CN107126424A - A kind of preparation method of enteric solubility Capsules - Google Patents
A kind of preparation method of enteric solubility Capsules Download PDFInfo
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- CN107126424A CN107126424A CN201710265408.5A CN201710265408A CN107126424A CN 107126424 A CN107126424 A CN 107126424A CN 201710265408 A CN201710265408 A CN 201710265408A CN 107126424 A CN107126424 A CN 107126424A
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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
- A61K9/4816—Wall or shell material
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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Abstract
The invention belongs to the technical field of medical capsule, and in particular to a kind of preparation method of enteric solubility Capsules.The present invention will be filtered after medical stone and phosphoric acid solution heating, and by filter residue and drying, mixture is mixed to obtain with sucrose fatty ester and oxaloacetic acid, by it with collecting sieving particle after steel ball ball milling, then sodium sulphate, sodium hydroxide solution and expoxy propane are added after mixing starch from sweet potato and distilled water, material is collected out in reaction end, dry, and mix obtained compounding glue with distilled water, sieving particle and carragheen, by copper mold completely into wherein after incubated overnight, it is stripped after cool drying, you can obtain enteric solubility Capsules.Enteric solubility Capsules obtained by the present invention eliminates enrobing processes, simple production process, reasonable, safe and reliable, and product quality meets national product quality, it is adaptable to various capsule production equipment large-scale industrial productions.
Description
Technical field
The invention belongs to the technical field of medical capsule, and in particular to a kind of preparation method of enteric solubility Capsules.
Background technology
Capsules is the major auxiliary burden for processing medicament capsule preparation.The Capsules used at present is processed by gelatin mostly
's.Gelatin is first soaked in water, is swelled rear glue, after send capsule production line through dipping in the works such as gum forming, dry solidification, cooling, cutting
Sequence obtains Capsules.Described glue is exactly by input mixing kettle together with the gelatin after being swelled and water, surfactant etc.
Heating is stirred, and sizing material is obtained after filtering, bubble removing, tune proportion.
Enteric hollow capsule refers to that softgel shell is insoluble in gastric juice, but can be disintegrated in intestinal juice or dissolve and discharge intracapsular medicine
Thing, softgel shell is also the major auxiliary burden for processing medicament capsule preparation.The enteric hollow capsule used at present is by gelatin machine-shaping
The enteric-coating material of the anti-hydrochloric acid in gastric juice of outsourcing afterwards.Gelatin is by the collagen in the connective tissues such as the skin of animal, bone, tendon, ligament
Through hydrolyzing obtained water soluble protein.Protein is easily influenceed by acid, alkali, the medicinal powder of Ruo Qinei fillings is acid or alkalescence compared with
By force, practice have shown that, in storage process, although also within the shelf-life, the quality of capsule also degradation is such as hardened, sent out
Crisp, not easy disintegrating, serious only remaining a pile powder.Gelatin hollow capsule has that raw material is expensive, raw material chromium is easily exceeded, using crowd
It is limited, easily by microorganism pollution the problems such as, plant-derived Capsules turns into the developing direction of capsule industry.Such as with hydroxypropyl first
Cellulose, prolan polysaccharide, starch are that stomach dissolution type plant hollow capsule prepared by primary raw material has been succeeded in developing and had
Through list marketing.At present, existing enteric solubility Capsules has gelatin and hydroxypropyl methylcellulose enteric solubility Capsules, in glue
One layer of enteric coating of softgel shell outer layer covers, or be prepared from by carrying out cross-linking reaction to gelatin.The hollow glue of both enteric solubilities
Capsule is both needed to carry out secondary enteric liquid coating in preparation technology.About the existing document of research of sodium alginate enteric solubility Capsules
Report, but such a capsulae enterosolubilis majority needs secondary calcifications to can be only achieved requirement insoluble in stomach, to be disintegrated in intestines, not only preparation technology
It is cumbersome, and capsule surface is uneven, rough after secondary enteric liquid coating, and the intestines of shaping are especially prepared after cross-linking reaction is carried out
The problem of molten Capsules there is likely to be residues of formaldehyde.Therefore, capsule surface after a kind of secondary enteric liquid is coated is researched and developed
Uniformly, smooth, the simple Capsules of preparation technology has important practical significance.
