CN114099434B - Preparation process of simethicone emulsion - Google Patents
Preparation process of simethicone emulsion Download PDFInfo
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- CN114099434B CN114099434B CN202111392356.0A CN202111392356A CN114099434B CN 114099434 B CN114099434 B CN 114099434B CN 202111392356 A CN202111392356 A CN 202111392356A CN 114099434 B CN114099434 B CN 114099434B
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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 provides a preparation process of a simethicone emulsion, which comprises the following steps: placing 20 parts by weight of simethicone bulk drug with the viscosity of 150-1000 cs and 0-1 part by weight of anti-sticking agent into an emulsifying machine, performing high-shear homogeneous mixing for 3-7 hours at the temperature of 130-150 ℃, adding water and 1-18 parts by weight of emulsifying agent when the temperature is reduced to 70-90 ℃, performing high-shear homogeneous mixing for 5-10 minutes, cooling to 40-60 ℃, adding aqueous solution prepared by 1-10 parts by weight of dispersing agent and aqueous solution containing 0.1-1 part by weight of antioxidant, 1-10 parts by weight of ethanol, 1-4 parts by weight of preservative and 0.1-1 part by weight of flavoring agent, and performing high-shear homogeneous mixing for 5-10 minutes to obtain the simethicone emulsion. The invention selects the dimeticone with a specific viscosity range, improves the stability of the emulsion, reduces the cost, and has stable quality of the final product, small difference between batches and strong operability.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a preparation process of a simethicone emulsion.
Background
The simethicone emulsion can change the surface tension of bubbles and break the bubbles due to the small surface tension, so that the simethicone emulsion is mainly used for eliminating the vesicular mucus in the stomach and the gas in the intestinal tract clinically.
The prior art reports the simethicone emulsion preparation technology. For example, JP57206611A discloses a simethicone emulsion and a method for producing the same, wherein the components comprise simethicone, an anti-sticking agent, an emulsifier, a dispersant, and a general emulsification process; the original grinding dimeticone emulsion specification shows that the dimeticone emulsion contains sodium carboxymethylcellulose, silicon dioxide, span 80, polysorbate 80, dibutyl hydroxy toluene, ethyl hydroxybenzoate, saccharin sodium, ethanol and essence. Compared with the original simethicone emulsion, the taste of the mental patients is influenced without the flavoring agent. Chinese application patent document CN102048690A discloses a stable dimeticone emulsion and a preparation method thereof, wherein the preparation method comprises the steps of heating dimeticone and silicon dioxide in an oven at 170 ℃, great potential safety hazards are brought to the production process, all auxiliary materials are transferred to a homogenizer, and the transfer process can cause samples to be polluted, so that the production cost is high.
Disclosure of Invention
The invention aims to provide a preparation process of a simethicone emulsion, which has the advantages of simple process, stable product quality and low cost.
The invention provides a preparation process of a simethicone emulsion, which comprises the following steps:
placing 20 parts by weight of simethicone raw material medicine and 0-1.5 parts by weight of anti-sticking agent into an emulsifying machine, carrying out high-shear homogeneous mixing for 3-7 hours at the temperature of 130-150 ℃, adding water and 1-20 parts by weight of emulsifying agent when the temperature is reduced to 70-90 ℃, carrying out high-shear homogeneous mixing for 5-10 minutes, then cooling to 40-60 ℃, adding an aqueous solution prepared by 1-10 parts by weight of dispersing agent and an aqueous solution containing 0.1-1 part by weight of antioxidant, 1-10 parts by weight of ethanol, 1-4 parts by weight of preservative and 0.1-1 part by weight of flavoring agent, and carrying out high-shear homogeneous mixing for 5-10 minutes to obtain a simethicone emulsion;
the viscosity of the simethicone raw material medicine is 150-1000 cs.
Preferably, the rotation speed of the high-shear homogeneous mixing is 6000 to 14000rpm.
Preferably, the antisticking agent is selected from one or more of talcum powder, magnesium stearate, silicon dioxide and colloidal silicon dioxide.
Preferably, the emulsifier is one or more of tween 20, tween 40, tween 60, tween 80, span 20 and span 80.
Preferably, the dispersing agent is one or more of sodium carboxymethylcellulose, ethanol and sodium acrylate.
Preferably, the antioxidant is one or more of dibutyl hydroxytoluene, propyl gallate and tert-butyl hydroquinone.
Preferably, the preservative is one or more of methyl p-hydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate and butyl p-hydroxybenzoate.
