabolism and synthesis of protein are helped. The injection can be widely used for various patients of parenteral nutrition treatment and particularly suitable for the low-immunity and various infected patients.
Description
Technical field
Fat milk technology of preparing that the present invention relates to Oleum Camelliae and application thereof, specifically, relates to a kind of Oleum Camelliae fat emulsion injection and preparation method thereof and application.
Background technology
Oleum Camelliae, has another name called Oleum Camelliae, tea tree oil or Camellia oil, is plant of theaceae oil tea or Camellia yuansienensis is produced the Vegetable oil lipoprotein that rich fatty seed obtains through squeezing or lixiviate. Oleum Camelliae is mainly made up of oleic acid, linoleic acid, linolenic acid and fractional saturation fatty acid, Oleum Camelliae mid-oleic is up to more than 75%, the polyunsaturated fatty acid such as linoleic acid, linolenic acid accounts for 10%, oleic acid is a kind of safe fats acid, the health of human body is extremely advantageous, there are the cholesterol reduced in blood, the effect of prevention cardiovascular disease and suppression tumor. The polyunsaturated fatty acid such as linoleic acid, linolenic acid is growth in humans and the indispensable essential fatty acid of physiological activity; In Oleum Camelliae, oleic acid, linoleic acid, linolenic acid content meet the United Nations grain and oil tissue FAO " standard of health-care edible oil " issued, and this is the good characteristic that other plant oil can not be comparable; In Oleum Camelliae, the content of non-saponifiable matter is less than 1%, it is mainly sterol (0.6%), including stigmasterol, 2,2-dihydro chondrillasterol, avenasterol and Herba Spinaciae steroid N alcohol, next to that triterpene substance, the content of tocopherol is about 8.7mg/100g, and the physicochemical property of Oleum Camelliae has necessarily similar to olive oil, but the tocopherol content of Oleum Camelliae is far above olive oil by contrast, and oxidation resistance is more excellent; Additionally Oleum Camelliae is possibly together with biological active substanceies such as camellin, Tsubaki-saponin and tea polyphenols, the multiple cardiovascular disease that energy treatment of vascular hardening is caused, and tea polyphenols has the reduction multiple effect such as cholesterol, Cancer Chemoprevention, without the aflatoxin that carcinogenecity is very strong, there are the potentiality being applied to field of medicaments.
Lipomul was applied in the sixties in 20th century in parenteral nutrition, and jointly provided energy with glucose. extensive use lipomul in surgery and critical patient, it is therefore an objective in order to provide energy and essential fatty acid, promotes wound healing and tissue repair. there are 2 kinds of lipomuls comparatively conventional clinically at present: a kind of is lipomul based on soybean oil, by long chain triglyceride (longchaintriglycerides, LCT) composition, wherein 62% is polyunsaturated fatty acid (polyunsaturatedfattyacid, PUFA), Recent study finds linoleic acid (PUFA) too high levels in long-chain fat Ruzhong, oxidation preventive content is relatively low, polyunsaturated fatty acid is taken in too much easy oxidized formation and is aoxidized fat and be deposited in blood vessel wall and cause thrombosis, in wound, when infecting contour metabolism state, granulocyte activity can be affected, cause immune function depression, lipid peroxidation increases, increase the weight of body damage. another kind be containing in 50% medium chain triglyceride (mediumchaintriglyceride, MCT) and 50%LCT/Long-chain triglycerides. but in/although long chain fat emulsion reduces the ratio of LCT, is substantially better than long chain fat emulsion, but natural anti-oxidation agent content is relatively low in nitrogen balance and prealbumin level etc., fatty acid proportion is still unsatisfactory.
Therefore a kind of fatty acid proportion of exploitation is reasonable, and the lipomul that natural anti-oxidation agent content is high has important medical value and realistic meaning. But, current temporarily but without about the Patents of Oleum Camelliae fat emulsion injection preparation method and purposes and bibliographical information.
Summary of the invention
It is an object of the invention to overcome the deficiencies in the prior art, it is provided that a kind of Oleum Camelliae fat emulsion injection, for parenteral nutrition, it is possible to be effective against lipid peroxidation process, supplement in energy and essential fatty acid process and alleviate immune damage.
The preparation method that another object of the present invention is to provide this Oleum Camelliae fat emulsion injection.