The content of the invention
The technical problems to be solved by the invention：Need to carry out secondary enteric in the preparation for current enteric solubility Capsules
Clothing is coated, and preparation technology is cumbersome, and capsule surface is uneven, rough after secondary coating, and removing residue formaldehyde lacks after cross-linking reaction
Fall into.There is provided a kind of preparation method of enteric solubility Capsules.
In order to solve the above technical problems, the present invention uses technical scheme as described below：
A kind of preparation method of enteric solubility Capsules, specific preparation process is：
（1）In mass ratio 1:3, it is that 20% phosphoric acid solution is put into container to take medical stone and mass fraction, and container is heated,
Heating-up temperature is 90~100 DEG C, then is filtered while hot, collects filter residue, and is dried, and obtains dry filter residue；
（2）Sucrose fatty ester, oxaloacetic acid and dry filter residue are stirred, stirring mixture is obtained, and be put into ball mill
Ball milling is carried out, ball milling thing is collected, and crosses 300 mesh sieves, sieving particle is collected, it is standby；
（3）In mass ratio 1:4, take starch from sweet potato and distilled water to be put into reactor, protected using nitrogen, design temperature be 40~
45 DEG C, 30~45min is stirred, sodium sulphate is added, continues to stir after 20~25min, is separately added into the hydroxide of mass fraction 25%
Sodium solution and expoxy propane, 2~3h of stirring reaction, are discharged while hot, collect out material, and material pH is adjusted out into using hydrochloric acid
Property, then be spray-dried, obtain dried object；
（4）Count by weight, take 70~80 parts of distilled water, 30~35 parts of dried objects, 12~16 parts of standby sieving particles and 4
~6 parts of carragheens, are put into mixer and stir, and obtain compounding glue；
（5）Compounding glue is placed in 55 DEG C of incubators and stood overnight, takes copper mold to be completely immersed in the compound gel after standing overnight
In liquid, 15~20s is stood, copper mold for taking out viscose glue is put into tipper upset and is cooled to room temperature, then by the copper of viscose glue after cooling
Mould is put into 60 DEG C of drying boxes and dried, and copper mold for being subsequently dried rear viscose glue is stripped, and collects demoulding thing, you can obtain enteric
Type Capsules.
Described step（2）The mass ratio of middle sucrose fatty ester, oxaloacetic acid and dry filter residue is 1:3:7~1:3:9.
Described step（2）Temperature in middle ball mill is 45~50 DEG C.
Described step（3）The addition of middle sodium sulphate is the 5~10% of starch from sweet potato quality, the hydroxide of mass fraction 25%
The addition of sodium solution is the 9~12% of starch from sweet potato quality, and the addition of expoxy propane is the 15~20% of starch from sweet potato quality.
The present invention is compared with other method, and advantageous effects are：
（1）The present invention reduces surface by the use of, as matrix, being modified to the beneficial medical stone of human body by surface, acetylation process
Crosslinking ability, the uniformity of capsule surface after increase is coated, then activated by ball milling, increase fixing property, then pass through
Hydroxypropylation is carried out to starch from sweet potato, its inoxidizability and light resistance is improved, and then make the enteric solubility Capsules surface of preparation
Smoothness；
（2）Enteric solubility Capsules obtained by the present invention is entirely capable of meeting《Chinese Pharmacopoeia》Enteric hollow capsule standard, in gastric juice
In do not dissolve, in intestinal juice dissolve；
（3）The raw materials used compatibility of the present invention is good, and obtained enteric solubility Capsules flat smooth, inoxidizability, light resistance are good,
Color stability, not fugitive color.
