CN102048690A - Dimeticone emulsion and preparation method thereof - Google Patents

Dimeticone emulsion and preparation method thereof Download PDF

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Publication number
CN102048690A
CN102048690A CN 201110008000 CN201110008000A CN102048690A CN 102048690 A CN102048690 A CN 102048690A CN 201110008000 CN201110008000 CN 201110008000 CN 201110008000 A CN201110008000 A CN 201110008000A CN 102048690 A CN102048690 A CN 102048690A
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simethicone
emulsion
water
standby
behind
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刘萍
王国华
杨勇
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Sichuan Jewelland Pharmaceutical Co Ltd
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Sichuan Jewelland Pharmaceutical Co Ltd
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Abstract

The invention discloses a dimeticone emulsion. Every 1000ml of dimeticone emulsion is prepared from 20g of dimeticone, 0.3-0.5g of silicon dioxide, 5-8g of polysorbate, 5-10g of Span, 5-10g of sodium carboxymethyl cellulose, 0.05-0.15g of 2,6-di-tert-butyl-para-cresol, 0.05-0.1g of saccharin sodium, 0.5-2g of ethylparaben, 10-20ml of ethanol, 0.1-0.3g of fresh milk essence and the balance of water. The dimeticone emulsion has the advantages of high stability and favorable defoaming capability. The invention also discloses a preparation method for the dimeticone emulsion. The preparation method disclosed by the invention has the advantages of simple technique and low energy consumption, and lowers the production cost; and the prepared dimeticone emulsion has favorable uniformity.