Preferably, the flavoring agent is one or more of saccharin sodium, essence and sucrose.
Preferably, the viscosity of the simethicone raw material medicine is 350-500 cs.
The invention provides a preparation process of a simethicone emulsion, which comprises the following steps: placing 20 parts by weight of simethicone raw material medicine and 0-1 part by weight of anti-sticking agent into an emulsifying machine, carrying out high-shear homogeneous mixing for 3-7 hours at the temperature of 130-150 ℃, adding water and 1-18 parts by weight of emulsifying agent when the temperature is reduced to 70-90 ℃, carrying out high-shear homogeneous mixing for 5-10 minutes, then cooling to 40-60 ℃, adding aqueous solution prepared by 1-10 parts by weight of dispersing agent and aqueous solution containing 0.1-1 part by weight of antioxidant, 1-10 parts by weight of ethanol, 1-4 parts by weight of preservative and 0.1-1 part by weight of flavoring agent, and carrying out high-shear homogeneous mixing for 5-10 minutes to obtain a simethicone emulsion; the viscosity of the simethicone raw material medicine is 150-1000 cs. The invention selects the simethicone raw material medicine in a specific viscosity range, is favorable for improving the stability of the emulsion, reduces the cost of equipment and operation, has simple production process, can prepare a sample in an emulsifying machine, does not need multiple processes to mutually transfer materials, reduces the cost and the labor intensity, saves time and energy, does not determine the quality of the product according to the experience of workers, ensures stable quality of the final product, has small batch-to-batch difference and strong operability, and ensures continuous production.
Detailed Description
The invention provides a preparation process of a simethicone emulsion, which comprises the following steps:
placing 20 parts by weight of simethicone raw material medicine and 0-1 part by weight of anti-sticking agent into an emulsifying machine, carrying out high-shear homogeneous mixing for 3-7 hours at the temperature of 130-150 ℃, adding water and 1-18 parts by weight of emulsifying agent when the temperature is reduced to 70-90 ℃, carrying out high-shear homogeneous mixing for 5-10 minutes, then cooling to 40-60 ℃, adding aqueous solution prepared by 1-10 parts by weight of dispersing agent and aqueous solution containing 0.1-1 part by weight of antioxidant, 1-10 parts by weight of ethanol, 1-4 parts by weight of preservative and 0.1-1 part by weight of flavoring agent, and carrying out high-shear homogeneous mixing for 5-10 minutes to obtain a simethicone emulsion;
the viscosity of the simethicone raw material medicine is 150-1000 cs.
In the invention, the viscosity of the simethicone raw material medicine is preferably 150-1000 cs, and more preferably 350-500 cs.
In the invention, the antisticking agent is selected from one or more of talcum powder, magnesium stearate, silicon dioxide and colloidal silicon dioxide; the weight portion of the anti-sticking agent is preferably 0 to 1.5 parts, more preferably 0.5 to 1.2 parts, such as 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part, 1.0 part, 1.1 part, 1.2 parts, 1.3 parts, 1.4 parts, 1.5 parts, and preferably a range value with any value as an upper limit or a lower limit.
In the invention, the emulsifier is one or more of tween 20, tween 40, tween 60, tween 80, span 20 and span 80, and more preferably is a mixture of tween 80 and span 80. The emulsifier is preferably 1 to 20 parts by weight, more preferably 5 to 20 parts by weight, such as 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, 11 parts, 12 parts, 13 parts, 14 parts, 15 parts, 16 parts, 17 parts, 18 parts, 19 parts, 20 parts by weight, and preferably any of the above numerical values is used as an upper limit or a lower limit.
In the invention, the dispersant is one or more of sodium carboxymethylcellulose, ethanol and sodium acrylate; the weight portion of the dispersant is preferably 1 to 10 portions, such as 1 portion, 2 portions, 3 portions, 4 portions, 5 portions, 6 portions, 7 portions, 8 portions, 9 portions and 10 portions, and the upper limit or the lower limit of any value is preferably selected.
In the invention, the antioxidant is one or more of dibutyl hydroxy toluene, propyl gallate and tert-butyl hydroquinone; the antioxidant is preferably 0.1-1 part by weight, such as 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part and 1 part by weight, and preferably any of the above values is used as an upper limit or a lower limit.
In the invention, the preservative is one or more of methyl p-hydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate and butyl p-hydroxybenzoate; the preservative is preferably used in an amount of 1 to 4 parts by weight, for example, 1 part, 2 parts, 3 parts or 4 parts by weight, and any of the above-mentioned values is preferably used as the upper limit or the lower limit.
