CN112451501A - Soft capsule containing chloral hydrate and preparation method thereof - Google Patents
Soft capsule containing chloral hydrate and preparation method thereof Download PDFInfo
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- CN112451501A CN112451501A CN202011561929.3A CN202011561929A CN112451501A CN 112451501 A CN112451501 A CN 112451501A CN 202011561929 A CN202011561929 A CN 202011561929A CN 112451501 A CN112451501 A CN 112451501A
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- chloral hydrate
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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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/11—Aldehydes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/20—Hypnotics; Sedatives
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Abstract
The invention relates to the technical field of medicinal preparations, in particular to a medicinal preparation containing chloral hydrate, and particularly relates to a soft capsule shell and a preparation method thereof. An isolating layer is arranged between the gelatin capsule shell and the content of the chloral hydrate soft capsule. The isolating layer is cacao butter, cacao butter substitute, mixed fatty glyceride, polyethylene glycol, polyoxyl [ 40 ] stearate, poloxamer 188 or any combination thereof. The isolating layer prevents chloral hydrate from contacting with gelatin capsule skin, improves the stability of chloral hydrate and prevents aging of gelatin capsule skin. The safety and the effectiveness of the preparation are ensured.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a medicinal preparation containing chloral hydrate, and particularly relates to a soft capsule shell and a preparation method thereof.
Background
Chloral hydrate is effective in treating insomnia, and is suitable for patients with difficulty in falling asleep. As a hypnotic, the medicine has obvious effect, the sleeping state is close to natural sleeping, and the side effect is little. Meanwhile, the Chinese medicinal composition can be used as a medicament before anesthesia, before operation and before sleep electroencephalogram examination, can calm and relieve anxiety, and ensures that the corresponding treatment process is safer and more stable; it can also be used for treating convulsion, epilepsy, and convulsion due to infantile hyperpyrexia and tetanus. Thus, chloral hydrate is used for sedative hypnosis, particularly for children.
In the prior art, the feeding mode of the chloral hydrate is oral feeding and rectal feeding, and the chloral hydrate has strong irritation, bitter taste and special odor, so that crying, vomiting, even choking, choking and suffocation of children are easily caused, and the chloral hydrate is not easily accepted by families. Common rectal administration dosage forms include enemas and suppositories, rectal enema can be performed by a professional nurse, the process is complex, and the intestinal lavage liquid overflows carelessly slightly, so that administration dosage is wrong. The suppository is convenient to use and accurate in administration dosage, and a hollow suppository and a soft capsule suppository are preferably selected to ensure quick response.
The chloral hydrate has poor stability and is easy to decompose at high temperature. Therefore, the hospital preparation needs refrigeration, has the effective period of only 30 days, and cannot be popularized and used. The patent CN110151687A effectively improves the product stability of the chloral hydrate solution by reducing the pH value of the solution and simultaneously increasing the concentration of the chloral hydrate. However, the solution has a low pH value and a high concentration, which results in a poor taste of the product, and has a certain irritation, which is not suitable for direct administration, nor for rectal administration.
The structure of the chloral hydrate contains aldehyde groups, which can react with gelatin components in the soft capsule, so that the chloral hydrate is decomposed and the gelatin capsule skin is aged. In order to improve the stability of the preparation, patent CN101596174A provides an inner coating film capable of separating the content from the soft capsule shell, the coating film is composed of liquid paraffin, povidone, polyacrylic resin ii, polyvinyl alcohol 400 and citric acid, and the solvent is salad oil, which aims to solve the problems that the activity of the effective components of the traditional Chinese medicine is affected and the soft capsule shell is denatured, leaked and locally deformed due to the reaction between the natural acid or natural aldehyde ketone in the traditional Chinese medicine and the soft capsule shell after the soft capsule in the prior art is coated with the traditional Chinese medicine content. The method has complex components and special requirements on the process and equipment.
Patent CN111643476A provides a soft capsule having a film coating between the gelatin capsule shell and the content, wherein the film coating is composed of hydroxypropyl methylcellulose HPMC, glycerol and water. The film coating prevents the capsule shell from directly contacting with the content, and prevents low molecular aldehydes in the soft capsule from generating crosslinking reaction on the gelatin capsule shell, thereby relieving the aging phenomenon of the capsule shell and improving the stability of the soft capsule. The rubber needs to be dried for 2 times, and no existing equipment is available for industrial mass production.
Disclosure of Invention
In view of the problems of the prior art, the present invention is to provide a stable soft capsule containing chloral hydrate. In addition, a preparation method and application of the chloral hydrate soft capsule are provided.
In order to realize the above, the invention adopts the following technical scheme.
The invention provides a chloral hydrate soft capsule, wherein an isolating layer is arranged between a gelatin capsule shell and a content of the soft capsule.
