CN107441056B - Film coating premix for ginseng and radix clematidis tablets, preparation method of film coating premix and ginseng and radix clematidis tablet coating method - Google Patents

Film coating premix for ginseng and radix clematidis tablets, preparation method of film coating premix and ginseng and radix clematidis tablet coating method Download PDF

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CN107441056B
CN107441056B CN201710573252.7A CN201710573252A CN107441056B CN 107441056 B CN107441056 B CN 107441056B CN 201710573252 A CN201710573252 A CN 201710573252A CN 107441056 B CN107441056 B CN 107441056B
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parts
tablet
ginseng
premix
film
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CN107441056A (en
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唐宗兴
赵建权
甘奇超
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Chongqing Pharmaceutical Research Institute Co Ltd
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    • 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
    • A61K9/2873Proteins, e.g. gelatin
    • 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
    • A61K9/2813Inorganic compounds
    • 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
    • A61K9/282Organic compounds, e.g. fats
    • A61K9/2826Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/2853Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention discloses a Shenxian tablet film coating premix which comprises the following components in parts by weight: hydroxypropyl methylcellulose: 5-10 parts; 2-10 parts of medicinal gelatin; polyvinylpyrrolidone vinyl acetate copolymer: 2-5 parts; polyethylene glycol: 1-5 parts; tween 80: 1-2 parts; talc powder: 1-5 parts; titanium dioxide: 1-4 parts; colorant: 1-10 parts. The ginseng and hawthorn mixed tablet has the advantages of moisture resistance, light resistance, taste masking, wear resistance and the like, is not easy to generate splinters, spots and mildew, prolongs the effective period of medicine preservation, expands the application range of patients, and can be taken by patients who are not prone to sugar and diabetics for a long time.

