CN112121172A - Sustained-release film coating premix and preparation method thereof - Google Patents

Sustained-release film coating premix and preparation method thereof Download PDF

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Publication number
CN112121172A
CN112121172A CN202011028216.0A CN202011028216A CN112121172A CN 112121172 A CN112121172 A CN 112121172A CN 202011028216 A CN202011028216 A CN 202011028216A CN 112121172 A CN112121172 A CN 112121172A
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Prior art keywords
release film
ethyl cellulose
slow
film coating
sustained
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CN112121172B (en
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陈佩英
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BEIJING YINGMAO PHARMACEUTICAL CO LTD
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BEIJING YINGMAO PHARMACEUTICAL CO LTD
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

The application relates to the field of medicine coating preparation, and particularly discloses a slow-release film coating premix and a preparation method thereof. The slow-release film coating premix is prepared from the following raw materials in parts by weight: modified ethyl cellulose, a lubricant, a plasticizer, a pore-forming agent, a filler, a colorant and a solvent; the modified ethyl cellulose is prepared from ethyl cellulose, auricularia auricula polysaccharide, sodium caseinate and water; the preparation method comprises the following steps: adding ethyl cellulose, auricularia auricula polysaccharide and sodium caseinate into water, heating and stirring, filtering to obtain a solid, and drying to obtain modified ethyl cellulose; uniformly mixing the modified ethyl cellulose, the lubricant, the plasticizer, the pore-forming agent and the solvent, and then drying to obtain a primary mixture; and adding a covering agent and a coloring agent into the primary mixture, continuously mixing, grinding and finally mixing to obtain the slow-release film coating premix. The slow-release film coating premix has the advantage of improving the moisture resistance of a slow-release film coating.

Description

Sustained-release film coating premix and preparation method thereof
Technical Field
The application relates to the field of medicine coating preparation, in particular to a slow-release film coating premix and a preparation method thereof.
Background
The sustained release preparation is a preparation which slowly releases the medicine in water or some special media, can be suitable for various administration routes and is prepared into various medicinal dosage forms, and has the advantages of reducing the administration times, facilitating the long-term administration of patients, enabling the medicine to be slowly absorbed at a proper speed and reducing the toxic and side effects of the medicine along with the improvement of the requirements of accuracy and precision of the medicine effect exerted by people.
The sustained release preparation mainly plays a role in sustained release, and the sustained release film coating is generally made of a material containing cellulose film, such as ethyl cellulose, which is an ideal insoluble carrier material without toxicity and pharmacological activity, and the ethyl cellulose is suitable for both water-soluble drugs and water-insoluble drugs.
The related technology discloses a sustained-release preparation containing ethyl cellulose, wherein a sustained-release coating is prepared from ethyl cellulose, caprylic-capric glyceride, oleic acid, ammonia water and water, and the obtained sustained-release coating has high film-forming quality of the ethyl cellulose.
When the slow release film coating is used for a Chinese medicinal component preparation, the whole medicament is easy to absorb moisture and soften, and the storage and use of the medicament are influenced because the moisture absorption of the Chinese medicinal components is strong and the barrier capability of the ethyl cellulose to water penetration is not high after film formation.
Disclosure of Invention
In order to improve the moisture resistance of the sustained-release film coating, the application provides a sustained-release film coating premix and a preparation method thereof.
In a first aspect, the present application provides a sustained-release film-coated premix, which adopts the following technical scheme:
the slow-release film coating premix is prepared from the following raw materials in parts by weight:
65-75 parts of modified ethyl cellulose;
8-16 parts of a lubricant;
3-7 parts of a plasticizer;
6-10 parts of a pore-foaming agent;
2-3 parts of a filler;
1-2 parts of a coloring agent;
5-10 parts of a solvent;
the modified ethyl cellulose is prepared from ethyl cellulose, auricularia auricula polysaccharide, sodium caseinate and water.
By adopting the technical scheme, because the ethyl cellulose is pretreated by the auricularia auricula polysaccharide, the auricularia auricula polysaccharide is combined with the ethyl cellulose under the action of sodium caseinate, and a small amount of water can be absorbed after the ethyl cellulose is formed into a film possibly due to the combination of the auricularia auricula polysaccharide and the ethyl cellulose to form a compact water film so as to prevent subsequent water from permeating, so that the moisture resistance of the slow-release film coating is improved under the condition of keeping the slow-release capacity of the slow-release film coating.
