CN108245494A - Make the process that soft capsule content is not stratified - Google Patents
Make the process that soft capsule content is not stratified Download PDFInfo
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- CN108245494A CN108245494A CN201810148134.6A CN201810148134A CN108245494A CN 108245494 A CN108245494 A CN 108245494A CN 201810148134 A CN201810148134 A CN 201810148134A CN 108245494 A CN108245494 A CN 108245494A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
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Abstract
Make the process that soft capsule content is not stratified：(1) will be added in the vegetable oil or animal oil of Chinese medicine dried cream powder equivalent in ingredients pot, the Chinese medicine dried cream powder that weight ratio is 20 35%, the water of input 5 15% is slowly added under stirring, while material-compound tank is begun to warm up；(2) is sufficiently stirred 10 30 minutes；(3) throws 2 10% beeswax to material-compound tank, puts into part vegetable oil or animal oil, begins heat to beeswax thawing；(4) is continuously added in remaining vegetable oil or animal oil to material-compound tank, is vacuumized and is sufficiently stirred 20 40 minutes；(5) above-mentioned liquid is transferred in dry colloid mill by carries out continuous emulsification；(6) is sieved（80 140 mesh）；Finally by be sufficiently stirred, (8) sieving, (9) pills, (10) drying etc. processes finished product is made；The present invention solves the problems, such as soft capsule content layering, realizes that content is uniform, loading amount is accurate, stable quality, neat and artistic effect.
Description
Technical field
The invention belongs to Chinese patent medicine soft capsule preparing technical fields, and in particular to be one kind make soft capsule content regardless of
The process of layer.
Background technology
Soft capsule refers to oily drug, drug solution or drug suspension, paste even drug powder quantifying pressure injection
And be encapsulated in elastomeric flexible glued membrane and manufactured solid pharmaceutical preparation, dropping preparation method can be used or is prepared by pressing, be after tablet, injection
A kind of novel form to grow up afterwards.Soft capsule dosage form be chiefly used in it is light sensitive, meet it is damp and hot unstable, oxidizable and volatile
Drug, have it is aesthetic in appearance, be uniformly dispersed, loading amount is accurate, bioavilability is high, the advantages of can covering adverse drug smell.
Common Chinese medicine soft capsule content is generally collectively constituted by main ingredient and diluent, suspending agent, wetting agent etc., the property of content
The quality of soft capsule can be directly affected with ratio.
General Chinese patent medicine soft capsule conventional preparation techniques are：
Chinese medicine composition and vegetable oil are mixed, by heating, stirring, emulsifying, being sieved, pill, the processes such as drying are made
Soft capsule finished product.There is the requirement of absolute to production equipment.
Easily occur molding bad such as hangover, inclined ball in Chinese medicinal soft capsule production process, in storage phenomena such as oil leak, adhesion.
Therefore soft capsule technology of preparing improvements still in need, particularly the content of soft capsule easily occurs in drug storage cycle
Uneven, delamination, cyst fluid comes into full contact with capsule material after layering, can accelerate the aging of soft capsule, while influences product appearance.This
If the soft capsule containing solids cannot emulsify uniformly completely outside, after generating layering, easily lead to product active ingredient dosage not
Standard influences patient's using effect.Consulted by middle National IP Network, about solve Chinese medicinal soft capsule content lamination problem report compared with
Few, part research data shows that increase may be used or replace auxiliary material or change auxiliary material and is matched with matrix components.Generally use
Polyethylene glycols, due to its water imbibition, capsule shells moisture can shift rapidly to content, make the flexibility decrease of glue shell；Using helping
Suspension, predominantly beeswax, aluminum monostearate, ethyl cellulose etc. are more generally to use beeswax；Using wetting agent, predominantly
Surfactant, such as tween, sapn.The other methods of the prior art are not all prompted in this field, how to be improved Chinese medicine and are done
Stability of the cream fine powder in vegetable oil, in favor of solving the problems, such as that soft capsule content during storage is layered.
In order to further improve soft capsule content stability, it is ensured that the quality of product.Inventor prepares work in tradition
Technological improvement is carried out on the basis of skill, the sample prepared by present invention process and traditional handicraft carries out long-time stability data pair
Than research, it was demonstrated that present invention process method can make soft capsule stable effective ingredients uniform, not generate the phenomenon that content is layered.
