CN110420193A - A kind of alpha-lipoic acid slow-release tablet preparation method - Google Patents
A kind of alpha-lipoic acid slow-release tablet preparation method Download PDFInfo
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- CN110420193A CN110420193A CN201910833448.4A CN201910833448A CN110420193A CN 110420193 A CN110420193 A CN 110420193A CN 201910833448 A CN201910833448 A CN 201910833448A CN 110420193 A CN110420193 A CN 110420193A
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- alpha
- lipoic acid
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- sustained release
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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
- A61K31/33—Heterocyclic compounds
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
- A61K31/385—Heterocyclic compounds having sulfur as a ring hetero atom having two or more sulfur atoms in the same ring
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/06—Free radical scavengers or antioxidants
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Abstract
The invention discloses a kind of alpha-lipoic acid slow-release tablet preparation methods, comprising the following steps: step S1, alpha-lipoic acid and vitamin C is added and grinds mixed machine, pelletizes, dry, tabletting after mixing, plain piece is made；Step S2, plain piece is coated using sustained release coating pre-mixing agent, while according to rate of release needs, adjusts sustained release coating pre-mixing agent dosage, reaching expected rate of release；Wherein sustained release coating pre-mixing agent includes: 20~80 parts of main filmogen, 1~10 part of antiblocking agent and 2~8 parts of plasticizer by weight.The present invention is using vitamin C as solubilizer, so that the alpha-lipoic acid slow-release tablet being prepared is easier to digest and assimilate；It joined antiblocking agent in coating pre-mixing agent, on the one hand can on the other hand increase the wearability of clothing film with resist blocking and that；Meanwhile also joined plasticizer in sustained release coating pre-mixing agent, so that the toughness of clothing film enhances, clothing film will not be damaged in coating process.
Description
Technical field
The present invention relates to technical field of medicine more particularly to a kind of alpha-lipoic acid slow-release tablet preparation methods.
Background technique
Alpha-lipoic acid is a kind of free radical resisting substance that human body oneself can generate, and has important physiology living human body
Property, there are ordinary tablet, sustained release tablets in foreign countries as dietary supplements, also there is 24 hours controlled release tablets.
But alpha-lipoic acid is slightly soluble in water, non-digestible as ordinary tablet, it is difficult to play a role, if be added wherein
Solubilizer then can make ordinary tablet be easier to absorb.
Summary of the invention
To solve in the prior art, in alpha-lipoic acid slow-release tablet preparation process, existing ordinary tablet is non-digestible
The technical issues of, technical scheme is as follows:
Alpha-lipoic acid slow-release tablet preparation method in the present invention, comprising the following steps:
Step S1, alpha-lipoic acid and vitamin C are added and grind mixed machine, pelletized, dry, tabletting after mixing, element is made
Piece；
Step S2, plain piece is coated using sustained release coating pre-mixing agent, while according to rate of release needs, adjusts sustained release
It is coated pre-mixing agent dosage, reaches expected rate of release；
Wherein sustained release coating pre-mixing agent includes: 20~80 parts of main filmogen, 1~10 part of antiblocking agent by weight
And 2~8 parts of plasticizer.
It in a preferred embodiment, by weight include 300 parts of alpha-lipoic acids and 1000 parts of dimension lifes in step S1
Plain C.
In a preferred embodiment, the main filmogen is ethyl cellulose.
In a preferred embodiment, the antiblocking agent is silica, titanium dioxide, talcum powder, plant charcoal
One of black, Black Rouge, red ferric oxide, yellow ferric oxide are a variety of.
In a preferred embodiment, the plasticizer is rapeseed oil, soybean oil, olive oil, walnut oil, peanut
One of oil, cocoa butter, sunflower oil, condensed milk, sesame oil, palm oil, corn oil are a variety of.
In a preferred embodiment, plain piece is coated using sustained release coating pre-mixing agent, the weight of coating and plain piece
Than being less than 1:10.
In a preferred embodiment, plain piece is coated using sustained release coating pre-mixing agent, the weight of coating and plain piece
Than for 1:25~1:12.
In a preferred embodiment, the alpha-lipoic acid slow-release tablet is suitable for pharmaceutical grade sustained release tablets and food-grade
Sustained release tablets.