In the present invention, the weight portion of ethanol is preferably 1 to 10 parts, such as 1 part, 2 parts, 3 parts, 4 parts, 5 parts, 6 parts, 7 parts, 8 parts, 9 parts, 10 parts, and preferably any of the above values is a range with an upper limit or a lower limit.
The flavoring agent is preferably one or more of saccharin sodium, essence and sucrose, the weight portion of the flavoring agent is preferably 0.1-1 part, such as 0.1 part, 0.2 part, 0.3 part, 0.4 part, 0.5 part, 0.6 part, 0.7 part, 0.8 part, 0.9 part and 1 part, and the upper limit or the lower limit of any numerical value is preferably selected.
Firstly, mixing two emulsifiers to prepare a mixed emulsifier for later use, and mixing a dispersant and a proper amount of water to prepare an aqueous solution of the dispersant for later use; mixing antioxidant and ethanol, and mixing with antiseptic, flavoring agent and water.
Firstly, putting the raw material medicines and an anti-sticking agent into an emulsifying machine, controlling the temperature to be 130-150 ℃, and carrying out high-shear homogeneous mixing for 3-7 h;
the temperature of the mixing may be 130 ℃, 135 ℃, 140 ℃, 145 ℃, 150 ℃; the time for high shear intimate mixing is preferably 4 to 6 hours, such as 3 hours, 4 hours, 5 hours, 6 hours or 7 hours.
After the temperature of the mixed materials is reduced to 70-90 ℃, adding the mixed standby emulsifier materials into the mixed standby emulsifier materials, adding a proper amount of water into the mixed standby emulsifier materials, homogenizing and mixing the materials for 5-10 min under high shear,
preferably, the temperature is reduced to 75-85 deg.C, such as 70 deg.C, 75 deg.C, 80 deg.C, 85 deg.C, 90 deg.C; the mixing time is preferably 5-10 min, such as 5min, 6min, 7min, 8min, 9min, 10min.
Then cooling to 40-60 ℃, adding the residual mixed materials such as dispersant, antioxidant and the like, metering the volume to 1000ml, carrying out high-shear homogeneous mixing for 5-10 min, and cooling to room temperature to obtain the simethicone emulsion.
Preferably, cooling to 40-60 deg.C, such as 40 deg.C, 45 deg.C, 50 deg.C, 55 deg.C, 60 deg.C, mixing time is preferably 5-10 min, such as 5min, 6min, 7min, 8min, 9min, 10min.
The invention provides a preparation process of a simethicone emulsion, which comprises the following steps: placing 20 parts by weight of simethicone raw material medicine and 0-1 part by weight of anti-sticking agent into an emulsifying machine, carrying out high-shear homogeneous mixing for 3-7 hours at the temperature of 130-150 ℃, adding water and 1-20 parts by weight of emulsifying agent when the temperature is reduced to 70-90 ℃, carrying out high-shear homogeneous mixing for 5-10 minutes, then cooling to 40-60 ℃, adding aqueous solution prepared by 1-10 parts by weight of dispersing agent and aqueous solution containing 0.1-1 part by weight of antioxidant, 1-10 parts by weight of ethanol, 1-4 parts by weight of preservative and 0.1-1 part by weight of flavoring agent, and carrying out high-shear homogeneous mixing for 5-10 minutes to obtain a simethicone emulsion; the viscosity of the simethicone raw material medicine is 100-1000 cs. The invention selects the simethicone raw material medicine within a specific viscosity range, is beneficial to improving the stability of the emulsion, reduces the cost of equipment and operation, has simple production process, can prepare a sample in an emulsifying machine, does not need multiple procedures to mutually transfer materials, reduces the cost and labor intensity, saves time and energy, does not determine the quality of a product according to the experience of workers, ensures stable quality of a final product, has small batch-to-batch difference and strong operability, and ensures continuous production.
In order to further illustrate the present invention, the following examples are provided to describe the preparation process of a simethicone emulsion in detail, but should not be construed as limiting the scope of the present invention.
