CN103462926B - A kind of Famciclovir tablet and preparation method thereof - Google Patents
A kind of Famciclovir tablet and preparation method thereof Download PDFInfo
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- CN103462926B CN103462926B CN201310432394.3A CN201310432394A CN103462926B CN 103462926 B CN103462926 B CN 103462926B CN 201310432394 A CN201310432394 A CN 201310432394A CN 103462926 B CN103462926 B CN 103462926B
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- famciclovir
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- sodium bicarbonate
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- 229960004396 famciclovir Drugs 0.000 title claims abstract description 65
- GGXKWVWZWMLJEH-UHFFFAOYSA-N famcyclovir Chemical compound N1=C(N)N=C2N(CCC(COC(=O)C)COC(C)=O)C=NC2=C1 GGXKWVWZWMLJEH-UHFFFAOYSA-N 0.000 title claims abstract description 65
- 238000002360 preparation method Methods 0.000 title claims abstract description 30
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims abstract description 44
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims abstract description 22
- 235000017557 sodium bicarbonate Nutrition 0.000 claims abstract description 22
- 239000007864 aqueous solution Substances 0.000 claims abstract description 12
- 239000000080 wetting agent Substances 0.000 claims abstract description 11
- 239000000945 filler Substances 0.000 claims abstract description 8
- 239000000314 lubricant Substances 0.000 claims abstract description 7
- 238000005550 wet granulation Methods 0.000 claims abstract description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 20
- 239000000243 solution Substances 0.000 claims description 11
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 10
- 235000019359 magnesium stearate Nutrition 0.000 claims description 10
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 10
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 10
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 10
- 238000001035 drying Methods 0.000 claims description 7
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 239000008101 lactose Substances 0.000 claims description 6
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 4
- 229930195725 Mannitol Natural products 0.000 claims description 4
- 229920000881 Modified starch Polymers 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 4
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 claims description 4
- 239000000594 mannitol Substances 0.000 claims description 4
- 235000010355 mannitol Nutrition 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 239000000741 silica gel Substances 0.000 claims description 4
- 229910002027 silica gel Inorganic materials 0.000 claims description 4
- 229940045902 sodium stearyl fumarate Drugs 0.000 claims description 4
- 239000008107 starch Substances 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 abstract description 3
- 230000000840 anti-viral effect Effects 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000003826 tablet Substances 0.000 description 28
- 239000008187 granular material Substances 0.000 description 16
- 230000000052 comparative effect Effects 0.000 description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 10
- 238000004090 dissolution Methods 0.000 description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 7
- 206010013786 Dry skin Diseases 0.000 description 6
- UYTPUPDQBNUYGX-UHFFFAOYSA-N guanine Chemical compound O=C1NC(N)=NC2=C1N=CN2 UYTPUPDQBNUYGX-UHFFFAOYSA-N 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 description 5
- NIPNSKYNPDTRPC-UHFFFAOYSA-N N-[2-oxo-2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 NIPNSKYNPDTRPC-UHFFFAOYSA-N 0.000 description 4
- 238000005304 joining Methods 0.000 description 4
- 239000013558 reference substance Substances 0.000 description 4
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 238000003556 assay Methods 0.000 description 3
- JNTOCHDNEULJHD-UHFFFAOYSA-N Penciclovir Chemical class N1C(N)=NC(=O)C2=C1N(CCC(CO)CO)C=N2 JNTOCHDNEULJHD-UHFFFAOYSA-N 0.000 description 2
- 239000002671 adjuvant Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 2
- 208000007514 Herpes zoster Diseases 0.000 description 1
- XQFRJNBWHJMXHO-RRKCRQDMSA-N IDUR Chemical compound C1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(I)=C1 XQFRJNBWHJMXHO-RRKCRQDMSA-N 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 230000001476 alcoholic effect Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000007919 dispersible tablet Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 239000012738 dissolution medium Substances 0.000 description 1
- 238000011978 dissolution method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000857 drug effect Effects 0.000 description 1
- 125000001495 ethyl group Chemical group [H]C([H])([H])C([H])([H])* 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000010812 external standard method Methods 0.000 description 1
- 239000000706 filtrate Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 210000004051 gastric juice Anatomy 0.000 description 1
- 210000004392 genitalia Anatomy 0.000 description 1
- 238000004128 high performance liquid chromatography Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- GBMDVOWEEQVZKZ-UHFFFAOYSA-N methanol;hydrate Chemical compound O.OC GBMDVOWEEQVZKZ-UHFFFAOYSA-N 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 description 1
- 229960001179 penciclovir Drugs 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000000870 ultraviolet spectroscopy Methods 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of for antiviral Famciclovir tablet, said preparation is using the aqueous solution of famciclovir and sodium bicarbonate as wetting agent, by the component comprising following weight portion by wet granulation and tabletting form: famciclovir 100 parts, sodium bicarbonate 40-65 part, filler 80-200 part, lubricant is appropriate.Compared with prior art, the present invention is without the need to adding disintegrating agent, and tablet can disintegrate stripping rapidly, and preparation technology is simple simultaneously, is applicable to large production requirement.
