CN104784126B - A kind of preparation method of Acyclovir Tablet composition - Google Patents
A kind of preparation method of Acyclovir Tablet composition Download PDFInfo
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- CN104784126B CN104784126B CN201410019865.2A CN201410019865A CN104784126B CN 104784126 B CN104784126 B CN 104784126B CN 201410019865 A CN201410019865 A CN 201410019865A CN 104784126 B CN104784126 B CN 104784126B
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Abstract
The present invention relates to a kind of preparation methods of Acyclovir Tablet.Including（1）Granulation；（2）It is dry；（3）Whole grain is always mixed；（4）Tabletting；（5）Packaging and other steps, drying temperature and drying time in process of the invention, selection is reasonable, effectively controls.In addition the Acyclovir Tablet moisture that prepared by the method for the present invention is suitable, and disintegration time is accurately reasonable.
Description
Technical field
The preparation method of the present invention relates to a kind of medical configuration product containing organic effective component, more particularly to a kind of Ah former times Lip river
The preparation method of Wei tablet.
Background technology
Acyclovir（Aciclovir）For a kind of purine nucleoside analogs of synthesis.It is mainly used for herpes simplex virus institute
The various infection caused can be used for initial or recurring skin, mucous membrane, the HSV senses that external genital organs infection and immune deficiency person occur
Dye.To treat the choice drug of HSV encephalitis, incidence is reduced and reduces the death rate being superior to arabinosy ladenosine.It can be additionally used in band-like
Bleb, the infection such as Epstein-Barr virus and the concurrent varicella of immune deficiency person.Part is only used for skin, and the skin absorption of acyclovir is less.
Acyclovir was researched and developed successfully by Glaxo Wellcome company of Britain in 1981, and uncleosides as antiviral agents is belonged to.The medicine is for the first time
It is listed in Britain, to the various herpesvirals of skin and ophthalmology, especially single blister I, II type virus, cytomegalovirus and B-mode liver
The diseases such as the chronic hepatitis of scorching antigen positive are effective.As the milestone of second generation antiviral drugs, relatively wide with antiviral spectrum,
The features such as effect is strong, high selectivity, safety, higher oral hygiene availability, is clinically to be used to treat herpe simplex disease at present
The choice drug of poison infection.
Tablet grows up on the basis of pill use, it was created for 19th-century forties, at the end of the 19th century with
It the appearance of compression machinery and continuously improves, the production and application of tablet have obtained rapid development.In recent ten years, tablet is given birth to
Also there is larger development in terms of production technology and mechanical equipment, such as boiling granulating, direct compression of full-powder, half film coating, new auxiliary
Material, new process and production linkageization etc..The quality requirement of tablet medicine includes：Appearance character, tablet weight variation, hardness and friability
Degree, disintegration time limited, dissolution rate or release, uniformity of dosage units etc., wherein disintegration time limited are most important for the treatment of disease.It is existing
Having in technology selects binder improper, and supplementary material water content is improper, and lubricant can all be caused disintegration time limited using excessive these
Extend, wherein supplementary material water content is most important, and drying process is improper in present preparation method, causes water content control inaccurate
The problems such as.
Invention content
Present invention aim to address above-mentioned deficiencies, provide a kind of preparation method of Acyclovir Tablet.
Realizing the technical solution of the object of the invention is：A kind of preparation method of Acyclovir Tablet, including（1）Granulation；（2）
It is dry；（3）Whole grain is always mixed；（4）Tabletting；（5）Packaging.
The preparation method of above-mentioned Acyclovir Tablet specifically has following steps：
（1）Granulation：The polyvinylpyrrolidone for weighing specified amount is set in stainless steel barrel, and 95% ethyl alcohol of calculation amount and same is added
Etc. weight purified water, 8% polyvinylpyrrolidone ethanol solution is made as adhesive in stirring and dissolving；Weigh recipe quantity Ah
VACV, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch, which are added in wet granulator, to be mixed after five minutes, and bonding is added
Agent, is stirred for discharging for 3-4 minutes, is pelletized on oscillating granulator with 16 mesh nylon mesh；
（2）It is dry：Wet granular is dried with heated-air circulation oven, temperature is controlled at 70--80 DEG C, and dry 3.5 ± 0.5 is small
When, pellet moisture control is 3.5%---6.0%；
（3）Whole grain is always mixed：Particle is sieved into whole grain with 16 mesh stainless steels on oscillating granulator, magnesium stearate, micro mist is added
Silica gel is always mixed 30 minutes with three-dimensional mixer.Do the inspection of semifinished product；
（4）Tabletting：Particle answers tabletting weight after the assay was approved, according to granule content calculating, with tabletting machine, selects ф
The shallow round punches of 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection；
（5）Packaging：Qualified slice, thin piece will be examined to be packed with Aluminium-coating Packer, packing specification is 12 sheet panels, outer packing specification
For packaging/case in the box of 2 plates/box × 10/middle packaging × 40.