Examples 1 to 5:
is composed of simethicone and pharmaceutic adjuvant, wherein the pharmaceutic adjuvant comprises an anti-sticking agent, an emulsifying agent, a dispersing agent, an antioxidant, a preservative, a flavoring agent and water; the detailed formula composition is shown in table 1;
the viscosity of the raw material medicine is as follows: the viscosity of the dimeticone is less than or equal to 1000cs;
mixing 1, placing the raw material medicines and the anti-sticking agent in an emulsifying machine, controlling the temperature to be 130-150 ℃, and carrying out high-shear homogeneous mixing for 3-7 h;
and (3) mixing: mixing the two emulsifiers uniformly to prepare a mixed emulsifier;
and (3) mixing: mixing the dispersing agent with a proper amount of water, and uniformly dissolving for later use;
and (4) mixing: mixing the antioxidant and ethanol, mixing with antiseptic, flavoring agent and water, and mixing the solution uniformly for later use;
after the temperature of the material mixed 1 is reduced to 70-90 ℃, adding the material mixed 2 and adding a proper amount of water, carrying out high-shear homogeneous mixing for 5-10 min, then cooling to 40-60 ℃, adding the material mixed 3 and the material mixed 4, fixing the volume to 1000ml, carrying out high-shear homogeneous mixing for 5-10 min, and cooling to room temperature.
TABLE 1 amounts of raw materials for examples 1 to 5
Dimethicone emulsion-defoaming capability test
Material Triton X-100
Samples 1 to 5 are examples 1 to 5, and sample 6 is a commercially available silicone oil (trade name GASCON; manufacturer: 124618312475.
The method comprises the following steps: taking seven 50ml portions of 1 percent Triton X-100 aqueous solution, carefully injecting into seven clean 500ml measuring cylinders, respectively adding 2ml of dimeticone emulsion into the front 6 measuring cylinders, not adding the 7 th sample, sealing the outlet of the 7 measuring cylinders by using a sealing film, simultaneously placing in a vibrating screen for 2min, taking out to record the foam height of each measuring cylinder, setting the foam height of the 7 th measuring cylinder as 100 percent, and calculating the defoaming capability according to the foam reduction percentage of each measuring cylinder; samples 1 to 6 were each repeated 6 times and the average was calculated.
The results are shown in Table 2
TABLE 2 defoaming Capacity
| Sample number | Sample No. 1 | Sample 2 | Sample 3 | Sample 4 | Sample No. 5 | Sample No. 6 |
| Defoaming capability | 85％ | 88％ | 92％ | 98％ | 85％ | 90％ |
Table 2 data results show that: the defoaming capability of the samples in the embodiment 3 and the embodiment 4 of the invention is obviously improved compared with that of the commercial raw product dimeticone.
The defoaming capability of the sample in the example 4 is better, so that the sample in the example 4 is selected for lofting in the influence factor test, and the result is shown in table 3;
TABLE 3 Effect of dimethicone emulsion experiment in example 4
The sample in the embodiment 4 is placed under the condition of influencing factors, the detection of the physical and chemical properties of the sample meets the requirements, and the performance is stable.
Example 4 Long-term testing of samples, the results are shown in Table 4
TABLE 4 Long term experiments on Dimethicone emulsions in example 4
Example 4 the sample is placed under long-term experimental conditions, the detection of the physical and chemical properties of the sample meets the requirements, and the performance is stable.
Example 4 sample accelerated testing, results are shown in Table 5
Table 4 accelerated test of simethicone emulsion in example 4
The sample in the embodiment 4 is placed under the acceleration condition, the physical and chemical property detection of the sample meets the requirement, and the performance is stable.
Example 6:
table 5 raw material amounts of example 6
| Name of ingredient | Example 4 |
| Dimethicone | 20.00mg |
| Silicon dioxide | 1.2mg |
| Polysorbate 80 | 10mg |
| Span 80 | 10mg |
| Sodium carboxymethylcellulose | 8mg |
| Ethanol | 10mg |
| Dibutylhydroxytoluene | 0.1mg |
| Hydroxyphenyl Ethyl ester | 1mg |
| Saccharin sodium salt | 0.4mg |
| Vanilla essence | 0.3mg |
| Water (I) | 943mg |
| Remarks for note | The viscosity of the dimeticone is 332.5-367.5 cs |
(1) Evenly mixing the dimeticone and the silicon dioxide, placing the mixture in an oven at the temperature of 170 ℃ for 4 hours, taking out the mixture, cooling the mixture to room temperature,
obtaining a dimeticone silicon dioxide compound for later use;
(2) Dispersing sodium carboxymethylcellulose in 500ml of water to obtain a uniform solution for later use;
(3) Dissolving 2, 6-di-tert-butyl-p-cresol in ethanol to obtain a uniform ethanol solution for later use;
(4) Mixing polysorbate and span uniformly to obtain mixed emulsifier for use;
(5) Dissolving saccharin sodium, fresh milk essence and ethylparaben with 100ml water to obtain uniform solution;
(6) Mixing the dimeticone silicon dioxide compound and the mixed emulsifier at 75 ℃, adding 200ml of 75 ℃ water, homogenizing in a homogenizer for 3min at the homogenizing rotation speed of 10000r/min, then stirring, cooling, and stirring at the stirring rotation speed of 20r/min;
(7) Step 6, adding the sodium carboxymethylcellulose dispersion solution when the temperature is reduced to 40 ℃,
2, 6-di-tert-butyl-p-cresol ethanol solution, saccharin sodium, fresh milk essence and ethylparaben solution, and finally adding water to reach the constant volume of 1000ml, stirring and cooling to room temperature.
