CN115137711B - Preparation method of ganoderan slow-release capsule - Google Patents
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- CN115137711B CN115137711B CN202210668978.XA CN202210668978A CN115137711B CN 115137711 B CN115137711 B CN 115137711B CN 202210668978 A CN202210668978 A CN 202210668978A CN 115137711 B CN115137711 B CN 115137711B
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4891—Coated capsules; Multilayered drug free capsule shells
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
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- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P37/04—Immunostimulants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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Abstract
The invention discloses a preparation method of a ganoderan slow-release capsule, which relates to the technical field of traditional Chinese medicine preparations.
Description
Technical field:
the invention relates to the technical field of traditional Chinese medicine preparations, in particular to a preparation method of a ganoderan slow-release capsule.
The background technology is as follows:
ganoderan is a secondary metabolite of mycelia of fungus belonging to genus Ganoderma of family Polyporaceae, and is present in mycelia and fruiting body of fungus belonging to genus Ganoderma. Ganoderan is one of the most effective components of ganoderma lucidum, and is therefore particularly valued by the traditional Chinese medicine and technology workers, and the most research reports on ganoderan are also reported. The number of the separated ganoderan is 200 or more, and dozens of structures of the ganoderan are clarified, and the molecular weight of the ganoderan is measured.
Ganoderan has various pharmacological activities: improving immunity, accelerating blood microcirculation, improving oxygen supply capacity, reducing ineffective oxygen consumption in static state, eliminating free radicals, improving cell membrane sealing degree, resisting radiation, improving DNA, RNA and protein synthesis ability of liver, bone marrow and blood, and prolonging life. The various pharmacological activities of ganoderma lucidum are mostly related to ganoderan.
Because the ganoderan has specific physiological activity and clinical effect, is safe and nontoxic, and can be widely applied to the industries of medicines, foods and cosmetics. The ganoderma lucidum polysaccharide can improve the immunity of organisms, and can achieve the aim of curing diseases by being matched with radiotherapy and chemotherapy under the condition that the immunity of organisms of cancer patients is damaged by radiotherapy and chemotherapy. In addition, ganoderan can inhibit the release of allergic reaction medium, thus blocking the occurrence of nonspecific reaction, and thus can inhibit cancer cell recurrence and metastasis after operation. The lucid ganoderma preparation which is put into use comprises tablets, injection, medicinal granules, oral liquid, syrup, wine and the like, and has certain clinical curative effect. The invention aims to provide a ganoderan slow-release capsule, which improves the bioavailability of ganoderan through slow release.
The invention comprises the following steps:
the invention aims to solve the technical problem of providing a preparation method of a ganoderan slow-release capsule, which is characterized in that a ganoderan slow-release effect is given by a capsule coating mode, the release speed of ganoderan is controlled, and the action time of ganoderan is prolonged.
The technical problems to be solved by the invention are realized by adopting the following technical scheme:
the invention aims at providing a preparation method of a ganoderan slow-release capsule, which comprises the following steps:
(1) Preparing the contents, the hollow capsules and the coating material;
the content comprises ganoderan and a filler, the hollow capsule is a gelatin hollow capsule, and the coating material comprises a slow release agent, a plasticizer and an anti-sticking agent;
(2) Uniformly mixing ganoderan and a filler according to a weight ratio to obtain a content, and uniformly mixing a slow release agent, a plasticizer and an anti-sticking agent to obtain a coating material;
(3) Filling the content into gelatin hollow capsules to obtain ganoderan capsules;
(4) Adding a coating material into ethanol, and performing ultrasonic dispersion to obtain a coating liquid;
(5) Coating the ganoderan capsule with the coating solution, and drying to gain weight by 10-15% to obtain ganoderan sustained release capsule.
Preferably, the weight ratio of the ganoderan to the filler is (10-50): 50-90.
Preferably, the weight ratio of the slow release agent to the plasticizer to the anti-sticking agent is 100 (5-20): 1-10.
