CN101229450A - Method of drying soft capsule - Google Patents
Method of drying soft capsule Download PDFInfo
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- CN101229450A CN101229450A CNA2007101345733A CN200710134573A CN101229450A CN 101229450 A CN101229450 A CN 101229450A CN A2007101345733 A CNA2007101345733 A CN A2007101345733A CN 200710134573 A CN200710134573 A CN 200710134573A CN 101229450 A CN101229450 A CN 101229450A
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- soft capsule
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- rubber
- polyethylene glycol
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Abstract
The invention relates to a method for drying soft capsules, in particular to a method for drying soft capsules by using a solvent as a dehydrating agent. The invention is characterized in that the soft capsules are directly immerged in the dehydrating agent and taken out after soaking. The dehydrating agent is a mixture composed of a compound of acetone, glycerin, propylene glycol, absolute ethyl alcohol and polyethylene glycol and one or some of the compound by any proportion. The method of the invention adopts the dehydrating agent to dry the soft capsules has the advantages of good drying effect, low energy consumption and stable products.
Description
Technical field:
The present invention relates to a kind of method of drying soft capsule, being specifically related to a kind of is the method that dehydrating agent comes drying soft capsule with the solvent.
Background technology:
The basic side's of the rubber preparation of soft capsule constituent is gelatin, G ﹠ W, and wherein the content of water mostly is 30%-40%; Existing soft capsule drying process is the soft capsule moulding after roll the cage drying, and it is dry more than 48 hours to send into drying room again; The moisture of its soft capsule finished product rubber and content is all higher, phenomenons such as disintegration delay, capsule and pill distortion, content infiltration often occur.
Summary of the invention:
The objective of the invention is to overcome the deficiency of existing soft capsule drying process, provide a kind of and use, can obtain the drying means of the soft capsule product of stabilizing quality for soft capsule production.
The present invention implements by following steps:
The method of this dehydrating agent drying soft capsule is soaked for soft capsule directly being immersed dehydrating agent, and soft capsule is immersed in the dehydrating agent fully, takes out, and washes ball, drying, packing.
Above-mentioned soft capsule forms for suppressing or dripping to make, and adopts component of the same race or different component dehydrating agent to soak 1～5 time, and the accumulative total soak time is 0.5～120 hour.
Dehydrating agent is a kind of or several mixtures formed with the arbitrary proportion mixing in acetone, glycerine, propane diols, absolute ethyl alcohol and the polyethylene glycol compounds.
The polyethylene glycol compounds is the series of products of Macrogol 200～polyethylene glycol 1500 such as a kind of or several mixtures formed with the arbitrary proportion mixing in Macrogol 200, Liquid Macrogol, PEG400, Macrogol 600, polyethylene glycol 800, cetomacrogol 1000 and the polyethylene glycol 1500.
In addition, the content of soft capsule is the preparation that Chinese medicine and auxiliary material or medicinal chemicals and auxiliary material are made into; The softgel shell of soft capsule is become to be grouped into by gelatin, plasticizer and water etc.
Beneficial effect of the present invention: have compared with prior art that drying effect is good, energy consumption is low, the characteristics that product is stable.
Below be that two kinds of drying means product stabilities are investigated the result:
1. by required rubber and the content of prescription preparation motherwort soft capsule, compacting soft capsule.This soft capsule is embodiment 1 indication with a collection of soft capsule.Part soft capsule advances 18 ℃ of dryings of drying room by traditional drying means and transferred to 28 ℃ of dryings after 30 hours again 18 hours, gets product A; A part adopts method of the present invention to use solvent seasoning, gets product B; Product A and product B are carried out study on the stability, the results are shown in Table 1.
Two kinds of drying means product stability contrasts of table 1
| Product A | Product B | |
| 30 ℃, RH75% placed 0 day | Rubber moisture 8.0%, content moisture 10.4%. | Rubber moisture 4.8%, content moisture 7.2%; Form is good. |
| 30 ℃, RH75% placed 6 months | Rubber moisture 7.6%, content moisture 10.2%; Capsule and pill distortion, adhesion. | Rubber moisture 5.0%, content moisture 7.1%; Form is good. |
2. by required rubber and the content of prescription preparation Isosorbide Mononitrate capsule, compacting soft capsule.This soft capsule is embodiment 2 indications with a collection of soft capsule.Part soft capsule advances 18 ℃ of dryings of drying room by traditional drying means and transferred to 28 ℃ of dryings after 30 hours again 18 hours, gets products C; A part adopts method of the present invention to use solvent seasoning, gets product D; Products C and product D are carried out study on the stability, the results are shown in Table 2.
