CN112641821A - Formula of fat emulsion injection and preparation method thereof - Google Patents
Formula of fat emulsion injection and preparation method thereof Download PDFInfo
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- CN112641821A CN112641821A CN202011641348.0A CN202011641348A CN112641821A CN 112641821 A CN112641821 A CN 112641821A CN 202011641348 A CN202011641348 A CN 202011641348A CN 112641821 A CN112641821 A CN 112641821A
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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)
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- 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
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
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- 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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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P3/02—Nutrients, e.g. vitamins, minerals
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Abstract
The invention discloses a formula of a fat emulsion injection and a preparation method thereof. The fat emulsion injection comprises soybean oil, egg yolk lecithin, glycerol, oleic acid and sodium hydroxide; based on 1000mL of fat emulsion injection, the fat emulsion injection comprises 90-110g of soybean oil, 11-13g of egg yolk lecithin, 20-26g of glycerol and 0.4-0.6g of oleic acid, and the pH value of an aqueous phase is adjusted to 11.0-11.5 by sodium hydroxide. Tests prove that the fat emulsion injection is more stable under the alkaline condition, the pH value of a water phase is adjusted to 11.0-11.5 by using sodium hydroxide in the prepared fat emulsion injection, the final pH value of an injection obtained after the water phase and an oil phase are emulsified is 8.0-8.5, and the stability of a fat emulsion oil-in-water system can be improved.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a formula of a fat emulsion injection and a preparation method thereof.
Background
The fat emulsion injection is an energy supplement medicine, is mainly suitable for being one of components of intravenous nutrition, provides energy and essential fatty acid for organisms, is used for supplementing energy and essential fatty acid for parenteral nutrition, prevents and treats human essential fatty acid deficiency, and also provides essential fatty acid for patients who cannot maintain and recover normal essential fatty acid level by oral administration. Clinical tests prove that the glycerin fructose injection can achieve better effects on dehydration and intracranial pressure reduction treatment of patients with high intracranial pressure.
Soybean oil is the main nutrient component in the fat emulsion injection, egg yolk lecithin is the commonly used emulsifier of the fat emulsion injection, and the oil phase and the water phase form a stable oil-in-water system through the emulsification of the egg yolk lecithin. The instability of the oil-in-water system can cause the phenomena of demulsification, oil floating, layering and the like, and the safety and the curative effect of the product are influenced. The yolk lecithin is a lipophilic surfactant and has a strong emulsifying effect, but a small amount of floating oil possibly exists in the long-term storage process due to vibration, high temperature and the like, and a small amount of oleic acid is added as an auxiliary emulsifier to improve the stability of the emulsion. Oleic acid can form sodium oleate under the alkaline condition, the emulsifying effect of the sodium oleate is weaker than that of egg yolk lecithin, but the sodium oleate is a hydrophilic surfactant and can be acted together with the egg yolk lecithin in liquid medicine, so that the stability of the fat emulsion oil-in-water system can be greatly improved.
Disclosure of Invention
The invention aims to provide a formula of a fat emulsion injection and a preparation method thereof, so as to improve the long-term stability of the fat emulsion injection.
The fat emulsion injection comprises soybean oil, egg yolk lecithin, glycerol, oleic acid and sodium hydroxide; based on 1000mL of fat emulsion injection, the fat emulsion injection comprises 90-110g of soybean oil, 11-13g of egg yolk lecithin, 20-26g of glycerol and 0.4-0.6g of oleic acid, and the pH value of an aqueous phase is adjusted to 11.0-11.5 by sodium hydroxide.
The preparation method of the fat emulsion injection comprises the following steps:
(1) weighing soybean oil, yolk lecithin, glycerol and oleic acid according to the prescription amount respectively;
(2) preparing a water phase: adding the injection water and glycerol according to the prescription amount, stirring and mixing uniformly, filtering by a filter element with the diameter of 0.22 mu m, adjusting the pH value to 11.0-11.5 by using 0.1mol/L sodium hydroxide solution, keeping the temperature at 60-80 ℃ for later use, and continuously filling nitrogen for protection in the water phase preparation process;
(3) preparation of oil phase: adding soybean oil and oleic acid according to the formula amount, heating to 60-70 ℃, adding egg yolk lecithin, shearing until the solution is clear, and continuously filling nitrogen for protection in the oil phase preparation process;
(4) preparing colostrum: mixing the oil phase and the water phase by a shearing machine, and circularly emulsifying for 1-3 times to obtain primary emulsion;
(5) preparation of refined milk: homogenizing the primary emulsion at 500-700bar under high pressure for 4-7 times to obtain refined milk, and detecting properties, pH value and milk particle of the refined milk; and after the product is qualified, filling, sterilizing, and performing light inspection and packaging.