To achieve these goals, the present invention adopts the following technical scheme that
A kind of Oleum Camelliae fat emulsion injection, containing, for example lower composition in every liter of water for injection: Oleum Camelliae 0.01��30kg, injection long-chain oil 0.01��20kg, emulsifying agent 0.5��10kg, isoosmotic adjusting agent 0.1��15kg, antioxidant 0��0.50kg; Regulating pH is 5.5��9.50. Best pH is 6.0��8.0.
As preferably, in above-mentioned Oleum Camelliae fat emulsion injection, described injection long-chain oil is the one in soybean oil, safflower oil, Semen Maydis oil.
As preferably, in above-mentioned Oleum Camelliae fat emulsion injection, described emulsifying agent is one or more in soybean phospholipid, egg yolk lecithin, poloxamer, glycerin mono-fatty acid ester.
As preferably, in above-mentioned Oleum Camelliae fat emulsion injection, described isoosmotic adjusting agent is one or more in glycerol, sorbitol, xylitol, glucose, sodium chloride.
As preferably, in above-mentioned Oleum Camelliae fat emulsion injection, described antioxidant is tocopherol.
The preparation method of above-mentioned Oleum Camelliae fat emulsion injection, comprises the steps: 1. to prepare oil phase and aqueous phase: by Oleum Camelliae and injection long-chain oil, adding emulsifying agent, heated and stirred makes emulsifying agent dissolve, and adds antioxidant, stirring, obtains oil phase; Taking water for injection, add isoosmotic adjusting agent, agitating heating is dissolved, and obtains aqueous phase; 2. injectable emulsion is prepared: oil phase and heated aqueous being mixed, emulsifying 5��300 minutes, obtain colostrum, by further for colostrum emulsifying, regulating its pH by pH adjusting agent is 5.5��9.5, injects water to ormal weight, to obtain final product.
As preferably, in the preparation method of above-mentioned Oleum Camelliae fat emulsion injection, described step 1., 2. in heating-up temperature be 50��90 DEG C, be more preferred from 60��80 DEG C.
As preferably, above-mentioned pH adjusting agent is selected from but is not limited to the one in sodium hydroxide solution (concentration is 0.001��5M), hydrochloric acid (concentration is 0.001��5M), is adjusted to the pH value that Emulsion is suitable.
As preferably, emulsifying can use emulsification pretreatment device emulsifying or stirring and emulsifying, shears or the speed of stirring is 500��10000 revs/min when preparing colostrum; Further emulsifying refers to including but not limited to the methods such as microjet high pressure homogenization emulsifying, mechanical agitation emulsifying, ultrasonic emulsification, colloid mill emulsifying, it is preferable that microjet high pressure homogenizer homogenizing emulsifying (pressure is 500��25000psi).
As preferably, for reaching the sanitary standard needed for usual ejection preparation, gained Oleum Camelliae fat emulsion injection can be carried out subpackage, nitrogen charging, sterilization. Wherein sterilization refers to but is not limited to the Disinfection Methods such as flowing steam, high steam, it is preferable that rotary high pressure vapor sterilization (temperature 100��121 DEG C, 5��120 minutes time).
Compared with prior art, there is advantages that
1, the present invention is to be the fat emulsion injection that main component mixes by Oleum Camelliae and long-chain oil, for white or off-white color emulsion liquid, or has opalescence, and mean diameter is 100��500nm. It had both met human body power supply and the primary demand to essential fatty acid, greatly reduced the untoward reaction that too much omega 6 polyunsaturated fatty acid brings simultaneously. Compared with common soybean oil fat milk, the present invention increases omega-3 polyunsaturated fatty acids ratio by reducing omega 6 polyunsaturated fatty acid, optimizes various fat compatibility, accelerates lipid metabolism level, help the synthesis of body substance metabolism and protein. Can be widely applied to the patient of various Parenteral Nutrition Treatment, be particularly suited for hypoimmunity and various infected patient.
2, make full use of Oleum Camelliae and contain the advantage of higher natural tocopherol, increase the effect of human body active vitamin emulsion stability and anti peroxidation of lipid, protect human normal physiological function. Making full use of the feature that Oleum Camelliae mid-oleic is high, protection human body will not reduce immunologic function while using fat emulsion formulation to supplement essential fatty acid better. For parenteral nutrition, supply body energy and supplementary fatty acid.
Detailed description of the invention:
Embodiment being set forth below and further describes the present invention, this embodiment is merely to illustrate the present invention and the present invention is not limited.