Two kinds of drying means product stability contrasts of table 2
| Products C | Product D | |
| 30 ℃, RH75% placed 0 day | Rubber moisture 8.4%, content moisture 11.2%. | Rubber moisture 5.4%, content moisture 9.1%; Form is good. |
| 30 ℃, RH75% placed 6 months | Rubber moisture 8.1%, content moisture 11.3%; The material migration " is sweated " the capsule and pill surface in the content. | Rubber moisture 5.2%, content moisture 8.9%; Form is good. |
The specific embodiment
Embodiment 1:
Get the Herba Leonuri extractum powder and add polyethylene glycol 400 auxiliary materials such as grade, be made into soup, the soft capsule that is pressed into directly immerses PEG400 solution and soaked 12 hours; Take out, wash ball,, placed 2 hours under humidity 35% condition, survey the moisture of rubber and content 28 ℃ of temperature.
Acetone method is adopted in the rubber determination of moisture, is specially: get rubber 0.5g, the accurate title, decide, and puts in the dry tool plug test tube, and precision adds acetone 10ml, soaked 3 hours, measures by the Xiu Shi aquametry that takes of version pharmacopeia in 2005; Blank sample 10ml acetone moisture is measured in retinue, and the moisture of deduction blank sample gets water content in the rubber.
The determination of moisture of content adopts the Xiu Shi aquametry that takes of version pharmacopeia in 2005 to survey water content in the content.
Embodiment 2:
Get the Isosorbide Mononitrate raw material and add polyethylene glycol 400 auxiliary materials such as grade, the soft capsule that is pressed into directly immerses PEG400: glycerine (2: 1) solution, stir constantly, soaked 12 hours, and took out, wash ball, 28 ℃ of temperature, placed 1 hour under humidity 35% condition, survey the moisture of rubber and content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, water content in the content.
Embodiment 3:
Get the Herba Leonuri extractum powder and add polyethylene glycol 400 auxiliary materials such as grade, be made into soup, the soft capsule that is pressed into directly immerses in the acetone soln, soaks 2 hours; Take out, wash ball,, placed 2 hours under humidity 39% condition, survey the moisture of rubber and content 28 ℃ of temperature.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 6.6% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 9.3%.
Embodiment 4:
Get the Herba Leonuri extractum powder and add polyethylene glycol 400 auxiliary materials such as grade, be made into soup, the soft capsule that is pressed into directly immerses PEG400: propane diols (3: 1) solution, soaked 8 hours, stir constantly, take out, immerse again in the PEG400 and soaked 96 hours, take out, wash ball, 25 ℃ of temperature, placed 1 hour under humidity 37% condition, survey the moisture of rubber and content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 4.3% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 5.6%.
Embodiment 5:
Get the Herba Leonuri extractum powder and add polyethylene glycol 400 auxiliary materials such as grade, be made into soup, the soft capsule that is pressed into directly immerses Macrogol 200: PEG400: soaked 8 hours in polyethylene glycol 800 (4: 4: the 1) solution, stir constantly, take out, immerse PEG400 again: acetone (4: 1) solution soaked 18 hours, take out, wash ball, 28 ℃ of temperature, placed 1 hour under humidity 35% condition, survey the moisture of rubber and content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 4.7% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 6.6%.
Embodiment 6:
Get the Herba Leonuri extractum powder and add polyethylene glycol 400 auxiliary materials such as grade, be made into soup, the soft capsule that is pressed into directly immerses in the glycerine and soaked 4 hours, stirs constantly; Take out, wash ball,, placed 3 hours under humidity 40% condition, survey the moisture of rubber and content 28 ℃ of temperature.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 6.3% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 8.8%.
Embodiment 7:
Get the Herba Leonuri extractum powder and add polyethylene glycol 400 auxiliary materials such as grade, be made into soup, the soft capsule that is pressed into directly immerses PEG400 solution and soaks 5 times, each 3 hours; Take out, wash ball,, placed 2 hours under humidity 38% condition, survey the moisture of rubber and content 28 ℃ of temperature.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 4.3% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 6.9%.
Embodiment 8:
Get the 'Sheng Mai ' soft capsule extract powder and add plant wet goods auxiliary material, be made into content, the soft capsule that is pressed into directly immerses in the propylene glycol solution, soaks 5 hours, take out, immerse again in the absolute ethyl alcohol, soaked 2 hours, take out, 28 ℃ of temperature, placed 1 hour under humidity 35% condition, measure rubber moisture.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 3.5% in the rubber with embodiment 1.
Embodiment 9:
Get the Isosorbide Mononitrate raw material and add polyethylene glycol 400 auxiliary materials such as grade, the soft capsule that is pressed into directly immerses PEG400: glycerine (4: 1) solution, stir constantly, soak 2 times, each 8 hours, take out, wash ball, 26 ℃ of temperature, placed 1 hour under humidity 35% condition, survey the moisture of rubber and content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 4.4% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 8.6%.
