CN104784126A - Acyclovir tablet composition preparation method - Google Patents
Acyclovir tablet composition preparation method Download PDFInfo
- Publication number
- CN104784126A CN104784126A CN201410019865.2A CN201410019865A CN104784126A CN 104784126 A CN104784126 A CN 104784126A CN 201410019865 A CN201410019865 A CN 201410019865A CN 104784126 A CN104784126 A CN 104784126A
- Authority
- CN
- China
- Prior art keywords
- granulate
- dry
- acyclovir
- tabletting
- preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The present invention relates to an acyclovir tablet composition preparation method, which comprises (1) granulation, (2) drying, (3) particle finishing and total mixing, (4) tableting, (5) packaging, and other steps. According to the present invention, the drying temperature and the drying time in the process method are reasonably selected and are effectively controlled; and the acyclovir tablet prepared through the method of the present invention has characteristics of suitable moisture content and accurate and reasonable disintegration time.
Description
Technical field
The present invention relates to the preparation method of a kind of medicine containing organic effective component configuration product, particularly a kind of preparation method of Acyclovir Tablet.
Background technology
The purine nucleoside analogs that acyclovir (Aciclovir) is a kind of synthesis.Be mainly used in the various infection caused by herpes simplex virus, can be used for onset or recurring skin, mucosa, the HSV that external genitalia infects and immunodeficiency person occurs infects.For the choice drug for the treatment of HSV encephalitis, minimizing sickness rate and reduction mortality rate are all better than vidarabine.Also can be used for herpes zoster, Epstein-Barr virus, and the infection such as the concurrent chickenpox of immunodeficiency person.Local is only for skin, and the skin of acyclovir absorbs less.Acyclovir researched and developed successfully in 1981 by Glaxo Wellcome company of Britain, belongs to uncleosides as antiviral agents.This medicine is first in Britain's listing, and to the various herpesviruss of skin and ophthalmology, particularly single bleb I, II type virus, the diseases such as the chronic hepatitis of cytomegalovirus and the hepatitis B antigen positive are effective.As the milestone of second filial generation antiviral drugs, having that antiviral spectrum is comparatively wide, effect is strong, selectivity is high, safety, oral hygiene availability comparatively high, is the choice drug being used for the treatment of herpes simplex infections at present clinically.
Tablet uses on basis at pill and grows up, and its wound is used for 19th-century forties, and to 19 end of the centurys along with the appearance of compression machinery with update, the production of tablet and application obtain and develop rapidly.In recent ten years, also there is larger development tablet manufacturing technology and plant equipment aspect, as boiling granulating, direct compression of full-powder, half film coating, new adjuvant, new technology and production interlockization etc.The prescription of tablet medicine comprises: appearance character, tablet weight variation, hardness and friability, disintegration, dissolution or release, uniformity of dosage units etc., and wherein disintegration is most important for the treatment of disease.Select adhesive improper in prior art, supplementary material water content is improper, and lubricant uses too much these all can cause the prolongation of disintegration, and wherein supplementary material water content is most important, in present preparation method, drying process is improper, causes the problems such as water content control inaccuracy.
Summary of the invention
The object of the invention is to solve above-mentioned deficiency, a kind of preparation method of Acyclovir Tablet is provided.
The technical scheme realizing the object of the invention is: a kind of preparation method of Acyclovir Tablet, comprises (1) and granulates; (2) dry; (3) granulate always mixes; (4) tabletting; (5) pack.
The preparation method of above-mentioned Acyclovir Tablet, concrete has following steps:
(1) granulate: the polyvinylpyrrolidone taking ormal weight is put in stainless steel cask, adds the purified water of amount of calculation 95% ethanol and equivalent weight, stirring and dissolving, makes 8% polyvinylpyrrolidone alcoholic solution as binding agent; Take the acyclovir of recipe quantity, after hyprolose, microcrystalline Cellulose, carboxymethyl starch sodium add and mix 5 minutes in wet granulator, add binding agent, then stir discharging in 3-4 minute, granulate on oscillating granulator by 16 order nylon mesh;
(2) dry: wet granular is dry with heated-air circulation oven, and temperature controls at 70--80 DEG C, dry 3.5 ± 0.5 hours, pellet moisture controlled as 3.5%---6.0%;
(3) granulate always mixes: by granule on oscillating granulator with 16 order stainless steel sift granulate, add magnesium stearate, micropowder silica gel three-dimensional mixer always mixed 30 minutes.Do the inspection of semifinished product;
(4) tabletting: granule after the assay was approved, calculates according to granule content and answers tabletting weight, with tabletting machine, select the shallow round punch of ф 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection;
(5) pack: packed by the slice, thin piece Aluminium-coating Packer be up to the standards, packing specification is 12/plate, and outer package specification is 2 plates/box × 10 box/intermediate package × 40 intermediate package/case.