Alpha-lipoic acid slow-release tablet preparation method in the present invention, compared with prior art, it has the advantage that:
Alpha-lipoic acid slow-release tablet preparation method in the present invention, using vitamin C as solubilizer, so that being prepared
Alpha-lipoic acid slow-release tablet be easier to digest and assimilate；Coating pre-mixing agent in joined antiblocking agent, on the one hand can with resist blocking and that,
On the other hand the wearability of clothing film is increased；Meanwhile also joined plasticizer in sustained release coating pre-mixing agent, so that clothing film
Toughness enhancing, clothing film will not be damaged in coating process.Sustained release coating pre-mixing agent in the present invention can be not only used for preparing piece
Agent coating, it can also be used to coating of pellets.
Production controllability of the invention is good: although the present invention can not directly control practical coating thickness (practical packet when being coated
Clothing is lossy, and loss can be fluctuated in a certain range), but can be by controlling coating powder weight, Jin Ershe when preparation coating pre-mixing agent
Set maximum coating weight gain.If loss ratio normal condition is big when coating, cause practical weight gain small, rate of release is faster than standard model
It encloses, the benefit that can do over again coating, to meet the range of rate of release standard.
Alpha-lipoic acid slow-release tablet of the invention, alpha-lipoic acid pass through the channel release in thin layer clothing film, release speed
Degree is at the uniform velocity to discharge, and meets the definition in pharmacopeia to controlled release.Controlled release is more preferable than slow release effect.
Detailed description of the invention
Fig. 1 is the flow chart of alpha-lipoic acid slow-release tablet preparation method in the present invention.
Specific embodiment
Below in conjunction with attached drawing of the invention, technical solution of the present invention is clearly and completely described.Based on this hair
Embodiment in bright, every other implementation obtained by those of ordinary skill in the art without making creative efforts
Example, shall fall within the protection scope of the present invention.
In coating pre-mixing agent according to the present invention, ingredient has:
Main filmogen: ethyl cellulose；
Antiblocking agent: silica, titanium dioxide, talcum powder, plant carbon black, Black Rouge, red ferric oxide, yellow oxidation
Iron；Which kind of specifically used antiblocking agent needs to select as needed.
Plasticizer: rapeseed oil, soybean oil, olive oil, walnut oil, peanut oil, cocoa butter, sunflower oil, condensed milk, sesame
Oil, palm oil, corn oil.Which kind of specifically used plasticizer needs to select as needed.
It in addition to the three components, further include some auxiliary materials: Arabic gum, cycloheptaamylose, Brazil wax, acetate
Starch, D-mannital, guar gum, pectin, potassium alginate, sodium alginate, xanthan gum (also known as xanthan gum), methylcellulose,
Polyoxyethylene mountain, pears alcohol acid anhydride monoleate, polyvinyl alcohol, carragheen, maltitol, citric acid fatty glyceride, Propiram
Polysaccharide, hydroxypropul starch, hydroxypropyl methyl cellulose, sodium lactate, lactitol (also known as 4- β-D galactopyranose-D-glucitol),
Sodium carboxymethyl starch, sodium carboxymethylcellulose, sodium carbonate, sodium bicarbonate, oxidation hydroxypropul starch, cyclohexaamylose, γ-ring-type
Dextrin, dextrin, PVP K30, polyethylene glycol, soluble starch, glyceryl triacetate, pregelatinized starch, sucrose, polyethylene pyrrole
Pyrrolidone, white granulated sugar, maltodextrin, soft white sugar.
In the following, the practicability and validity of data verification the application will be utilized.
Comparative example
Pre-mixing agent is coated used in the coating of pellets in the prior art that this comparative example uses, coating pre-mixing agent includes ethyl
5~7 parts of cellulose, 6~8 parts of PVP K30, using the coating pre-mixing agent of said ratio to the alpha-lipoic acid plain piece in the application
Coating, the multiple alpha-lipoic acid slow-release tablets for a batch being prepared.
Embodiment 1
Alpha-lipoic acid slow-release tablet preparation method, flow chart are shown in Fig. 1, comprising the following steps:
Step S1,300mg alpha-lipoic acid and 1000mg vitamin C are added and grind mixed machine, pelletize, dry after mixing,
Plain piece is made in tabletting；
Step S2, plain piece is coated using sustained release coating pre-mixing agent, while according to rate of release needs, adjusts sustained release
It is coated pre-mixing agent dosage, reaches expected rate of release；
Wherein sustained release coating pre-mixing agent includes: 20 parts of ethyl cellulose, 1 part of silica and 2 portions of olives by weight
Oil.