Embodiment 10:
Get the Isosorbide Mononitrate raw material and add polyethylene glycol 400 auxiliary materials such as grade, the soft capsule that is pressed into directly immerses PEG400 solution, soaks 24 hours, takes out, and 28 ℃ of temperature, places 2 hours under humidity 35% condition, surveys the moisture of rubber and content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 5.0% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 7.9%.
Embodiment 11:
Get the Nimodipine raw material and add polyethylene glycol 400 auxiliary materials such as grade, the soft capsule that is pressed into directly immerses in the PEG400 solution, stirs constantly, soaked 24 hours, and took out, wash ball, 27 ℃ of temperature, placed 2 hours under humidity 30% condition, measure the moisture of rubber and the moisture of content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 4.6% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 8.1%.
Embodiment 12:
Get the Nimodipine raw material and add polyethylene glycol 400 auxiliary materials such as grade, the soft capsule that is pressed into directly immerses glycerine: ethanol: in PEG400 (1: 2: the 3) solution, stir constantly, soaked 12 hours, take out, wash ball, 28 ℃ of temperature, placed 2 hours under humidity 32% condition, measure the moisture of rubber and the moisture of content.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 5.5% in the rubber with embodiment 1.
What version pharmacopeia in 2005 was adopted in the determination of moisture of content takes the Xiu Shi aquametry, in the content water content be 8.7%.
Embodiment 13:
Get the Alfacalcidol raw material and add plant wet goods auxiliary material, drip the soft capsule of making and directly immerse in the PEG400 solution, stir constantly, soaked 12 hours, take out, wash ball,, placed 2 hours under humidity 40% condition, measure the moisture of rubber 28 ℃ of temperature.
Acetone method is adopted in the rubber determination of moisture, and method gets water content 4.5% in the rubber with embodiment 1.
Claims (6)
1. the method for a drying soft capsule is characterized in that soft capsule is directly immersed dehydrating agent soaks the back taking-up.
2. the method for drying soft capsule according to claim 1, soft capsule adopt component of the same race or different component dehydrating agent to soak 1～5 time, and the accumulative total soak time is 0.5～120 hour.
3. the method for drying soft capsule according to claim 1 is characterized in that described soft capsule forms for suppressing or dripping to make.
4. the method for drying soft capsule according to claim 1 and 2 is characterized in that described dehydrating agent is a kind of or several mixtures formed with the arbitrary proportion mixing in acetone, glycerine, propane diols, absolute ethyl alcohol, the polyethylene glycol compounds.
5. the method for drying soft capsule according to claim 4 is characterized in that described polyethylene glycol compounds is the series of products of Macrogol 200～polyethylene glycol 1500.
6. the method for drying soft capsule according to claim 5, the series of products that it is characterized in that described Macrogol 200～polyethylene glycol 1500 are that a kind of in Macrogol 200, Liquid Macrogol, PEG400, Macrogol 600, polyethylene glycol 800, cetomacrogol 1000 and the polyethylene glycol 1500 or several mix mixtures of forming with arbitrary proportion.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101345733A CN101229450A (en) | 2007-11-01 | 2007-11-01 | Method of drying soft capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007101345733A CN101229450A (en) | 2007-11-01 | 2007-11-01 | Method of drying soft capsule |
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| Publication Number | Publication Date |
|---|---|
| CN101229450A true CN101229450A (en) | 2008-07-30 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2007101345733A Pending CN101229450A (en) | 2007-11-01 | 2007-11-01 | Method of drying soft capsule |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103356505A (en) * | 2013-05-02 | 2013-10-23 | 上海信谊万象药业股份有限公司 | Preparation method of hygroscopicity-content-containing soft capsules |
| CN105105146A (en) * | 2015-09-21 | 2015-12-02 | 江南大学 | Probiotics activity retention method and application thereof to solid-state fatty food |
| US10711119B2 (en) | 2018-01-10 | 2020-07-14 | Cp Kelco Aps | Carrageenan-based compositions for films and capsules |
-
2007
- 2007-11-01 CN CNA2007101345733A patent/CN101229450A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103356505A (en) * | 2013-05-02 | 2013-10-23 | 上海信谊万象药业股份有限公司 | Preparation method of hygroscopicity-content-containing soft capsules |
| CN105105146A (en) * | 2015-09-21 | 2015-12-02 | 江南大学 | Probiotics activity retention method and application thereof to solid-state fatty food |
| US10711119B2 (en) | 2018-01-10 | 2020-07-14 | Cp Kelco Aps | Carrageenan-based compositions for films and capsules |
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Open date: 20080730 |