Preferably, the weight percentage of the coating material in the coating liquid is 30-40%.
Preferably, the filler is at least one of pregelatinized starch, microcrystalline cellulose, lactose, mannitol, sorbitol. Fillers, also known as diluents, are used to increase the weight or volume of the contents, thereby facilitating filling of the capsule.
Preferably, the sustained release agent is a copolymer of 3- (allylamino) ethyl propionate and S-allyl-D-cysteine, and the weight average molecular weight of the copolymer is 5000-50000. The copolymer forms gel after meeting water, delays the release of ganoderan in the capsule content, thereby playing the role of a slow release agent.
Further preferably, the molar ratio of the ethyl 3- (allylamino) propionate to the S-allyl-D-cysteine is (3-5): 1.
Preferably, the plasticizer is at least one of polyethylene glycol, propylene glycol and glycerin. The plasticizer has the functions of reducing the glass transition temperature of the slow release agent and improving the flexibility of the coating film.
Preferably, the anti-sticking agent is at least one of talcum powder, stearic acid and magnesium stearate. The anti-sticking agent has the function of adjusting the viscosity of the coating liquid and preventing the adhesion of the capsule.
The second purpose of the invention is to provide a ganoderan slow-release capsule prepared by the preparation method. The slow release capsule with ganoderan as the content is prepared by the preparation method, and the slow release effect of the capsule is controlled by a coating layer of the capsule.
The beneficial effects of the invention are as follows: the invention adopts a mode of coating the capsule to prepare the ganoderan slow-release capsule, the slow-release agent in the coating plays a role of controlling the release rate of ganoderan in the capsule content, reduces the fluctuation of peak valley of blood concentration, ensures that the ganoderan can play a role smoothly, reduces the taking times, improves the taking compliance of patients, reduces the total dosage of taking medicine, and improves the bioavailability of ganoderan.
Description of the drawings:
FIG. 1 shows in vitro release curves of ganoderan sustained release capsules prepared in examples and comparative examples of the present invention.
The specific embodiment is as follows:
the invention is further described in connection with the following embodiments in order to make the technical means, the creation features, the achievement of the purpose and the effect of the invention easy to understand.
No. 0 gelatin empty capsules were purchased from Aodone capsule physical plant.
Ganoderan is purchased from shanxi guanchen biotechnology limited, specification 50%.
Example 1
1. Preparation of the sustained release agent:
50mL of n-butanol is heated to 95 ℃, a mixed solution is added dropwise under the constant temperature condition, the mixed solution consists of 3- (allylamino) ethyl propionate (23.58 g,0.15 mol), S-allyl-D-cysteine (8.06 g,0.05 mol), 1.58g of benzoyl peroxide and 1.27g of dodecyl mercaptan, the reaction is continued for 3 hours at 95 ℃ after the completion of the dropwise addition in 1 hour, and the solvent is removed in a vacuum mode, so as to obtain the sustained release agent.
2. The preparation of the ganoderan slow-release capsule comprises the following steps:
(1) The contents, empty capsules and coating materials were prepared.
(2) According to the weight ratio, the ganoderan and the filler are uniformly mixed to obtain the content, and the sustained release agent, the plasticizer and the anti-sticking agent are uniformly mixed to obtain the coating material.
(3) Filling the content into 0# gelatin hollow capsule to obtain ganoderan capsule.
(4) And adding a coating material into ethanol, and performing ultrasonic dispersion to obtain a coating liquid, wherein the weight percentage of the coating material in the coating liquid is 30%.
(5) Coating the ganoderan capsule with the coating solution, drying, and weighting by 15% to obtain ganoderan sustained release capsule.
Example 2
1. Preparation of the sustained release agent:
50mL of n-butanol is heated to 95 ℃, mixed solution is added dropwise under the constant temperature condition, the mixed solution consists of 3- (allylamino) ethyl propionate (39.30 g,0.25 mol), S-allyl-D-cysteine (8.06 g,0.05 mol), 2.37g of benzoyl peroxide and 1.89g of dodecyl mercaptan, after the dropwise addition is completed in 1h, the reaction is continued for 3h at 95 ℃, and the solvent is removed in a vacuum mode, so as to obtain the sustained release agent.