The demulsification studies were conducted on the products of examples 1-6 and the results were as follows:
in the embodiments 1-5, the sample is directly activated by the equipment, so that the simethicone and the silicon dioxide can be uniformly mixed in the whole activation process, the sample activated by the method is very stable, and no precipitate is generated in the embodiments 1-5 in the demulsification research process; example 6 the sample prepared by heating dimethicone and silica at 170 c prior to emulsification in the emulsifier itself showed precipitation in the demulsification study.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (9)
1. A preparation process of a simethicone emulsion comprises the following steps:
placing 20 parts by weight of simethicone raw material medicine and 0-1.5 parts by weight of anti-sticking agent into an emulsifying machine, carrying out high-shear homogeneous mixing for 3-7 hours at the temperature of 130-150 ℃, adding water and 1-20 parts by weight of emulsifying agent when the temperature is reduced to 70-90 ℃, carrying out high-shear homogeneous mixing for 5-10 minutes, then cooling to 40-60 ℃, adding an aqueous solution prepared by 1-10 parts by weight of dispersing agent and an aqueous solution containing 0.1-1 part by weight of antioxidant, 1-10 parts by weight of ethanol, 1-4 parts by weight of preservative and 0.1-1 part by weight of flavoring agent, and carrying out high-shear homogeneous mixing for 5-10 minutes to obtain a simethicone emulsion;
the viscosity of the simethicone raw material medicine is 150-1000 cs.
2. The process according to claim 1, wherein the high-shear homogeneous mixing is performed at 6000 to 14000rpm.
3. The preparation process according to claim 1, wherein the antisticking agent is selected from one or more of talc, magnesium stearate, silica and colloidal silica.
4. The preparation process according to claim 1, wherein the emulsifier is one or more of tween 20, tween 40, tween 60, tween 80, span 20 and span 80.
5. The preparation process according to claim 1, wherein the dispersant is one or more of sodium carboxymethylcellulose, ethanol and sodium acrylate.
6. The preparation process according to claim 1, wherein the antioxidant is one or more of dibutyl hydroxytoluene, propyl gallate and tert-butyl hydroquinone.
7. The preparation process of claim 1, wherein the preservative is one or more of methylparaben, ethylparaben, propylparaben and butylparaben.
8. The preparation process of claim 1, wherein the flavoring agent is one or more of saccharin sodium, essence, and sucrose.
9. The preparation process according to claim 1, wherein the dimethicone raw material drug has a viscosity of 350-500 cs.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5275822A (en) * | 1989-10-19 | 1994-01-04 | Valentine Enterprises, Inc. | Defoaming composition |
| 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 |
| CN102048690A (en) * | 2011-01-14 | 2011-05-11 | 四川健能制药有限公司 | Dimeticone emulsion and preparation method thereof |
-
2021
- 2021-11-19 CN CN202111392356.0A patent/CN114099434B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5275822A (en) * | 1989-10-19 | 1994-01-04 | Valentine Enterprises, Inc. | Defoaming composition |
| 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 |
| CN102048690A (en) * | 2011-01-14 | 2011-05-11 | 四川健能制药有限公司 | Dimeticone emulsion and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| Novel anhydrous emulsions: Formulation as controlled release vehicles;Orawan Suitthimeathegorn等;《International Journal of Pharmaceutics》;20050725;第298卷(第2期);文章摘要 * |
| 西甲硅油乳剂;杨莉等;《中国新药杂志》;20071231;第16卷(第8期);第651页左栏第1段至右栏第3段 * |
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Denomination of invention: Preparation process of a dimethyl silicone oil emulsion Effective date of registration: 20230410 Granted publication date: 20221216 Pledgee: Bohai Bank Co.,Ltd. Haikou Branch Pledgor: Hainan xinkaiyuan Pharmaceutical Technology Co.,Ltd. Registration number: Y2023980037652 |