The preparation method of above-mentioned Acyclovir Tablet, described step (2) preferably baking temperature controls at 75 DEG C, dry 3.5 hours, and it is 3.5% that pellet moisture controls.
The preparation method of above-mentioned Acyclovir Tablet, described step (2) more preferably baking temperature controls at 78 DEG C, dry 4.0 hours, and it is 4.0% that pellet moisture controls.
Beneficial effect of the present invention: baking temperature and drying time in (1) process of the present invention, selects rationally, effectively to control.(2) the Acyclovir Tablet moisture prepared of the inventive method is suitable, and disintegration time is accurately reasonable.
Detailed description of the invention
(embodiment 1) takes each main ingredient according to following quality:
Acyclovir 400g, hydroxypropyl cellulose 60g, carboxymethyl starch sodium 60g, microcrystalline Cellulose 44g
5% polyvinylpyrrolidone alcoholic solution 10g, magnesium stearate 10g, micropowder silica gel 20g.
Prepare (1) in accordance with the following steps to granulate: the polyvinylpyrrolidone taking ormal weight is put in stainless steel cask, adds the purified water of amount of calculation 95% ethanol and equivalent weight, stirring and dissolving, makes 8% polyvinylpyrrolidone alcoholic solution as binding agent; Take the acyclovir of recipe quantity, after hyprolose, microcrystalline Cellulose, carboxymethyl starch sodium add and mix 5 minutes in wet granulator, add binding agent, then stir discharging in 3-4 minute, granulate on oscillating granulator by 16 order nylon mesh;
(2) dry: wet granular is dry with heated-air circulation oven, and temperature controls at 70 DEG C, dry 4.5 hours, it was 3.8% that pellet moisture controls;
(3) granulate always mixes: by granule on oscillating granulator with 16 order stainless steel sift granulate, add magnesium stearate, micropowder silica gel three-dimensional mixer always mixed 30 minutes.Do the inspection of semifinished product;
(4) tabletting: granule after the assay was approved, calculates according to granule content and answers tabletting weight, with tabletting machine, select the shallow round punch of ф 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection;
(5) pack: packed by the slice, thin piece Aluminium-coating Packer be up to the standards, packing specification is 12/plate, and outer package specification is 2 plates/box × 10 box/intermediate package × 40 intermediate package/case.
Adopting disintegration of tablet time limit analyzer to measure disintegration is 11.5 minutes.
(embodiment 2) takes each main ingredient according to following quality:
Acyclovir 400g, hydroxypropyl cellulose 60g, carboxymethyl starch sodium 60g, microcrystalline Cellulose 44g
5% polyvinylpyrrolidone alcoholic solution 10g, magnesium stearate 10g, micropowder silica gel 20g.
Prepare (1) in accordance with the following steps to granulate: the polyvinylpyrrolidone taking ormal weight is put in stainless steel cask, adds the purified water of amount of calculation 95% ethanol and equivalent weight, stirring and dissolving, makes 8% polyvinylpyrrolidone alcoholic solution as binding agent; Take the acyclovir of recipe quantity, after hyprolose, microcrystalline Cellulose, carboxymethyl starch sodium add and mix 5 minutes in wet granulator, add binding agent, then stir discharging in 3-4 minute, granulate on oscillating granulator by 16 order nylon mesh;
(2) dry: wet granular is dry with heated-air circulation oven, and temperature controls at 75 DEG C, dry 3.5 hours, it was 3.5% that pellet moisture controls;
(3) granulate always mixes: by granule on oscillating granulator with 16 order stainless steel sift granulate, add magnesium stearate, micropowder silica gel three-dimensional mixer always mixed 30 minutes.Do the inspection of semifinished product;
(4) tabletting: granule after the assay was approved, calculates according to granule content and answers tabletting weight, with tabletting machine, select the shallow round punch of ф 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection;
(5) pack: packed by the slice, thin piece Aluminium-coating Packer be up to the standards, packing specification is 12/plate, and outer package specification is 2 plates/box × 10 box/intermediate package × 40 intermediate package/case.
Adopting disintegration of tablet time limit analyzer to measure disintegration is 11.5 minutes.
(embodiment 3) takes each main ingredient according to following quality:
Acyclovir 400g, hydroxypropyl cellulose 60g, carboxymethyl starch sodium 60g, microcrystalline Cellulose 44g
5% polyvinylpyrrolidone alcoholic solution 10g, magnesium stearate 10g, micropowder silica gel 20g.