Invention content
The object of the present invention is to provide a kind of processes for making soft capsule content not stratified, realize product in market
Content is not stratified in flow process, stable homogeneous, quality meet imperial requirement always.To achieve these goals,
Inventor has purchased the commercially available Chinese patent medicine soft capsule in part by market survey, literature search, detect its in relation to after index by
Analysis finds that content water content has great influence to the stability of whole system.Therefore the present invention is proposed using oil-water mixing
The surface tension raising of oil is mutually reduced into the surface tension of fine powder simultaneously, prevents fine powder from assembling, it is steady so as to fulfill dirty solution system
It is fixed.
In order to complete above-mentioned task, the technical solution adopted by the present invention is as follows：
A kind of process for making soft capsule content not stratified, which is characterized in that step is as follows：
(1) will be added in the vegetable oil or animal oil of Chinese medicine dried cream powder equivalent in ingredients pot, slowly be added under stirring
Enter the Chinese medicine dried cream powder that weight ratio is 20-35%, put into the water of 5-15%, while (temperature 30-60 is begun to warm up to material-compound tank
℃)；
(2) is sufficiently stirred 10-30 minutes；
(3) throws the beeswax of 2-10% to material-compound tank, puts into part vegetable oil or animal oil, begins heat to beeswax and melt
Change；
(4) is continuously added in remaining vegetable oil or animal oil to material-compound tank, is vacuumized and is sufficiently stirred 20-40 minutes；
(5) above-mentioned liquid is transferred in dry colloid mill by carries out continuous emulsification；
(6) is sieved (80-140 mesh)；
Finally by be sufficiently stirred, (8) sieving, (9) pills, (10) drying etc. processes finished product is made.
(9) wherein the step of, includes setting process in pill making crafts.
Production process does not need to the absolutely dry requirement of equipment, can be carried out before step is (1) using 50-90% alcohol
Disinfection is rinsed.
Chinese medicine composition involved in the present invention can be carried by the way that water boiling and precipitation with ethanol, reflux, crushing, distillation, diacolation etc. are a variety of
Taking technique obtains, and Chinese medicine composition final form contained by soft capsule content is not dried cream powder but thick medicinal extract.In content
The proportioning of each material is Chinese medicine composition：Vegetable oil or animal oil：Water：Wax=20-35%:45-65%：5-15%:2-10%.
The phenomenon that Chinese medicine composition is layered in vegetable oil or animal oil is solved by using oil-water mixed phase.The ratio of water once exceeds
Range is easy to cause emulsification uneven, content layering and soft capsule leakage.
Step of the present invention is (9) in the fixating shape step in pill making crafts, needs stringent control time and temperature, 2-10 hours
Soft capsule, is laid in dry pallet by (20-50 DEG C of temperature is hereinafter, humidity 20-50%) after sizing, thickness 1-5cm, does
(20-50 DEG C of temperature, humidity 20-50%) time 80-150 hours dry, final content moisture control is in 3-12%.
Above-described vegetable oil includes soybean oil, peanut oil, linseed oil, castor oil, rape seed oil, corn in the present invention
In the fruits such as oil, grape seed oil, safflower seed oil, attar of rose, walnut oil, pumpkin seed oil, green tea seed oil, olive oil or seed
The serial unrighted acid of extraction；Animal oil includes what is extracted in the range of animal such as fish oil, seal oil, snow frog oil, oviductus ranae
Saturated fatty acid；Water includes purified water, distilled water, deionized water, redistilled water；Beeswax include cera alba, cera flava, middle beeswax,
Western beeswax.More than vegetable oil, animal oil, water, beeswax can be one of which or two or more mixtures.
1 present invention of table and conventional process techniques effect stability correction data
Explanation：“+”：Content is layered；"-" content is not layered, stable homogeneous.