Embodiment
In mass ratio 1:3, it is that 20% phosphoric acid solution is put into container to take medical stone and mass fraction, and container is placed in into water
In bath, design temperature is 90~100 DEG C, is incubated 40~50min, is filtered, and collects filter residue, and filter residue is put into 110 DEG C does
2~3h is dried in dry case, dry filter residue, in mass ratio 1 is obtained:3:7~1:3:9, take sucrose fatty ester, oxaloacetic acid and drying
Filter residue is well mixed, and obtains stirring mixture, and is put into ball mill, adds a diameter of 50mm of 3~4 times of mixture quality of stirring
Steel ball, control ball mill mill in temperature be 45~50 DEG C, with 300r/min 1~2h of ball milling, then to the ball milling in ball mill
Mixture crosses 300 mesh sieves, collects sieving particle；In mass ratio 1:4, take starch from sweet potato and distilled water to be put into reactor, use
Nitrogen is protected, and design temperature is 40~45 DEG C, stirs 30~45min with 150r/min, adds starch from sweet potato quality 5~10%
Sodium sulphate, continue stir 20~25min after, be separately added into the sodium hydroxide of mass fraction 25% of starch from sweet potato quality 9~12%
The expoxy propane of solution and starch from sweet potato quality 15~20%, 2~3h of stirring reaction, discharges while hot, collects out material, uses salt
Acid adjusts out material pH to neutrality, then is spray-dried, and obtains dried object；Count by weight, take 70~80 parts of distilled water, 30
~35 parts of dried objects, 12~16 parts of sieving particles and 4~6 parts of carragheens, are put into mixer, with 200r/ at 40~45 DEG C
Min stirs 35~40min, obtains compounding glue；Compounding glue is placed in 55 DEG C of incubators and stood overnight, the leaching completely of copper mold is taken
Enter in the compounding glue after standing overnight, stand 15~20s, copper mold of taking-up viscose glue is put into tipper upset and is cooled to room
Temperature, then copper mold of viscose glue after cooling is put into 60 DEG C of drying boxes dry 30~40min, it is subsequently dried copper mold of rear viscose glue
It is stripped, collects demoulding thing, you can obtain enteric solubility Capsules.
Example 1
In mass ratio 1:3, it is that 20% phosphoric acid solution is put into container to take medical stone and mass fraction, and container is placed in into water-bath
In, design temperature is 90 DEG C, is incubated 40min, is filtered, and collects filter residue, and filter residue is put into 110 DEG C of drying boxes and dries 2h,
Filter residue, in mass ratio 1 must be dried:3:7, take sucrose fatty ester, oxaloacetic acid and dry filter residue to be well mixed, mixing must be stirred
Thing, and be put into ball mill, add temperature in a diameter of 50mm of 3 times of mixture quality of stirring steel ball, control ball mill mill
For 45 DEG C, with 300r/min ball milling 1h, then the ball-milled mixtures in ball mill are crossed with 300 mesh sieves, sieving particle is collected；By matter
Amount compares 1:4, take starch from sweet potato and distilled water to be put into reactor, protected using nitrogen, design temperature is 40 DEG C, with 150r/min
30min is stirred, the sodium sulphate of starch from sweet potato quality 5% is added, continues to stir after 20min, is separately added into starch from sweet potato quality 9%
The sodium hydroxide solution of mass fraction 25% and starch from sweet potato quality 15% expoxy propane, stirring reaction 2h discharges while hot, collects
Go out material, material pH is adjusted out to neutrality using hydrochloric acid, then be spray-dried, obtain dried object；Count by weight, take 70 parts
Distilled water, 30 parts of dried objects, 12 parts of sieving particles and 4 parts of carragheens, are put into mixer, are stirred at 40 DEG C with 200r/min
35min, obtains compounding glue；Compounding glue is placed in 55 DEG C of incubators and stood overnight, takes copper mold to be completely immersed in and stands overnight
In compounding glue afterwards, 15s is stood, copper mold of taking-up viscose glue is put into tipper upset and is cooled to room temperature, then will be glued after cooling
Copper mold of glue, which is put into 60 DEG C of drying boxes, dries 30min, and copper mold for being subsequently dried rear viscose glue is stripped, and collects the demoulding
Thing, you can obtain enteric solubility Capsules.