The isolating layer is selected from one or more of cocoa butter, cocoa butter substitute, mixed fatty glyceride, polyethylene glycol, polyoxyl (40) stearate or poloxamer 188.
The gelatin capsule shell at least contains gelatin, glycerol and water.
The contents contain at least chloral hydrate and polyethylene glycol.
The contents at least contain chloral hydrate and polyethylene glycol-400.
The isolating layer, preferably the isolating layer, is selected from one or more of mixed fatty glyceride 34 type, mixed fatty glyceride 36 type, mixed fatty glyceride 38 type, polyethylene glycol-600, polyethylene glycol-800, or polyethylene glycol-1000, and any combination thereof.
The invention provides a preparation method of a chloral hydrate soft capsule, which is characterized by comprising the following steps of uniformly spreading gelatin glue solution by using a soft capsule pelleting press, cooling the gelatin glue solution into a rubber, spreading isolation layer solution on the surface of the rubber, and pressing the content wrapped by the rubber with the isolation layer spread into the soft capsule.
The invention provides a preparation method of the chloral hydrate soft capsule, which comprises the following steps,
step 1, preparing gelatin liquid: heating the prescribed amount of water, glycerol and gelatin in a gelatin melting tank, and mixing uniformly;
step 2, preparing contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved;
step 3, preparing an isolating layer solution: heating the components of the isolating layer until the components are melted to obtain isolating layer liquid;
and 4, uniformly spreading the gelatin glue solution by using a soft capsule pelleting press, cooling to obtain a rubber, spreading the isolating layer solution on the surface of the rubber, wrapping the content of the rubber with the isolating layer, pressing to obtain the soft capsule, and finally drying to obtain the soft capsule.
The invention provides a preparation method of chloral hydrate soft capsules, which comprises the following specific steps
Step 1, preparing gelatin liquid: heating water, glycerol and gelatin in a gelatin melting tank to 70-80 deg.C, mixing, keeping the temperature for 1-2 hr, standing, and removing bubbles by vacuum to obtain gelatin solution;
step 2, preparing contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved to obtain a content;
step 3, preparing an isolating layer solution: heating the components of the isolating layer until the components are melted to obtain isolating layer liquid;
and 4, uniformly spreading the gelatin glue solution by using a soft capsule pelleting press, cooling to obtain a rubber, spreading the isolating layer solution on the surface of the rubber (the surface is contacted with the content), wrapping the content by the rubber with the isolating layer, pressing to obtain the soft capsule, and finally drying until the water content of the rubber is about 10 percent. The isolation layer removes the contents.
The invention provides application of the chloral hydrate soft capsule in preparing a medicament for treating insomnia, hypnosis, sedation, anticonvulsant or epilepsy persistence.
Compared with the prior art, the invention has the following beneficial effects.
The invention adds isolation in the inner layer of the hydrated chloral soft capsule rubber, avoids the direct contact between the capsule skin and the content, and prevents the reaction between the hydrated chloral and the gelatin. Improves the stability of the chloral hydrate, reduces the aging of the capsule skin, and ensures the release and the bioavailability.
Detailed Description
The technical scheme and the technical effect of the invention are described in detail by combining specific embodiments. The following examples are only preferred embodiments of the present invention, and are not intended to limit the present invention, and it will be apparent to those skilled in the art that various changes and modifications can be made in the present invention, and any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the scope of the present invention.
To demonstrate the protection of chloral hydrate and capsule skin with and without an isolation layer, comparative experiments were conducted.
Example 1
Prescription: 80 parts of gelatin, 20 parts of glycerol, 80 parts of water, 50 parts of chloral hydrate, 80 parts of polyethylene glycol-40080 parts and a proper amount of mixed fatty glyceride 34.
The process comprises the following steps: preparing gelatin liquid: heating water, glycerol and gelatin in a gelatin melting tank to 70 deg.C, mixing, keeping the temperature for 2 hr, standing, and removing bubbles under vacuum to obtain gelatin solution.
Preparation of contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved to obtain the content.
Preparing an isolating layer solution: heating mixed fatty glyceride 34 to 35 deg.C to melt to obtain isolation layer solution.
Adding gelatin solution into 60 deg.C capsule box with soft capsule pelleting machine, spreading on rubber wheel, cooling to obtain rubber sheet, spreading the rubber sheet on the surface of the rubber sheet (the surface will contact with the content) via isolation layer spreading wheel, injecting the content into the capsule through spray body and pressing wheel, making into soft capsule, and drying until the water content of the rubber sheet is about 10%.