Description

Film coating premix for ginseng and radix clematidis tablets, preparation method of film coating premix and ginseng and radix clematidis tablet coating method
Technical Field
The invention relates to a coating agent, in particular to a Shenxian tablet film coating premix, a preparation method thereof and a Shenxian tablet coating method.
Background
The Shenxian tablet is a Chinese patent medicine for warming kidney, replenishing vital essence, benefiting qi and nourishing blood, and is especially suitable for treating symptoms of soreness and weakness of waist and knees and the like caused by deficiency of both kidney yin and yang and deficiency of heart qi. The ginseng and radix clematidis tablets sold on the market are generally sugar-coated tablets, but the sugar-coated tablets can increase the extra weight of the tablet core to 50-100%, and can cause great harm to human bodies after long-term use, particularly to sugar-prohibited patients and diabetic patients. And the dust generated in the production process of syrup coating is flying, the environment is easily polluted, a large space in a clean area is needed in each preparation process of sugar melting, glue melting, pigment adding, tablet airing, material storage and the like, the production process is complex, operators are mostly relied on experience in the operation process, and the operation process does not conform to the Good Manufacturing Practice (GMP). In addition, because of the uncontrollable factors in the process of coating with syrup, especially in the production and storage processes of Chinese patent medicines with strong moisture absorption, the defects of splintering, flower spots, mildew spots, over-time disintegration, difficult storage, content reduction, long production time, long tablet airing time and the like are easy to occur.
The film coating premix supplied on the market is adopted to carry out film coating on the Shenxian tablets, and the disadvantages of poor adhesive force, strong hygroscopicity, easy occurrence of cracks on the surface and the like exist. The water-based film coating premixing auxiliary material has poor moisture resistance and crack resistance, and cannot solve the problem of unstable quality caused by moisture absorption and bring great quality hidden trouble to products. The non-aqueous film coating premixing auxiliary materials need to use organic solvents, so that an explosion-proof facility has to be considered in a coating workshop, the coating workshop is also not environment-friendly, and the use cost of the solvents is obviously increased.
Therefore, those skilled in the art are working on developing an environment-friendly, simple, stable film-coating premix for ginseng tablet suitable for diabetics, a preparation method thereof and a ginseng tablet coating method.
Disclosure of Invention
In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is to provide an environment-friendly, simple, stable film-coating premix for ginseng tablet suitable for diabetes patients, a preparation method thereof, and a coating method for ginseng tablet.
In order to achieve the purpose, the invention provides a shenxian tablet film coating premix which comprises the following components in parts by weight:
Figure BDA0001350231300000021
preferably, the film coating premix for the Shenxian tablets comprises the following components in parts by weight:
Figure BDA0001350231300000022
Figure BDA0001350231300000031
the hydroxypropyl methylcellulose is preferably hydroxypropyl methylcellulose E5;
the polyethylene glycol is preferably one or two of polyethylene glycol 4000 or polyethylene glycol 6000.
The preparation method of the film coating premix for the Shenxian tablets comprises the following steps:
(1) weighing the following raw material components in parts by weight: 5-10 parts of hydroxypropyl methyl cellulose, 2-10 parts of medicinal gelatin, 2-5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 1-5 parts of polyethylene glycol, 1-2 parts of tween 80, 1-5 parts of talcum powder, 1-4 parts of titanium dioxide and 1-10 parts of colorant;
(2) adding the raw material components in the step (1) into a grinder to be ground and sieved;
(3) and uniformly mixing the crushed raw material components to prepare the film coating premix of the Shenxian tablets.
The ginseng tablet coating method using the film coating premix coating of the ginseng tablet specifically comprises the following steps:
(1) dissolving the film coating premix in purified water to prepare a solution with the weight percentage of the film coating premix being 15-20%;
(2) stirring the solution obtained in the step (1) and sieving the solution by a 100-mesh sieve;
(3) preheating a ginseng and radix clematidis tablet core to 45-50 ℃;
(4) setting the air inlet temperature of the coating machine to be 65-90 ℃ and the air outlet temperature to be 48-53 ℃;
(5) putting the sieved solution obtained in the step (2) and the radix ginseng and radix clematidis tablet core heated in the step (3) into a coating machine, and setting the spraying speed of the coating machine to be 120-20 Oml/min;
(6) after spraying is finished, continuously blowing the liquid for 5-10 minutes by using rolling hot air, and taking out;
(7) and (4) drying the tablets obtained in the step (6) at the temperature of 30-35 ℃ for 4-6 hours to obtain the ginseng and hawthorn tablet film-coated tablets.
The invention has the following beneficial effects:
① has short production period, automatic operation, no pollution to environment, and ensured worker health;
② has the advantages of reduced material consumption, increased weight, good appearance, clear mark, and no counterfeit;
③ the film coating premix is composed of high molecular compound, is nontoxic and tasteless, and can satisfy the requirement of long-term administration;
④ has advantages of moisture-proof, light-proof, taste-masking, and wear-resistant, and has advantages of low liability to generation of splinter, mottle, and mildew, and prolonged shelf life of the medicine;
⑤ is easy to disintegrate, and has improved dissolution and bioavailability;
⑥ the film coated tablet has small volume, smooth tablet shape, and easy and convenient swallowing for children and women;
