CN112791059A - Preparation method of plant empty capsule - Google Patents
Preparation method of plant empty capsule Download PDFInfo
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- CN112791059A CN112791059A CN202110313263.8A CN202110313263A CN112791059A CN 112791059 A CN112791059 A CN 112791059A CN 202110313263 A CN202110313263 A CN 202110313263A CN 112791059 A CN112791059 A CN 112791059A
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/07—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use
- A61J3/071—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of capsules or similar small containers for oral use into the form of telescopically engaged two-piece capsules
- A61J3/077—Manufacturing capsule shells
-
- 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
- A61K47/38—Cellulose; Derivatives thereof
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Manufacturing & Machinery (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Jellies, Jams, And Syrups (AREA)
Abstract
The invention belongs to the technical field of pharmaceutic adjuvants, and particularly relates to a preparation method of a plant empty capsule. The invention comprises the following steps: (1) weighing 100 parts of cellulose according to parts by mass, adding 300-600 parts of purified water with the temperature of over 75 ℃, and stirring until the cellulose is dissolved to form cellulose glue; (2) transferring the glue solution to a glue groove of a full-automatic capsule production line, and dipping the glue solution at room temperature; (3) after the mould dipped with the glue runs to an upper platform of a full-automatic capsule production line, drying and shaping the capsule by using compressed air; (4) after shaping, fine drying, demoulding, cutting and sleeving are finished on a full-automatic capsule production line to obtain the plant hollow capsule. The invention has scientific and reasonable design, does not need to add gel, reduces the forming control temperature, saves energy, protects environment, has low water content of the prepared hollow capsule, expands the application range of the hollow capsule, and has more stable drug dissolution performance during application.
Description
Technical Field
The invention belongs to the technical field of pharmaceutic adjuvants, and particularly relates to a preparation method of a plant empty capsule.
Background
According to the general rule of capsules (hollow capsules) published by the pharmacopoeia of China, the hollow capsules usually comprise two parts (namely a capsule cap and a capsule body), the capsule body and the capsule cap are cylindrical, wherein the longer end is called the capsule body, the shorter end is called the capsule cap, and the capsule cap and the capsule body are tightly sleeved and locked. The capsule should have smooth surface, uniform color, smooth cut, no deformation, and no odor.
The hollow capsules are classified according to the source of the main film-forming material, and can be divided into hollow capsules of animal origin and hollow capsules of non-animal origin. The hollow capsule of animal origin means that the main film-forming material of the hollow capsule is originated from animals. The non-animal-derived hollow capsule means that the film-forming material for producing the hollow capsule is non-animal-derived and does not contain any animal-derived substances. Such as hypromellose empty capsules, pullulan empty capsules, hydroxypropyl starch empty capsules, and the like. The production process comprises preparing glue solution, dipping glue, shaping, drying, demoulding, cutting and sheathing to form the hollow capsule.
In the existing production process of the hollow capsule, when the hollow capsule is shaped after being dipped in glue, the hollow capsule is shaped by utilizing the properties of a film-forming material, for example, the hollow capsule of an animal source is shaped by utilizing the gel property of animal gelatin, the hollow capsule of a non-animal source is shaped by adding a gelling agent, and the hollow capsule of hydroxypropyl methylcellulose can also be shaped by utilizing the thermal gel property of the hollow capsule of hydroxypropyl methylcellulose. However, the temperature of the above shaping method is high, the production cycle is long, and the drug dissolution performance is poor.
Disclosure of Invention
The technical problem to be solved by the invention is as follows: the preparation method of the plant hollow capsule overcomes the defects of the prior art, has scientific and reasonable design, does not need to add gel, reduces the forming control temperature, is energy-saving and environment-friendly, has low water content in the prepared hollow capsule, expands the application range of the hollow capsule, and has more stable drug dissolution performance in application.
The preparation method of the plant empty capsule comprises the following steps:
(1) weighing 100 parts of cellulose according to parts by mass, adding 300-600 parts of purified water with the temperature of over 75 ℃, and stirring at a low speed until the cellulose is completely dissolved to form bubble-free cellulose glue solution;
(2) transferring the glue solution to a glue groove of a full-automatic capsule production line, and dipping the glue solution at room temperature;
(3) after the mould dipped with the glue runs to an upper platform of a full-automatic capsule production line, the capsule is quickly dried and shaped by using compressed air;
(4) after shaping, fine drying, demoulding, cutting and sleeving are finished on a full-automatic capsule production line to obtain the plant hollow capsule.
The cellulose is a mixture with three viscosities of 3.0mPa.s, 6.5mPa.s and 50 mPa.s.
Preferably, the cellulose having a viscosity of 3.0mpa.s is 20-35% by weight of the mixture, the cellulose having a viscosity of 6.5mpa.s is 50-75% by weight of the mixture, and the cellulose having a viscosity of 50mpa.s is 5-15% by weight of the mixture.