Embodiment 1:
Claiming 160g Oleum Camelliae and the refining injection soybean oil of 40g, add Ovum Gallus domesticus Flavus lecithin 12g, heating makes emulsifying agent dissolve to 75 DEG C of stirrings, stirs to obtain oil phase; Take 860ml water for injection, add 22.5g glycerol, be heated with stirring to 75 DEG C of dissolvings, obtain aqueous phase. Again by oil phase and heated aqueous to 75 DEG C of mixing, with emulsification pretreatment device emulsifying 5min (rotating speed 1600 revs/min), obtain colostrum, by colostrum microjet high pressure homogenizer homogenizing (pressure 5000psi) three times, regulating its pH with sodium hydroxide solution or hydrochloric acid solution is 8.0, injects water to 1000ml, subpackage, nitrogen charging, 115 DEG C of sterilizings 30 minutes, obtain Oleum Camelliae fat milk. This Emulsion mean diameter 345.3nm, pH are 7.90, and the relative total fatty acids ratio of oleic acid is about 60%, and other indices meet the requirement of vein emulsion.
Embodiment 2:
Claim 140g Oleum Camelliae and 60g refined maize oil, add soybean phospholipid 12g, heat and make emulsifying agent dissolve to 75 DEG C of stirrings, add 0.05g tocopherol, stirring, obtain oil phase; Take 860ml water for injection, add 17.6g sorbitol, be heated with stirring to 75 DEG C of dissolvings, obtain aqueous phase. Again by oil phase and heated aqueous to 75 DEG C of mixing, with emulsification pretreatment device emulsifying 5min (rotating speed 1600 revs/min), obtain colostrum, by colostrum microjet high pressure homogenizer homogenizing (pressure 5000psi) three times, regulating its pH with sodium hydroxide solution or hydrochloric acid solution is 8.5, injects water to 1000ml, subpackage, nitrogen charging, 115 DEG C of sterilizings 30 minutes, obtain Oleum Camelliae fat milk. This Emulsion mean diameter 420.1nm, pH are 8.90, and the relative total fatty acids ratio of oleic acid is about 60%, and other indices meet the requirement of vein emulsion.
Embodiment 3:
Claim 100g Oleum Camelliae and the refining safflower oil of 100g, add soybean phospholipid 12g, heat and make emulsifying agent dissolve to 65 DEG C of stirrings, add 1g tocopherol, stirring, obtain oil phase; Take 860ml water for injection, add 22.5g sorbitol, be heated with stirring to 65 DEG C of dissolvings, obtain aqueous phase. Again by oil phase and heated aqueous to 65 DEG C of mixing, with emulsification pretreatment device emulsifying 5min (rotating speed 1600 revs/min), obtain colostrum, by colostrum microjet high pressure homogenizer homogenizing (pressure 5000psi) three times, regulating its pH with sodium hydroxide solution or hydrochloric acid solution is 9.0, injects water to 1000ml, subpackage, nitrogen charging, 115 DEG C of sterilizings 30 minutes, obtain Oleum Camelliae fat milk. This Emulsion mean diameter 230.0nm, pH are 8.50, and the relative total fatty acids ratio of oleic acid is about 60%, and other indices meet the requirement of vein emulsion.
Embodiment 4:
Claim 150g Oleum Camelliae and 50g refined soybean oil, add soybean phospholipid 12g, heat and make emulsifying agent dissolve to 75 DEG C of stirrings, add 0.05g tocopherol, stirring, obtain oil phase; Take 860ml water for injection, add 22.5g xylitol, be heated with stirring to 70 DEG C of dissolvings, obtain aqueous phase. Again by oil phase and heated aqueous to 70 DEG C of mixing, with emulsification pretreatment device emulsifying 5min (rotating speed 1600 revs/min), obtain colostrum, by colostrum microjet high pressure homogenizer homogenizing (pressure 5000psi) three times, regulating its pH with sodium hydroxide solution or hydrochloric acid solution is 8.6, injects water to 1000ml, subpackage, nitrogen charging, 115 DEG C of sterilizings 30 minutes, obtain Oleum Camelliae fat milk. This Emulsion mean diameter 179.9nm, pH are 8.20, and the relative total fatty acids ratio of oleic acid is about 60%, and other indices meet the requirement of vein emulsion.
