CN104857520B - A kind of sodium alginate coating solution composition and coating method - Google Patents
A kind of sodium alginate coating solution composition and coating method Download PDFInfo
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Abstract
Sodium alginate coating solution composition, main component include sodium alginate (1.5 2.5) parts by weight, polyethylene glycol (11 20) parts by weight, pure water (95 98) parts by weight.Lactose (2 5) parts by weight are added, in enteric coated products.The separation layer that coatingss are coated is in use, weightening 2 3%；The enteric layer of coating is in use, weightening：7 10%.The present invention provides a kind of coating solution especially enteric coating liquid and preparation method thereof, upper more convenient in application, and it is more preferable to be prepared into enteric coating liquid effect.The two intermiscibility is good, and especially enteric index reaches high standard, and it is easy to prepare.
Description
Technical field
The present invention discloses a kind of sodium alginate coating solution and coating method, suitable for medicine and field of food.
Background technology
Prior art CN87101144.1 discloses the method that enteric coated tablet is prepared by the use of algin as enteric coating raw material,
Good acid-resisting and alkali solubility are had according to calcium alginate, are uniformly adhered after can powdery algin be combined with syrup in element
Calcium alginate is then converted to after appropriate moistening and enteric coated tablet is made on piece.
Enteric-coating material at home and abroad have developed rapidly, and be widely used, and common are：Shellac, phthalic acid acetate fiber
Element, sodium alginate, polyvinyl acetate phthalate, acrylic resin, hydroxypropyl methyl cellulose phthalate etc..
Because the needs of product, such as some products meet the perishable decomposition of hydrochloric acid in gastric juice, strong impulse effect is produced to gastric mucosa,
Cause Nausea and vomiting.These products must be acted in enteron aisle and absorbed etc., promote development and the hair of enteric-coating material
Exhibition application.
Sodium alginate also known as sodium alginate, seaweed gel, algin, alginates, it is the natural polysaccharide carbon by being extracted in sea-tangle
Hydrate.Sodium alginate has advantages below as enteric-coating material：(1) carbohydrate of natural polymer is belonged to,
Nontoxic, nonflammable, explosive, disintegration effect is good, produces expansion during pH >=5, pH ＞ 6 are disintegrated.(2) have good water-resistance and
Stability, thus storage is not likely to produce rupture, deforms or go mouldy under field conditions (factors).Zheng Su pretty young woman et al. application algin is in enteric
The research of soft capsule, the results showed that its stable in physicochemical property, safety, low toxicity, enteric effect is good, enteric steady quality, suitable for work
Industry metaplasia is produced.
However, enteric coating liquid is upper more convenient in application, prior art does not have disclosure, how to be prepared into enteric coating liquid
More worth research.
The content of the invention
The present invention seeks to proposed a kind of enteric coating liquid composition and the method being coated with this coating solution, answered
Use more convenient.In order to solve product must be acted in enteron aisle with absorb, propose a kind of effect preferably and suitable for producing
Enteric coating liquid and coating method.Especially enteric index reaches high standard, and it is easy to prepare, and is easily controlled casing tablet quality
Coated product.
The technical scheme is that sodium alginate coating solution composition, main component includes sodium alginate (1.5-2.5)
Parts by weight, polyethylene glycol (11-20) parts by weight, pure water (95-98) parts by weight.
Lactose (2-5) parts by weight are added, in enteric coated products.
The method that coating is prepared using above-mentioned sodium alginate coating solution：
Spacer layer coating liquid composition：Hydroxypropyl methyl cellulose, polyethylene glycol, pure water or 50% ethanol water；
Enteric layer coating solution composition：Sodium alginate, lactose, polyethylene glycol, pure water；
Wherein, the separation layer that coatingss are coated, increase weight 2-3%；The enteric layer of coating, weightening：7-10%, it is bag
Mass ratio after clothing coating；
When prepared by separation layer and enteric layer coating, sprayed with separation layer and sodium alginate enteric layer coating solution, separation layer dries
Dry temperature is 50-60 DEG C, and label temperature is 30-40 DEG C；Enteric layer drying temperature is 70-80 DEG C, and label temperature is 30-40 DEG C,
Separation layer and enteric layer are formed respectively.
