CN107114792A - A kind of preparation method of enteric soft capsules - Google Patents
A kind of preparation method of enteric soft capsules Download PDFInfo
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- CN107114792A CN107114792A CN201710327062.7A CN201710327062A CN107114792A CN 107114792 A CN107114792 A CN 107114792A CN 201710327062 A CN201710327062 A CN 201710327062A CN 107114792 A CN107114792 A CN 107114792A
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- Prior art keywords
- soft capsule
- oil
- enteric soft
- gelatin
- fish oil
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- 239000007901 soft capsule Substances 0.000 title claims abstract description 119
- 238000002360 preparation method Methods 0.000 title claims abstract description 25
- 235000021323 fish oil Nutrition 0.000 claims abstract description 42
- 238000000576 coating method Methods 0.000 claims abstract description 38
- 239000011248 coating agent Substances 0.000 claims abstract description 36
- 239000003292 glue Substances 0.000 claims abstract description 36
- 239000002775 capsule Substances 0.000 claims abstract description 17
- 235000019198 oils Nutrition 0.000 claims abstract description 13
- 108010010803 Gelatin Proteins 0.000 claims description 44
- 239000008273 gelatin Substances 0.000 claims description 44
- 229920000159 gelatin Polymers 0.000 claims description 44
- 235000019322 gelatine Nutrition 0.000 claims description 44
- 235000011852 gelatine desserts Nutrition 0.000 claims description 44
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 27
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 26
- 239000007788 liquid Substances 0.000 claims description 24
- 238000000034 method Methods 0.000 claims description 22
- 239000006187 pill Substances 0.000 claims description 19
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Natural products OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 17
- 239000004925 Acrylic resin Substances 0.000 claims description 12
- 239000003921 oil Substances 0.000 claims description 12
- 229920000178 Acrylic resin Polymers 0.000 claims description 9
- 239000003814 drug Substances 0.000 claims description 9
- 238000002844 melting Methods 0.000 claims description 9
- 230000008018 melting Effects 0.000 claims description 9
- 239000004014 plasticizer Substances 0.000 claims description 9
- 229920000642 polymer Polymers 0.000 claims description 9
- 238000003756 stirring Methods 0.000 claims description 8
- -1 citric acid triester Chemical class 0.000 claims description 7
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 claims description 7
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 6
- 239000010647 garlic oil Substances 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 4
- 235000008390 olive oil Nutrition 0.000 claims description 4
- 239000004006 olive oil Substances 0.000 claims description 4
- 235000008524 evening primrose extract Nutrition 0.000 claims description 3
- 239000010475 evening primrose oil Substances 0.000 claims description 3
- 229940089020 evening primrose oil Drugs 0.000 claims description 3
- MJYQFWSXKFLTAY-OVEQLNGDSA-N (2r,3r)-2,3-bis[(4-hydroxy-3-methoxyphenyl)methyl]butane-1,4-diol;(2r,3r,4s,5s,6r)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O.C1=C(O)C(OC)=CC(C[C@@H](CO)[C@H](CO)CC=2C=C(OC)C(O)=CC=2)=C1 MJYQFWSXKFLTAY-OVEQLNGDSA-N 0.000 claims description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 2
- 239000002202 Polyethylene glycol Substances 0.000 claims description 2
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 claims description 2
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 2
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 claims description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 2
- 235000004426 flaxseed Nutrition 0.000 claims description 2
- 229920001223 polyethylene glycol Polymers 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 claims description 2
- 235000005282 vitamin D3 Nutrition 0.000 claims description 2
- 239000011647 vitamin D3 Substances 0.000 claims description 2
- 229940021056 vitamin d3 Drugs 0.000 claims description 2
- HDDLVZWGOPWKFW-UHFFFAOYSA-N trimethyl 2-hydroxypropane-1,2,3-tricarboxylate Chemical compound COC(=O)CC(O)(C(=O)OC)CC(=O)OC HDDLVZWGOPWKFW-UHFFFAOYSA-N 0.000 claims 2
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 claims 1
- 239000000499 gel Substances 0.000 claims 1
- 150000005691 triesters Chemical class 0.000 claims 1
- 239000001069 triethyl citrate Substances 0.000 claims 1
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 claims 1
- 235000013769 triethyl citrate Nutrition 0.000 claims 1
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 238000009413 insulation Methods 0.000 abstract 1
- 239000008188 pellet Substances 0.000 abstract 1
- 230000035699 permeability Effects 0.000 abstract 1
- 238000001035 drying Methods 0.000 description 8
- 235000011187 glycerol Nutrition 0.000 description 8
