CN101829335B - Film coating agent for vitamin medicaments and preparation method thereof - Google Patents
Film coating agent for vitamin medicaments and preparation method thereof Download PDFInfo
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- CN101829335B CN101829335B CN2010101353958A CN201010135395A CN101829335B CN 101829335 B CN101829335 B CN 101829335B CN 2010101353958 A CN2010101353958 A CN 2010101353958A CN 201010135395 A CN201010135395 A CN 201010135395A CN 101829335 B CN101829335 B CN 101829335B
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Abstract
The invention relates to a film coating agent for vitamin medicaments, which comprises the following components in parts by weight: 30-60 parts of hydroxypropyl methyl cellulose, 5-30 parts of plasticizer and 2-30 parts of Arabic gum. The invention also relates to a production method of the film coating agent for the vitamin medicaments, which comprises the following steps of: (1) weighing the hydroxypropyl methyl cellulose, the plasticizer and the Arabic gum by weight parts; and (2) adding the hydroxypropyl methyl cellulose, the plasticizer and the Arabic gum into a high-speed shearing machine and uniformly mixing the materials at the speed of 350-600 rpm to prepare a finished coating agent product. The coating agent has safety and no toxicity; the formed coating film has favorable blocking function on gases, such as oxygen, and the like, plays a favorable protection role for the vitamin medicaments which are easy to oxidize, prevents oxidization and discoloration of the vitamin medicaments and improves the stability of the product; and the preparation method of the coating agent has the outstanding advantages of high production efficiency, low energy consumption, favorable application performance of the finished coating agent product, and the like.
Description
Technical field
The invention belongs to the coating materials field, especially a kind of film coating agent that is used for vitamin medicaments and preparation method thereof.
Background technology
Vitamin is human essential nutrients, has defying age, prevents heart disease, the function of anticancer aspect.In recent years, the Stresstabs of numerous brands comes into the market, have replenish comprehensively, taking convenience, the different body constitution crowds' of adaptation characteristics, become a kind of effective means that people improve body constitution and resistance.
But vitamin ingredients is unstable, as containing more unsaturated double-bond in the vitamin A structure, is prone to oxidation, poor stability; Have the dienol of company structure in the vitamin C molecule, multiple degradation reaction takes place easily,, influence drug quality so after vitamin tablet (the particularly compound vitamin medicine) long term storage phenomenon of content decline, tablet surface flavescence, piebaldism can take place.For addressing the above problem, adopt film-coated method usually, form layer protective layer at medical surfaces, isolated vitamin medicaments contacts with oxygen, thus the prolong drug shelf-life guarantees drug quality.
Film coating agent commonly used is main filmogen with hydroxypropyl emthylcellulose (HPMC); And material possess hydrophilic properties such as HPMC; The porosity of clothing film is big after the film forming, and promptly to airborne aqueous vapor and oxygen obstruction ability, aqueous vapor and oxygen can see through coating membrane and get into medicine inside.Therefore use on vitamin medicaments, the protection effect is bad behind the coating, is easy to take place the situation of oxidation of drug, so the phenomenon of tablet surface variable color, piebaldism is very general, causes drug quality to descend.In a lot of research documents, be employed in hydrophobicity compositions such as adding acrylic resin in the coated formula, play good moisture-proof role, but not obvious to the barriering effect of oxygen.Therefore, improve the vitamins tablet of preservation and steady quality coating materials helps to(for) the obstructing capacity of gases such as oxygen, carbon dioxide.
Summary of the invention
The objective of the invention is to overcome the deficiency of prior art, a kind of film coating agent that is used for vitamin medicaments is provided, this coating materials can form tight obstruct to gases such as oxygen, avoids oxidation of drug, variable color, improves product stability.
Another object of the present invention is to be provided for the method for preparing of the film coating agent of vitamin medicaments.
The present invention solves its technical problem and takes following technical scheme to realize:
A kind of film coating agent that is used for vitamin medicaments, the component of this film coating agent and ratio of weight and number thereof are:
Hydroxypropyl emthylcellulose 30～60;
Plasticizer 10～25;
Arabic gum 5～30.
And described film coating agent also comprises coloring agent, and its content is 5～30 weight portions.
And described coloring agent is white titanium pigment, color lake or ferrum oxide.
And the particle diameter of described coloring agent is between 0.1～20 μ m.
And described plasticizer is Polyethylene Glycol, glycerol or triethyl citrate.
A kind of production method that is used for the film coating agent of vitamin medicaments, this method may further comprise the steps:
(1) takes by weighing hydroxypropyl emthylcellulose, plasticizer and arabic gum according to the weight fraction ratio;
(2) hydroxypropyl emthylcellulose, plasticizer and arabic gum are added in the high-speed shearing machine, make mixing of materials even, make the coating materials finished product with 350～600 rev/mins speed.
And this method is further comprising the steps of: in step (1), take by weighing coloring agent; After in step (2), adding the coloring agent mix homogeneously, the high speed shear motor speeds is brought up to 900～1200 rev/mins, coloring agent is fully disperseed, make the coating materials finished product.