Example 2
Prescription: 80 parts of gelatin, 20 parts of glycerol, 80 parts of water, 50 parts of chloral hydrate, 80 parts of polyethylene glycol-40080 parts and a proper amount of polyethylene glycol-800.
The process comprises the following steps: preparing gelatin liquid: heating water, glycerol and gelatin in a gelatin melting tank to 70 deg.C, mixing, keeping the temperature for 2 hr, standing, and removing bubbles under vacuum to obtain gelatin solution.
Preparation of contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved to obtain the content.
Preparing an isolating layer solution: heating polyethylene glycol-800 to 30 deg.C to melt to obtain isolation layer solution.
Adding gelatin solution into 60 deg.C capsule box with soft capsule pelleting machine, spreading on rubber wheel, cooling to obtain rubber sheet, spreading the rubber sheet on the surface of the rubber sheet (the surface will contact with the content) via isolation layer spreading wheel, injecting the content into the capsule through spray body and pressing wheel, making into soft capsule, and drying until the water content of the rubber sheet is about 10%.
Example 3
Prescription: 80 parts of gelatin, 20 parts of glycerol, 80 parts of water, 50 parts of chloral hydrate, 80 parts of polyethylene glycol-40080, and proper amounts of polyethylene glycol-800 and polyethylene glycol-600.
The process comprises the following steps: preparing gelatin liquid: heating water, glycerol and gelatin in a gelatin melting tank to 70 deg.C, mixing, keeping the temperature for 2 hr, standing, and removing bubbles under vacuum to obtain gelatin solution.
Preparation of contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved to obtain the content.
Preparing an isolating layer solution: taking polyethylene glycol-600 and polyethylene glycol-800 according to the ratio of 1:1, heating to 25 ℃ to melt, and obtaining the isolating layer liquid.
Adding gelatin solution into 60 deg.C capsule box with soft capsule pelleting machine, spreading on rubber wheel, cooling to obtain rubber sheet, spreading the rubber sheet on the surface of the rubber sheet (the surface will contact with the content) via isolation layer spreading wheel, injecting the content into the capsule through spray body and pressing wheel, making into soft capsule, and drying until the water content of the rubber sheet is about 10%.
Comparative example 1
Prescription: 80 parts of gelatin, 20 parts of glycerol, 80 parts of water, 50 parts of chloral hydrate and 80 parts of polyethylene glycol-400.
The process comprises the following steps: preparing gelatin liquid: heating water, glycerol and gelatin in a gelatin melting tank to 70 deg.C, mixing, keeping the temperature for 2 hr, standing, and removing bubbles under vacuum to obtain gelatin solution.
Preparation of contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved to obtain the content.
Adding gelatin solution into 60 deg.C capsule box with soft capsule pelleting machine, spreading on rubber wheel, cooling to obtain rubber, injecting the content into capsule via spray body and pressing wheel, making into soft capsule, and drying until the water content of rubber is about 10%.
We performed stability lofting (25 ℃, 60% RH) on comparative example 1, examples 1, 2, 3, and performed the relevant material and melting time limit checks at 0, 1, 2, 3, and 6 months, respectively. The results for the relevant substances (% of chloroform degradation product) are given in the following table:
| sample (I) | 0 month | 1 month | 2 month | 3 month | 6 month |
| Comparative example 1 | 0.01 | 0.73 | 1.34 | 1.98 | 3.56 |
| Example 1 | 0.01 | 0.08 | 0.15 | 0.21 | 0.40 |
| Example 2 | 0.01 | 0.07 | 0.13 | 0.18 | 0.33 |
| Example 3 | 0.01 | 0.07 | 0.14 | 0.18 | 0.34 |
Melting time limit result: comparative example 1 an insoluble film appeared after standing for 3 months at 25 ℃ and 60% RH, and the insoluble film became denser by 6 months and the drug could not be released. The insoluble film does not appear in the months of examples 1, 2 and 3 to 6, the melting time is less than 50 minutes, and the method conforms to the regulation of the Chinese pharmacopoeia 2015 edition.
Claims (10)
1. The chloral hydrate soft capsule is characterized in that an isolating layer is arranged between a gelatin capsule shell and contents of the soft capsule.
2. The chloral hydrate soft capsule of claim 1, wherein the barrier layer is selected from one or more of cocoa butter, cocoa butter replacers, mixed fatty acid glycerides, polyethylene glycol, polyoxyl (40) stearate, or poloxamer 188.
3. The chloral hydrate soft capsule according to claim 1 or 2, wherein the gelatin capsule shell contains at least gelatin, glycerin and water.
4. The chloral hydrate soft capsule according to claim 1 or 2, wherein the content contains at least chloral hydrate and polyethylene glycol.
5. The chloral hydrate soft capsule according to claim 1 or 2, wherein the contents contain at least chloral hydrate and polyethylene glycol-400.