Preferably, the cellulose is one or more of hydroxypropyl methylcellulose, hydroxyethyl methylcellulose, or hydroxyethyl cellulose.
Preferably, in the step (1), the stirring speed is controlled to be 15-25r/min during low-speed stirring, and the temperature of the cellulose gel is 35-50 ℃. If a small amount of bubbles appear, the bubbles can be removed by vacuum pumping.
Preferably, in the step (3), the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 10-15m/s according to the type of the capsule and the viscosity ratio of the raw materials, and the drying time of the compressed air is 3-5 seconds.
Preferably, in the step (3), in the drying and shaping process, the water loss amount of the glue solution on the mold is controlled to be 50-60 wt% according to the type of the capsule and the viscosity ratio of the raw materials.
Preferably, in the step (4), the fine drying temperature is 30-50 ℃, and the water content of the empty capsule which is produced off the machine is 2% at the lowest.
Preferably, in the step (1), medicinal grade or food grade pigment is also added, and the addition amount is 0-5.0 wt%.
The invention provides a novel capsule shaping mode after dipping the hollow capsule in glue, the provided shaping mode is suitable for materials which have good film-forming performance and do not have gel performance, such as cellulose, and the shaping mode not only can effectively reduce the shaping control temperature and save energy compared with the high-temperature thermal gel shaping mode which adopts hydroxypropyl methylcellulose, but also is suitable for the cellulose without thermal gel characteristic, thereby widening the selection space of capsule materials.
The principle of drying and shaping in the invention is as follows: the compressed air causes the local air to flow rapidly, thereby accelerating the rapid loss of the moisture of the glue solution on the die, and along with the rapid dehydration of the glue solution on the die, the content of the cellulose with different viscosities is rapidly increased, the viscosity is also rapidly increased, and the purpose of sizing the glue solution is achieved.
Compared with the prior art, the invention achieves the following beneficial effects:
(1) the hollow capsule produced by the invention completely accords with the regulation of Chinese pharmacopoeia, the water content of the hollow capsule is as low as 2 percent, and the hollow capsule is more suitable for filling and using water-absorbing medicinal powder, thereby expanding the application range of the hollow capsule and providing a better choice for pharmaceutical factories;
(2) the compressed air is introduced and used, so that the drying time of the hollow capsule is reduced by 30 percent, the production period is shortened, and the production efficiency is improved;
(3) according to the invention, a single film-forming material is used, and the drying and shaping scheme is adopted, so that the produced hollow capsule does not contain any gelling agent, and the dissolution performance of the medicine is more stable;
(4) the use of the high-viscosity cellulose improves the toughness of the hollow capsule, reduces the water content of the hollow capsule, and the capsule can not be brittle when the water content of the hollow capsule is at least 2 percent;
(5) the invention can realize the recovery of the annular capsule shell-stub bar generated after the hollow capsule is cut, thereby saving the preparation cost of the hollow capsule;
(6) the invention can be added with medicinal grade and food grade pigments with the addition amount of 0-5.0 percent to produce colored capsules.
Detailed Description
The present invention will be further described with reference to the following examples.
Example 1
Adding 20kg of 3.0mpa.s hydroxypropyl methylcellulose, 75kg of 6.5mpa.s hydroxypropyl methylcellulose and 5kg of 50mpa.s hydroxypropyl methylcellulose into a sol-gel tank, then adding 550kg of 75 ℃ purified water, starting stirring at the stirring speed of 25r/min, and naturally cooling to 50 ℃ to form transparent uniform bubble-free sol.
Transferring the glue solution to a full-automatic capsule production line provided with a 0# mould, and carrying out glue dipping, drying and shaping, fine drying, demoulding, cutting, nesting and demoulding, cutting and nesting to obtain the transparent hydroxypropyl methyl cellulose hollow capsule.
The drying and shaping parameters are set as follows: the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 12m/s, the drying time of the compressed air is 4 seconds, and the fine drying temperature is set to be 45 ℃.
The water content of the empty capsule in the machine is 2.4 wt%.
Example 2
Adding 35kg of 3.0mpa.s hydroxypropyl methylcellulose, 50kg of 6.5mpa.s hydroxypropyl methylcellulose and 15kg of 50mpa.s hydroxypropyl methylcellulose into a sol tank, then adding 600kg of purified water at 75 ℃, starting stirring at the stirring speed of 15r/min, and naturally cooling to 40 ℃ to form transparent uniform bubble-free sol.
Transferring the glue solution to a full-automatic capsule production line provided with a 0# mould, and carrying out glue dipping, drying and shaping, fine drying, demoulding, cutting, nesting and demoulding, cutting and nesting to obtain the transparent hydroxypropyl methyl cellulose hollow capsule.