Description

A kind of simethicone Emulsion and preparation method thereof
Technical field
The invention belongs to field of pharmaceutical preparations, relating to a kind of elimination gastric has bubble property mucus, drives away the medicine of enteral gas, is specifically related to a kind of simethicone Emulsion and preparation method thereof.
Background technology
Simethicone is a dimethylsiloxane polymer, is medical science defoamer commonly used clinically, because its surface tension is little, can change bubble surface tension force, and it is broken, thereby eliminates foam.
Existing simethicone often is prepared into solid orally ingestible, and inconvenient infant uses, and in addition, simethicone is an oily mater, and it is bad to be prepared into the solid dosage forms dispersion, is not easy to the discharge of gastrointestinal tract micro-bubble, the alleviation of restriction flatulence.
Japan Patent JP57206611A discloses a kind of simethicone Emulsion and preparation method thereof, disclosed prescription contains: polyoxyethylene sorbitan monoleate, sorbitan monooleate (sorbester p17), 2,6-ditertbutylparacresol (BHT), sodium carboxymethyl cellulose, ethanol etc., the emulsifying process that process using is common.
The applicant in the process of research simethicone Emulsion, the unexpected discovery, by the screening to the ratio and the preparation technology of simethicone and silicon dioxide, the froth breaking ability of simethicone Emulsion increases significantly.
Summary of the invention
The invention provides a kind of simethicone Emulsion, in every 1000ml Emulsion, be grouped into by following one-tenth: simethicone 20g, silicon dioxide 0.3~0.5g, Polysorbate 5~8g, span 5~10g, sodium carboxymethyl cellulose 5~10g, 2,6 ditertiary butyl p cresol 0.05~0.15g, saccharin sodium 0.05~0.1g, ethyl hydroxybenzoate 0.5~2g, ethanol 10~20ml, fresh milk essence 0.1~0.3g, surplus are water.
The good stability of this simethicone Emulsion, the froth breaking ability reaches more than 96%.
The present invention further provides a kind of preparation method of simethicone Emulsion, may further comprise the steps:
(1) behind simethicone and the silicon dioxide mixing, constant temperature was placed 4~6 hours in 170 ℃ of baking ovens, took out postcooling to room temperature, and it is standby to get the simethicone silica composite;
(2) sodium carboxymethyl cellulose is scattered in the suitable quantity of water, makes into behind the homogeneous solution standby;
(3) the dissolve with ethanol 2,6 ditertiary butyl p cresol makes into behind the uniform alcoholic solution standby;
(4) Polysorbate makes into blended emulsifier with the span mix homogeneously, and is standby;
(5) saccharin sodium and fresh milk essence, ethyl hydroxybenzoate make into behind the uniform solution standby with the suitable quantity of water dissolving;
(6) the simethicone silica composite mixes at 75~80 ℃ with blended emulsifier, adds in an amount of 75~80 ℃ of water, and homogenizing 3~5min in homogenizer stirs cooling then;
(7) step 6 adds the sodium carboxymethyl cellulose dispersion soln when temperature is reduced to 40~50 ℃, the 2,6 ditertiary butyl p cresol alcoholic solution, and saccharin sodium and fresh milk essence, ethyl hydroxybenzoate solution add water at last and are settled to 1000ml, stir to be cooled to room temperature.
This technology is simple, and energy consumption is low, has reduced production cost, the simethicone Emulsion good uniformity of preparing, particle diameter more than 90% between 1~5 micron.
The specific embodiment
The present invention is further illustrated below in conjunction with specific embodiment, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.Adjuvant in following examples can be replaced with pharmaceutically acceptable similar adjuvant, perhaps reduces, increases.
Embodiment 1
1, prescription:
Figure 483441DEST_PATH_IMAGE001
2, processing step:
(1) behind simethicone and the silicon dioxide mixing, constant temperature was placed 4 hours in 170 ℃ of baking ovens, took out postcooling to room temperature, and it is standby to get the simethicone silica composite;
(2) sodium carboxymethyl cellulose is scattered in the 500ml water, makes into behind the homogeneous solution standby;
(3) the dissolve with ethanol 2,6 ditertiary butyl p cresol makes into behind the uniform alcoholic solution standby;
(4) Polysorbate makes into blended emulsifier with the span mix homogeneously, and is standby;
(5) saccharin sodium and fresh milk essence, ethyl hydroxybenzoate make into behind the uniform solution standby with the 100ml water dissolution;
(6) the simethicone silica composite mixes at 75 ℃ with blended emulsifier, add in 75 ℃ of water of 200ml, and homogenizing 3min in homogenizer, homogenizing rotating speed 10000r/min stirs then, cooling, speed of agitator 20r/min;
(7) step 6 adds the sodium carboxymethyl cellulose dispersion soln when temperature is reduced to 40 ℃, the 2,6 ditertiary butyl p cresol alcoholic solution, and saccharin sodium and fresh milk essence, ethyl hydroxybenzoate solution add water at last and are settled to 1000ml, stir to be cooled to room temperature.
Microscopic examination, Emulsion particle diameter more than 90% between 1~3 micron.
Embodiment 2
1, prescription:
Figure 213630DEST_PATH_IMAGE002
2, processing step:
(1) behind simethicone and the silicon dioxide mixing, constant temperature was placed 6 hours in 170 ℃ of baking ovens, took out postcooling to room temperature, and it is standby to get the simethicone silica composite;
(2) sodium carboxymethyl cellulose is scattered in the 600ml water, makes into behind the homogeneous solution standby;
(3) the dissolve with ethanol 2,6 ditertiary butyl p cresol makes into behind the uniform alcoholic solution standby;
(4) Polysorbate makes into blended emulsifier with the span mix homogeneously, and is standby;
(5) saccharin sodium and fresh milk essence, ethyl hydroxybenzoate make into behind the uniform solution standby with the 100ml water dissolution;
(6) the simethicone silica composite mixes at 80 ℃ with blended emulsifier, add in 80 ℃ of water of 150ml, and homogenizing 5min in homogenizer, homogenizing rotating speed 7000r/min stirs then, cooling, speed of agitator 30r/min;
(7) step 6 adds the sodium carboxymethyl cellulose dispersion soln when temperature is reduced to 50 ℃, the 2,6 ditertiary butyl p cresol alcoholic solution, and saccharin sodium and fresh milk essence, ethyl hydroxybenzoate solution add water at last and are settled to 1000ml, stir to be cooled to room temperature.
Microscopic examination, Emulsion particle diameter more than 90% between 3~5 microns.
Influence factor's test
Figure 868734DEST_PATH_IMAGE003
Accelerated test
?
Figure 263943DEST_PATH_IMAGE004
Simethicone Emulsion---froth breaking ability determination test
Material: logical X-100(Triton X-100 in the spy)
Specimen:
Sample 1: embodiment 1;
Sample 2: embodiment 2;
Sample 3: implement 1 prescription and prepared with reference to Japan Patent JP57206611A;
Sample 4: implement 2 prescription and prepared with reference to Japan Patent JP57206611A;
Sample 5: commercially available product simethicone Emulsion (specification: 20mg/ml);
Sample 6: commercially available product Simethicone emulsion (specification: 40mg/ml);
Method: get and lead to seven parts of X-100 aqueous solution 50ml in 1% spy, carefully inject the 500ml graduated cylinder of seven cleanings, add simethicone Emulsion 2ml respectively in 5 graduated cylinders forward, add Simethicone emulsion 1ml in the 6th graduated cylinder, the 7th graduated cylinder do not add.Seal seven graduated cylinder ports, place the strong jolting of shaking screen 2 minutes simultaneously, take out, write down the foam height of each graduated cylinder.Foam height with the 7th graduated cylinder of n.s is 100%, reduces foam volume percentage calculation froth breaking ability with each sample.Triplicate is averaged.
The result: the average froth breaking ability of six duplicate samples sees the following form:
Figure 140632DEST_PATH_IMAGE005
The data show embodiment of the invention 1 and embodiment 2 sample froth breaking abilities are compared sample 3~sample 6 and are significantly increased.