In coating process, controls the finally weight ratio of coating and plain piece and a batch is made between 1:25~1:12
Multiple alpha-lipoic acid slow-release tablets.Alpha-lipoic acid slow-release tablet prepared by the present invention is 12 hours controlled release tablets.
Embodiment 2
Alpha-lipoic acid slow-release tablet preparation method, comprising the following steps:
Step S1,300mg alpha-lipoic acid and 1000mg vitamin C are added and grind mixed machine, pelletize, dry after mixing,
Plain piece is made in tabletting；
Step S2, plain piece is coated using sustained release coating pre-mixing agent, while according to rate of release needs, adjusts sustained release
It is coated pre-mixing agent dosage, reaches expected rate of release；
Wherein sustained release coating pre-mixing agent include: by weight 80 parts ethyl cellulose, 10 parts of Black Rouges, red ferric oxides
Mixture and 8 portions of corn oils.
In coating process, control is finally coated and the weight ratio of plain piece is between 1:25~1:12, one be prepared
Multiple alpha-lipoic acid slow-release tablets of a batch.Alpha-lipoic acid slow-release tablet prepared by the present invention is 12 hours controlled release tablets.
Embodiment 3
Alpha-lipoic acid slow-release tablet preparation method, comprising the following steps:
Step S1,300mg alpha-lipoic acid and 1000mg vitamin C are added and grind mixed machine, pelletize, dry after mixing,
Plain piece is made in tabletting；
Step S2, plain piece is coated using sustained release coating pre-mixing agent, while according to rate of release needs, adjusts sustained release
It is coated pre-mixing agent dosage, reaches expected rate of release；
Wherein sustained release coating pre-mixing agent includes: 50 parts of ethyl cellulose, 6 parts of talcum powder and 5 portions of peanut oil by weight.
In coating process, control is finally coated and the weight ratio of plain piece is between 1:25~1:12, one be prepared
Multiple alpha-lipoic acid slow-release tablets of a batch.Alpha-lipoic acid slow-release tablet prepared by the present invention is 12 hours controlled release tablets.
The alpha-lipoic acid slow-release tablet that comparative example and Examples 1 to 3 are prepared is utilized respectively friability tester to survey
Try its friability.Limit rotary drum 100 times of friability tester.Acquired results are shown in Table 1:
The test of 1 friability of table
| Appearance character | Qualification rate | |
| Comparative example 1 | More rupture | 85.32% |
| Embodiment 1 | Less rupture | 98.65% |
| Embodiment 2 | Less rupture | 97.89% |
| Embodiment 3 | Less rupture | 98.01% |
It can be seen from the results above that alpha-lipoic acid slow-release tablet wearability of the invention and toughness are preferable.
Why limiting alpha-lipoic acid and vitamin C by weight is 300 parts and 1000 parts, is determined by experiment.
Experiment shows after adding the granulation of 300mg alpha-lipoic acid, drying, tabletting using 1000mg vitamin C, under 37 degree of environment, the piece
Agent is dissolved in 30 minutes.And after adding the granulation of 1000mg alpha-lipoic acid, drying, tabletting using 1000mg vitamin C, at 37 degree
Under environment, dissolution is had no within more than 10 hours.
The above description is merely a specific embodiment, but scope of protection of the present invention is not limited thereto, any
Those familiar with the art in the technical scope disclosed by the present invention, can easily think of the change or the replacement, and should all contain
Lid is within protection scope of the present invention.Therefore, protection scope of the present invention should be based on the protection scope of the described claims.
Claims (8)
1. a kind of alpha-lipoic acid slow-release tablet preparation method, which comprises the following steps:
Step S1, alpha-lipoic acid and vitamin C are added and grind mixed machine, pelletized, dry, tabletting after mixing, plain piece is made；
Step S2, plain piece is coated using sustained release coating pre-mixing agent, while according to rate of release needs, adjusts sustained release coating
Pre-mixing agent dosage reaches expected rate of release；
Wherein sustained release coating pre-mixing agent includes: 20~80 parts of main filmogen, 1~10 part of antiblocking agent and 2 by weight
~8 parts of plasticizer.
2. a kind of alpha-lipoic acid slow-release tablet preparation method according to claim 1, which is characterized in that by weight in step S1
Measuring part includes 300 parts of alpha-lipoic acids and 1000 parts of vitamin Cs.
