CN110154284B - Release agent for hollow hard capsules and preparation method thereof - Google Patents
Release agent for hollow hard capsules and preparation method thereof Download PDFInfo
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- CN110154284B CN110154284B CN201910514418.7A CN201910514418A CN110154284B CN 110154284 B CN110154284 B CN 110154284B CN 201910514418 A CN201910514418 A CN 201910514418A CN 110154284 B CN110154284 B CN 110154284B
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- release agent
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- starch
- carnauba wax
- sodium dodecyl
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C33/00—Moulds or cores; Details thereof or accessories therefor
- B29C33/56—Coatings, e.g. enameled or galvanised; Releasing, lubricating or separating agents
- B29C33/60—Releasing, lubricating or separating agents
- B29C33/62—Releasing, lubricating or separating agents based on polymers or oligomers
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Abstract
The invention discloses a release agent for hollow hard capsules and a preparation method thereof, wherein the release agent is prepared from the following components in parts by weight, wherein the components comprise 500-510 parts of purified water, 15-20 parts of carnauba wax, 20-25 parts of starch and 1-3 parts of sodium dodecyl sulfate. Mixing sodium dodecyl sulfate with purified water, adding starch, heating to 35-40 deg.C, stirring, adding carnauba wax, heating to 70-80 deg.C under 1.5-2 atmospheric pressure, stirring, naturally cooling to 40 deg.C, and filtering to obtain the release agent. Compared with the prior art, the release agent disclosed by the invention is simple in components, reduces the addition of grease on the basis of ensuring the release effect, and ensures the safety of the release agent. Because the addition of fat and oil with nutritive value is reduced, the antibacterial property of the release agent is improved under the condition of not adding a preservative.
Description
Technical Field
The invention belongs to the technical field of hard capsule preparation, and particularly relates to a release agent for hollow hard capsules and a preparation method thereof.
Background
The capsule is used as a dosage form for solid, semi-solid, liquid, pill or herbal preparation, and provides good disintegrability after administration, ensures the active substance to pass through intestines and stomach, and reduces dissolution waste. At present, the hollow capsule is prepared by taking gelatin extracted from cow bones or pigskin as a main raw material, and the gelatin has good characteristics when being prepared into the capsule. In the production of hollow capsules, the release agent is selected and used in consideration of the fact that the quality of the capsule after being formed and released directly influences the qualification rate of products.
The existing release agents are various in types, most of the release agents take grease as an active ingredient, but the application of a large amount of grease can lead the obtained release agent to have poor antibacterial property, the mold after production is difficult to clean, in addition, because the grease is easy to breed bacteria, in order to prolong the quality of the hollow capsule, a preservative is selected, and the physical and mental health of human beings is also influenced. It is worth exploring how to select a release agent which is safe in ingredients, low in cost and simple to prepare.
Disclosure of Invention
Aiming at the technical problems, the invention provides the release agent for the hollow hard capsules and the preparation method thereof, the release agent has simple components, and the synergistic promotion effect of the carnauba wax and the sodium dodecyl sulfate improves the release effect of the release agent.
The release agent for the hollow hard capsules comprises, by weight, 500-510 parts of purified water, 15-20 parts of carnauba wax, 20-25 parts of starch and 1-3 parts of sodium dodecyl sulfate.
The improvement is that the release agent for the hollow hard capsules comprises the following components in parts by weight: 508 parts of purified water, 17 parts of carnauba wax, 23 parts of starch and 2 parts of sodium dodecyl sulfate.
In a refinement, the starch is corn starch.
The improvement is that the coating film material of the hollow hard capsule is gelatin.
The preparation method of the release agent for the hollow hard capsules comprises the following steps:
step 1, weighing purified water, carnauba wax, starch and sodium dodecyl sulfate according to parts by weight; and 2, mixing the sodium dodecyl sulfate with the purified water, adding the starch, heating to 35-40 ℃, uniformly stirring, adding the carnauba wax, heating to 70-80 ℃ under 1.5-2 atmospheric pressures, continuously stirring, naturally cooling to 40 ℃, and filtering to obtain the release agent.
The improvement is that when the temperature is heated to 35-40 ℃ in the step 2, the temperature rise speed is 1-2 ℃/min.
As a modification, the stirring speed in step 2 was 150-200 rpm.
The improvement is that when the temperature is heated to 70-80 ℃ in the step 2, the temperature rise speed is 5-12 ℃/min.