Embodiment 5:
Claim 200g Oleum Camelliae and 50g refined soybean oil, add soybean phospholipid 12g, heat and make emulsifying agent dissolve to 75 DEG C of stirrings, stir, obtain oil phase; Take 750ml water for injection, add 22.5g poloxamer, be heated with stirring to 80 DEG C of dissolvings, obtain aqueous phase. Again by oil phase and heated aqueous to 80 DEG C of mixing, with emulsification pretreatment device emulsifying 5min (rotating speed 1600 revs/min), obtain colostrum, by colostrum microjet high pressure homogenizer homogenizing (pressure 5000psi) three times, regulating its pH with sodium hydroxide solution or hydrochloric acid solution is 8.3, injects water to 1000ml, subpackage, nitrogen charging, 115 DEG C of sterilizings 30 minutes, obtain Oleum Camelliae fat milk. This Emulsion mean diameter 195.9nm, pH are 8.5, and the relative total fatty acids ratio of oleic acid is about 60%, and other indices meet the requirement of vein emulsion.
Embodiment 6 effect experiment is studied:
Choose Oleum Camelliae fat milk best prescription ratio (embodiment 1) and carry out drug efficacy study, and take soybean oil fat milk (i.e. long chain fat emulsion injection) as comparison, embody the pharmacology advantage of Oleum Camelliae fat milk.
1, parenteral nutrition and antioxidation
20 albefaction Wistar rats are assigned randomly to 4 groups, often 5 rats of group. Group 1 is comfort group, and group 2 is control group 72h, group 3 use long chain fat emulsion injection 72h, group 4 use Oleum Camelliae fat milk 72h. Administration is by carotid injection, and carries out the hepalobectomy of 70%. Additionally except comfort group, control group does not have intravenous administration and carries out hepalobectomy. The index weighing liver regeneration ability includes the carnitine levels in relative liver weight, cell mitogen index, proliferating cell nuclear antigen label index, hepatic tissue sample. Thiobarbituric acid reactive material is as weighing lipid peroxidation and an index of oxidative tissue damage. Alanine aminotransferase (ALT), aspartate transaminase (AST), alkali phosphatase (AP) is the index weighing hepatic injury.
Oil phase main fatty acid and tocopherol content in 1. two kinds of fat milks of table
The each Testing index test data result of table 2.
It is shown that fat milk administration group group 3 provides nutrition all can to group 4 mouse of liver procedure so that it is liver regeneration ratio relatively control group group 2 is bigger, it is provided that parenteral nutrition is conducive to the regeneration of rat liver. The relative liver weight of group 4 increases ratio group more than 3, organizes 4 Oleum Camelliae fat milk group lipid peroxidations simultaneously and reduces, makes liver function index closer to Normal serum levels, therefore, organize 4 Oleum Camelliae fat milks and be more beneficial for liver regeneration, and have good anti-oxidation characteristics.
2, protection immune system effect
Interleukin 2 Receptor ��-chain (CD25) is CD4+ and CD8+T lymphocytic activity mark, and its quantity can point out the increase that Activated T-lymphocytes is bred, the enhancing of immunocompetence. The expression flow cytometer of Interleukin 2 Receptor ��-chain measures. The lymphocyte of Wistar Rats Spleen, after 48h cultivates, takes out cell and washes twice in PBS. Then at 4 DEG C, 30min is hatched by the monoclonal antibody of Interleukin 2 Receptor ��-chain. After washing twice with PBS again, in cell suspension and 2% formaldehyde PBS and analyze, CD25 positive cell percentage will be utilized to calculate Interleukin 2 Receptor ��-chain (CD25).
CD25 positive cell percentage result after 3. two kinds of fat milk administrations of table
| Fat milk kind | Soybean oil fat milk | Oleum Camelliae fat milk (embodiment 1) |
| CD25 positive cell percentage % | 42.25 �� 3.43 (groups 3) | 59.55 �� 3.56 (groups 4) |
Result prompting can reduce the suppression of immunocyte containing the Oleum Camelliae fat milk that oleic acid content is higher, is conducive to protection human immune system while supplementary fatty acid, reduces the side effect of fat emulsion formulation.
Claims (10)
1. an Oleum Camelliae fat emulsion injection, it is characterised in that containing, for example lower composition in every liter of water for injection: Oleum Camelliae 0.01 ~ 30kg, injection long-chain oil 0.01 ~ 20kg, emulsifying agent 0.5 ~ 10kg, isoosmotic adjusting agent 0.1 ~ 15kg, antioxidant 0 ~ 0.50kg; Regulating pH is 5.5 ~ 9.50.
2. Oleum Camelliae fat emulsion injection according to claim 1, it is characterised in that described injection long-chain oil is the one in soybean oil, safflower oil, Semen Maydis oil.
3. Oleum Camelliae fat emulsion injection according to claim 1, it is characterised in that described emulsifying agent is one or more in soybean phospholipid, egg yolk lecithin, poloxamer, glycerin mono-fatty acid ester.