- 238000010438 heat treatment Methods 0.000 description 7
- 239000002994 raw material Substances 0.000 description 7
- 239000008213 purified water Substances 0.000 description 5
- MBMBGCFOFBJSGT-KUBAVDMBSA-N all-cis-docosa-4,7,10,13,16,19-hexaenoic acid Chemical compound CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCC(O)=O MBMBGCFOFBJSGT-KUBAVDMBSA-N 0.000 description 4
- 239000011247 coating layer Substances 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 210000002784 stomach Anatomy 0.000 description 4
- JAZBEHYOTPTENJ-JLNKQSITSA-N all-cis-5,8,11,14,17-icosapentaenoic acid Chemical compound CC\C=C/C\C=C/C\C=C/C\C=C/C\C=C/CCCC(O)=O JAZBEHYOTPTENJ-JLNKQSITSA-N 0.000 description 3
- 235000020669 docosahexaenoic acid Nutrition 0.000 description 3
- 235000020673 eicosapentaenoic acid Nutrition 0.000 description 3
- 229960005135 eicosapentaenoic acid Drugs 0.000 description 3
- JAZBEHYOTPTENJ-UHFFFAOYSA-N eicosapentaenoic acid Natural products CCC=CCC=CCC=CCC=CCC=CCCCC(O)=O JAZBEHYOTPTENJ-UHFFFAOYSA-N 0.000 description 3
- 210000001035 gastrointestinal tract Anatomy 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 238000005303 weighing Methods 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 206010067171 Regurgitation Diseases 0.000 description 2
- 206010047700 Vomiting Diseases 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 229940090949 docosahexaenoic acid Drugs 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000002702 enteric coating Substances 0.000 description 2
- 238000009505 enteric coating Methods 0.000 description 2
- 210000004051 gastric juice Anatomy 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 239000010410 layer Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 238000003825 pressing Methods 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 238000005086 pumping Methods 0.000 description 2
- DVSZKTAMJJTWFG-SKCDLICFSA-N (2e,4e,6e,8e,10e,12e)-docosa-2,4,6,8,10,12-hexaenoic acid Chemical compound CCCCCCCCC\C=C\C=C\C=C\C=C\C=C\C=C\C(O)=O DVSZKTAMJJTWFG-SKCDLICFSA-N 0.000 description 1
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- GZJLLYHBALOKEX-UHFFFAOYSA-N 6-Ketone, O18-Me-Ussuriedine Natural products CC=CCC=CCC=CCC=CCC=CCC=CCCCC(O)=O GZJLLYHBALOKEX-UHFFFAOYSA-N 0.000 description 1
- 241000251468 Actinopterygii Species 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000283690 Bos taurus Species 0.000 description 1
- 241000283073 Equus caballus Species 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 241000219925 Oenothera Species 0.000 description 1
- 235000004496 Oenothera biennis Nutrition 0.000 description 1
- 241001494479 Pecora Species 0.000 description 1
- 102000057297 Pepsin A Human genes 0.000 description 1
- 108090000284 Pepsin A Proteins 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000006255 coating slurry Substances 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 239000008367 deionised water Substances 0.000 description 1
- 229910021641 deionized water Inorganic materials 0.000 description 1
- KAUVQQXNCKESLC-UHFFFAOYSA-N docosahexaenoic acid (DHA) Natural products COC(=O)C(C)NOCC1=CC=CC=C1 KAUVQQXNCKESLC-UHFFFAOYSA-N 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 239000000944 linseed oil Substances 0.000 description 1
- 235000021388 linseed oil Nutrition 0.000 description 1
- 238000011068 loading method Methods 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 235000011837 pasties Nutrition 0.000 description 1
- 229940111202 pepsin Drugs 0.000 description 1
- 229920000058 polyacrylate Polymers 0.000 description 1
- 150000004291 polyenes Chemical class 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- 239000011241 protective layer Substances 0.000 description 1
- 239000008036 rubber plasticizer Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000002344 surface layer Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
- A23L33/12—Fatty acids or derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
Landscapes
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
- Polymers & Plastics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention relates to a kind of preparation method of enteric soft capsules.The enteric soft capsules include content and capsule shells, the content is the combination of fish oil or fish oil and other components, and preparation method adds coating solution during being included in rubber glue, vacuumizes pressurize colloidal sol, vacuumizing again makes glue bubble-free, and it is standby that glue is statically placed in into 65 70 DEG C of insulations；Gained glue is used to form soft capsule shell；In the soft capsule shell that content is wrapped in glue formation by pellet press, enteric soft capsules are made.Gained enteric soft capsules can prevent decoction from corroding rubber, increase shelf life of products, be not in oil leak, the phenomenon of permeability, increase disintegration time and soft capsule is rich in toughness.