3. a kind of alpha-lipoic acid slow-release tablet preparation method according to claim 1, which is characterized in that described main at membrane material
Material is ethyl cellulose.
4. a kind of alpha-lipoic acid slow-release tablet preparation method according to claim 1, which is characterized in that the antiblocking agent
For one of silica, titanium dioxide, talcum powder, plant carbon black, Black Rouge, red ferric oxide, yellow ferric oxide or a variety of.
5. a kind of alpha-lipoic acid slow-release tablet preparation method according to claim 1, which is characterized in that the plasticizer is
Rapeseed oil, soybean oil, olive oil, walnut oil, peanut oil, cocoa butter, sunflower oil, condensed milk, sesame oil, palm oil, corn oil
One of or it is a variety of.
6. a kind of alpha-lipoic acid slow-release tablet preparation method according to claim 1, which is characterized in that utilize sustained release coating
Pre-mixing agent is coated plain piece, and coating and the weight ratio of plain piece are less than 1:10.
7. a kind of alpha-lipoic acid slow-release tablet preparation method according to claim 6, which is characterized in that utilize sustained release coating
Pre-mixing agent is coated plain piece, and the weight ratio of coating and plain piece is 1:25~1:12.
8. described in any item a kind of alpha-lipoic acid slow-release tablet preparation methods according to claim 1~7, which is characterized in that institute
Alpha-lipoic acid slow-release tablet is stated suitable for pharmaceutical grade sustained release tablets and food-grade sustained release tablets.
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| CN201910833448.4A CN110420193A (en) | 2019-09-04 | 2019-09-04 | A kind of alpha-lipoic acid slow-release tablet preparation method |
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| CN201910833448.4A CN110420193A (en) | 2019-09-04 | 2019-09-04 | A kind of alpha-lipoic acid slow-release tablet preparation method |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112870222A (en) * | 2021-01-27 | 2021-06-01 | 陕西思瑰瑞食品科技有限公司 | Vitamin C zinc-added sustained and controlled release tablet and preparation method thereof |
| CN112891314A (en) * | 2021-01-27 | 2021-06-04 | 陕西思瑰瑞食品科技有限公司 | Vitamin C and ferrous sulfate sustained and controlled release tablet and preparation method thereof |
| CN112891313A (en) * | 2021-01-27 | 2021-06-04 | 陕西思瑰瑞食品科技有限公司 | Potassium ion sustained and controlled release tablet and preparation method thereof |
| WO2023272692A1 (en) * | 2021-07-01 | 2023-01-05 | 思瑰瑞保健食品有限公司 | Method for preparing sustained-and-controlled-release vitamin c tablet |
| WO2023272694A1 (en) * | 2021-07-01 | 2023-01-05 | 思瑰瑞保健食品有限公司 | Vitamin c and zinc sustained release tablet, and preparation method therefor |
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| CN104688705A (en) * | 2015-02-09 | 2015-06-10 | 武汉泽智生物医药有限公司 | Alpha-lipoic acid sustained-release tablet and preparation method thereof |
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2019
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| CN104688705A (en) * | 2015-02-09 | 2015-06-10 | 武汉泽智生物医药有限公司 | Alpha-lipoic acid sustained-release tablet and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112870222A (en) * | 2021-01-27 | 2021-06-01 | 陕西思瑰瑞食品科技有限公司 | Vitamin C zinc-added sustained and controlled release tablet and preparation method thereof |
| CN112891314A (en) * | 2021-01-27 | 2021-06-04 | 陕西思瑰瑞食品科技有限公司 | Vitamin C and ferrous sulfate sustained and controlled release tablet and preparation method thereof |
| CN112891313A (en) * | 2021-01-27 | 2021-06-04 | 陕西思瑰瑞食品科技有限公司 | Potassium ion sustained and controlled release tablet and preparation method thereof |
| WO2023272692A1 (en) * | 2021-07-01 | 2023-01-05 | 思瑰瑞保健食品有限公司 | Method for preparing sustained-and-controlled-release vitamin c tablet |
| WO2023272694A1 (en) * | 2021-07-01 | 2023-01-05 | 思瑰瑞保健食品有限公司 | Vitamin c and zinc sustained release tablet, and preparation method therefor |
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Application publication date: 20191108 |