6. The chloral hydrate soft capsule according to any one of claims 1 to 5, wherein the barrier layer is selected from one or more of mixed fatty glyceride 34 type, mixed fatty glyceride 36 type, mixed fatty glyceride 38 type, polyethylene glycol-600, polyethylene glycol-800, or polyethylene glycol-1000.
7. The method for preparing a chloral hydrate soft capsule according to any one of claims 1 to 6, comprising the steps of spreading the gelatin solution uniformly and cooling to form a gelatin skin by a soft capsule pelleting machine, spreading the separating layer solution on the surface of the gelatin skin, and compressing the content of the gelatin skin coated with the separating layer to form the soft capsule.
8. The method for preparing chloral hydrate soft capsules according to claim 7, comprising the steps of,
step 1, preparing gelatin liquid: heating the prescribed amount of water, glycerol and gelatin in a gelatin melting tank, and mixing uniformly;
step 2, preparing contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved;
step 3, preparing an isolating layer solution: heating the components of the isolating layer until the components are melted to obtain isolating layer liquid;
and 4, uniformly spreading the gelatin glue solution by using a soft capsule pelleting press, cooling to obtain a rubber, spreading the isolating layer solution on the surface of the rubber, wrapping the content of the rubber with the isolating layer, pressing to obtain the soft capsule, and finally drying to obtain the soft capsule.
9. The method for preparing chloral hydrate soft capsules according to claim 7, comprising the following steps
Step 1, preparing gelatin liquid: heating water, glycerol and gelatin in a gelatin melting tank to 70-80 deg.C, mixing, keeping the temperature for 1-2 hr, standing, and removing bubbles by vacuum to obtain gelatin solution;
step 2, preparing contents: taking the prescription amount of chloral hydrate and polyethylene glycol-400, and stirring until the chloral hydrate and the polyethylene glycol-400 are dissolved to obtain a content;
step 3, preparing an isolating layer solution: heating the components of the isolating layer until the components are melted to obtain isolating layer liquid;
and 4, uniformly spreading the gelatin glue solution by using a soft capsule pelleting press, cooling to obtain a rubber, spreading the isolating layer solution on the surface of the rubber, wrapping the content of the rubber with the spread isolating layer, pressing to obtain the soft capsule, and finally drying until the water content of the rubber is about 10 percent.
10. Use of the chloral hydrate soft capsules according to any one of claims 1 to 6 for the preparation of a medicament for the treatment of insomnia, hypnosis, sedation, anticonvulsant, or depressive disorders.
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| CN202011561929.3A CN112451501B (en) | 2020-12-25 | 2020-12-25 | A soft capsule containing chloral hydrate and its preparation method |
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| CN202011561929.3A CN112451501B (en) | 2020-12-25 | 2020-12-25 | A soft capsule containing chloral hydrate and its preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115721627A (en) * | 2022-11-10 | 2023-03-03 | 南通华山药业有限公司 | Motherwort soft capsule and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB752362A (en) * | 1953-11-09 | 1956-07-11 | Scherer Corp R P | Plasticized gelatin capsules |
| CN101596174A (en) * | 2009-07-13 | 2009-12-09 | 北京航洋胶囊技术有限公司 | A kind of soft capsule and preparation method thereof |
| CN105434393A (en) * | 2014-09-25 | 2016-03-30 | 四川国为制药有限公司 | Soft capsule containing high-content omega-3 polyunsaturated fatty acid |
| CN111643476A (en) * | 2020-07-22 | 2020-09-11 | 辽宁中医药大学 | Soft capsule shell and preparation method thereof |
-
2020
- 2020-12-25 CN CN202011561929.3A patent/CN112451501B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB752362A (en) * | 1953-11-09 | 1956-07-11 | Scherer Corp R P | Plasticized gelatin capsules |
| CN101596174A (en) * | 2009-07-13 | 2009-12-09 | 北京航洋胶囊技术有限公司 | A kind of soft capsule and preparation method thereof |
| CN105434393A (en) * | 2014-09-25 | 2016-03-30 | 四川国为制药有限公司 | Soft capsule containing high-content omega-3 polyunsaturated fatty acid |
| CN111643476A (en) * | 2020-07-22 | 2020-09-11 | 辽宁中医药大学 | Soft capsule shell and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 山西锦洋药用辅料有限公司: "药用级混合脂肪酸甘油酯医用辅料药典标准", 《化工仪器网》 * |
| 王艳霞: "癫持续状态的急救及其并发症的预防", 《中国煤炭工业医学杂志》 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115721627A (en) * | 2022-11-10 | 2023-03-03 | 南通华山药业有限公司 | Motherwort soft capsule and preparation method thereof |
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