Description
Technical Field
The invention relates to a preparation method of an enteric soft capsule, belonging to the technical field of soft capsule preparation.
Background
At present, soft capsule preparations develop rapidly in China, and various soft capsule preparations are hundreds of types, including VE soft capsules, evening primrose soft capsules, lecithin soft capsules, polyene healthy soft capsules, deep sea fish oil soft capsules and the like. Common types and various types of soft capsules of health care product preparations, such as VD3 soft capsules, olive oil soft capsules and the like. A plurality of oily, liquid, suspension liquid, etc. pasty raw medicinal liquid can be processed into soft capsule. Although soft capsule formulations are rapidly developed in China, many technical problems are also presented. For example, the shell of the soft capsule mainly uses animal gelatin as a raw material and glycerin as a plasticizer, and the soft capsule has the functions of plasticization and moisture retention, and has the problems of unqualified disintegration time, unstable shelf life, color change of the content of the capsule and the like. The soft capsule contents generally comprise a pure oil active ingredient and one or a combination of more of linseed oil, olive oil and evening primrose oil. After being taken by a human body, the uncoated soft capsule can be rapidly disintegrated in the stomach, and the situations of regurgitation, nausea and the like can be caused.
The fish oil is unsaturated fatty acid extracted from marine fish, has rich EPA and DHA, and is beneficial to human body. However, fish oil has a strong fishy smell, and thus causes nausea and vomiting due to discomfort. For this purpose, fish oil soft capsules need to be coated. For example, CN102614153A discloses a natural enteric soft capsule comprising a soft capsule and an enteric coating layer; the preparation method comprises pressing the content and the rubber into soft capsule, and spraying a coating layer on the surface of the soft capsule in a coating pan. In the prior art, the traditional process of soft capsule coating technology is that capsules are prepared firstly, then coating slurry is prepared, and the slurry is sprayed on the soft capsules by coating equipment to form a film. The soft capsule prepared by the method only forms a coating layer on the surface of the capsule, no coating layer is arranged between the content (fish oil) and the rubber, the content liquid medicine is easy to etch the rubber when the soft capsule is stored for a long time, the extrusion resistance and the collision resistance of the single-layer film coated soft capsule are limited, and particularly, the situations of oil leakage and the like are easy to occur after the content liquid medicine etches the rubber.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a preparation method of an enteric soft capsule, in particular to a preparation method of a pure oil enteric soft capsule.
The technical scheme of the invention is as follows:
a method for preparing an enteric soft capsule, comprising:
-providing a content being fish oil, or a mixture of fish oil and one or a combination of garlic oil, VD3 oil, flaxseed/oil, olive oil, evening primrose oil,
-providing a coating liquid, wherein the coating liquid comprises the following components in percentage by mass: 10-20% of acrylic resin polymer, 1-5% of citric acid triester, 0.5-3% of propylene glycol, 1-5% of talcum powder, 0-2% of absolute ethyl alcohol and the balance of water;
-providing a capsule shell component for forming a soft capsule shell together with a coating liquid,
the rubber comprises the following components in percentage by mass: 25-50% of gelatin, 10-30% of plasticizer and the balance of water;
the method comprises the following steps:
(1) adding the water and the plasticizer into a gelatin melting tank according to the proportion of the rubber components, adding the coating liquid at the temperature of 65-80 ℃, uniformly stirring, adding gelatin, vacuumizing until the pressure is-0.05 to-0.1 MPa, keeping the pressure of the gelatin for 40-60 minutes, vacuumizing until the gelatin liquid is free of bubbles, standing the gelatin liquid at the temperature of 65-70 ℃, and keeping the temperature for 1.5-2.5 hours; the obtained glue solution is used for forming a soft capsule shell;
(2) and (2) putting the glue solution prepared in the step (1) into a glue solution box of a pill press, putting the content into a medicine solution box of the pill press, and wrapping the content in a soft capsule shell formed by the glue solution through the pill press to prepare the enteric soft capsule.