The drying and shaping parameters are set as follows: the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 15m/s, the drying time of the compressed air is 5 seconds, and the fine drying temperature is set to be 50 ℃.
The water content of the empty capsule of the machine is 2.1 wt%.
Example 3
Adding 100kg of stub bar into a sol tank, then adding 550kg of purified water with the temperature of 75 ℃, starting stirring at the stirring speed of 25r/min, and naturally cooling to 45 ℃ to form transparent uniform sol liquid without bubbles.
Transferring the glue solution to a full-automatic capsule production line provided with a 0# mould, and carrying out glue dipping, drying and shaping, fine drying, demoulding, cutting, nesting and demoulding, cutting and nesting to obtain the transparent hydroxypropyl methyl cellulose hollow capsule.
The drying and shaping parameters are set as follows: the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 12m/s, the drying time of the compressed air is 4 seconds, and the fine drying temperature is set to be 45 ℃.
The water content of the empty capsule in the machine is 2.5 wt%.
Example 4
Adding 25kg of 3.0mpa.s methyl cellulose, 65kg of 6.5mpa.s hydroxyethyl cellulose and 10kg of 50mpa.s hydroxyethyl methyl cellulose into a sol-dissolving tank, then adding 600kg of purified water at 75 ℃, starting stirring at the stirring speed of 18r/min, and naturally cooling to 45 ℃ to form transparent uniform gel liquid without bubbles.
Transferring the glue solution to a full-automatic capsule production line provided with a 0# mould, and carrying out glue dipping, drying and shaping, fine drying, demoulding, cutting, nesting and demoulding, cutting and nesting to obtain the transparent hydroxypropyl methyl cellulose hollow capsule.
The drying and shaping parameters are set as follows: the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 10m/s, the drying time of the compressed air is 3 seconds, and the fine drying temperature is set to be 30 ℃.
The water content of the empty capsule in the machine is 5.4 wt%.
Example 5
Adding 20kg of 3.0mpa.s hydroxypropyl methylcellulose, 75kg of 6.5mpa.s hydroxypropyl methylcellulose and 5kg of 50mpa.s hydroxypropyl methylcellulose into a sol tank, then adding 550kg of purified water at 75 ℃, starting stirring at the stirring speed of 25r/min, naturally cooling to 50 ℃, and then adding 0.3kg of food-grade lemon yellow pigment to form yellow bubble-free uniform sol liquid.
Transferring the glue solution to a full-automatic capsule production line provided with a 0# mould, and carrying out glue dipping, drying and shaping, fine drying, demoulding, cutting, nesting and demoulding, cutting and nesting to obtain the yellow hydroxypropyl methyl cellulose hollow capsule.
The drying and shaping parameters are set as follows: the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 13m/s, the drying time of the compressed air is 4 seconds, and the fine drying temperature is set to be 45 ℃.
The water content of the empty capsule in the machine is 2.3 wt%.
Comparative example 1
Adding 20kg of 3.0mpa.s hydroxypropyl methylcellulose and 80kg of 6.5mpa.s hydroxypropyl methylcellulose into a sol tank, adding no 50mpa.s hydroxypropyl methylcellulose, adding 550kg of 75 ℃ purified water, stirring at the speed of 25r/min, and naturally cooling to 50 ℃ to form transparent uniform bubble-free sol.
Transferring the glue solution to a full-automatic capsule production line provided with a 0# mould, and carrying out glue dipping, drying and shaping, fine drying, demoulding, cutting, nesting and demoulding, cutting and nesting to obtain the transparent hydroxypropyl methyl cellulose hollow capsule.
The drying and shaping parameters are set as follows: the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 10m/s, the drying time of the compressed air is 3 seconds, and the fine drying temperature is set to be 45 ℃.
The water content of the empty capsule in the machine is 3.0 wt%.
The detection data of each item of the obtained cellulose empty capsule are shown in table 1.
TABLE 1
Of course, the foregoing is only a preferred embodiment of the invention and should not be taken as limiting the scope of the embodiments of the invention. The present invention is not limited to the above examples, and equivalent changes and modifications made by those skilled in the art within the spirit and scope of the present invention should be construed as being included in the scope of the present invention.
Claims (9)
1. A preparation method of a plant empty capsule is characterized by comprising the following steps: the method comprises the following steps:
(1) weighing 100 parts of cellulose according to parts by mass, adding 300-600 parts of purified water with the temperature of over 75 ℃, and stirring until the cellulose is dissolved to form cellulose glue;
(2) transferring the glue solution to a glue groove of a full-automatic capsule production line, and dipping the glue solution at room temperature;
(3) after the mould dipped with the glue runs to an upper platform of a full-automatic capsule production line, drying and shaping the capsule by using compressed air;
(4) after shaping, fine drying, demoulding, cutting and sleeving are finished on a full-automatic capsule production line to obtain the plant hollow capsule.
2. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: the cellulose is a mixture with three viscosities of 3.0mPa.s, 6.5mPa.s and 50 mPa.s.
3. The method for preparing the plant empty capsule according to claim 2, wherein the method comprises the following steps: cellulose having a viscosity of 3.0mpa.s is 20-35% by weight of the mixture, cellulose having a viscosity of 6.5mpa.s is 50-75% by weight of the mixture, and cellulose having a viscosity of 50mpa.s is 5-15% by weight of the mixture.
4. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: the cellulose is one or more of hydroxypropyl methylcellulose, hydroxyethyl methylcellulose, methylcellulose or hydroxyethyl cellulose.
5. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: in the step (1), when stirring at low speed, the stirring speed is controlled at 15-25r/min, and the temperature of the cellulose gel is 35-50 ℃.
6. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: in the step (3), the pressure of the compressed air is 0.5MPa, the flow rate of the compressed air is controlled to be 10-15m/s, and the drying time of the compressed air is 3-5 seconds.
7. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: in the step (3), the water loss of the glue solution on the mould is controlled to be 50-60 wt% in the drying and shaping process.
8. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: in the step (4), the fine drying temperature is 30-50 ℃, and the lowest water content of the empty capsule after production is 2%.
9. The method for preparing a plant empty capsule according to claim 1, wherein the method comprises the following steps: in the step (1), medicinal grade or food grade pigment is also added, and the adding amount is 0-5.0 wt%.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110313263.8A CN112791059A (en) | 2021-03-24 | 2021-03-24 | Preparation method of plant empty capsule |
| ZA2022/02525A ZA202202525B (en) | 2021-03-24 | 2022-03-01 | Preparation method of hollow vegetable capsule |
| LU501607A LU501607B1 (en) | 2021-03-24 | 2022-03-07 | Preparation method of hollow vegetable capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110313263.8A CN112791059A (en) | 2021-03-24 | 2021-03-24 | Preparation method of plant empty capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN112791059A true CN112791059A (en) | 2021-05-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110313263.8A Pending CN112791059A (en) | 2021-03-24 | 2021-03-24 | Preparation method of plant empty capsule |
Country Status (3)
| Country | Link |
|---|---|
| CN (1) | CN112791059A (en) |
| LU (1) | LU501607B1 (en) |
| ZA (1) | ZA202202525B (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947709A (en) * | 2005-10-14 | 2007-04-18 | 上海众伟生化有限公司 | Vegetative hard capsule casing material and its prodn. method |
| CN101023934A (en) * | 2006-12-26 | 2007-08-29 | 北京理工大学 | Method for preparing novel medicine capsule and plant capsule |
| CN102499985A (en) * | 2011-12-15 | 2012-06-20 | 山西吉呈生物技术有限公司 | Hard-shell capsule based on cellulose |
| CN103656655A (en) * | 2013-12-11 | 2014-03-26 | 江苏力凡胶囊有限公司 | Empty capsule and preparation method thereof |
| CN105056245A (en) * | 2015-07-31 | 2015-11-18 | 刘百平 | Process for manufacturing hydroxypropyl methyl cellulose hollow capsules |
| CN112353777A (en) * | 2020-11-27 | 2021-02-12 | 青岛聚大洋藻业集团有限公司 | Hydroxypropyl methylcellulose hollow capsule containing silicon dioxide and preparation method thereof |
-
2021
- 2021-03-24 CN CN202110313263.8A patent/CN112791059A/en active Pending
-
2022
- 2022-03-01 ZA ZA2022/02525A patent/ZA202202525B/en unknown
- 2022-03-07 LU LU501607A patent/LU501607B1/en active IP Right Grant
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1947709A (en) * | 2005-10-14 | 2007-04-18 | 上海众伟生化有限公司 | Vegetative hard capsule casing material and its prodn. method |
| CN101023934A (en) * | 2006-12-26 | 2007-08-29 | 北京理工大学 | Method for preparing novel medicine capsule and plant capsule |
| CN102499985A (en) * | 2011-12-15 | 2012-06-20 | 山西吉呈生物技术有限公司 | Hard-shell capsule based on cellulose |
| CN103656655A (en) * | 2013-12-11 | 2014-03-26 | 江苏力凡胶囊有限公司 | Empty capsule and preparation method thereof |
| CN105056245A (en) * | 2015-07-31 | 2015-11-18 | 刘百平 | Process for manufacturing hydroxypropyl methyl cellulose hollow capsules |
| CN112353777A (en) * | 2020-11-27 | 2021-02-12 | 青岛聚大洋藻业集团有限公司 | Hydroxypropyl methylcellulose hollow capsule containing silicon dioxide and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| LU501607B1 (en) | 2022-09-26 |
| ZA202202525B (en) | 2022-05-25 |
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