⑦ it is suitable for diabetic patients and diabetic patients, and has wide application range.
Detailed Description
The present invention is further illustrated by the following examples, which are set forth to illustrate, but are not to be construed as the limit of the present invention.
The components and weights of examples 1-10 are shown in Table 1, wherein examples 1-5 are gelatin for bone preparation, and examples 6-10 are gelatin for skin preparation; the polyvinylpyrrolidone vinyl acetate copolymers of examples 1-10 were polyvinylpyrrolidone vinyl acetate copolymers (6: 4).
Table 1: examples 1-10 formulary tables
Unit: kg of
Figure 3
The raw material components in the embodiments 1-10 are respectively added into a pulverizer to be pulverized and sieved by a 120-mesh sieve, and the raw material components are uniformly mixed to prepare the film coating premix of the Shenxian tablets.
The film coating premix obtained in the examples 1-10 is used for coating the ginseng tablet, a proper amount of the film coating premix in each example is prepared into a solution with the weight percentage of 15-20% of the film coating premix, and 200 ginseng tablet cores are coated respectively, wherein the parameters in the coating process in each example are set as shown in the table 2.
Table 2: coating process parameter setting table
Figure 4
The coating is carried out by using the film coating premix of the Shenxian tablets obtained in the examples 1 to 10, and the specific steps are as follows:
(1) the film coating premixes of examples 1-10 were dissolved in purified water to prepare film coating premixes with the weight percentage of the film coating premixes as the parameters (weight percentage of the film coating premixes) in table 2;
(2) stirring the solution obtained in the step (1) and sieving the solution by a 100-mesh sieve;
(3) preheating tablet cores of the radix clematidis tablets in examples 1-10 to 45-50 ℃ according to the parameters (tablet core preheating temperature) in the table 2;
(4) setting the air inlet temperature of the coating machine in the embodiment 1-10 to be 65-90 ℃ according to the parameter (air inlet temperature of the coating machine) in the table 2, and setting the air outlet temperature to be 48-53 ℃ according to the parameter (air outlet temperature of the coating machine) in the table 2;
(5) putting the sieved solution obtained in the step (2) and the radix codonopsis and radix clematidis tablet core heated in the step (3) into a coating machine, and setting the spraying speed of the coating machine to be 120-20 Oml/min according to the parameter (spraying speed of the coating machine) in the table 2;
(6) after spraying, respectively continuing to blow the ginseng xian tablets coated in the examples 1-10 for 5-10 minutes by using rolling hot air according to the parameters (hot air drying time) in the table 2, and taking out;
(7) and (3) respectively placing the tablets obtained in the step (6) in a drying room with the parameters (drying room temperature) set in the table 2, and drying for 4-6 hours according to the parameters (drying room drying time) in the table 2 to respectively obtain the ginseng tablet film-coated tablets of the examples 1-10.
The preparation method is characterized in that comparative examples 1-10 are additionally arranged, 200 ginseng xianxian tablet core tablets are arranged in each comparative example, the ginseng xianxian tablet core tablets adopted in the examples and the comparative examples are produced in the same batch, the weight error is not more than 0.3 per thousand, and the ginseng xianxian tablets are coated by adopting traditional syrup in the comparative examples.
After all the ginseng radix and immortal tablets are coated, 100 tablets of film-coated tablets of practical examples 1-10 and sugar-coated tablets of comparative example of ginseng radix and immortal tablets are weighed, and the weight change of the coated ginseng radix and immortal tablets is shown in table 3 relative to tablet cores of the plain tablets.
Table 3: tables for weight changes after coating for examples 1 to 10 and comparative examples 1 to 10
Examples Weight increase ratio (%) Comparative example Weight increase ratio (%)
Example 1 3.33 Comparative example 1 82.56
Example 2 4.58 Comparative example 2 79.33
Example 3 3.07 Comparative example 3 90.67
Example 4 4.92 Comparative example 4 64.51
Example 5 3.53 Comparative example 5 72.38
Example 6 3.67 Comparative example 6 54.93
Example 7 3.01 Comparative example 7 91.52
Example 8 4.02 Comparative example 8 89.98
Example 9 3.56 Comparative example 9 86.53
Example 10 3.17 Comparative example 10 74.67
Example mean values 3.69 Average of comparative examples 78.71
From the tests, the ginseng and radix clematidis tablet is coated, the weight of the tablet core is only increased by 3% -5%, the average weight is increased by 75.02% compared with the weight of the traditional sugar-coated tablet, the coating materials are saved, and the film-coated tablet is smaller than the sugar-coated tablet in volume and is more convenient to carry.
The film-coated ginseng tablets of examples 1 to 10 and the sugar-coated tablets of comparative examples 1 to 10 were placed in the same natural environment, and the breakage, swelling and mildew were observed and recorded every day until day 90, and the breakage rate, moisture absorption rate and mildew rate were shown in table 4.
Table 4: tables for changes in tablets of examples 1 to 10 and comparative examples 1 to 10
Figure BDA0001350231300000081
By comparing the examples with the comparative examples, after the radix clematidis tablet is coated by the film coating premix and the coating method for the radix clematidis tablet, the breakage rate of the radix clematidis tablet is obviously reduced, the moisture absorption rate is greatly reduced, and the mildew rate is controlled below 1 percent. Compared with sugar-coated tablets, the film-coated Shenxian tablets have better quality and lower storage requirement. In a word, the application of the invention ensures that the storage and transportation of the Shenxian tablets are more efficient and simpler.
The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims (4)