The enteric soft capsule prepared by the invention is dried to obtain the finished enteric soft capsule, and the surface layer containing the coating component is formed on the inner surface and the outer surface of the finished enteric soft capsule. The wall thickness of the soft capsule shell is adjusted by a pelleting press, and the preferred wall thickness is 80mm-90 mm. The preparation of soft capsules is not particularly restricted and is carried out according to the prior art, for example, the above-mentioned glue solution flows through a rubber wheel, is cooled and then is rolled into a rubber, and then the content is wrapped in the rubber by a mould to form a soft capsule shell.
According to the invention, the pressure of vacuumization after sol maintaining in the step (1) is preferably-0.08 to-0.1 MPa.
According to the invention, the viscosity of the glue solution obtained in the step (1) is 12000-14000Pa ∙ S; the viscosity of the glue solution is measured at 65 ℃ by using an Engler viscometer.
According to the invention, the mass ratio of the content to the rubber is preferably 1: 0.4-0.5.
Preferably, the content is one of:
a. 1-2% of garlic oil and 98-99% of fish oil by mass percentage;
b. 1-3% of vitamin D3(VD3) oil and 97-99% of fish oil by mass percentage;
c. 100% of fish oil.
Preferably, according to the invention, the fish oil is 18/12 fish oil or 50/25 fish oil. The 8/12 fish oil or 50/25 fish oil contains docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA); in the product specification, 8/12 fish oil is marked as EPA18/DHA12, and 50/25 fish oil is marked as EPA50/DHA 25. Is available on the market.
According to the invention, the coating solution preferably comprises the following components in percentage by mass: 13-15% of acrylic resin polymer, 2-4% of citric acid triester, 1-2% of propylene glycol, 1.5-3% of talcum powder, 0-2% of absolute ethyl alcohol and the balance of water. Wherein,
the acrylic resin polymer is any one suitable for enteric soft capsules. Preferably, the acrylic resin polymer is polyacrylic resin II or polyacrylic resin III. Further preferably 2000-4000 in number average molecular weight.
According to the invention, the rubber preferably comprises the following components in percentage by mass: 30-35% of gelatin, 15-20% of plasticizer and the balance of water. Wherein the rubber plasticizer is selected from glycerol, propylene glycol, ethylparaben, ethylene glycol, crystalline sorbitol and/or polyethylene glycol.
In the ingredients of the invention, the water is purified water, deionized water or drinking water; the gelatin is edible gelatin. The gelatin is selected from one or more of animal offal and skin gelatin of cattle, horse, sheep, etc. Gelatin is commercially available or prepared according to the prior art.
The pill press of the invention is a domestic 250-type full-automatic soft capsule pill press. The product is commercially available.
The enteric soft capsule prepared by the invention contains the coating component in the capsule, so that the protective layer is additionally arranged between the content and the rubber to prevent the capsule from being eroded by the liquid medicine of the content, and the coating component is arranged on the outer layer of the rubber, so that the stomach can not be dissolved and absorbed in the intestinal tract after the capsule is taken, adverse reactions such as regurgitation, vomiting and the like can not be caused, and the quality guarantee period of the capsule can be prolonged.