Preferably, in the raw materials for preparing the modified ethyl cellulose, the weight ratio of the ethyl cellulose to the auricularia auricula polysaccharide to the sodium caseinate to the water is 10 (1.4-2.5) to (0.2-0.6) to (30-40).
By adopting the technical scheme, the weight ratio range is beneficial to improving the combination stability of the auricularia auricula polysaccharide and the ethyl cellulose, so that the moisture resistance of the sustained-release film coating is improved.
Preferably, the polysaccharide content of the auricularia auricula polysaccharide is 10-20%.
By adopting the technical scheme, the polysaccharide content range of the auricularia auricula polysaccharide is beneficial to improving the moisture resistance of the slow-release film coating, and the slow-release film coating is controlled at a slow-release speed.
Preferably, the raw materials of the slow-release film coating premix also comprise 1-2 parts by weight of K-carrageenan.
By adopting the technical scheme, after the K-type carrageenan and the raw materials of the slow-release film coating are mixed, the effect of blocking water permeation of the slow-release film coating is improved, and the moisture resistance of the slow-release film coating is further improved.
Preferably, the plasticizer is selected from dibutyl sebacate or triethyl citrate.
By adopting the technical scheme, the dibutyl sebacate and the triethyl citrate can ensure that the slow-release film coating is softer and is not easy to crack.
Preferably, the lubricant is selected from one of talcum powder or magnesium stearate.
By adopting the technical scheme, the talcum powder and the magnesium stearate can play a role in reducing agglomeration when the raw materials are mixed, and the raw materials are uniformly mixed.
Preferably, the pore-foaming agent is polyethylene glycol 6000.
By adopting the technical scheme, the polyethylene glycol 6000 can form small holes on the membrane, which is beneficial to the release of the medicine.
Preferably, the covering agent is titanium dioxide and the colorant is allura red aluminum lake.
By adopting the technical scheme, the slow release film coating is red and uniform in color.
Preferably, the solvent is ethanol with a mass concentration of 95%.
By adopting the technical scheme, the dispersing and mixing of the raw materials are facilitated.
In a second aspect, the present application provides a method for preparing a sustained-release film-coated premix, which adopts the following technical scheme:
the preparation method of the slow-release film coating premix comprises the following steps:
s1, adding ethyl cellulose, auricularia auricula polysaccharide and sodium caseinate into water, heating and stirring at 80-90 ℃ for 3-4 hours, filtering to obtain a solid, and drying to obtain modified ethyl cellulose;
s2, uniformly mixing the modified ethyl cellulose, the lubricant, the plasticizer, the pore-forming agent and the solvent at 18-30 ℃ for 1-2 h, and then drying at 35-45 ℃ for 4-6 h to obtain a primary mixture;
and S3, adding a covering agent and a coloring agent into the primary mixture, continuously mixing for 0.5-1 h, grinding for 4-5 h, and finally mixing for 1-2 h to obtain the slow-release film coating premix.
Through adopting above-mentioned technical scheme, earlier with the raw materials primary mixing, make each raw materials misce bene, add covering agent and colorant again, help improving the color and luster degree of consistency to through grinding, reduce the granularity of raw materials, thereby further improve the degree of consistency of mixing.
In summary, the present application has the following beneficial effects:
1. because the black fungus polysaccharide is adopted to pretreat the ethyl cellulose, the black fungus polysaccharide and the ethyl cellulose are combined under the action of the sodium caseinate, the water resistance of the ethyl cellulose after film formation is improved, and the moisture resistance of the slow release film coating is improved under the condition of keeping the slow release capability of the slow release film coating.
2. Still add K type carrageenan in the raw materials in this application, the water-blocking capacity after ethyl cellulose film formation can further be improved to the addition of K type carrageenan to improve the moisture resistance of slow release film coating.
3. According to the method, the raw materials except the covering agent and the coloring agent are mixed firstly, and then the covering agent and the coloring agent are added for mixing, so that the color uniformity of the product is improved.