Has the advantages that:
compared with the prior art, the release agent disclosed by the invention is simple in components, reduces the addition of grease on the basis of ensuring the release effect, and ensures the safety of the release agent. Because the addition of fat and oil with nutritive value is reduced, the antibacterial property of the release agent is improved under the condition of not adding a preservative. In addition, the synergistic effect of the sodium dodecyl sulfate and the carnauba wax promotes the demoulding effect of the hard capsule, and has good market prospect.
Detailed Description
The invention is further described with reference to specific examples.
Example 1
The release agent for the hollow hard capsules consists of 500 parts by weight of purified water, 15 parts by weight of carnauba wax, 20 parts by weight of corn starch and 1 part by weight of sodium dodecyl sulfate.
The preparation method of the release agent for the hollow hard capsules comprises the following steps:
step 1, weighing purified water, carnauba wax, starch and sodium dodecyl sulfate according to parts by weight;
and 2, mixing the sodium dodecyl sulfate with the purified water, adding starch, heating to 35 ℃ at a heating rate of 1 ℃/min, uniformly stirring at 150rpm, adding carnauba wax, heating to 70 ℃ at a heating rate of 5 ℃/min under 1.5 atmospheric pressures, continuously stirring, and filtering when naturally cooling to 40 ℃ to obtain the release agent.
The release agent of the embodiment 1 is used for producing gelatin hard hollow capsules, according to the national standard detection, the release condition of the release agent in application is determined, the A-type defect proportion is 0.85%, the B-type defect proportion is 3%, the C-type defect proportion is 5.2%, the release effect is good, the physicochemical indexes of the obtained hard capsules are not influenced, and the qualification rate of products is 92.8%.
Example 2
The release agent for the hollow hard capsules consists of 508 parts of purified water, 17 parts of carnauba wax, 23 parts of corn starch and 2 parts of sodium dodecyl sulfate by weight.
The preparation method of the release agent for the hollow hard capsules comprises the following steps:
step 1, weighing purified water, carnauba wax, starch and sodium dodecyl sulfate according to parts by weight;
and 2, mixing the sodium dodecyl sulfate with the purified water, adding starch, heating to 38 ℃ at a heating rate of 1.8 ℃/min, uniformly stirring at 178rpm, adding carnauba wax, heating to 75 ℃ at a heating rate of 8 ℃/min under 2 atmospheres, continuously stirring, and filtering when naturally cooling to 40 ℃ to obtain the release agent.
The release agent of the embodiment 2 is used for producing gelatin hard hollow capsules, according to the national standard detection, the release condition of the release agent in application is determined, the A-type defect proportion is 0.78%, the B-type defect proportion is 2.8%, the C-type defect proportion is 3.5%, the release effect is good, the physical and chemical indexes of the obtained hard capsules are not influenced, and the product qualification rate is 96.4%.
Example 3
The release agent for the hollow hard capsules consists of 510 parts by weight of purified water, 20 parts by weight of carnauba wax, 25 parts by weight of corn starch and 3 parts by weight of sodium dodecyl sulfate.
The preparation method of the release agent for the hollow hard capsules comprises the following steps:
step 1, weighing purified water, carnauba wax, starch and sodium dodecyl sulfate according to parts by weight;
and 2, mixing the sodium dodecyl sulfate with the purified water, adding starch, heating to 40 ℃ at the heating rate of 2 ℃/min, uniformly stirring at 200rpm, adding carnauba wax, heating to 80 ℃ at the heating rate of 12 ℃/min under 2 atmospheric pressures, continuously stirring, naturally cooling to 40 ℃, and filtering to obtain the release agent.
The release agent of the embodiment 3 is used for producing the gelatin hard hollow capsule, according to the national standard detection, the release condition of the release agent in application is determined, the A-type defect proportion is 0.81 percent, the B-type defect proportion is 3.0 percent, the C-type defect proportion is 3.2 percent, the release effect is good, the physical and chemical indexes of the obtained hard capsule are not influenced, and the qualification rate of the product is 95.8 percent.
Comparative example 1
The same procedure as in example 2 was repeated except that in step 2, the temperature was raised to 75 ℃ at normal temperature and pressure at one time.
The release agent of the comparative example 1 is used for producing the gelatin hard hollow capsule, according to the national standard detection, the release condition of the release agent in application is determined, the A-type defect proportion is 0.95%, the B-type defect proportion is 4.5%, the C-type defect proportion is 6.2%, the release effect is good, the physicochemical indexes of the obtained hard capsule are not influenced, and the qualification rate of the product is 75.8%.