4. Oleum Camelliae fat emulsion injection according to claim 1, it is characterised in that described isoosmotic adjusting agent is one or more in glycerol, sorbitol, xylitol, glucose, sodium chloride.
5. Oleum Camelliae fat emulsion injection according to claim 1, it is characterised in that described antioxidant is tocopherol.
6. Oleum Camelliae fat emulsion injection according to claim 1, it is characterised in that described pH is 6.0 ~ 8.0.
7. the preparation method of Oleum Camelliae fat emulsion injection described in claim 1, it is characterised in that comprise the steps: 1. to prepare oil phase and aqueous phase: by Oleum Camelliae and injection long-chain oil, add emulsifying agent, heated and stirred makes emulsifying agent dissolve, add antioxidant, stirring, obtain oil phase; Taking water for injection, add isoosmotic adjusting agent, agitating heating is dissolved, and obtains aqueous phase; 2. injectable emulsion is prepared: oil phase and heated aqueous being mixed, emulsifying 5 ~ 300 minutes, obtain colostrum, by further for colostrum emulsifying, regulating its pH by pH adjusting agent is 5.5 ~ 9.5, injects water to ormal weight, to obtain final product.
8. preparation method according to claim 7, it is characterised in that described step 1., 2. in heating-up temperature be 50 ~ 90 DEG C.
9. preparation method according to claim 8, it is characterised in that described step 1., 2. in heating-up temperature be 60 ~ 80 DEG C.
10. the application in preparing parenteral nutrition or antioxidation or immune system protection medicine of the Oleum Camelliae fat emulsion injection described in claim 1.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106821977A (en) * | 2017-01-22 | 2017-06-13 | 福建医科大学 | Tea oil nanoemulsion and preparation method thereof |
| CN110898009A (en) * | 2019-12-11 | 2020-03-24 | 刘春华 | Safflower seed oil microemulsion and preparation method and application thereof |
| CN111840409A (en) * | 2020-07-08 | 2020-10-30 | 赣州哈克生物科技有限公司 | Preparation method and preparation equipment of tea oil fat emulsion |
| CN116098951A (en) * | 2023-02-23 | 2023-05-12 | 广东嘉博制药有限公司 | A multiple oil-fat emulsion injection containing tea oil |
| CN116210906A (en) * | 2022-12-30 | 2023-06-06 | 广州白云山汉方现代药业有限公司 | Preparation method and application of ganoderma lucidum spore oil oral liquid for improving taste |
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| CN101601649A (en) * | 2009-07-20 | 2009-12-16 | 山东大学 | A kind of Ubenimex fat emulsion injection and preparation method thereof |
| CN102058531A (en) * | 2011-01-11 | 2011-05-18 | 西安力邦制药有限公司 | Preparation method of fat emulsion of cerebral protection therapeutic drug |
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| CN101194919A (en) * | 2008-01-10 | 2008-06-11 | 沈阳药科大学 | Hippophae rhamnoides seed oil fatty milk injection and technique of preparing the same |
| CN101601649A (en) * | 2009-07-20 | 2009-12-16 | 山东大学 | A kind of Ubenimex fat emulsion injection and preparation method thereof |
| CN102058531A (en) * | 2011-01-11 | 2011-05-18 | 西安力邦制药有限公司 | Preparation method of fat emulsion of cerebral protection therapeutic drug |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106821977A (en) * | 2017-01-22 | 2017-06-13 | 福建医科大学 | Tea oil nanoemulsion and preparation method thereof |
| CN110898009A (en) * | 2019-12-11 | 2020-03-24 | 刘春华 | Safflower seed oil microemulsion and preparation method and application thereof |
| CN111840409A (en) * | 2020-07-08 | 2020-10-30 | 赣州哈克生物科技有限公司 | Preparation method and preparation equipment of tea oil fat emulsion |
| CN116210906A (en) * | 2022-12-30 | 2023-06-06 | 广州白云山汉方现代药业有限公司 | Preparation method and application of ganoderma lucidum spore oil oral liquid for improving taste |
| CN116098951A (en) * | 2023-02-23 | 2023-05-12 | 广东嘉博制药有限公司 | A multiple oil-fat emulsion injection containing tea oil |
| CN116098951B (en) * | 2023-02-23 | 2024-05-24 | 广东嘉博制药有限公司 | A multiple oil-fat emulsion injection containing tea oil |
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Application publication date: 20160601 |