Traditional handicraft is respectively adopted in inventor and present invention process has carried out the trial-manufacture of sample of three batches of Chinese medicinal soft capsules, passes through
The long-term stable experiment of 12 months is investigated, and is found after being improved to traditional handicraft, using oil-water mixed phase by the surface of oil
Tension raising reduces the surface tension of fine powder simultaneously, prevents fine powder from assembling, can be achieved on dirty solution stable system, and micro-
Biological indicators are qualified.In addition, the implementation of the present invention brings other advantageous effects to the production process of Chinese medicinal soft capsule：(1) it passes
The necessary absolute of production equipment united used in manufacturing technique requirent production process of soft capsules, the present invention can make in implementing
It is carried out disinfection with 50-90% alcohol to production equipment flushing, further reduced the risk of microbial contamination, better assure that
The quality of product；(2) a large amount of vegetable oil can be generally used in soft capsule preparation process as dispersed phase, preparation process of the present invention
It is middle to replace oily substance with part water, the grease intake of patient is considerably reduced from another degree, is more advantageous to three
High crowd takes.(3) product of the present invention compares that quality is more stable, and content is not stratified with traditional preparation methods product, and loading amount is accurate
Really, piebald soft capsule will not be formed.Therefore Market Feedback is good, can be substantially reduced patient's the rate of complaints.
Specific embodiment
Embodiment 1：
Weight ratio is added in crush in unit for 36% Chinese medicine dried cream powder and is pulverized and sieved (80-100 mesh)；It will be with Chinese medicine dry cream
The soybean oil of powder equivalent is added in ingredients pot, and Chinese medicine dried cream powder, the purifying of input about total amount 4% are slowly added under stirring
Water, while material-compound tank is begun to warm up, it is sufficiently stirred 25 minutes (40-55 DEG C of temperature)；Weight ratio is thrown for 4% beeswax to dispensing
Tank, the soybean oil that input weight ratio is 10% begin heat to beeswax thawing, continuously add soybean oil of the remaining weight than 10%
Into material-compound tank, vacuumize (vacuum degree -0.06--0.08MPa) and be sufficiently stirred 30 minutes；Above-mentioned liquid is transferred to dry
Continuous emulsification is carried out in colloid mill, is sieved with 100 mesh sieve simultaneously；Content is at 405mg/ -430mg/ in pill, setting time
3-8 hours (25 DEG C of temperature is hereinafter, humidity 20-45%)；Capsule and pill is laid in dry pallet by restocking after shaping, thickness 2-
3CM；Dry 96-124 hours (26-30 DEG C of temperature, humidity is below 30%), final content moisture control is in 3-12%.
Embodiment 2:
Weight ratio is added in crush in unit for 28% Chinese medicine dried cream powder and is pulverized and sieved (80-100 mesh)；It will be with Chinese medicine dry cream
The soybean oil of powder equivalent is added in ingredients pot, is slowly added to Chinese medicine dried cream powder under stirring, input about total amount 16% it is pure
Change water, while material-compound tank is begun to warm up, be sufficiently stirred 20 minutes (40-55 DEG C of temperature)；Weight ratio is thrown for 8% beeswax to matching
Batch can, input weight ratio be 10% soybean oil, begin heat to beeswax thawing, continuously add remaining weight than for 10% it is big
(vacuum degree -0.06--0.08MPa) in soya-bean oil to material-compound tank, is vacuumized to be sufficiently stirred 30 minutes；Above-mentioned liquid is transferred to dry
Continuous emulsification is carried out in dry colloid mill, is sieved with 100 mesh sieve simultaneously；Content is at 405mg/ -430mg/ in pill, sizing
Time 3-8 hour (25 DEG C of temperature is hereinafter, humidity 20-45%)；Capsule and pill is laid in dry pallet by restocking after shaping, thick
Spend 2-3CM；Dry 96-124 hours (26-30 DEG C of temperature, humidity is below 30%), final content moisture control is in 3-
12%.
Embodiment 3:
Weight ratio is added in crush in unit for 32% Chinese medicine dried cream powder and is pulverized and sieved (80-100 mesh)；It will be with dried cream powder etc.