Detailed Description
The present application is further described in detail in connection with the following examples.
Ethyl cellulose was selected from shanghai seiki biotechnology limited;
auricularia auricula polysaccharide is selected from Shaanxi Senyue biotechnology limited company, and the polysaccharide content is 10%, 20% and 50%;
polyethylene glycol 6000 is selected from Xian jin Xiang pharmaceutic adjuvant limited company;
the K-type carrageenan is selected from Kelong Biotech limited of Hebei;
allure red aluminum lake was purchased from Hebei Lihua Biotech limited.
Examples
Example 1
The slow-release film coating premix is prepared by the following method:
s1, adding 1000g of ethyl cellulose, 500g of auricularia auricula polysaccharide with polysaccharide content of 50%, 35g of sodium caseinate and 3000g of water into a reaction kettle, heating and stirring at 80 ℃ for 4h, filtering to obtain a solid, and drying the solid in a 50 ℃ oven for 1h to obtain modified ethyl cellulose;
s2, uniformly mixing 650g of modified ethyl cellulose obtained in the step S1, 160g of talcum powder, 30g of dibutyl sebacate, 80g of polyethylene glycol 6000 and 50g of 95% ethanol at 18 ℃ to obtain a stirring mixed solution, stirring the stirring mixed solution for 1h, and then drying at 45 ℃ for 4h to obtain a primary mixture;
s3, adding 30g of titanium dioxide and 20g of allura red aluminum lake into the primary mixture obtained in the step S2, continuously mixing for 1h at 18 ℃, then adding the mixture into a grinding machine for grinding for 4h, sieving the ground mixture with a sieve mesh of 50 meshes, and finally mixing the sieved mixture for 2h at 18 ℃ to obtain the slow-release film coating premix.
Example 2
The slow-release film coating premix is prepared by the following method:
s1, adding 1000g of ethyl cellulose, 500g of auricularia auricula polysaccharide with polysaccharide content of 50%, 60g of sodium caseinate and 4000g of water into a reaction kettle, heating and stirring at 90 ℃ for 4 hours, filtering to obtain a solid, and drying the solid in a 50 ℃ oven for 1 hour to obtain modified ethyl cellulose;
s2, uniformly mixing 750g of modified ethyl cellulose obtained in the step S1, 80g of magnesium stearate, 70g of triethyl citrate, 100g of polyethylene glycol 6000 and 80g of ethanol with the mass concentration of 95% at 24 ℃ to obtain a stirring mixed solution, stirring the mixed solution for 2 hours, and then drying at 35 ℃ for 6 hours to obtain a primary mixture;
s3, adding 30g of titanium dioxide and 20g of allura red aluminum lake into the primary mixture obtained in the step S2, continuously mixing for 1h at 24 ℃, then adding the mixture into a grinding machine for grinding for 4h, sieving the ground mixture with a sieve mesh of 50 meshes, and finally mixing the sieved mixture for 1h at 24 ℃ to obtain the slow-release film coating premix.
Example 3
The slow-release film coating premix is prepared by the following method:
s1, adding 1000g of ethyl cellulose, 500g of auricularia auricula polysaccharide with polysaccharide content of 50%, 20g of sodium caseinate and 3000g of water into a reaction kettle, heating and stirring at 85 ℃ for 3h, filtering to obtain a solid, and drying the solid in a 50 ℃ oven for 1h to obtain modified ethyl cellulose;
s2, uniformly mixing 720g of modified ethyl cellulose obtained in the step S1, 100g of talcum powder, 60g of dibutyl sebacate, 60g of polyethylene glycol 6000 and 100g of 95% ethanol at 30 ℃ to obtain a stirring mixed solution, stirring the stirring mixed solution for 1h, and then drying at 40 ℃ for 5h to obtain a primary mixture;
s3, adding 20g of titanium dioxide and 10g of allura red aluminum lake into the primary mixture obtained in the step S2, continuously mixing for 0.5h at 30 ℃, then adding the mixture into a grinding machine for grinding for 5h, sieving the ground mixture to obtain a sieve with a sieve mesh of 50 meshes, and finally mixing the sieved mixture for 1h at 30 ℃ to obtain the slow-release film coating premix.