Beneficial effect of the present invention：The present invention provides a kind of coating solution especially enteric coating liquid and preparation method thereof, is answering
Use it is more convenient, prior art do not have disclosure, it is more preferable to be prepared into enteric coating liquid effect.Obtained by concise formula of the invention
Separation layer and sodium alginate enteric layer are obtained, the two intermiscibility is good, and especially enteric index reaches high standard, and it is easy to prepare, easily
The quality of casing piece is controlled, is the quality-high and inexpensive material that medicine and nutritional preparation use.
Embodiment
Nattokinase containing largely energy thrombus in natto, Nattokinase can lose activity in sour environment.Sea
Mosanom enteric coating makes natto tablet be not decomposed in stomach, is just absorbed after having arrived enteron aisle.Prepared below with natto label
Enteric coated tablet is embodiment, method of the detailed description by the use of sodium alginate as enteric liquid.
1st, it is formulated：
Enteric coating formula of liquid：Sodium alginate coating solution composition, main component include sodium alginate (1.5-2.5) weight
Part, lactose (2-5) parts by weight, polyethylene glycol (11-20) parts by weight, pure water (95-98) parts by weight.
2nd, enteric coating process conditions：
Tablet hardness：12-20kg/cm2；
Coating weight gain, separation layer：Increase weight 2-3%；Enteric layer：Weightening：7-10%.
After enteric coating liquid is well mixed by weight ratio, the viscosity determined under various concentrations is as follows：
Note：Test temperature is controlled at 20 DEG C.
Enteric coating liquid concentration control as can be seen from the above table is more suitable for being coated in 1%-2%, and the scope of viscosity is more reasonable.
3rd, slaking test：
When prepared by separation layer and enteric layer coating, sprayed with separation layer and sodium alginate enteric layer coating solution, separation layer dries
Dry temperature is 50-60 DEG C, and label temperature is 30-40 DEG C；Enteric layer drying temperature is 70-80 DEG C, and label temperature is 30-40 DEG C,
Separation layer and enteric layer are formed respectively.
Natto enteric coatel tablets are checked 2 hours in hydrochloric acid solution (9 → 1000), as a result see the table below：
Natto enteric coatel tablets slaking test
| Test period | Simulated gastric fluid |
| 30 minutes | Tablet does not change |
| 60 minutes | Figure of tablet does not change, and shed a little flour |
| 90 minutes | Figure of tablet does not change, and shed a little flour |
| 120 minutes | Figure of tablet does not change, and shed a little flour |
As can be seen from the above table, natto enteric coatel tablets do not have crack, disintegration or ruckbildung in simulated gastric fluid, and taking-up is hung
Basket, after being washed with a small amount, simulated intestinal fluid slaking test is carried out, as a result see the table below：
Natto enteric coatel tablets slaking test
| Test group | Simulated intestinal fluid |
| First group | The all disintegrations of left side hanging basket 8 minute 6；The all disintegrations of right side hanging basket 17 minute 6. |
| Second group | The all disintegrations of left side hanging basket 12 minute 6；The all disintegrations of right side hanging basket 13 minute 6. |
| 3rd group | The all disintegrations of left side hanging basket 9 minute 6；The all disintegrations of right side hanging basket 14 minute 6. |
| 4th group | The all disintegrations of left side hanging basket 8 minute 6；The all disintegrations of right side hanging basket 30 minute 6. |
As can be seen from the above table, natto enteric coatel tablets meet《Pharmacopoeia of People's Republic of China》The regulation of disintegration time limited inspection technique.
4th, natto enteric coatel tablets activity test：
After natto enteric coatel tablets are carried out into simulated gastric fluid slaking test, take out and carry out natto kinase activity experiment, as a result see below
Table：
Natto enteric coatel tablets slaking test
Natto enteric coatel tablets activity assays
As can be seen from the above table, after natto label carries out sodium alginate enteric coating, remain to keep good in simulated gastric fluid
Activity.
Although preferred embodiment of the invention is disclosed above, so it is not limited to the present invention.Technology belonging to the present invention
Has usually intellectual in field, without departing from the spirit and scope of the present invention, when can be used for a variety of modifications and variations.Cause
This, the scope of protection of the present invention is defined by those of the claims.