Compared with the prior art, the invention has the advantages that:
1. in the method, water and a plasticizer are mixed with a coating solution at the temperature of 65-75 ℃ in the glue dissolving process, gelatin is added, then the vacuum pumping is carried out until the pressure is-0.05 to-0.1 MPa, the pressure maintaining sol is carried out for 40-60 minutes, the glue dissolving temperature, the vacuum degree and the pressure maintaining sol time are set, so that the raw materials are fully and uniformly dissolved, the soft capsule has proper toughness and softness, then the vacuum pumping is carried out to ensure that the glue solution is free of bubbles, and the glue solution is statically placed at the temperature of 65-70 ℃ for heat preservation for 1.5-2.5 hours; the total time of the pressure maintaining sol time and the standing and heat preserving time is not more than 3.5 hours, so that the situation that the toughness and the softness of the capsule shell are influenced by the adhesion of the raw materials due to the overlarge sol dissolving time is avoided. The optimal proposal is that the viscosity of the Engler viscosity glue solution does not exceed 14000Pa ∙ S. The enteric coating soft capsule has high toughness and good stability in long-term storage.
2. The method of the invention is to add the coating liquid in the process of gelatin melting, and the coating effect is achieved on the inner surface and the outer surface of the soft capsule. The obtained soft capsule has increased disintegration time, can not disintegrate in stomach, can be absorbed by intestinal tract, and has no uncomfortable reaction.
3. The soft capsule product of the invention has good compression and collision resistance, obviously improves the product quality, and avoids the problems caused by collision or impact and the like. The problem that the traditional outer coating film is broken and falls off when being collided or impacted is solved.
4. The soft capsule of the invention can well prevent the soft capsule from being eroded by the liquid medicine of the content, so that the shelf life of the soft capsule is prolonged, and the phenomena of oil leakage and oil seepage are avoided.
5. The preparation method of the enteric soft capsule of the invention directly adds the coating liquid when the glue solution is prepared, thus reducing the fussy traditional coating procedure.
Detailed Description
The present invention is further modified by the following examples, in which the raw materials are all commercially available products.
The acrylic polymer in the examples is polyacrylic resin II. The water in the examples is purified water. The viscosity of the dope described in the examples was measured at 65 ℃ using an Engler viscometer.
In the examples, the specification of the enteric soft capsule is 1000mg per capsule, wherein 1000mg is the content.
Examples 1,
A preparation method of an enteric soft capsule comprises the following raw materials by mass percent:
content (2): 2% of garlic oil and 98% of fish oil; stirring and mixing uniformly in a dispensing tank;
coating liquid: 15% of acrylic resin polymer, 2.25% of citric acid triester, 1.05% of propylene glycol, 1.7% of talcum powder and 80% of purified water; mixing in a container.
Rubber components: 50% of gelatin, 17% of glycerol and 33% of water.
The preparation steps are as follows:
weighing glycerol and water according to a ratio, putting into a gelatin melting tank, starting a heating gelatin melting tank, heating to 75 ℃, adding the prepared coating solution, uniformly stirring, adding gelatin, keeping the pressure of the gelatin at-0.06-0.7 MPa, and vacuumizing to ensure that the gelatin solution is bubble-free (the vacuum pressure is-0.8 MPa); then, the glue solution is kept stand at 65 ℃ and kept warm for about 2h to obtain the glue solution with the viscosity of 12000Pa ∙ S, which is measured by an Engler viscometer at 65 ℃. The obtained glue solution is used for forming a soft capsule shell in a pill press.
Preparation of the contents: 2 percent of garlic oil and 98 percent of fish oil are stirred and mixed evenly in a dispensing tank.
Preparing the soft capsule: and (2) injecting the prepared glue solution into a glue solution box of a pill press by using a 250 type full-automatic soft capsule pill press, injecting contents into a medicine solution box of the pill press, adjusting the thickness of a rubber to be 85mm, wrapping the contents in a soft capsule shell (rubber) formed by the glue solution to prepare the enteric soft capsule with the specification of 1000 mg/capsule, placing the pressed soft capsule in a rotating cage for shaping, and then placing the soft capsule in a drying tray for drying to prepare the fish oil enteric soft capsule.
Example 2
A preparation method of an enteric soft capsule comprises the following raw materials by mass percent:
the soft capsule content is 18/12 fish oil (EPA18/DHA12) 100%
Coating liquid: 13% of acrylic resin polymer, 3.25% of citric acid triester, 1.05% of propylene glycol, 2% of talcum powder, 80.7% of purified water and 1% of absolute ethyl alcohol.