Example 2
In mass ratio 1:3, it is that 20% phosphoric acid solution is put into container to take medical stone and mass fraction, and container is placed in into water-bath
In, design temperature is 100 DEG C, is incubated 50min, is filtered, and collects filter residue, and filter residue is put into 110 DEG C of drying boxes and dries 3h,
Filter residue, in mass ratio 1 must be dried:3:9, take sucrose fatty ester, oxaloacetic acid and dry filter residue to be well mixed, mixing must be stirred
Thing, and be put into ball mill, add temperature in a diameter of 50mm of 4 times of mixture quality of stirring steel ball, control ball mill mill
For 50 DEG C, with 300r/min ball milling 2h, then the ball-milled mixtures in ball mill are crossed with 300 mesh sieves, sieving particle is collected；By matter
Amount compares 1:4, take starch from sweet potato and distilled water to be put into reactor, protected using nitrogen, design temperature is 45 DEG C, with 150r/min
45min is stirred, the sodium sulphate of starch from sweet potato quality 10% is added, continues to stir after 25min, is separately added into starch from sweet potato quality
12% sodium hydroxide solution of mass fraction 25% and the expoxy propane of starch from sweet potato quality 20%, stirring reaction 3h, discharge while hot,
Material is collected out, material pH is adjusted out to neutrality using hydrochloric acid, then is spray-dried, dried object is obtained；Count, take by weight
80 parts of distilled water, 35 parts of dried objects, 16 parts of sieving particles and 6 parts of carragheens, are put into mixer, with 200r/min at 45 DEG C
40min is stirred, compounding glue is obtained；Compounding glue is placed in 55 DEG C of incubators and stood overnight, takes copper mold to be completely immersed in standing
In compounding glue after overnight, 20s is stood, copper mold of taking-up viscose glue is put into tipper upset and is cooled to room temperature, then will cooling
Copper mold of viscose glue, which is put into 60 DEG C of drying boxes, afterwards dries 40min, and copper mold for being subsequently dried rear viscose glue is stripped, and collects de-
Mould thing, you can obtain enteric solubility Capsules.
Example 3
In mass ratio 1:3, it is that 20% phosphoric acid solution is put into container to take medical stone and mass fraction, and container is placed in into water-bath
In, design temperature is 95 DEG C, is incubated 45min, is filtered, and collects filter residue, and filter residue is put into 110 DEG C of drying boxes and dried
2.5h, obtains dry filter residue, in mass ratio 1:3:8, take sucrose fatty ester, oxaloacetic acid and dry filter residue to be well mixed, must stir
Mixture is mixed, and is put into ball mill, a diameter of 50mm of 3 times of mixture quality of stirring steel ball, control ball mill mill is added
Interior temperature is 48 DEG C, with 300r/min ball milling 1.5h, and then the ball-milled mixtures in ball mill are crossed with 300 mesh sieves, collects sieving
Particle；In mass ratio 1:4, take starch from sweet potato and distilled water to be put into reactor, protected using nitrogen, design temperature is 43 DEG C,
38min is stirred with 150r/min, the sodium sulphate of starch from sweet potato quality 8% is added, continues to stir after 22min, is separately added into sweet potato
The sodium hydroxide solution of mass fraction 25% of starch quality 10% and the expoxy propane of starch from sweet potato quality 18%, stirring reaction 2.5h,
Discharge while hot, collect out material, material pH is adjusted out to neutrality using hydrochloric acid, then be spray-dried, obtain dried object；By weight
Number meter, takes 75 parts of distilled water, 32 parts of dried objects, 14 parts of sieving particles and 5 parts of carragheens, is put into mixer, at 42 DEG C
38min is stirred with 200r/min, compounding glue is obtained；Compounding glue is placed in 55 DEG C of incubators and stood overnight, takes copper mold complete
It is complete to immerse in the compounding glue after standing overnight, 18s is stood, copper mold of taking-up viscose glue is put into tipper upset and is cooled to room
Temperature, then copper mold of viscose glue after cooling is put into 60 DEG C of drying boxes dry 35min, copper mold for being subsequently dried rear viscose glue is carried out
The demoulding, collects demoulding thing, you can obtain enteric solubility Capsules.
Enteric solubility Capsules obtained in present example 1~3 is subjected to performance detection, as a result as shown in table 1.