Prepare (1) in accordance with the following steps to granulate: the polyvinylpyrrolidone taking ormal weight is put in stainless steel cask, adds the purified water of amount of calculation 95% ethanol and equivalent weight, stirring and dissolving, makes 8% polyvinylpyrrolidone alcoholic solution as binding agent; Take the acyclovir of recipe quantity, after hyprolose, microcrystalline Cellulose, carboxymethyl starch sodium add and mix 5 minutes in wet granulator, add binding agent, then stir discharging in 3-4 minute, granulate on oscillating granulator by 16 order nylon mesh;
(2) dry: wet granular is dry with heated-air circulation oven, and temperature controls at 78 DEG C, dry 4.0 hours, it was 4.0% that pellet moisture controls;
(3) granulate always mixes: by granule on oscillating granulator with 16 order stainless steel sift granulate, add magnesium stearate, micropowder silica gel three-dimensional mixer always mixed 30 minutes.Do the inspection of semifinished product;
(4) tabletting: granule after the assay was approved, calculates according to granule content and answers tabletting weight, with tabletting machine, select the shallow round punch of ф 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection;
(5) pack: packed by the slice, thin piece Aluminium-coating Packer be up to the standards, packing specification is 12/plate, and outer package specification is 2 plates/box × 10 box/intermediate package × 40 intermediate package/case.
Adopting disintegration of tablet time limit analyzer to measure disintegration is 11.2 minutes.
(embodiment 5) takes each main ingredient according to following quality:
Acyclovir 400g, hydroxypropyl cellulose 60g, carboxymethyl starch sodium 60g, microcrystalline Cellulose 44g
5% polyvinylpyrrolidone alcoholic solution 10g, magnesium stearate 10g, micropowder silica gel 20g.
Prepare (1) in accordance with the following steps to granulate: the polyvinylpyrrolidone taking ormal weight is put in stainless steel cask, adds the purified water of amount of calculation 95% ethanol and equivalent weight, stirring and dissolving, makes 8% polyvinylpyrrolidone alcoholic solution as binding agent; Take the acyclovir of recipe quantity, after hyprolose, microcrystalline Cellulose, carboxymethyl starch sodium add and mix 5 minutes in wet granulator, add binding agent, then stir discharging in 3-4 minute, granulate on oscillating granulator by 16 order nylon mesh;
(2) dry: wet granular is dry with heated-air circulation oven, and temperature controls at 80 DEG C, dry 3.5 hours, it was 3.5% that pellet moisture controls;
(3) granulate always mixes: by granule on oscillating granulator with 16 order stainless steel sift granulate, add magnesium stearate, micropowder silica gel three-dimensional mixer always mixed 30 minutes.Do the inspection of semifinished product;
(4) tabletting: granule after the assay was approved, calculates according to granule content and answers tabletting weight, with tabletting machine, select the shallow round punch of ф 9.0mm.Tablet weight variation is controlled by regulation in tableting processes, must not exceed ± 5%, slice, thin piece does product inspection;
(5) pack: packed by the slice, thin piece Aluminium-coating Packer be up to the standards, packing specification is 12/plate, and outer package specification is 2 plates/box × 10 box/intermediate package × 40 intermediate package/case.
Adopting disintegration of tablet time limit analyzer to measure disintegration is 11.2 minutes.
Above-described specific embodiment; object of the present invention, technical scheme and beneficial effect are further described; be understood that; the foregoing is only specific embodiments of the invention; be not limited to the present invention; within the spirit and principles in the present invention all, any amendment made, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (4)
1. a preparation method for Acyclovir Tablet compositions, is characterized in that: comprise (1) and granulate; (2) dry; (3) granulate always mixes; (4) tabletting; (5) pack.