1. A Shenxian tablet film coating premix is characterized in that: the composition comprises the following components in parts by weight:
Figure FDA0002281696750000011
wherein the hydroxypropyl methylcellulose is hydroxypropyl methylcellulose E5;
the polyethylene glycol is one or two of polyethylene glycol 4000 or polyethylene glycol 6000.
2. The film-coated premix for Shenxian tablet as claimed in claim 1, which is characterized in that: the composition comprises the following components in parts by weight:
Figure FDA0002281696750000012
Figure FDA0002281696750000021
3. the process for preparing the film-coated premix of Shenxian tablet as claimed in claim 1, wherein: the method comprises the following steps:
(1) weighing the following raw material components in parts by weight: 5-10 parts of hydroxypropyl methyl cellulose, 2-10 parts of medicinal gelatin, 2-5 parts of polyvinylpyrrolidone-vinyl acetate copolymer, 1-5 parts of polyethylene glycol, 1-2 parts of tween 80, 1-5 parts of talcum powder, 1-4 parts of titanium dioxide and 1-10 parts of colorant;
(2) adding the raw material components in the step (1) into a grinder to be ground and sieved;
(3) and uniformly mixing the crushed raw material components to prepare the film coating premix of the Shenxian tablets.
4. A ginseng tablet coating method is characterized in that: the film-coated premix coating of the shenxian tablet as claimed in claim 1, comprising the following steps:
(1) dissolving the film coating premix in purified water to prepare a solution with the weight percentage of the film coating premix being 15-20%;
(2) stirring the solution obtained in the step (1) and sieving the solution by a 100-mesh sieve;
(3) preheating a ginseng and radix clematidis tablet core to 45-50 ℃;
(4) setting the air inlet temperature of the coating machine to be 65-90 ℃ and the air outlet temperature to be 48-53 ℃;
(5) putting the sieved solution obtained in the step (2) and the radix ginseng and radix clematidis tablet core heated in the step (3) into a coating machine, and setting the spraying speed of the coating machine to be 120-200 ml/min;
(6) after spraying is finished, continuously blowing the liquid for 5-10 minutes by using rolling hot air, and taking out;
(7) and (4) drying the tablets obtained in the step (6) at the temperature of 30-35 ℃ for 4-6 hours to obtain the ginseng and hawthorn tablet film-coated tablets.
CN201710573252.7A 2017-07-14 2017-07-14 Film coating premix for ginseng and radix clematidis tablets, preparation method of film coating premix and ginseng and radix clematidis tablet coating method Active CN107441056B (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101120953A (en) * 2006-08-10 2008-02-13 上海新菲尔生物制药工程技术有限公司 Complete water type thin film coating pre-mixture for traditional Chinese medicine tablets
CN101467978A (en) * 2007-12-29 2009-07-01 谭光明 Complete-water stomach dissolved type moisture-proofing film coating premix

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101120953A (en) * 2006-08-10 2008-02-13 上海新菲尔生物制药工程技术有限公司 Complete water type thin film coating pre-mixture for traditional Chinese medicine tablets
CN101467978A (en) * 2007-12-29 2009-07-01 谭光明 Complete-water stomach dissolved type moisture-proofing film coating premix

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
参仙片的质量标准研究;杨清林等;《中成药》;20090731;第31卷(第7期);参见全文 *

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