Example 4
The difference between this example and example 3 is that, in step S1, the amount of auricularia auricula polysaccharide added is 140 g.
Example 5
The difference between this example and example 3 is that, in the step of S1, the addition amount of auricularia auricula polysaccharide is 250 g.
Example 6
The difference between this example and example 3 is that, in the step of S1, the addition amount of auricularia auricula polysaccharide is 200 g.
Example 7
The present example is different from example 6 in that the polysaccharide content of auricularia auricula polysaccharide is 10% in the step of S1.
Example 8
The present example is different from example 6 in that, in the step of S1, the polysaccharide content of auricularia auricula-judae polysaccharide is 20%.
Example 9
This example is different from example 8 in that 10g K carrageenan was further added to the stirred mixture in step S2.
Example 10
This example is different from example 8 in that 20g K carrageenan was further added to the stirred mixture in step S2.
Comparative example
Comparative example 1
Aiming at the related slow-release coating premix of the background art, the slow-release coating premix of the comparative example is prepared according to the following method:
weighing 100g of ethyl cellulose and 25g of caprylic/capric glyceride, premixing, plasticizing granules to obtain ethyl cellulose plasticized granules, and mixing the ethyl cellulose plasticized granules with 200g of dichloromethane overnight; then stirring the ethyl cellulose colloidal solution until the appearance is uniform; 9.5g of oleic acid is dripped and stirred for 30 min; dropwise adding 72g of ammonia water, stirring for 30min, adding 350g of purified water, cooling to room temperature, and continuously stirring for about 1h to form light yellow-white EC coarse emulsion; distilling the emulsion at normal pressure, distilling off dichloromethane solvent and recovering, and distilling under reduced pressure when no solvent is condensed out continuously to obtain the product.
Comparative example 2
This comparative example is different from example 3 in that the step of S1 is omitted and in the step of S2, the modified ethylcellulose is replaced with an equal amount of ethylcellulose.
Comparative example 3
This comparative example is different from example 3 in that no auricularia auricula-polysaccharide was added in the step of S1.
Comparative example 4
This comparative example differs from example 3 in that in step S1, no sodium caseinate was added.
Comparative example 5
This comparative example differs from example 3 in that the step of S1 was omitted and 50g of carrageenan k-type was added in the step of S2.
Performance test
The sustained-release film coating premix obtained in each example and comparative example obtained in the application is coated on plain tablets by a coating machine, the plain tablets adopt berberine tablets, and the coated tablets are prepared, and compared with the plain tablets, the average weight gain of the coated tablets is 3.8%.
And (3) moisture resistance testing: grouping the plain tablets and the coated tablets as test pieces, pre-weighing the test pieces to obtain and calculate the average original weight of the test pieces of each group, placing the test pieces in a constant temperature and humidity box (the temperature is 40 +/-2 ℃, and the humidity is 75 +/-5%) to perform an accelerated test for 60 days, weighing the test pieces on the 5 th day, the 10 th day, the 20 th day, the 40 th day and the 60 th day during the test period to obtain the average weight of the test pieces of each group, and calculating the moisture absorption rate and the calculation formula of the moisture absorption rate of the test pieces: (average weight of test piece-average original weight of test piece)/average original weight of test piece, the test results are shown in table 1.
And (3) testing the release speed: taking a coated tablet, adopting a device for a dissolution determination method (XC first method which is an appendix of the second part of the 2000 edition of Chinese pharmacopoeia), taking 900ml of phosphate buffer solution (pH value 7.4) as a solvent according to a release determination method (XD first method which is an appendix of the second part of the 2000 edition of Chinese pharmacopoeia), and taking 100 revolutions per minute, operating according to the method, sampling in a medium solution for 1h, 2h, 4h, 6h and 8h, respectively taking 10ml of the medium solution, filtering, and timely supplementing 10ml of the medium solution in an operating container; taking the subsequent filtrate as a sample to be tested. Measuring by visible ultraviolet spectrophotometry, and measuring absorbance at 274nm wavelength; and precisely weighing appropriate amount of berberine control, adding the above solvent, dissolving, quantitatively diluting to obtain solution containing about 0.25mg per 1ml, and measuring absorbance by the same method. The cumulative release of each tablet in different media and different time periods was calculated, and the test results are shown in table 1.
