Method of producing fat emulsion for intravenous injections

专利摘要:
A stable fat emulsion having low side effects, which is suitable as nutritive infusion fluid for intravenous injection, is provided. The emulsion contains 5-50 (W/V) % of soybean oil, yolk phospholipids in a weight ratio to the soybean oil of 1/4-1/25, 0.01-0.30 (W/V) % of a fatty acid or salt thereof having 12-20 carbon atoms and the balance of water.
公开号:SU1311604A3
申请号:SU802914601
申请日:1980-05-05
公开日:1987-05-15
发明作者:Окамото Хироюки；Цуда Есио；Екояма Казумаса
申请人:Дзе Грин Кросс Корпорейшн (Фирма)；
IPC主号:

专利说明:

. 1-13
The invention relates to medicine, in particular to methods for the preparation of emulsions for intravenous injection. The purpose of the invention is to increase the stability of the emulsion by producing particles with a diameter O, 1-1.0 µm.
The method is carried out as follows.
Example. 2.4 g of purified yolk phospholipid, 0.05 g of sodium oleate and 0.04 g of cholesterol are added to 20 g of purified soybean oil. The mixture is heated at 70 ° C to obtain a solution. 5.0 g of glycerin and 173 ml of distilled water for injection were added to the solution. The solution is then stirred vigorously at 70 ° C for 40 minutes in a homogenizer until a coarse emulsion is formed.
The coarse emulsion is finely dispersed by ten-fold passing through the Maiiton-Gaulin go-mogenizer at a pressure of 150 kg / cm in the first stage and then passed through the device 8 times at a total pressure of 500 kg / cm at 45 C. A very thin emulsion having an average particle size 0.08i; 0.2 (U., I
Example 2.k5.0r of purified soybean oil, 0.8 g of purified yolk phosphlipid, 0.01 g of sodium oleate and 0.005 g of cholesterol are added. The mixture is heated at 65 ° C to obtain a solution. 3 g of glycerin and 90 ml of distilled water for injection heated to 65 ° C are added to the solution. The resulting mixture is coarsely emulsified by means of a homomixer. The coarse emulsion is thinly emulsified by passing it through ten times through a Manton-Gaulin homogenizer at a pressure in the first stage of 100 kg / cm and then passed 8 times through the device at a total pressure of 700 kg / cm at 40 s. A homogeneous fine fat emulsion is obtained having an average particle size of 0.09 ± 0.01 jlt.
Example The raw material used is 50.0 g of purified soybean oil, 10.0 g of purified yolk phospholipid, 0.7 g of sodium oleate and 0.6 g of cholesterol, the mixture is heated to a temperature of about 70 ° C to form a solution. To the solution add 10.0 g of glycerol as an isotonic agent and 200 ml of distilled water for injection, which is preheated to
42
temperatures around 70 ° C; and the resulting mixture is emulsified in a coarse-grained manner using a mixer-homogenizer. Coarse emulsion emulsified
fine-grained by passing it once through a Manton Gaulin homogenizer at a pressure of 120 kg / cm in the first stage and then 10 times at a pressure of 500 kg / cm in the second stage
to obtain a homogenized, highly dispersed fat emulsion. Comparative experiments thus obtained emulsions were performed on the stability of the emulsion relative to the composition. Each composition is shown in the table.
The results were determined experimentally and compared by measuring the change in the average particle diameter of the emulsion.
The particle diameter of each sample of the emulsion was measured using an electron microscope immediately after preparation, after heat sterilization at 115 ° C for 12 minutes and after storage for 1 and 6 months at 4 ° C. An electronic microscope of model IEM-T S7 was used. Nippon Denshi Corporation. The average particle diameter was determined by measuring the particle size from a photograph taken using the carbon replica method.
The results are shown
3 table.
Based on the data in the table, it can be said that the use of an emulsifying system containing fatty acid and cholesterol, upon receipt
a fat emulsion gives an excellent effect for producing an emulsion having uniform and fine-grained particles, and for the stability of the emulsion under long-term storage conditions.

权利要求:
Claims (1)
[1]
Invention Formula
A method of producing an emulsion of fats for intravenous injection by dissolving soybean oil and phospholgatide yolk by heating, followed by emulsifying the resulting solution with water and glycerin, producing a coarse emulsion and homogenizing it to a certain dispersion, characterized in that particles with
with a diameter of 0.1-1.0 µm, cholesterol and sodium oleate are added to the coarse emulsion, and the components of the emulsion are used in the following ratio, in wt.%:
Soybean oil 5-20
Phospholipid
Yolka0.8-4.0
Cleaned-Wheel-Glice- 0.13 ± 0.03 0.19 ± 0.05
imiterinerin
Yolk - 0.045.0
nyt
20
phospho-Oleate Glyce - 0.09 ± 0.02 0.2 ± 0.03 0.13 ± 0.04 0.24
lipid nat-rin
pu 5.0
0.05
2.4Holes-Glice- 0.081: 0.03 0.10 ± 0.02 0.11 ±, 02 0.3
terin rin 0.04 5.0
Sodium oleate 0.05
Note. Experiments I and 2 are comparative experiments with experiment 3, which is the proposed composition.
Compiled by L. Shilina Editor N. Kishtulinets Tekhred; L. Serdyukova Corrector M. Demchik
Order 1904/57 Circulation 596 Subscription
VNIIPI USSR State Committee
for inventions and discoveries 113035, Moscow, Zh-35, Raushsk nab., 4/5
Production and printing company, Uzhgorod, st. Project, 4
Sodium Oleate Cholesterol Glycerin Water
0.01-0.30 0.005-0.300
3.0-4.0 Else
emulsification is carried out at 65-75 ° C for 20-60 minutes, and homogenization is carried out at 40-75 ° C and a pressure of 100-700 kg / cm.
0.20 ± 0.03- 0.24

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同族专利:

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公开号 | 公开日

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IT1146936B|1986-11-19|

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FR2455888A1|1980-12-05|

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DE2938807A1|1980-11-13|

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NL189899C|1993-09-01|

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GB2050799B|1983-07-20|

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BE885844A|1981-02-16|

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FR2455888B1|1983-07-29|

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AU5780980A|1980-11-13|

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HK66685A|1985-09-13|

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DE2938807C2|1982-07-01|

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JPS55147228A|1980-11-17|

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US4280996A|1981-07-28|

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FI70137B|1986-02-28|

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CH643735A5|1984-06-29|

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IT8048587D0|1980-05-05|

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AU518087B2|1981-09-10|

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FI801336A|1980-11-08|

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GB2050799A|1981-01-14|

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CA1142089A|1983-03-01|

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FI70137C|1990-12-28|

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JPS6030652B2|1985-07-17|

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NL8005797A|1982-05-17|

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NL189899B|1993-04-01|

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法律状态:

优先权:

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申请号 | 申请日 | 专利标题

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JP54055476A|JPS6030652B2|1979-05-07|1979-05-07|

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