Table 1
| Example | Thickness/mm | Water content/% | Film light transmittance/% | Gastric juice disintegration time limited/h | Intestinal juice disintegration time limited/% | Tensile strength/Mp | Elongation percentage/% |
| 1 | 0.09 | 9.2 | 86.5 | 5 | 5 | 29.3 | 2.2 |
| 2 | 0.11 | 9.8 | 88.9 | 6 | 7 | 32.6 | 2.6 |
| 3 | 0.10 | 9.3 | 87.3 | 5.5 | 6 | 31.8 | 2.4 |
Claims (4)
1. a kind of preparation method of enteric solubility Capsules, it is characterised in that specifically preparation process is：
（1）In mass ratio 1:3, it is that 20% phosphoric acid solution is put into container to take medical stone and mass fraction, and container is heated,
Heating-up temperature is 90~100 DEG C, then is filtered while hot, collects filter residue, and is dried, and obtains dry filter residue；
（2）Sucrose fatty ester, oxaloacetic acid and dry filter residue are stirred, stirring mixture is obtained, and be put into ball mill
Ball milling is carried out, ball milling thing is collected, and crosses 300 mesh sieves, sieving particle is collected, it is standby；
（3）In mass ratio 1:4, take starch from sweet potato and distilled water to be put into reactor, protected using nitrogen, design temperature be 40~
45 DEG C, 30~45min is stirred, sodium sulphate is added, continues to stir after 20~25min, is separately added into the hydroxide of mass fraction 25%
Sodium solution and expoxy propane, 2~3h of stirring reaction, are discharged while hot, collect out material, and material pH is adjusted out into using hydrochloric acid
Property, then be spray-dried, obtain dried object；
（4）Count by weight, take 70~80 parts of distilled water, 30~35 parts of dried objects, 12~16 parts of standby sieving particles and 4
~6 parts of carragheens, are put into mixer and stir, and obtain compounding glue；
（5）Compounding glue is placed in 55 DEG C of incubators and stood overnight, takes copper mold to be completely immersed in the compound gel after standing overnight
In liquid, 15~20s is stood, copper mold for taking out viscose glue is put into tipper upset and is cooled to room temperature, then by the copper of viscose glue after cooling
Mould is put into 60 DEG C of drying boxes and dried, and copper mold for being subsequently dried rear viscose glue is stripped, and collects demoulding thing, you can obtain enteric
Type Capsules.
2. a kind of preparation method of enteric solubility Capsules according to claim 1, it is characterised in that：Described step
（2）The mass ratio of middle sucrose fatty ester, oxaloacetic acid and dry filter residue is 1:3:7~1:3:9.
3. a kind of preparation method of enteric solubility Capsules according to claim 1, it is characterised in that：Described step
（2）Temperature in middle ball mill is 45~50 DEG C.
4. a kind of preparation method of enteric solubility Capsules according to claim 1, it is characterised in that：Described step
（3）The addition of middle sodium sulphate is the 5~10% of starch from sweet potato quality, and the addition of the sodium hydroxide solution of mass fraction 25% is red
The 9~12% of sweet potato starch quality, the addition of expoxy propane is the 15~20% of starch from sweet potato quality.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113447356A (en) * | 2021-07-12 | 2021-09-28 | 广州白云山星群(药业)股份有限公司 | Method and equipment for testing mechanical properties of soft capsule shell |
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| CN103893772A (en) * | 2014-04-21 | 2014-07-02 | 湖南同泰胶囊有限公司 | Hydroxypropyl starch empty capsules and preparation process thereof |
| CN103933011A (en) * | 2014-04-28 | 2014-07-23 | 中国科学院化学研究所 | Plant mass cement for preparing hollow capsule, as well as hollow capsule of plant mass cement |
| CN104800188A (en) * | 2015-05-13 | 2015-07-29 | 湖南尔康制药股份有限公司 | Preparation method of medical hydroxypropyl starch-based capsule |
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2017
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100998572A (en) * | 2006-12-20 | 2007-07-18 | 刘杰 | Hard medicine capsule |
| CN102836142A (en) * | 2012-08-03 | 2012-12-26 | 青岛源海底海洋生物技术有限公司 | Hollow capsule and preparation method thereof |
| CN103893772A (en) * | 2014-04-21 | 2014-07-02 | 湖南同泰胶囊有限公司 | Hydroxypropyl starch empty capsules and preparation process thereof |
| CN103933011A (en) * | 2014-04-28 | 2014-07-23 | 中国科学院化学研究所 | Plant mass cement for preparing hollow capsule, as well as hollow capsule of plant mass cement |
| CN104800188A (en) * | 2015-05-13 | 2015-07-29 | 湖南尔康制药股份有限公司 | Preparation method of medical hydroxypropyl starch-based capsule |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113447356A (en) * | 2021-07-12 | 2021-09-28 | 广州白云山星群(药业)股份有限公司 | Method and equipment for testing mechanical properties of soft capsule shell |
| CN113447356B (en) * | 2021-07-12 | 2022-02-18 | 广州白云山星群(药业)股份有限公司 | Method and equipment for testing mechanical properties of soft capsule shell |
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Application publication date: 20170905 |