The preparation method of above-mentioned Acyclovir Tablet, the step（2）It is preferred that drying temperature control is at 75 DEG C, it is dry
3.5 hours, pellet moisture control was 3.5%.
The preparation method of above-mentioned Acyclovir Tablet, the step（2）More preferable drying temperature control is dry at 78 DEG C
4.0 hours, pellet moisture control was 4.0%.
Beneficial effects of the present invention：（1）Drying temperature and drying time in the process of the present invention, selection is reasonable, has
Effect control.（2）Acyclovir Tablet moisture prepared by the method for the present invention is suitable, and disintegration time is accurately reasonable.
Specific implementation mode
（Embodiment 1）Each main and supplementary materials are weighed according to following quality：
Acyclovir 400g, hydroxypropyl cellulose 60g, sodium carboxymethyl starch 60g, microcrystalline cellulose 44g
5% polyvinylpyrrolidone ethanol solution 10g, magnesium stearate 10g, superfine silica gel powder 20g.
It prepares in accordance with the following steps（1）Granulation：The polyvinylpyrrolidone for weighing specified amount is set in stainless steel barrel, and meter is added
8% polyvinylpyrrolidone ethanol solution is made as bonding in the purified water of calculation amount 95% ethyl alcohol and equivalent weight, stirring and dissolving
Agent；The acyclovir of recipe quantity, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch is weighed to be added in wet granulator and mix
It closes after five minutes, adhesive is added, be stirred for discharging for 3-4 minutes, pelletized on oscillating granulator with 16 mesh nylon mesh；
（2）It is dry：Wet granular is dried with heated-air circulation oven, temperature is controlled at 70 DEG C, 4.5 hours dry, particle water
Sub-control is made as 3.8%；
（3）Whole grain is always mixed：Particle is sieved into whole grain with 16 mesh stainless steels on oscillating granulator, magnesium stearate, micro mist is added
Silica gel is always mixed 30 minutes with three-dimensional mixer.Do the inspection of semifinished product；
（4）Tabletting：Particle answers tabletting weight after the assay was approved, according to granule content calculating, with tabletting machine, selects ф
The shallow round punches of 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection；
（5）Packaging：Qualified slice, thin piece will be examined to be packed with Aluminium-coating Packer, packing specification is 12 sheet panels, outer packing specification
For packaging/case in the box of 2 plates/box × 10/middle packaging × 40.
Disintegration of tablet time limit analyzer is used to measure disintegration time limited as 11.5 minutes.
（Embodiment 2）Each main and supplementary materials are weighed according to following quality：
Acyclovir 400g, hydroxypropyl cellulose 60g, sodium carboxymethyl starch 60g, microcrystalline cellulose 44g
5% polyvinylpyrrolidone ethanol solution 10g, magnesium stearate 10g, superfine silica gel powder 20g.
It prepares in accordance with the following steps（1）Granulation：The polyvinylpyrrolidone for weighing specified amount is set in stainless steel barrel, and meter is added
8% polyvinylpyrrolidone ethanol solution is made as bonding in the purified water of calculation amount 95% ethyl alcohol and equivalent weight, stirring and dissolving
Agent；The acyclovir of recipe quantity, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch is weighed to be added in wet granulator and mix
It closes after five minutes, adhesive is added, be stirred for discharging for 3-4 minutes, pelletized on oscillating granulator with 16 mesh nylon mesh；
（2）It is dry：Wet granular is dried with heated-air circulation oven, temperature is controlled at 75 DEG C, 3.5 hours dry, particle water
Sub-control is made as 3.5%；
（3）Whole grain is always mixed：Particle is sieved into whole grain with 16 mesh stainless steels on oscillating granulator, magnesium stearate, micro mist is added
Silica gel is always mixed 30 minutes with three-dimensional mixer.Do the inspection of semifinished product；
（4）Tabletting：Particle answers tabletting weight after the assay was approved, according to granule content calculating, with tabletting machine, selects ф
The shallow round punches of 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection；
（5）Packaging：Qualified slice, thin piece will be examined to be packed with Aluminium-coating Packer, packing specification is 12 sheet panels, outer packing specification
For packaging/case in the box of 2 plates/box × 10/middle packaging × 40.