Claims (4)
1. sodium alginate coating solution composition, it is characterized in that, including enteric layer coating solution composition and the combination of spacer layer coating liquid
Thing, the enteric layer coating solution composition main component include sodium alginate 1.5-2.5 parts by weight, polyethylene glycol 11-20 weight
Part, pure water 95-98 parts by weight, lactose 2-5 parts by weight；Spacer layer coating liquid composition：Hydroxypropyl methyl cellulose, poly- second two
Alcohol, pure water or 50% ethanol water；The enteric layer coating solution concentration control is glued in 1%-2%, the enteric layer coating solution
Spend for 42-247.5mPa.s.
2. sodium alginate coating solution composition according to claim 1, it is characterized in that, the separation layer that coating solution is coated
In use, weightening 2-3%；The enteric layer of coating is in use, weightening：7-10%.
3. the method that sodium alginate coating solution composition according to claim 1 or claim 2 prepares coating, it is characterized in that, step is such as
Under：Spacer layer coating liquid composition：Hydroxypropyl methyl cellulose, polyethylene glycol, pure water or 50% ethanol water；Enteric layer bag
Clothing liquid composition：Sodium alginate 1.5-2.5 parts by weight, lactose 2-5 parts by weight, polyethylene glycol 11-20 parts by weight, pure water 95-98
Parts by weight；
Wherein, tablet hardness, 12-20kg/cm2；The separation layer that coating solution is coated, increase weight 2-3%；The enteric layer of coating, increase
Weight：7-10%；When prepared by separation layer and enteric layer coating, sprayed with separation layer and sodium alginate enteric layer coating solution, separation layer
Drying temperature is 50-60 DEG C, and label temperature is 30-40 DEG C；Enteric layer drying temperature is 70-80 DEG C, and label temperature is 30-40
DEG C, separation layer and enteric layer are formed respectively.
4. sodium alginate coating solution composition prepares the method for coating in natto tablet coating tablet is prepared according to claim 3
Application.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR102392313B1 (en) * | 2014-09-03 | 2022-05-02 | 라이온 가부시키가이샤 | Coated preparation and method for producing same |
| CN107349428A (en) * | 2017-06-07 | 2017-11-17 | 常州道博化工有限公司 | A kind of preparation method of moistureproof stable type film coating pre-mix dose |
| CN108543072A (en) * | 2018-04-09 | 2018-09-18 | 鲍引健 | A kind of composition for coating and its associated uses |
| CN110302169A (en) * | 2019-08-01 | 2019-10-08 | 张慧芬 | A kind of sliding film coated tablet and preparation method thereof |
| CN111990674B (en) * | 2020-01-14 | 2021-07-02 | 青岛圣邦健康食品有限公司 | Enteric coating material, preparation method thereof and enteric product |
| CN115364067A (en) * | 2022-07-13 | 2022-11-22 | 武汉工程大学 | Nattokinase enteric capsule and preparation method thereof |
| CN118453531A (en) * | 2024-05-23 | 2024-08-09 | 江苏科玛美保科技有限公司 | Preparation method of enteric coated sustained release tablet |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102343093A (en) * | 2010-07-30 | 2012-02-08 | 中国科学院海洋研究所 | Seaweed polysaccharide medicinal plant film coating and preparation method thereof |
| CN102614153A (en) * | 2012-04-16 | 2012-08-01 | 广东仙乐制药有限公司 | Natural enteric soft capsule and preparation method thereof |
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| JPWO2005025609A1 (en) * | 2003-09-10 | 2007-11-08 | 株式会社Ｎｒｌファーマ | Lactoferrin material composition |
| KR102201077B1 (en) * | 2013-03-08 | 2021-01-11 | 라이온 가부시키가이샤 | Coating composition, coated preparation and method for producing same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102343093A (en) * | 2010-07-30 | 2012-02-08 | 中国科学院海洋研究所 | Seaweed polysaccharide medicinal plant film coating and preparation method thereof |
| CN102614153A (en) * | 2012-04-16 | 2012-08-01 | 广东仙乐制药有限公司 | Natural enteric soft capsule and preparation method thereof |
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