The rubber comprises 45% of gelatin, 17% of glycerol and 38% of water.
The preparation steps are as follows:
preparing glue solution: weighing glycerol and water according to a ratio, putting into a gelatin melting tank, starting a heating gelatin melting tank, heating to 70 ℃, adding the prepared coating solution, stirring uniformly, adding gelatin, keeping the pressure of the gelatin at-0.07-0.8 MPa, vacuumizing (the vacuum pressure is-0.9 MPa) to ensure that the gelatin solution is free of bubbles, standing the gelatin solution at 65 ℃ for 2.5h, and obtaining the gelatin solution with the viscosity of 13000Pa ∙ S. The obtained glue solution is used for forming a soft capsule shell in a pill press.
Preparing the soft capsule: and (2) injecting the prepared glue solution into a glue solution box of a pill press by using a 250 type full-automatic soft capsule pill press, injecting contents into a medicine solution box of the pill press, adjusting the thickness of a rubber to be 80mm, wrapping the contents in the rubber to prepare 1000 mg/granule enteric soft capsules, placing the pressed soft capsules in a rotating cage for shaping, and then placing the soft capsules in a drying tray for drying to prepare the fish oil enteric soft capsules.
Example 3
A preparation method of an enteric soft capsule comprises the following raw materials by mass percent:
content (2): VD3 oil 3%, 50/25 fish oil 97%; stirring and mixing evenly in a dispensing tank.
Coating liquid: 14% of acrylic resin polymer, 2.75% of citric acid triester, 1.55% of propylene glycol, 2.7% of talcum powder and 80% of purified water.
Rubber components: 40% of gelatin, 19% of glycerol and 41% of water.
The preparation steps are as follows:
preparing glue solution: weighing glycerol and water according to a ratio, putting into a gelatin melting tank, starting a heating gelatin melting tank, heating to 75 ℃, adding the prepared coating solution, stirring uniformly, adding gelatin, keeping the pressure of the gelatin at-0.07-0.8 MPa, vacuumizing (the vacuum pressure is-0.85 MPa) to ensure that the gelatin solution is free of bubbles, standing the gelatin solution at 65 ℃ and keeping the temperature for 2h to obtain the gelatin solution with the viscosity of 12500Pa ∙ S.
Preparing the soft capsule: and (2) injecting the prepared glue solution into a glue solution box of a pill press by using a 250 type full-automatic soft capsule pill press, injecting contents into a medicine solution box of the pill press, adjusting the thickness of a rubber sheet to be 82mm, wrapping the contents in the rubber sheet to prepare 1000 mg/granule enteric soft capsules, placing the pressed soft capsules in a rotating cage for shaping, and then placing the soft capsules in a drying tray for drying to prepare the fish oil enteric soft capsules.
Comparative example 1: preparation of fish oil enteric soft capsule in traditional coating process
The fish oil enteric soft capsule is prepared by adopting the same contents and rubber components as in example 2. The difference is that the fish oil and the rubber are pressed into soft capsules, and then a coating layer is sprayed on the surfaces of the soft capsules in a coating pot.
The preparation steps are as follows:
(1) 18/12 stirring and mixing fish oil in a dispensing tank, operating a soft capsule device, adjusting the thickness of a rubber sheet and the loading amount of the content, pressing the content and the rubber sheet into a soft capsule with the specification of 1000 mg/capsule by a soft capsule machine, placing the pressed soft capsule in a rotating cage for shaping, and then placing the soft capsule in a drying tray for drying to obtain the fish oil soft capsule;
(2) the coating solution composition was the same as in example 2. Coating the prepared fish oil soft capsule with coating solution at air inlet temperature of 40-60 deg.C, air outlet temperature of 40-50 deg.C, heating at 45-70 deg.C, negative pressure value (-75 + -30) Pa, rotation speed of 5-6 r/min, temperature of 20-25 deg.C, and humidity below 50% to obtain enteric coated soft capsule with outer coating film.