Description
Technical field
The invention belongs to pharmaceutical preparations technology field, be used for antiviral Famciclovir tablet and preparation method thereof in particular to one.
Background technology
Famciclovir (Famciclovir) is the diethyl acyl fat of the 6-deoxidation derivative of penciclovir (penciclovir), molecular formula is C14H19N5O4, chemistry 2-[2-(2-amino-9H-purine-9-base) ethyl]-1 by name, ammediol-diethylester, be applicable to treatment herpes zoster and primary genitalia herpes, become one of key agents salable in world wide.Structural formula is:
CN101904825A discloses a kind of Falacyclovir dispersion piece and preparation method thereof.This technology has only prepared a kind of dispersible tablet, just shortens disintegration time, and quickly disintegrated slice, thin piece, its stripping is not necessarily fast.
Found by retrieval, prior art does not all provide corresponding technical scheme to the dissolution how improving famciclovir, and inventor considers that drug-eluting affects drug effect, therefore intends the Famciclovir tablet of a kind of Fast Stripping of exploitation.
Summary of the invention
In view of the deficiencies in the prior art, the present inventor is creationary by famciclovir and sodium bicarbonate salify, make use of the character of sodium bicarbonate and hydrochloric acid reaction simultaneously, appropriate sodium bicarbonate is used as effervescent materials, obtain a kind of Famciclovir tablet of Fast Stripping.
In order to realize object of the present invention, inventor is studied by lot of experiments preparation prescription and technique and explores, and finally obtains following technical scheme:
A kind of Famciclovir tablet, said preparation is using the aqueous solution of famciclovir and sodium bicarbonate as wetting agent, by the component (in prescription also can containing pharmaceutically acceptable adjuvants such as correctivess) comprising following weight portion by wet granulation and tabletting form:
Preferably, above-mentioned Famciclovir tablet, wherein: using the aqueous solution of famciclovir and sodium bicarbonate as wetting agent, by the component of following weight portion by wet granulation and tabletting form:
Further preferably, in above-mentioned Famciclovir tablet, the weight ratio of famciclovir and sodium bicarbonate is 1:0.5-0.6.
Further preferably, above-mentioned Famciclovir tablet, wherein said filler be selected from microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch one or more.
Further preferably, above-mentioned Famciclovir tablet, wherein said lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
Present invention also offers the preparation technology of above-mentioned Famciclovir tablet, the Famciclovir tablet of Fast Stripping can be prepared by this technique.Concrete technical scheme is as follows:
A preparation method for Famciclovir tablet, the method comprises the steps: famciclovir to be dissolved in sodium bicarbonate aqueous solution, with this solution for wetting agent, filler is granulated, dry, then even with mix lubricant, tabletting.
Preferably, the preparation method of above-mentioned Famciclovir tablet, wherein the weight ratio of famciclovir and sodium bicarbonate is 1:0.5-0.6.
The preparation method of Famciclovir tablet of the present invention, wherein said filler be selected from microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch one or more; Described lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
Famciclovir is dissolved in sodium bicarbonate aqueous solution by the present inventor, then using this aqueous solution as wetting agent, pharmaceutically acceptable adjuvant is granulated, dry, tabletting.When carrying out dissolution determination, because sodium bicarbonate and famciclovir become sodium salt, therefore dissolubility is good, inventor has added a part of sodium bicarbonate in appropriate amount simultaneously, hydrochloric acid in the sodium bicarbonate of this part and gastric juice reacts rapidly, effervescent effect helps tablet fater disintegration, and therefore not only disintegrate is fast for Tablets, and stripping is also very fast.Compared with prior art, the present invention is without the need to adding disintegrating agent, and tablet can disintegrate stripping rapidly, and preparation technology is simple simultaneously, is applicable to large production requirement.