2. The preparation of the ganoderan slow-release capsule comprises the following steps:
(1) The contents, empty capsules and coating materials were prepared.
(2) According to the weight ratio, the ganoderan and the filler are uniformly mixed to obtain the content, and the sustained release agent, the plasticizer and the anti-sticking agent are uniformly mixed to obtain the coating material.
(3) Filling the content into 0# gelatin hollow capsule to obtain ganoderan capsule.
(4) And adding a coating material into ethanol, and performing ultrasonic dispersion to obtain a coating liquid, wherein the weight percentage of the coating material in the coating liquid is 35%.
(5) Coating the ganoderan capsule with the coating solution, drying, and weighting by 12% to obtain ganoderan sustained release capsule.
Example 3
1. Preparation of the sustained release agent:
as in example 2.
2. The preparation of the ganoderan slow-release capsule comprises the following steps:
(1) The contents, empty capsules and coating materials were prepared.
(2) According to the weight ratio, the ganoderan and the filler are uniformly mixed to obtain the content, and the sustained release agent, the plasticizer and the anti-sticking agent are uniformly mixed to obtain the coating material.
(3) Filling the content into 0# gelatin hollow capsule to obtain ganoderan capsule.
(4) And adding a coating material into ethanol, and performing ultrasonic dispersion to obtain a coating liquid, wherein the weight percentage of the coating material in the coating liquid is 30%.
(5) Coating the ganoderan capsule with the coating solution, drying, and weighting by 10% to obtain ganoderan sustained release capsule.
Example 4
1. Preparation of the sustained release agent:
as in example 2.
2. The preparation of the ganoderan slow-release capsule comprises the following steps:
(1) The contents, empty capsules and coating materials were prepared.
(2) According to the weight ratio, the ganoderan and the filler are uniformly mixed to obtain the content, and the sustained release agent, the plasticizer and the anti-sticking agent are uniformly mixed to obtain the coating material.
(3) Filling the content into 0# gelatin hollow capsule to obtain ganoderan capsule.
(4) And adding a coating material into ethanol, and performing ultrasonic dispersion to obtain a coating liquid, wherein the weight percentage of the coating material in the coating liquid is 40%.
(5) Coating the ganoderan capsule with the coating solution, drying, and weighting by 10% to obtain ganoderan sustained release capsule.
Comparative example 1
1. Preparation of the sustained release agent:
as in example 2, except that S-allyl-D-cysteine was deleted, the amount of S-allyl-D-cysteine was added to ethyl 3- (allylamino) propionate.
2. The preparation of the ganoderan slow-release capsule comprises the following steps:
as in example 2.
Comparative example 2
1. Preparation of the sustained release agent:
as in example 2, except that ethyl 3- (allylamino) propionate was deleted, the amount of ethyl 3- (allylamino) propionate was added to S-allyl-D-cysteine.
2. The preparation of the ganoderan slow-release capsule comprises the following steps:
as in example 2.
Comparative example 3
The preparation of the ganoderan slow-release capsule comprises the following steps:
as in example 2, with the exception that Uttky RL-PO was used as the slow release agent.
The ganoderan sustained release capsules prepared in examples 1 to 4 and comparative examples 1 to 3 were taken as samples, according to the two-part release assay (appendix X D first method) of "chinese pharmacopoeia" 2010 edition, a dissolution assay (appendix X C first method) device was used, 900mL of phosphate buffer solution with ph=6.8 was used as a release medium, the rotation speed was 100rpm, 10mL was sampled at 37±0.5 ℃ at regular time (10 mL of release medium was simultaneously replenished), filtration was performed with a 0.45 μm microporous filter membrane, and 10 μl of the filtrate was precisely measured and injected into a high performance liquid chromatograph for release assay, and the results are shown in table 1. And the in vitro release profile was plotted according to the results, see figure 1.