TABLE 1
Figure RE-GDA0002784874090000061
According to table 1, the coated tablet of comparative example 1 is a slow release coated premix related to the background art, compared with example 3, the coated tablet prepared from the slow release film coated premix of example 3 has lower moisture absorption rate and similar release rate, which shows that the slow release film coated premix obtained in example 3 has better moisture resistance.
Comparative example 2 is a slow release type film coating premix prepared directly from ethylcellulose, and compared with example 3, the moisture absorption rate of the coated tablet prepared from the slow release type film coating premix of example 3 is lower, probably because auricularia auricula polysaccharide pretreats the ethylcellulose, and the auricularia auricula polysaccharide is combined with the ethylcellulose, so that the hydrophilicity of the ethylcellulose is enhanced, and a small amount of water can be absorbed after the ethylcellulose is formed into a film, a compact water film is formed, the subsequent water permeation is prevented, and the moisture resistance of the slow release type film coating premix is enhanced.
Comparative example 3 is that no auricularia auricula polysaccharide is added, comparative example 4 is that no sodium caseinate is added, compared with comparative example 2, the moisture absorption rates of the coated tablets prepared by the sustained-release film coating premix obtained in comparative example 3 and comparative example 4 are not much different from the moisture absorption rate of the coated tablets prepared by the sustained-release film coating premix obtained in comparative example 2, probably because the auricularia auricula polysaccharide can be better combined with the ethyl cellulose under the action of the sodium caseinate, so that the modification of the ethyl cellulose is realized, and the moisture resistance of the sustained-release film coating premix is improved.
The addition amount of the auricularia auricula polysaccharide in the examples 4 to 6 is within the range of (1.4 to 2.5) of the auricularia auricula polysaccharide which is an ethyl cellulose, and compared with the example 3 with the addition amount exceeding the range, the moisture absorption rate of the coated tablet prepared by the sustained-release film coating premix in the examples 4 to 6 is not greatly different, and the release speed is slower, which is probably because the increase of the hydrophilicity of the ethyl cellulose is controlled by controlling the addition amount of the auricularia auricula polysaccharide, the stability of the ethyl cellulose is maintained, the release speed is slowed down, and the sustained-release effect is improved.
The polysaccharide content of the auricularia auricula polysaccharides in the examples 7 to 8 is 10 to 20%, compared with the polysaccharide content exceeding the range of the example 6, the moisture absorption rate of the coated tablet prepared by the sustained-release film coating premix prepared in the examples 7 to 8 is not greatly different, but the release speed is slower, probably because the hydrophilic property of the ethyl cellulose is further limited by controlling the polysaccharide content of the auricularia auricula polysaccharides, the stability of the ethyl cellulose is maintained, so that the release speed is slowed down, and the sustained-release effect is improved.
The carrageenan K is added in examples 9 to 10, and compared with example 8, the moisture absorption rate of the coated tablet prepared by the sustained-release film coating premix prepared in examples 9 to 10 is further reduced, which may be because the carrageenan K has certain hydrophilicity, and after the ethyl cellulose forms a compact water film, the presence of the carrageenan K can improve the stability of the water film, thereby improving the water film moisture permeation preventing ability, and further enhancing the moisture resistance of the sustained-release film coating premix.
Compared with the example 3, the moisture absorption rate of the coated tablet prepared by the slow-release film coating premix prepared in the comparative example 5 is not reduced because the K-carrageenan acts on a compact water film formed after the ethyl cellulose is modified, so that the moisture resistance of the slow-release film coating premix can be improved.
The present embodiment is only for explaining the present application, and it is not limited to the present application, and those skilled in the art can make modifications of the present embodiment without inventive contribution as needed after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present application.

Claims (10)

1. The slow-release film coating premix is characterized by being prepared from the following raw materials in parts by weight:
65-75 parts of modified ethyl cellulose;
8-16 parts of a lubricant;
3-7 parts of a plasticizer;
7-15 parts of a pore-foaming agent;
2-3 parts of a covering agent;
1-2 parts of a coloring agent;
5-10 parts of a solvent;
the modified ethyl cellulose is prepared from ethyl cellulose, auricularia auricula polysaccharide, sodium caseinate and water.