Disintegration of tablet time limit analyzer is used to measure disintegration time limited as 11.5 minutes.
（Embodiment 3）Each main and supplementary materials are weighed according to following quality：
Acyclovir 400g, hydroxypropyl cellulose 60g, sodium carboxymethyl starch 60g, microcrystalline cellulose 44g
5% polyvinylpyrrolidone ethanol solution 10g, magnesium stearate 10g, superfine silica gel powder 20g.
It prepares in accordance with the following steps（1）Granulation：The polyvinylpyrrolidone for weighing specified amount is set in stainless steel barrel, and meter is added
8% polyvinylpyrrolidone ethanol solution is made as bonding in the purified water of calculation amount 95% ethyl alcohol and equivalent weight, stirring and dissolving
Agent；The acyclovir of recipe quantity, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch is weighed to be added in wet granulator and mix
It closes after five minutes, adhesive is added, be stirred for discharging for 3-4 minutes, pelletized on oscillating granulator with 16 mesh nylon mesh；
（2）It is dry：Wet granular is dried with heated-air circulation oven, temperature is controlled at 78 DEG C, 4.0 hours dry, particle water
Sub-control is made as 4.0%；
（3）Whole grain is always mixed：Particle is sieved into whole grain with 16 mesh stainless steels on oscillating granulator, magnesium stearate, micro mist is added
Silica gel is always mixed 30 minutes with three-dimensional mixer.Do the inspection of semifinished product；
（4）Tabletting：Particle answers tabletting weight after the assay was approved, according to granule content calculating, with tabletting machine, selects ф
The shallow round punches of 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection；
（5）Packaging：Qualified slice, thin piece will be examined to be packed with Aluminium-coating Packer, packing specification is 12 sheet panels, outer packing specification
For packaging/case in the box of 2 plates/box × 10/middle packaging × 40.
Disintegration of tablet time limit analyzer is used to measure disintegration time limited as 11.2 minutes.
（Embodiment 5）Each main and supplementary materials are weighed according to following quality：
Acyclovir 400g, hydroxypropyl cellulose 60g, sodium carboxymethyl starch 60g, microcrystalline cellulose 44g
5% polyvinylpyrrolidone ethanol solution 10g, magnesium stearate 10g, superfine silica gel powder 20g.
It prepares in accordance with the following steps（1）Granulation：The polyvinylpyrrolidone for weighing specified amount is set in stainless steel barrel, and meter is added
8% polyvinylpyrrolidone ethanol solution is made as bonding in the purified water of calculation amount 95% ethyl alcohol and equivalent weight, stirring and dissolving
Agent；The acyclovir of recipe quantity, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch is weighed to be added in wet granulator and mix
It closes after five minutes, adhesive is added, be stirred for discharging for 3-4 minutes, pelletized on oscillating granulator with 16 mesh nylon mesh；
（2）It is dry：Wet granular is dried with heated-air circulation oven, temperature is controlled at 80 DEG C, 3.5 hours dry, particle water
Sub-control is made as 3.5%；
（3）Whole grain is always mixed：Particle is sieved into whole grain with 16 mesh stainless steels on oscillating granulator, magnesium stearate, micro mist is added
Silica gel is always mixed 30 minutes with three-dimensional mixer.Do the inspection of semifinished product；
（4）Tabletting：Particle answers tabletting weight after the assay was approved, according to granule content calculating, with tabletting machine, selects ф
The shallow round punches of 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection；
（5）Packaging：Qualified slice, thin piece will be examined to be packed with Aluminium-coating Packer, packing specification is 12 sheet panels, outer packing specification
For packaging/case in the box of 2 plates/box × 10/middle packaging × 40.
Disintegration of tablet time limit analyzer is used to measure disintegration time limited as 11.2 minutes.
Particular embodiments described above has carried out further in detail the purpose of the present invention, technical solution and advantageous effect
It describes in detail bright, it should be understood that the above is only a specific embodiment of the present invention, is not intended to restrict the invention, it is all
Within the spirit and principles in the present invention, any modification, equivalent substitution, improvement and etc. done should be included in the guarantor of the present invention
Within the scope of shield.