Effect test of enteric Soft Capsule
The enteric soft capsules prepared in examples 1-3 and the products of the traditional coating procedure in comparative example 1 were subjected to long-term sample retention under the same experimental conditions to simulate artificial gastric juice with disintegration time as an index for investigation.
The experimental conditions are as follows: the temperature is 30 ℃, the pepsin, the water bath kettle and the artificial gastric juice environment are simulated.
The experimental results are as follows: as described in table 1.
Table 1 case sample vs. coating procedure sample disintegration time
The experimental result shows that the disintegration time of the sample is qualified when being more than 60 minutes, the disintegration time of the fish oil enteric soft capsule prepared by the method is qualified, and the disintegration time of the fish oil enteric soft capsule prepared by the method is longer than that of the sample prepared by the traditional coating process, which shows that the product of the invention is not dissolved in stomach and is dissolved and absorbed in intestinal tract.
Claims (10)
1. A method for preparing an enteric soft capsule, comprising:
-providing a content being fish oil, or a mixture of fish oil and one or a combination of garlic oil, VD3 oil, flaxseed/oil, olive oil, evening primrose oil,
-providing a coating liquid, wherein the coating liquid comprises the following components in percentage by mass: 10-20% of acrylic resin polymer, 1-5% of citric acid triester, 0.5-3% of propylene glycol, 1-5% of talcum powder, 0-2% of absolute ethyl alcohol and the balance of water;
-providing a capsule shell component for forming a soft capsule shell together with a coating liquid,
the rubber comprises the following components in percentage by mass: 25-50% of gelatin, 10-30% of plasticizer and the balance of water;
the method comprises the following steps:
(1) adding the water and the plasticizer into a gelatin melting tank according to the proportion of the rubber components, adding the coating liquid at the temperature of 65-75 ℃, uniformly stirring, adding gelatin, vacuumizing until the pressure is-0.05 to-0.1 MPa, keeping the pressure of the gelatin for 40-60 minutes, vacuumizing until the gelatin liquid is free of bubbles, standing the gelatin liquid at the temperature of 65-70 ℃, and keeping the temperature for 1.5-2.5 hours; the obtained glue solution is used for forming a soft capsule shell;
(2) and (2) putting the glue solution prepared in the step (1) into a glue solution box of a pill press, putting the content into a medicine solution box of the pill press, and wrapping the content in a soft capsule shell formed by the glue solution through the pill press to prepare the enteric soft capsule.
2. The method for preparing enteric soft capsules according to claim 1, wherein the viscosity of the gel solution obtained in step (1) is 12000-14000Pa ∙ S; the viscosity of the glue solution is measured at 65 ℃ by using an Engler viscometer.
3. The method for preparing the enteric soft capsule of claim 1, wherein the mass ratio of the content to the capsule shell is 1: 0.4-0.5.
4. The method of preparing enteric soft capsules of claim 1, wherein the content is one of:
a. 1-2% of garlic oil and 98-99% of fish oil by mass percentage;
b. 1-3% of vitamin D3(VD3) oil and 97-99% of fish oil by mass percentage;
c. 100% of fish oil.
5. The method for preparing enteric soft capsules of claim 1 or 4, wherein said fish oil is 18/12 fish oil or 50/25 fish oil.
6. The preparation method of the enteric soft capsule of claim 1, wherein the coating solution comprises the following components in percentage by mass: 13-15% of acrylic resin polymer, 2-4% of citric acid triester, 1-2% of propylene glycol, 1.5-3% of talcum powder, 0-2% of absolute ethyl alcohol and the balance of water.
7. The method for preparing enteric soft capsules according to claim 1 or 6, characterized in that the tri-ester of citric acid is trimethyl citrate or triethyl citrate.
8. The preparation method of the enteric soft capsule of claim 1, wherein the capsule skin comprises the following components by mass percent: 30-35% of gelatin, 15-20% of plasticizer and the balance of water.
9. The method for preparing enteric soft capsules according to claim 1 or 8, wherein the capsule skin plasticizer is selected from glycerol, propylene glycol, ethylparaben, ethylene glycol, crystalline sorbitol or/and polyethylene glycol.
10. The method for preparing enteric soft capsules of claim 1, wherein the wall thickness of the soft capsule shell is 80mm to 90 mm.
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