2. The sustained-release film-coated premix according to claim 1, which is characterized in that: in the preparation raw materials of the modified ethyl cellulose, the weight ratio of the ethyl cellulose to the auricularia auricula polysaccharide to the sodium caseinate to the water is 10 (1.4-2.5) to (0.2-0.6) to (30-40).
3. The sustained-release film-coated premix according to claim 1, which is characterized in that: the polysaccharide content of the auricularia auricula polysaccharide is 10-20%.
4. The sustained-release film-coated premix according to claim 1, which is characterized in that: the slow-release film coating premix raw material also comprises 1-2 parts by weight of K-type carrageenan.
5. The sustained-release film-coated premix according to claim 1, which is characterized in that: the plasticizer is selected from dibutyl sebacate or triethyl citrate.
6. The sustained-release film-coated premix according to claim 1, which is characterized in that: the lubricant is selected from one of talcum powder or magnesium stearate.
7. The sustained-release film-coated premix according to claim 1, which is characterized in that: the pore-foaming agent is polyethylene glycol 6000.
8. The sustained-release film-coated premix according to claim 1, which is characterized in that: the filler is titanium dioxide, and the colorant is allura red aluminum lake.
9. The sustained-release film-coated premix according to claim 1, which is characterized in that: the solvent is ethanol with the mass concentration of 95%.
10. The preparation method of the slow-release film coating premix is characterized by comprising the following steps:
s1, adding ethyl cellulose, auricularia auricula polysaccharide and sodium caseinate into water, heating and stirring at 80-90 ℃ for 3-4 h, filtering to obtain a solid, and drying to obtain modified ethyl cellulose;
s2, uniformly mixing and stirring the modified ethyl cellulose, the lubricant, the plasticizer, the pore-forming agent and the solvent at 18-30 ℃ for 1-2 h, and then drying at 35-45 ℃ for 4-6 h to obtain a primary mixture;
and S3, adding a covering agent and a coloring agent into the primary mixture, continuously mixing for 0.5-1 h, grinding for 4-5 h, sieving the ground mixture, and finally mixing for 1-2 h to obtain the slow-release film coating premix.
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009008005A1 (en) * 2007-07-06 2009-01-15 Lupin Limited Pharmaceutical compositions of rifaximin
CN102641505A (en) * 2012-05-18 2012-08-22 北京英茂药业有限公司 Membrane-controlled sustained release film-coated premix and preparation method thereof
CN102988994A (en) * 2013-01-06 2013-03-27 北京英茂药业有限公司 Slow-release film-coated premixed agent and preparation method thereof
CN103861114A (en) * 2014-03-13 2014-06-18 中国科学院化学研究所 Functional vegetated substrate hollow capsule
US20150313846A1 (en) * 2006-05-24 2015-11-05 Flamel Ireland Limited Prolonged-release multimicroparticulate oral pharmaceutical form

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150313846A1 (en) * 2006-05-24 2015-11-05 Flamel Ireland Limited Prolonged-release multimicroparticulate oral pharmaceutical form
WO2009008005A1 (en) * 2007-07-06 2009-01-15 Lupin Limited Pharmaceutical compositions of rifaximin
CN102641505A (en) * 2012-05-18 2012-08-22 北京英茂药业有限公司 Membrane-controlled sustained release film-coated premix and preparation method thereof
CN102988994A (en) * 2013-01-06 2013-03-27 北京英茂药业有限公司 Slow-release film-coated premixed agent and preparation method thereof
CN103861114A (en) * 2014-03-13 2014-06-18 中国科学院化学研究所 Functional vegetated substrate hollow capsule

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
JIN GU ET AL.: "Polylactic acid composites incorporating casein functionalized cellulose nanoshiskers", 《JOURNAL OF BIOLOGICAL ENGINEERING》 *
杨秀清 等: "改性酪蛋白/羧甲基纤维素钠共混纤维制备与性能", 《合成纤维》 *
胡崇茂 ET AL.: "全水型薄膜包衣预混剂在复方丹参片生产中的应用研究", 《首都医药》 *

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