Tests prove that the fat emulsion injection is more stable under the alkaline condition, the pH value of a water phase is adjusted to 11.0-11.5 by using sodium hydroxide in the prepared fat emulsion injection, the final pH value of an injection obtained after the water phase and an oil phase are emulsified is 8.0-8.5, and the stability of a fat emulsion oil-in-water system can be improved.
Detailed Description
The present invention is described in further detail below with reference to specific embodiments, which are given for the purpose of illustration only and are not intended to limit the scope of the invention.
Example 1
The raw material feeds are shown in table 1:
TABLE 1
| Serial number | Raw materials | The feeding amount is g/1000ml |
| 1 | Soybean oil | 100 |
| 2 | Egg yolk lecithin | 12 |
| 3 | Glycerol | 22.5 |
| 4 | Oleic acid | 0.5 |
| 5 | Sodium hydroxide | Proper amount of |
| 6 | Water for injection | Is added to 1000 |
The preparation method comprises the following steps:
1) weighing the soybean oil, the egg yolk lecithin, the glycerol and the oleic acid according to the prescription amount;
2) preparing a water phase: adding the injection water and glycerol according to the prescription amount, stirring and mixing uniformly, filtering by a filter element with the diameter of 0.22 mu m, and respectively adjusting the pH value to 9.0, 10.0, 11.0 and 11.5 by using 0.1mol/L sodium hydroxide solution; keeping the temperature at 80 ℃ for later use, and continuously filling nitrogen for protection in the water phase preparation process;
3) preparation of oil phase: adding soybean oil and oleic acid according to the prescription amount, heating to 70 ℃, adding egg yolk lecithin, shearing until the solution is clear, and continuously filling nitrogen for protection in the oil phase preparation process;
4) preparing colostrum: mixing the oil phase and the water phase with a shearing machine, and circularly emulsifying for 3 times to obtain primary emulsion;
5) preparation of refined milk: homogenizing the primary emulsion at high pressure of 500-700bar for 6 times to obtain refined milk, and detecting properties, pH value and milk particles of the refined milk;
6) after the determination is qualified, filling;
7) and (3) sterilization: 115-121 ℃, and ensuring that the F0 value is more than 12;
8) and (6) inspecting and packaging by using a lamp.
Example 2
The raw material feeds are shown in table 2:
TABLE 2
| Serial number | Raw materials | The feeding amount is g/1000ml |
| 1 | Soybean oil | 100 |
| 2 | Egg yolk lecithin | 12 |
| 3 | Glycerol | 22.5 |
| 4 | Sodium hydroxide | Proper amount of |
| 5 | Water for injection | Is added to 1000 |
The preparation method comprises the following steps:
1) weighing propofol, soybean oil, egg yolk lecithin, glycerol and oleic acid in the formula amount;
2) preparing a water phase: adding the injection water and glycerol according to the prescription amount, stirring and mixing uniformly, filtering by a filter element with the diameter of 0.22 mu m, and respectively adjusting the pH value to 10.0 by using 0.1mol/L sodium hydroxide; keeping the temperature at 80 ℃ for later use, and continuously filling nitrogen for protection in the water phase preparation process;
3) preparation of oil phase: adding soybean oil and oleic acid according to the prescription amount, heating to 70 ℃, adding egg yolk lecithin, shearing until the solution is clear, and continuously filling nitrogen for protection in the oil phase preparation process;
4) preparing colostrum: mixing the oil phase and the water phase at a certain proportion by a shearing machine, and circularly emulsifying for 3 times to obtain primary emulsion;
5) preparation of refined milk: homogenizing the primary emulsion for 6 times at 500-700bar to obtain refined emulsion, and taking the refined emulsion to detect properties, pH value and emulsion particles;
6) after the determination is qualified, filling;
7) and (3) sterilization: 115-121 ℃, and ensuring that the F0 value is more than 12;
8) and (6) inspecting and packaging by using a lamp.