TABLE 1
The foregoing has shown and described the basic principles and main features of the present invention and the advantages of the present invention. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, and that the above embodiments and descriptions are merely illustrative of the principles of the present invention, and various changes and modifications may be made without departing from the spirit and scope of the invention, which is defined in the appended claims. The scope of the invention is defined by the appended claims and equivalents thereof.
Claims (8)
1. The preparation method of the ganoderan slow-release capsule is characterized by comprising the following steps:
(1) Preparing the contents, the hollow capsules and the coating material;
the content comprises ganoderan and a filler, the hollow capsule is a gelatin hollow capsule, and the coating material comprises a slow release agent, a plasticizer and an anti-sticking agent;
(2) Uniformly mixing ganoderan and a filler according to a weight ratio to obtain a content, and uniformly mixing a slow release agent, a plasticizer and an anti-sticking agent to obtain a coating material;
(3) Filling the content into gelatin hollow capsules to obtain ganoderan capsules;
(4) Adding a coating material into ethanol, and performing ultrasonic dispersion to obtain a coating liquid;
(5) Coating the ganoderan capsule with coating liquid, and drying to gain weight by 10-15% to obtain ganoderan slow-release capsule;
the slow release agent is a copolymer of 3- (allylamino) ethyl propionate and S-allyl-D-cysteine, and the weight average molecular weight of the copolymer is 5000-50000; the mole ratio of the 3- (allylamino) ethyl propionate to the S-allyl-D-cysteine is (3-5): 1.
2. The method of manufacturing according to claim 1, characterized in that: the weight ratio of the ganoderan to the filler is (10-50) to (50-90).
3. The method of manufacturing according to claim 1, characterized in that: the weight ratio of the slow release agent to the plasticizer to the anti-sticking agent is 100 (5-20) to 1-10.
4. The method of manufacturing according to claim 1, characterized in that: the weight percentage of the coating material in the coating liquid is 30-40%.
5. The method of manufacturing according to claim 1, characterized in that: the filler is at least one of pregelatinized starch, microcrystalline cellulose, lactose, mannitol and sorbitol.
6. The method of manufacturing according to claim 1, characterized in that: the plasticizer is at least one of polyethylene glycol, propylene glycol and glycerin.
7. The method of manufacturing according to claim 1, characterized in that: the anti-sticking agent is at least one of talcum powder, stearic acid and magnesium stearate.
8. The ganoderan sustained-release capsule prepared by the preparation method according to any one of claims 1 to 7.
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| CN202210668978.XA CN115137711B (en) | 2022-06-14 | 2022-06-14 | Preparation method of ganoderan slow-release capsule |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101703532A (en) * | 2009-11-20 | 2010-05-12 | 天津市弗兰德医药科技发展有限公司 | Ganoderan polysaccharide pellet and preparation method thereof |
| CN113598356A (en) * | 2021-07-27 | 2021-11-05 | 康道生物（南通）有限公司 | Preparation process of ganoderma lucidum spore oil soft capsule |
| CN113797236A (en) * | 2021-10-15 | 2021-12-17 | 江西仙客来生物科技有限公司 | Ganoderma lucidum spore oil vitamin E soft capsule |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009105912A1 (en) * | 2008-02-26 | 2009-09-03 | 广州汉方现代中药研究开发有限公司 | A fat emulsion containing ganoderma spore oil, its quality control methods and its use |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101703532A (en) * | 2009-11-20 | 2010-05-12 | 天津市弗兰德医药科技发展有限公司 | Ganoderan polysaccharide pellet and preparation method thereof |
| CN113598356A (en) * | 2021-07-27 | 2021-11-05 | 康道生物（南通）有限公司 | Preparation process of ganoderma lucidum spore oil soft capsule |
| CN113797236A (en) * | 2021-10-15 | 2021-12-17 | 江西仙客来生物科技有限公司 | Ganoderma lucidum spore oil vitamin E soft capsule |
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