Detailed description of the invention
Following examples further describe preparation process of the present invention and beneficial effect, embodiment is only for the object of illustration, do not limit the scope of the invention, the simultaneously apparent change made according to the present invention of those of ordinary skill in the art and modification are also contained within the scope of the invention.
Embodiment 1 Famciclovir tablet and preparation method thereof
Preparation method:
Recipe quantity takes famciclovir, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, joining recipe quantity crosses on the microcrystalline Cellulose of 100 mesh sieves, granulates, 60 DEG C of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Embodiment 2 Famciclovir tablet and preparation method thereof
Preparation method:
Recipe quantity takes famciclovir, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, joining recipe quantity crosses on the lactose of 100 mesh sieves, granulates, 50 DEG C of dryings, 20 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Embodiment 3 Famciclovir tablet and preparation method thereof
Preparation method:
Recipe quantity takes famciclovir, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, joining recipe quantity crosses on the microcrystalline Cellulose of 100 mesh sieves, granulates, 55 DEG C of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Comparative example 1 Famciclovir tablet and preparation method thereof
Preparation method:
Famciclovir, sodium bicarbonate, microcrystalline Cellulose all cross 100 mesh sieves, and recipe quantity takes rear mixing, and add pure water in right amount, 55 DEG C of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Comparative example 2 Famciclovir tablet and preparation method thereof
Preparation method:
Famciclovir pulverized 100 mesh sieves, recipe quantity takes famciclovir, lactose, the microcrystalline Cellulose of half amount and low-substituted hydroxypropyl cellulose mix homogeneously, using 5% PVP K30 50% alcoholic solution as binding agent, granulate, 65 DEG C of dryings, 30 mesh sieve granulate, then mix homogeneously with the magnesium stearate of the microcrystalline Cellulose of surplus and low-substituted hydroxypropyl cellulose, proportional quantities and Aspartane, tabletting.
Comparative example 3 Famciclovir tablet and preparation method thereof
Preparation method:
Recipe quantity takes famciclovir, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, joining recipe quantity crosses on the microcrystalline Cellulose of 100 mesh sieves, granulates, 55 DEG C of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
The dissolution of embodiment 4 Famciclovir Tablet and assay
1, dissolution.The Famciclovir Tablet prepared of Example 1-3 and comparative example 1-3 respectively, according to dissolution method (annex X C second method), with 0.lmol/L hydrochloric acid solution 900ml for dissolution medium, rotating speed is 50 turns per minute, operates in accordance with the law, through 15 minutes time, get solution 10ml, filter, it is appropriate that precision measures subsequent filtrate, quantitatively dilutes the solution made about containing 10 μ g in every lml with 0.lmol/L hydrochloric acid solution.According to UV-VIS spectrophotometry (annex IV A), measure absorbance at the wavelength place of 254nm immediately; Separately get famciclovir reference substance appropriate, accurately weighed, also quantitatively dilute the solution made about containing 10 μ g in every lml with 0.1mol/L dissolve with hydrochloric acid solution, be measured in the same method, the stripping quantity of the every sheet of meter grate.Limit is 80% of labelled amount, should conform with the regulations.
2, assay.Measure according to high performance liquid chromatography (annex V D), chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Methanol-water (10:90) is mobile phase; Determined wavelength is 254nm, gets famciclovir reference substance solution 5ml, adds the guanine reference substance stock solution lml under human guanine and other related substance items, shake up, get 20 μ l and note people's chromatograph of liquid, record chromatogram, the separating degree at famciclovir peak and guanine peak should meet the requirements.
Algoscopy: the famciclovir agreement that contracts a film or TV play to an actor or actress 50mg for preparing of Example 1-3 and comparative example 1-3 respectively, accurately weighed, put in 50ml measuring bottle, add 0.4% sodium hydroxide solution 5ml and make dissolving, be diluted with water to scale, shake up, precision measures 2ml, put in 100ml measuring bottle, be diluted with water to scale, shake up, precision measures 20 μ l, note people chromatograph of liquid, record chromatogram; Separately get famciclovir reference substance appropriate, be measured in the same method.By external standard method with calculated by peak area, to obtain final product.