The soybean oil of amount is added in ingredients pot, and Chinese medicine dried cream powder is slowly added under stirring, puts into the purified water of about total amount 10%,
Material-compound tank is begun to warm up simultaneously, is sufficiently stirred 30 minutes (40-55 DEG C of temperature)；Weight ratio is thrown for 10% beeswax to dispensing
Tank, the soybean oil that input weight ratio is 10% begin heat to beeswax thawing, continuously add remaining weight than the soybean for 6%
(vacuum degree -0.06--0.08MPa) in oil to material-compound tank, is vacuumized to be sufficiently stirred 30 minutes；Above-mentioned liquid is transferred to drying
Colloid mill in carry out continuous emulsification, sieve with 100 mesh sieve simultaneously；Content is at 405mg/ -430mg/, sizing in pill
Between 3-8 hours (25 DEG C of temperature is hereinafter, humidity 20-45%)；Capsule and pill is laid in dry pallet by restocking after shaping, thickness
2-3CM；Dry 96-124 hours (26-30 DEG C of temperature, humidity is below 30%), final content moisture control is in 3-
12%.
Embodiment 4:
Weight ratio is added in crush in unit for 24% Chinese medicine dried cream powder and is pulverized and sieved (80-100 mesh)；It will be with dried cream powder etc.
The soybean oil of amount is added in ingredients pot, and Chinese medicine dried cream powder is slowly added under stirring, puts into the purified water of about total amount 15%,
Material-compound tank is begun to warm up simultaneously, is sufficiently stirred 30 minutes (40-55 DEG C of temperature)；Weight ratio is thrown for 3% beeswax to material-compound tank,
The soybean oil that weight ratio is 20% is put into, beeswax thawing is begun heat to, continuously adds remaining weight than the soybean oil for 14%
Into material-compound tank, vacuumize (vacuum degree -0.06--0.08MPa) and be sufficiently stirred 30 minutes；Above-mentioned liquid is transferred to dry
Continuous emulsification is carried out in colloid mill, is sieved with 100 mesh sieve simultaneously；Content is at 405mg/ -430mg/ in pill, setting time
3-8 hours (25 DEG C of temperature is hereinafter, humidity 20-45%)；Capsule and pill is laid in dry pallet by restocking after shaping, thickness 2-
3CM；Dry 96-124 hours (26-30 DEG C of temperature, humidity is below 30%), final content moisture control is in 3-12%.
2 embodiment stabilizing effect of table is observed
Claims (8)
1. a kind of process for making soft capsule content not stratified, which is characterized in that step is as follows：
(1) will be added in the vegetable oil or animal oil of Chinese medicine dried cream powder equivalent in ingredients pot, and weight is slowly added under stirring
Amount puts into the water of 5-15%, while material-compound tank is begun to warm up than the Chinese medicine dried cream powder for 20-35%；
(2) is sufficiently stirred 10-30 minutes；
(3) throws the beeswax of 2-10% to material-compound tank, puts into part vegetable oil or animal oil, begins heat to beeswax thawing；
(4) is continuously added in remaining vegetable oil or animal oil to material-compound tank, is vacuumized and is sufficiently stirred 20-40 minutes；
(5) above-mentioned liquid is transferred in dry colloid mill by carries out continuous emulsification；
(6) is sieved（80-140 mesh）；
Finally by be sufficiently stirred, (8) sieving, (9) pills, (10) drying etc. processes finished product is made；
(9) wherein the step of, includes setting process in pill making craft.
2. the process according to claim 1 for making soft capsule content not stratified, which is characterized in that step (1) it
Before, it is carried out disinfection flushing using 50-90% alcohol.
3. the process according to claim 1 for making soft capsule content not stratified, which is characterized in that step (1) in relate to
And Chinese medicine composition be by water boiling and precipitation with ethanol, reflux, crushing, distill or make a variety of extraction processes of diacolation and obtain, soft capsule
Chinese medicine composition final form contained by content is not dried cream powder but thick medicinal extract.
4. the process according to claim 1 for making soft capsule content not stratified, which is characterized in that step (1) in
Heating temperature is 30-60 DEG C；(6) middle sieving was 80-140 mesh sieve to step.
5. the process according to claim 1 for making soft capsule content not stratified, which is characterized in that each in content
The proportioning of material is Chinese medicine composition：Vegetable oil or animal oil：Water：Wax=20-35%: 45-65%：5-15%:2-10%.