Claims (2)

1. simethicone Emulsion, it is characterized in that: in every 1000ml Emulsion, be grouped into by following one-tenth: simethicone 20g, silicon dioxide 0.3~0.5g, Polysorbate 5~8g, span 5~10g, sodium carboxymethyl cellulose 5~10g, 2,6 ditertiary butyl p cresol 0.05~0.15g, saccharin sodium 0.05~0.1g, ethyl hydroxybenzoate 0.5~2g, ethanol 10~20ml, fresh milk essence 0.1~0.3g, surplus are water.
2. the preparation method of the described simethicone Emulsion of claim 1 may further comprise the steps:
(1) behind simethicone and the silicon dioxide mixing, constant temperature was placed 4~6 hours in 170 ℃ of baking ovens, took out postcooling to room temperature, and it is standby to get the simethicone silica composite;
(2) sodium carboxymethyl cellulose is scattered in the suitable quantity of water, makes into behind the homogeneous solution standby;
(3) the dissolve with ethanol 2,6 ditertiary butyl p cresol makes into behind the uniform alcoholic solution standby;
(4) Polysorbate makes into blended emulsifier with the span mix homogeneously, and is standby;
(5) saccharin sodium and fresh milk essence, ethyl hydroxybenzoate make into behind the uniform solution standby with the suitable quantity of water dissolving;
(6) the simethicone silica composite mixes at 75~80 ℃ with blended emulsifier, adds in an amount of 75~80 ℃ of water, and homogenizing 3~5min in homogenizer stirs cooling then;
(7) step 6 adds the sodium carboxymethyl cellulose dispersion soln when temperature is reduced to 40~50 ℃, the 2,6 ditertiary butyl p cresol alcoholic solution, and saccharin sodium and fresh milk essence, ethyl hydroxybenzoate solution add water at last and are settled to 1000ml, stir to be cooled to room temperature.
CN 201110008000 2011-01-14 2011-01-14 Dimeticone emulsion and preparation method thereof Pending CN102048690A (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112791453A (en) * 2020-11-30 2021-05-14 宁夏顺邦达新材料有限公司 Preparation process of defoaming agent
CN113730352A (en) * 2021-08-25 2021-12-03 南京海纳医药科技股份有限公司 Dimethicone emulsion and preparation method thereof
CN114099434A (en) * 2021-11-19 2022-03-01 海南鑫开源医药科技有限公司 Preparation process of dimeticone emulsion
CN114949940A (en) * 2022-08-01 2022-08-30 东营江源化工有限公司 Defoaming agent for oil field and preparation method thereof

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS57206611A (en) * 1981-06-15 1982-12-18 Kissei Pharmaceut Co Ltd Production of stabilized dimethylpolysiloxane solution for internal use
CN1438040A (en) * 2003-02-26 2003-08-27 杨冬生 Gastroscope gel
CN1457684A (en) * 2003-05-20 2003-11-26 李仕清 Powdery bean product defoaming agent with calcium carbonate as filler
CN101053802A (en) * 2007-02-28 2007-10-17 王旭东 Water soluble compound organosilicon emulsion highly effective defoaming agent and its synthetic method
CN101357309A (en) * 2008-09-26 2009-02-04 贺明波 Silicon oil foam killer
CN101596181A (en) * 2009-07-03 2009-12-09 重庆健能医药开发有限公司 A kind of pharmaceutical composition that contains dimeticone/simethicone
CN101804199A (en) * 2010-03-30 2010-08-18 四川健能制药有限公司 Pharmaceutical composition used for alimentary canals and application thereof

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS57206611A (en) * 1981-06-15 1982-12-18 Kissei Pharmaceut Co Ltd Production of stabilized dimethylpolysiloxane solution for internal use
CN1438040A (en) * 2003-02-26 2003-08-27 杨冬生 Gastroscope gel
CN1457684A (en) * 2003-05-20 2003-11-26 李仕清 Powdery bean product defoaming agent with calcium carbonate as filler
CN101053802A (en) * 2007-02-28 2007-10-17 王旭东 Water soluble compound organosilicon emulsion highly effective defoaming agent and its synthetic method
CN101357309A (en) * 2008-09-26 2009-02-04 贺明波 Silicon oil foam killer
CN101596181A (en) * 2009-07-03 2009-12-09 重庆健能医药开发有限公司 A kind of pharmaceutical composition that contains dimeticone/simethicone
CN101804199A (en) * 2010-03-30 2010-08-18 四川健能制药有限公司 Pharmaceutical composition used for alimentary canals and application thereof

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112791453A (en) * 2020-11-30 2021-05-14 宁夏顺邦达新材料有限公司 Preparation process of defoaming agent
CN113730352A (en) * 2021-08-25 2021-12-03 南京海纳医药科技股份有限公司 Dimethicone emulsion and preparation method thereof
CN113730352B (en) * 2021-08-25 2022-11-11 南京海纳医药科技股份有限公司 Dimethicone emulsion and preparation method thereof
CN114099434A (en) * 2021-11-19 2022-03-01 海南鑫开源医药科技有限公司 Preparation process of dimeticone emulsion
CN114099434B (en) * 2021-11-19 2022-12-16 海南鑫开源医药科技有限公司 Preparation process of simethicone emulsion
CN114949940A (en) * 2022-08-01 2022-08-30 东营江源化工有限公司 Defoaming agent for oil field and preparation method thereof

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Application publication date: 20110511