The dissolution of table 1 embodiment Famciclovir Tablet, assay result
| Sample source | 5min dissolution (%) | 15min dissolution (%) | Content (%) |
| Embodiment 1 | 94.2 | 99.8 | 99.3 |
| Embodiment 2 | 99.6 | 99.2 | 99.7 |
| Embodiment 3 | 99.1 | 100.0 | 99.7 |
| Comparative example 1 | 37.9 | 74.4 | 98.4 |
| Comparative example 2 | 25.2 | 78.2 | 99.8 |
| Comparative example 3 | 26.9 | 72.5 | 99.2 |
It can be seen from the table, Famciclovir Tablet stripping prepared by embodiment of the present invention 1-3 is quick, the complete stripping of 5min; Sodium bicarbonate only mixes with famciclovir by comparative example 1, the non-salify of famciclovir, therefore stripping is slow; Comparative example 2 adopts prior art, and stripping is slow; Comparative example 3 decreases sodium bicarbonate consumption, although famciclovir and sodium bicarbonate salify, because sodium bicarbonate does not have unnecessary amount, when therefore stripping measures, can not play effervescent effect, therefore disintegration of tablet is slow, drug slow stripping.
Claims (7)
1. a Famciclovir tablet, is characterized in that: using the aqueous solution of famciclovir and sodium bicarbonate as wetting agent, by the component of following weight portion by wet granulation and tabletting form:
Described filler be selected from microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch one or more.
2. Famciclovir tablet according to claim 1, is characterized in that: the weight ratio of famciclovir and sodium bicarbonate is 1:0.5-0.6.
3. Famciclovir tablet according to claim 1, is characterized in that: described lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
4. a preparation method for Famciclovir tablet according to claim 1, is characterized in that comprising the steps: to be dissolved in sodium bicarbonate aqueous solution by famciclovir, with this solution for wetting agent, filler is granulated, drying, then even with mix lubricant, tabletting.
5. the preparation method of Famciclovir tablet according to claim 4, is characterized in that: the weight ratio of famciclovir and sodium bicarbonate is 1:0.5-0.6.
6. the preparation method of Famciclovir tablet according to claim 4, is characterized in that: described filler be selected from microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch one or more.
7. the preparation method of Famciclovir tablet according to claim 4, is characterized in that: described lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
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| CN201310432394.3A CN103462926B (en) | 2013-09-23 | 2013-09-23 | A kind of Famciclovir tablet and preparation method thereof |
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| CN201310432394.3A CN103462926B (en) | 2013-09-23 | 2013-09-23 | A kind of Famciclovir tablet and preparation method thereof |
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| CN106511286B (en) * | 2016-10-27 | 2019-12-20 | 四川省百草生物药业有限公司 | Famciclovir tablet with high stability and preparation method thereof |
| CN112168829B (en) * | 2020-09-24 | 2022-02-15 | 华南理工大学 | Application of antiviral drug in preparation of drug for treating myelodysplastic syndrome and prepared myelodysplastic syndrome drug |
| CN112057430A (en) * | 2020-10-17 | 2020-12-11 | 迪沙药业集团有限公司 | Famciclovir pharmaceutical composition |
| CN112587491B (en) * | 2021-01-03 | 2022-08-23 | 迪沙药业集团有限公司 | Famciclovir tablet composition |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101156856A (en) * | 2007-09-29 | 2008-04-09 | 刘全胜 | Falacyclovir dispersion piece and its preparation method |
| EP2133071A1 (en) * | 2008-06-09 | 2009-12-16 | Université de la Méditerranée | Process for making gastroretentive dosage forms |
| CN101961337A (en) * | 2009-07-24 | 2011-02-02 | 北京润德康医药技术有限公司 | Medicinal composition with aciclovir sodium as active ingredient |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101156856A (en) * | 2007-09-29 | 2008-04-09 | 刘全胜 | Falacyclovir dispersion piece and its preparation method |
| EP2133071A1 (en) * | 2008-06-09 | 2009-12-16 | Université de la Méditerranée | Process for making gastroretentive dosage forms |
| CN101961337A (en) * | 2009-07-24 | 2011-02-02 | 北京润德康医药技术有限公司 | Medicinal composition with aciclovir sodium as active ingredient |
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