6. the process according to claim 1 for making soft capsule content not stratified, which is characterized in that step of the present invention
(9) in the fixating shape step in pill making crafts, stringent control time and temperature needed, 2-10 hours：Wherein, 20-50 DEG C of temperature with
Under, humidity 20-50%；Soft capsule is laid in dry pallet after sizing, thickness 1-5cm, drying time, 80-150 was small
When；20-50 DEG C of temperature, humidity 20-50%.
7. the process according to claim 1 for making soft capsule content not stratified, which is characterized in that final content
Moisture is controlled in 3-12%.
8. the process for making soft capsule content not stratified according to one of claim 1-7, which is characterized in that described
Vegetable oil include soybean oil, peanut oil, linseed oil, castor oil, rape seed oil, corn oil, grape seed oil, safflower seed oil, rose
The serial unrighted acid extracted in the fruits such as oil, walnut oil, pumpkin seed oil, green tea seed oil, olive oil or seed；It is dynamic
Object oil includes the saturated fatty acid extracted in the range of animal such as fish oil, seal oil, snow frog oil, oviductus ranae；Water includes purified water, steams
Distilled water, deionized water, redistilled water；Beeswax includes cera alba, cera flava, middle beeswax, western beeswax；
More than vegetable oil, animal oil, water, beeswax, using one of which or two or more mixtures.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810148134.6A CN108245494A (en) | 2018-02-13 | 2018-02-13 | Make the process that soft capsule content is not stratified |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810148134.6A CN108245494A (en) | 2018-02-13 | 2018-02-13 | Make the process that soft capsule content is not stratified |
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| Publication Number | Publication Date |
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| CN108245494A true CN108245494A (en) | 2018-07-06 |
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ID=62744043
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201810148134.6A Pending CN108245494A (en) | 2018-02-13 | 2018-02-13 | Make the process that soft capsule content is not stratified |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114948897A (en) * | 2022-07-20 | 2022-08-30 | 广东广发制药有限公司 | Chinese patent medicine soft capsule content and preparation method thereof |
| CN116019222A (en) * | 2021-10-26 | 2023-04-28 | 安琪纽特股份有限公司 | Soft capsule content containing active ingredients and preparation method thereof |
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|---|---|---|---|---|
| KR20110127238A (en) * | 2009-02-23 | 2011-11-24 | 토마스 프란시스 하르팅 글라드 | Dispersion of phytosterols |
| CN103239485A (en) * | 2013-01-24 | 2013-08-14 | 上海同济生物制品有限公司 | Cordyceps sinensis soft capsule and preparation method thereof |
| CN103565775A (en) * | 2012-07-21 | 2014-02-12 | 上海同济生物制品有限公司 | Extraction solution soft capsule and preparation method for same |
| CN104383551A (en) * | 2014-12-09 | 2015-03-04 | 山西黄河中医药研究所（有限公司） | Traditional Chinese medicine soft capsule auxiliary material with universality and method for preparing traditional Chinese medicine soft capsules |
-
2018
- 2018-02-13 CN CN201810148134.6A patent/CN108245494A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110127238A (en) * | 2009-02-23 | 2011-11-24 | 토마스 프란시스 하르팅 글라드 | Dispersion of phytosterols |
| CN103565775A (en) * | 2012-07-21 | 2014-02-12 | 上海同济生物制品有限公司 | Extraction solution soft capsule and preparation method for same |
| CN103239485A (en) * | 2013-01-24 | 2013-08-14 | 上海同济生物制品有限公司 | Cordyceps sinensis soft capsule and preparation method thereof |
| CN104383551A (en) * | 2014-12-09 | 2015-03-04 | 山西黄河中医药研究所（有限公司） | Traditional Chinese medicine soft capsule auxiliary material with universality and method for preparing traditional Chinese medicine soft capsules |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116019222A (en) * | 2021-10-26 | 2023-04-28 | 安琪纽特股份有限公司 | Soft capsule content containing active ingredients and preparation method thereof |
| CN114948897A (en) * | 2022-07-20 | 2022-08-30 | 广东广发制药有限公司 | Chinese patent medicine soft capsule content and preparation method thereof |
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