2. the preparation method of Acyclovir Tablet according to claim 1, is characterized in that: have following steps:
(1) granulate: the polyvinylpyrrolidone taking ormal weight is put in stainless steel cask, adds the purified water of amount of calculation 95% ethanol and equivalent weight, stirring and dissolving, makes 8% polyvinylpyrrolidone alcoholic solution as binding agent; Take the acyclovir of recipe quantity, after hyprolose, microcrystalline Cellulose, carboxymethyl starch sodium add and mix 5 minutes in wet granulator, add binding agent, then stir discharging in 3-4 minute, granulate on oscillating granulator by 16 order nylon mesh;
(2) dry: wet granular is dry with heated-air circulation oven, and temperature controls at 70--80 DEG C, dry 3.5 ± 0.5 hours, pellet moisture controlled as 3.5%---6.0%;
(3) granulate always mixes: by granule on oscillating granulator with 16 order stainless steel sift granulate, add magnesium stearate, micropowder silica gel three-dimensional mixer always mixed 30 minutes, do the inspection of semifinished product;
(4) tabletting: granule after the assay was approved, calculates according to granule content and answers tabletting weight, with tabletting machine, select the shallow round punch of ф 9.0mm, control tablet weight variation in tableting processes by regulation, must not exceed ± 5%, slice, thin piece does product inspection;
(5) pack: packed by the slice, thin piece Aluminium-coating Packer be up to the standards, packing specification is 12/plate, and outer package specification is 2 plates/box × 10 box/intermediate package × 40 intermediate package/case.
3. the preparation method of Acyclovir Tablet according to claim 2, is characterized in that: described step (2) baking temperature controls at 75 DEG C, dry 3.5 hours, and it is 3.5% that pellet moisture controls.
4. the preparation method of Acyclovir Tablet according to claim 2, is characterized in that: described step (2) baking temperature controls at 78 DEG C, dry 4.0 hours, and it is 4.0% that pellet moisture controls.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410019865.2A CN104784126B (en) | 2014-01-16 | 2014-01-16 | A kind of preparation method of Acyclovir Tablet composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410019865.2A CN104784126B (en) | 2014-01-16 | 2014-01-16 | A kind of preparation method of Acyclovir Tablet composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104784126A true CN104784126A (en) | 2015-07-22 |
| CN104784126B CN104784126B (en) | 2018-09-21 |
Family
ID=53549633
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410019865.2A Active CN104784126B (en) | 2014-01-16 | 2014-01-16 | A kind of preparation method of Acyclovir Tablet composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN104784126B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
-
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 |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN104784126B (en) | 2018-09-21 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| WO2018177318A1 (en) | Metformin hydrochloride sustained-release tablets and preparation method therefor | |
| TWI704918B (en) | A pharmaceutical preparation comprising cyclin inhibitor and preparation method thereof | |
| CN106265581B (en) | Tranexamic acid tablet and preparation method thereof | |
| CN106389369A (en) | Ferrous fumarate folic acid compound film coated tablet preparation method | |
| HRP20000732A2 (en) | Homogeneous pharmaceutical compositions comprising abacavir, lamivudine and zidovudine | |
| CN102614220A (en) | Preparing method of paracetamol, caffein, atificial cow-bezoar and chlorphenamine maleate capsule content functional pellet | |
| CN104352473A (en) | Clonidine hydrochloride sustained release tablets and preparation method thereof | |
| CN103768063A (en) | Moxifloxacin hydrochloride pharmaceutical composition and preparation method thereof | |
| CN105434386B (en) | A kind of sustained-release tablet containing highly-water-soluble active constituent and preparation method thereof | |
| MX2012014402A (en) | Composition for preventing or treating osteoporosis, and manufacturing method therefor. | |
| CN104784126A (en) | Acyclovir tablet composition preparation method | |
| CN102416003A (en) | Method for preparing entecavir tablets | |
| CN105412132A (en) | Compound invermectin slow-release granules and preparation method thereof | |
| CN102895202A (en) | Cefetamet pivoxil hydrochloride dispersible tablet and preparation method thereof | |
| CN105640908A (en) | Milnacipran hydrochloride sustained-release tablets and preparing method thereof | |
| CN101732271A (en) | Dextromethorphan orally disintegrating tablets and preparation method thereof | |
| CN101502522A (en) | Acyclovir enteric sustained-release preparation composition and method for preparing the same | |
| CN110237097A (en) | A kind of Fufang Anfenwanan capsules pellet and preparation method thereof | |
| CN104784131A (en) | Preparation method of bambuterol hydrochloride tablet | |
| CN109432036B (en) | Anti-cervicitis tablet and preparation process thereof | |
| CN104784127A (en) | Acyclovir tablet composition | |
| CN103284973A (en) | Adefovir dipivoxil composition and preparation method thereof | |
| CN118526465B (en) | Preparation method of roflumilast capsules and product thereof | |
| CN102058553B (en) | Acyclovir sustained release tablet and preparation method thereof | |
| CN104434932B (en) | Pharmaceutical composition of clopidogrel hydrogen sulfate and acetylsalicylic acid tablet and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| EXSB | Decision made by sipo to initiate substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
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. |
|
| CP01 | Change in the name or title of a patent holder | ||
| CP01 | Change in the name or title of a patent holder |
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. |