Advantage of the present invention and good effect are:
1. the arabic gum prolonged application that is adopted in the coating materials of the present invention is in medicine and field of food, and it is safe, uses reliably, is applicable to the drug coating agent.
2. the arabic gum that is adopted in the coating materials of the present invention has the characteristic that side chain is many, viscosity is high; When arabic gum and HPMC use as filmogen jointly; Can space big on the HPMC film be filled, the clothing membrane porosity is reduced, thereby the oxygen permeability that reduces the clothing film can; The coating materials film thickness under identical use amount that contains arabic gum simultaneously increases, and has strengthened the resistance of air admission clothing film, and the amount of oxygen that therefore sees through in the clothing film entering medicine obviously reduces, and has avoided ingredient oxidized.
3. the arabic gum that is adopted in the coating materials of the present invention is a water-soluble material, with coating materials filmogens such as HPMC good intermiscibility is arranged, and film forming is complete tough and tensile.
4. the method for preparing of coating materials of the present invention; Under the low velocity shear condition, accomplish the abundant mixing of membrane and the uniform distribution of plasticizer; And the dry method of under the high speed shear condition, accomplishing coloring agent is disperseed; Can avoid coloring agent to reunite, have outstanding advantages such as production efficiency height, energy consumption is low, coating materials finished product application performance is good.
5. coating materials safety non-toxic of the present invention; Formed clothing film has good iris action to gases such as oxygen; Barrier property obviously is superior to the general thin coating materials; Avoid the oxidation of vitamin medicaments, improve product stability, thereby the vitamin drug of commute oxidation plays a very good protection; The coating materials method for preparing has outstanding advantages such as production efficiency height, energy consumption is low, coating materials finished product application performance is good.
The specific embodiment
Do further detailed description below in conjunction with embodiment, following examples are descriptive, are not determinate, can not limit protection scope of the present invention with this.
1. OTR oxygen transmission rate test: adopt casting or coating method to process thin film the coating materials powder body, on the OTR oxygen transmission rate tester, adopt equal-pressure method to measure, use illinois 800 type OTR oxygen transmission rate testers to test among the present invention.
2. moisture absorption ratio and outward appearance test: compound vitamin class drug use coating materials is carried out coating, and the thin membrane coated tablet after the completion is put into 40 ℃, the climatic chamber of 75% humidity, the highest moisture absorption ratio and the cosmetic variation of record medicine.
Prescription 1:
The ordinary coating agent prescription: hydroxypropyl emthylcellulose 60 grams, Polyethylene Glycol are 10 grams, and white titanium pigment 30 grams make the coating materials finished product behind the mix homogeneously.
Prescription 2
Embodiment 1
A kind of film coating agent that is used for vitamin medicaments, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 60 grams;
Polyethylene Glycol 20 grams;
Arabic gum 20 grams.
The step of the production method of the above-mentioned film coating agent that is used for vitamin medicaments is:
(1) takes by weighing hydroxypropyl emthylcellulose 60 grams, Polyethylene Glycol 20 grams, arabic gum 20 grams;
(2) hydroxypropyl emthylcellulose that takes by weighing, Polyethylene Glycol, arabic gum are added in the high-speed shearing machine, make mixing of materials even with 350 rev/mins speed, make the coating materials finished product, its production efficiency is high, energy consumption is lower.
Do not use coloring agent in the present embodiment, can form transparent clothing film, reflect the original appearance characteristics of product.
Prescription 3
Embodiment 2
A kind of film coating agent that is used for vitamin medicaments, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 30 grams;
Polyethylene Glycol 18 grams;
Arabic gum 30 grams;
White titanium pigment 22 grams.
The step of the production method of the above-mentioned film coating agent that is used for vitamin medicaments is:
(1) takes by weighing hydroxypropyl emthylcellulose 30 grams, Polyethylene Glycol 18 grams, arabic gum 30 grams, white titanium pigment 22 grams;
(2) hydroxypropyl emthylcellulose that takes by weighing, plasticizer Polyethylene Glycol, arabic gum, white titanium pigment are added in the high-speed shearing machine, make mixing of materials even with 500 rev/mins speed;
(3) the high speed shear motor speeds is brought up to 900 rev/mins, the white titanium pigment particle diameter is 10～20 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
Prescription 4
Embodiment 3
A kind of film coating agent that is used for vitamin medicaments, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 45 grams;
Glycerol 10 grams;
Arabic gum 20 grams;
Color lake 25 grams.
The step of the production method of the above-mentioned film coating agent that is used for vitamin medicaments is:
(1) takes by weighing hydroxypropyl emthylcellulose 45 grams, glycerol 10 grams, arabic gum 20 grams, color lake 25 grams;
(2) hydroxypropyl emthylcellulose that takes by weighing, Polyethylene Glycol, arabic gum, color lake are added in the high-speed shearing machine, make mixing of materials even with 500 rev/mins speed;
(3) the high speed shear motor speeds is brought up to 1000 rev/mins, the color lake particle diameter is 1～10 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
Prescription 5
Embodiment 4
A kind of film coating agent that is used for vitamin medicaments, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 60 grams;
Triethyl citrate 25 grams;
Arabic gum 10 grams;
Ferrum oxide 25 grams.