The corn starch serves as an adsorption substance and is effectively adhered to the die, the corn starch is gelatinized in a large amount by adopting one-step heating at normal temperature and normal pressure, after the mixing is finished, the effective components of the obtained release agent are greatly reduced by filtering, and the release effect after the application is also greatly influenced. Therefore, under a high-pressure environment, the heating can not only realize uniform stirring and mixing, but also ensure that the components are maximally used for preparing the release agent.
Comparative example 2
The procedure is as in example 2 except that carnauba wax is not included.
The release agent of the comparative example 2 is used for producing the gelatin hard hollow capsule, according to the national standard detection, the release condition of the release agent in application is detected, the determination shows that the A-type defect proportion is 0.90%, the B-type defect proportion is 3.8%, the C-type defect proportion is 4.5%, the release effect is good, the physicochemical indexes of the obtained hard capsule are not influenced, and the qualification rate of the product is 85.2%.
Comparative example 3
The procedure is as in example 2 except that sodium lauryl sulfate is not included.
The release agent of the comparative example 3 is used for producing the gelatin hard hollow capsule, according to the national standard detection, the release condition of the release agent in application is determined, the A-type defect proportion is 0.85%, the B-type defect proportion is 3.5%, the C-type defect proportion is 4.8%, the release effect is good, the physicochemical indexes of the obtained hard capsule are not influenced, and the qualification rate of the product is 83.4%.
The detection of the comparative example 2 and the comparative example 3 shows that the sodium dodecyl sulfate and the carnauba wax are adopted as the active agents in the components of the invention, so that the demolding effect of the demolding agent is improved, the cost input is reduced, a large amount of grease is reduced, and the reduction of the water consumption for mold cleaning is ensured.
Claims (8)
1. The release agent for the hollow hard capsules is characterized by comprising, by weight, 510 parts of purified water, 15-20 parts of carnauba wax, 20-25 parts of starch and 1-3 parts of sodium dodecyl sulfate.
2. The release agent for the hollow hard capsules as claimed in claim 1, wherein the components are respectively as follows in parts by weight: 508 parts of purified water, 17 parts of carnauba wax, 23 parts of starch and 2 parts of sodium dodecyl sulfate.
3. The release agent for an empty hard capsule according to claim 1, wherein the starch is corn starch.
4. The release agent for the hollow hard capsules according to claim 1, wherein the film material of the coating of the hollow hard capsules is gelatin.
5. A process for preparing the release agent for an empty hard capsule of claim 1, comprising the steps of: step 1, weighing purified water, carnauba wax, starch and sodium dodecyl sulfate according to parts by weight; and 2, mixing the sodium dodecyl sulfate with the purified water, adding the starch, heating to 35-40 ℃, uniformly stirring, adding the carnauba wax, heating to 70-80 ℃ under 1.5-2 atmospheric pressures, continuously stirring, naturally cooling to 40 ℃, and filtering to obtain the release agent.
6. The method for preparing a release agent for an empty hard capsule according to claim 5, wherein the temperature rise rate is 1-2 ℃/min when the heating is carried out to 35-40 ℃ in the step 2.
7. The method for preparing a release agent for hollow hard capsules according to claim 5, wherein the stirring speed in step 2 is 150-200 rpm.
8. The method for preparing a release agent for an empty hard capsule according to claim 5, wherein the temperature rise rate is 5-12 ℃/min when the temperature is raised to 70-80 ℃ in step 2.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201910514418.7A CN110154284B (en) | 2019-06-14 | 2019-06-14 | Release agent for hollow hard capsules and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910514418.7A CN110154284B (en) | 2019-06-14 | 2019-06-14 | Release agent for hollow hard capsules and preparation method thereof |
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| CN110154284A CN110154284A (en) | 2019-08-23 |
| CN110154284B true CN110154284B (en) | 2021-04-06 |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102248622A (en) * | 2011-06-30 | 2011-11-23 | 浙江大之医药胶囊有限公司 | Capsule mold release agent and preparation method thereof |
| CN104403737A (en) * | 2014-09-25 | 2015-03-11 | 安徽华盛科技控股股份有限公司 | Production process of CIT capsule demoulding agent |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0120835D0 (en) * | 2001-08-28 | 2001-10-17 | Smithkline Beecham Plc | Process |
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- 2019-06-14 CN CN201910514418.7A patent/CN110154284B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102248622A (en) * | 2011-06-30 | 2011-11-23 | 浙江大之医药胶囊有限公司 | Capsule mold release agent and preparation method thereof |
| CN104403737A (en) * | 2014-09-25 | 2015-03-11 | 安徽华盛科技控股股份有限公司 | Production process of CIT capsule demoulding agent |
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| CN110154284A (en) | 2019-08-23 |
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