Claims (1)
1. a kind of preparation method of Acyclovir Tablet composition, it is characterised in that：With following steps：According to following quality weighing
Take each main and supplementary materials：Acyclovir 400g, hydroxypropyl cellulose 60g, sodium carboxymethyl starch 60g, microcrystalline cellulose 44g, 5% poly- second
Alkene pyrrolidone ethanol solution 10g, magnesium stearate 10g, superfine silica gel powder 20g；
(1) it pelletizes：The polyvinylpyrrolidone for weighing specified amount is set in stainless steel barrel, and 95% ethyl alcohol of calculation amount and same weight is added
8% polyvinylpyrrolidone ethanol solution is made as adhesive in the purified water of amount, stirring and dissolving；Weigh the Ah former times of recipe quantity
Luo Wei, hydroxypropylcellulose, microcrystalline cellulose, sodium carboxymethyl starch, which are added in wet granulator, to be mixed after five minutes, and bonding is added
Agent, is stirred for discharging for 3-4 minutes, is pelletized on oscillating granulator with 16 mesh nylon mesh；
(2) dry：Wet granular is dried with heated-air circulation oven, temperature is controlled at 78 DEG C, 4.0 hours dry, pellet moisture control
It is made as 4%；
(3) whole grain is always mixed：Particle is sieved into whole grain with 16 mesh stainless steels on oscillating granulator, magnesium stearate, superfine silica gel powder is added
It is always mixed 30 minutes with three-dimensional mixer, does the inspection of semifinished product；
(4) tabletting：Particle answers tabletting weight after the assay was approved, according to granule content calculating, with tabletting machine, 9.0mm in selection
Shallow round punch controls tablet weight variation by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection；
(5) it packs：Qualified slice, thin piece will be examined to be packed with Aluminium-coating Packer, packing specification is 12 sheet panels, and outer packing specification is 2
Packaging/case in plate/box x10 boxes/middle packaging x40.
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| CN201410019865.2A CN104784126B (en) | 2014-01-16 | 2014-01-16 | A kind of preparation method of Acyclovir Tablet composition |
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| CN201410019865.2A CN104784126B (en) | 2014-01-16 | 2014-01-16 | A kind of preparation method of Acyclovir Tablet composition |
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| CN104784126B true CN104784126B (en) | 2018-09-21 |
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| CN108143752A (en) * | 2018-02-28 | 2018-06-12 | 仁和堂药业有限公司 | Compound antitussive object preparation and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1927342A (en) * | 2006-09-05 | 2007-03-14 | 江西本草天工科技有限责任公司 | Heat clearing and detoxicating dispersant tablet and method for making same |
| CN101804037A (en) * | 2009-02-13 | 2010-08-18 | 北京以岭生物工程有限公司 | Acyclovir dispersible tablet and preparation method thereof |
| CN101892133A (en) * | 2010-07-22 | 2010-11-24 | 兰州泰坦电子科技有限责任公司 | Effervescent tablet for removing pesticide residue on fruits and vegetables and preparation method and use method thereof |
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2014
- 2014-01-16 CN CN201410019865.2A patent/CN104784126B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1927342A (en) * | 2006-09-05 | 2007-03-14 | 江西本草天工科技有限责任公司 | Heat clearing and detoxicating dispersant tablet and method for making same |
| CN101804037A (en) * | 2009-02-13 | 2010-08-18 | 北京以岭生物工程有限公司 | Acyclovir dispersible tablet and preparation method thereof |
| CN101892133A (en) * | 2010-07-22 | 2010-11-24 | 兰州泰坦电子科技有限责任公司 | Effervescent tablet for removing pesticide residue on fruits and vegetables and preparation method and use method thereof |
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Effective date of registration: 20200217 Address after: 210032 No. 23 Xinke No. 2 Road, Jiangbei New District, Nanjing City, Jiangsu Province Patentee after: NANJING HAIJING PHARMACY CO.,LTD. Address before: Ruitai building Xincheng Technology Park Jianye District of Nanjing City, Jiangsu province 210019 17 floor Patentee before: NANJING REAL PHARMACEUTICAL Co.,Ltd. |
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Address after: 210032 No. 23 Xinke No. 2 Road, Jiangbei New District, Nanjing City, Jiangsu Province Patentee after: Nanjing Haijing Pharmaceutical Co.,Ltd. Address before: 210032 No. 23 Xinke No. 2 Road, Jiangbei New District, Nanjing City, Jiangsu Province Patentee before: NANJING HAIJING PHARMACY CO.,LTD. |
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