The step of the production method of the above-mentioned film coating agent that is used for vitamin medicaments is:
(1) takes by weighing hydroxypropyl emthylcellulose 60 grams, triethyl citrate 25 grams, arabic gum 10 grams, ferrum oxide 25 grams;
(2) hydroxypropyl emthylcellulose that takes by weighing, triethyl citrate, arabic gum, ferrum oxide are added in the high-speed shearing machine, make mixing of materials even with 600 rev/mins speed;
(3) the high speed shear motor speeds is brought up to 1200 rev/mins, the ferrum oxide particle diameter is 0.1～1 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
Listed method of testing among coating materials employing the present invention of prescription 1-5 is carried out OTR oxygen transmission rate, moisture absorption ratio and outward appearance test respectively, and its test result sees the following form:
| Project | Thin-films Oxygen vapor permeability (ml/m 2/day) | The highest moisture absorption ratio of medicine (%) | Cosmetic variation |
| Prescription 1 | 38 | 4.26 | Clothing film serious discoloration piebaldism |
| Prescription 2 | 29 | 4.03 | Visible medicine light discolouration in the transparent clothing film |
| Prescription 3 | 14 | 3.97 | Clothing film no change |
| Prescription 4 | 24 | 4.08 | The slight piebaldism of clothing film |
| Prescription 5 | 31 | 4.41 | Clothing film light discolouration piebaldism |
It is thus clear that, adopt the ordinary coating agent film OTR oxygen transmission rate of single hydroxypropyl emthylcellulose high, the vitamin ingredients oxidation stain is serious, and tablet surface produces dark piebaldism.After in coating materials, adding arabic gum, the thin-films Oxygen vapor permeability has had obvious decline, explains that clothing film compactness extent is higher, has effectively intercepted passing through of gas.Simultaneously, tablet piebaldism, variable color situation have greatly improved, and explain that also the oxidation of drug degree reduces.These change, and all are that interpolation and the consumption thereof with arabic gum has positive correlation.And significant change does not take place in the highest moisture absorption ratio of medicine behind the interpolation arabic gum, and the humidity resistance of visible arabic gum is not outstanding.
Film coating agent of the present invention has good gas barrier effect, is applicable to one-component or compound vitamin class medicine, can prevent oxidation of drug, variable color to being played a protective role by coating medicine.Simultaneously, because this coating materials edible is safe, also can be applicable on other product that gas barrier requirement is arranged, like food, drug particles, confection, seed, spice etc.
Claims (1)
1. film coating agent that is used for vitamin medicaments, the weight of its component and each component is:
Hydroxypropyl emthylcellulose 30 grams,
Polyethylene Glycol 18 grams,
Arabic gum 30 grams,
White titanium pigment 22 grams,
Its preparation method is:
(1) takes by weighing hydroxypropyl emthylcellulose 30 grams, Polyethylene Glycol 18 grams, arabic gum 30 grams, white titanium pigment 22 grams;
(2) hydroxypropyl emthylcellulose that takes by weighing, plasticizer Polyethylene Glycol, arabic gum, white titanium pigment are added in the high-speed shearing machine, make mixing of materials even with 500 rev/mins speed;
(3) the high speed shear motor speeds is brought up to 900 rev/mins, the white titanium pigment particle diameter is 10～20 μ m, and coloring agent fully disperses, and obtains the coating materials finished product of color even.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN2010101353958A CN101829335B (en) | 2010-03-30 | 2010-03-30 | Film coating agent for vitamin medicaments and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010101353958A CN101829335B (en) | 2010-03-30 | 2010-03-30 | Film coating agent for vitamin medicaments and preparation method thereof |
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| CN101829335A CN101829335A (en) | 2010-09-15 |
| CN101829335B true CN101829335B (en) | 2012-11-14 |
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| CN114569631B (en) * | 2022-02-08 | 2023-06-27 | 杭州民生健康药业股份有限公司 | Moisture-resistant vitamin mineral tablet and moisture-resistant treatment method thereof |
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| US6168806B1 (en) * | 1999-03-05 | 2001-01-02 | Fang-Yu Lee | Orally administrable nifedipine pellet and process for the preparation thereof |
| US6660302B1 (en) * | 2000-09-06 | 2003-12-09 | Chr. Hansen, Inc. | Dry-powder film coating composition and method of preparation |
| CN1857283A (en) * | 2006-03-28 | 2006-11-08 | 沈阳药科大学 | Control released gastrodin preparation |
| CN101559231B (en) * | 2009-06-01 | 2011-05-25 | 天津博科林药品包装技术有限公司 | High shearing production method for film coating agent |
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