The results are shown in the following table:
table 3: stability investigation result of fat emulsion injection
From the results of the stability studies in table 3, it can be seen that: the examination is carried out under the high-temperature test condition (60 +/-2 ℃), and the samples are taken for 5, 10 and 30 days; and detecting the appearance. Test results show that the stability of the fat emulsion injection is good in the process of 30-day stability investigation of influencing factors. The stability of the emulsion can be improved and the product quality can be ensured by adopting a proper pH value, formula amount of the stabilizer and preparation process.
The above is only a preferred embodiment of the present invention, and it should be noted that it is possible for those skilled in the art to make various changes and modifications without departing from the inventive concept of the present invention, and these are all protected by the present invention.
Claims (2)
1. A fat emulsion injection, comprising soybean oil, egg yolk lecithin, glycerol, oleic acid, and sodium hydroxide; based on 1000mL of fat emulsion injection, the fat emulsion injection comprises 90-110g of soybean oil, 11-13g of egg yolk lecithin, 20-26g of glycerol and 0.4-0.6g of oleic acid, and the pH value of an aqueous phase is adjusted to 11.0-11.5 by sodium hydroxide.
2. A method for preparing fat emulsion injection, which is characterized by comprising the following steps:
(1) weighing soybean oil, yolk lecithin, glycerol and oleic acid according to the prescription amount respectively;
(2) preparing a water phase: adding the injection water and glycerol according to the prescription amount, stirring and mixing uniformly, filtering by a filter element with the diameter of 0.22 mu m, adjusting the pH value to 11.0-11.5 by using 0.1mol/L sodium hydroxide solution, keeping the temperature at 60-80 ℃ for later use, and continuously filling nitrogen for protection in the water phase preparation process;
(3) preparation of oil phase: adding soybean oil and oleic acid according to the formula amount, heating to 60-70 ℃, adding egg yolk lecithin, shearing until the solution is clear, and continuously filling nitrogen for protection in the oil phase preparation process;
(4) preparing colostrum: mixing the oil phase and the water phase by a shearing machine, and circularly emulsifying for 1-3 times to obtain primary emulsion;
(5) preparation of refined milk: homogenizing the primary emulsion at 500-700bar under high pressure for 4-7 times to obtain refined milk, and detecting properties, pH value and milk particle of the refined milk; and after the product is qualified, filling, sterilizing, and performing light inspection and packaging.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011641348.0A CN112641821A (en) | 2020-12-31 | 2020-12-31 | Formula of fat emulsion injection and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011641348.0A CN112641821A (en) | 2020-12-31 | 2020-12-31 | Formula of fat emulsion injection and preparation method thereof |
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| CN112641821A true CN112641821A (en) | 2021-04-13 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114983941A (en) * | 2022-06-30 | 2022-09-02 | 瑞阳制药股份有限公司 | Homogenization preparation method of fat emulsion injection |
| 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 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101700225A (en) * | 2009-11-17 | 2010-05-05 | 蚌埠丰原涂山制药有限公司 | Fat emulsion injection and production method thereof |
| CN101836956A (en) * | 2010-05-31 | 2010-09-22 | 青岛华仁药业股份有限公司 | Preparation process of fat emulsion injection products and fat emulsion injection products |
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2020
- 2020-12-31 CN CN202011641348.0A patent/CN112641821A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101700225A (en) * | 2009-11-17 | 2010-05-05 | 蚌埠丰原涂山制药有限公司 | Fat emulsion injection and production method thereof |
| CN101836956A (en) * | 2010-05-31 | 2010-09-22 | 青岛华仁药业股份有限公司 | Preparation process of fat emulsion injection products and fat emulsion injection products |
Non-Patent Citations (1)
| Title |
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| 广州侨光制药厂: "脂肪乳注射液（10%）", 《职业医学》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114983941A (en) * | 2022-06-30 | 2022-09-02 | 瑞阳制药股份有限公司 | Homogenization preparation method of fat emulsion injection |
| 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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