CN103462918A - Valaciclovir hydrochloride tablet and preparation method thereof - Google Patents
Valaciclovir hydrochloride tablet and preparation method thereofDownload PDFInfo
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- CN103462918A CN103462918ACN2013104305023ACN201310430502ACN103462918ACN 103462918 ACN103462918 ACN 103462918ACN 2013104305023 ACN2013104305023 ACN 2013104305023ACN 201310430502 ACN201310430502 ACN 201310430502ACN 103462918 ACN103462918 ACN 103462918A
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- vacyclovir
- vacyclovir hydrochloride
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
Technical field
The invention belongs to the pharmaceutical preparations technology field, in particular to a kind of for antiviral tablets of vacyclovir hydrochloride agent and preparation method thereof.
Background technology
Valaciclovir hydrochlordide is to suppress DNA type antiviral drugs, clinically is mainly used in treating the viral infection such as varicella zoster and I type, II type herpes simplex, has become one of main medicine salable in world wide.Chemistry Valine by name-2-[6-2-amino-1,6 dihydro-9H-purine-9-yl] the ethyl ester hydrochlorate.This medicine this product is easily molten in water, in methanol, dissolves.
CN1513454A discloses a kind of dispersion tablet of vasilowy hydrochlaride and preparation method thereof.This technology has only prepared a kind of dispersible tablet, has just shortened disintegration time, and quickly disintegrated slice, thin piece, its stripping is not necessarily fast.
By retrieval, find, prior art does not all provide corresponding technical scheme to the dissolution that how to improve valaciclovir hydrochlordide, and the inventor considers that drug-eluting affects drug effect, therefore intends the tablets of vacyclovir hydrochloride agent of a kind of Fast Stripping of exploitation.
Summary of the invention
In view of the deficiencies in the prior art, the inventor is creationary by valaciclovir hydrochlordide and sodium bicarbonate salify, utilize the character of sodium bicarbonate and hydrochloric acid reaction simultaneously, appropriate sodium bicarbonate has been used as effervescent materials, obtained a kind of tablets of vacyclovir hydrochloride agent of Fast Stripping.
In order to realize purpose of the present invention, the inventor is studied and is explored preparation prescription and technique by lot of experiments, has finally obtained following technical scheme:
A kind of tablets of vacyclovir hydrochloride agent, said preparation is to using the aqueous solution of valaciclovir hydrochlordide and sodium bicarbonate as wetting agent, by the component that comprises following weight portion (also can contain the pharmaceutically acceptable adjuvants such as correctives in prescription), by wet granulation tabletting, is formed:
Preferably, above-mentioned tablets of vacyclovir hydrochloride agent, wherein: using the aqueous solution of valaciclovir hydrochlordide and sodium bicarbonate as wetting agent, formed by wet granulation tabletting by the component of following weight portion:
Further preferably, in above-mentioned tablets of vacyclovir hydrochloride agent, the weight ratio of valaciclovir hydrochlordide and sodium bicarbonate is 1:0.5-0.6.
Further preferably, above-mentioned tablets of vacyclovir hydrochloride agent, wherein said filler is selected from one or more in microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch.
Further preferably, above-mentioned tablets of vacyclovir hydrochloride agent, wherein said lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
The present invention also provides the preparation technology of above-mentioned tablets of vacyclovir hydrochloride agent, can prepare the tablets of vacyclovir hydrochloride agent of Fast Stripping by this technique.Concrete technical scheme is as follows:
A kind of preparation method of tablets of vacyclovir hydrochloride agent, the method comprises the steps: valaciclovir hydrochlordide is dissolved in sodium bicarbonate aqueous solution, take this solution as wetting agent, on filler, granulate, drying, then even with mix lubricant, tabletting.
Preferably, the preparation method of above-mentioned tablets of vacyclovir hydrochloride agent, wherein the weight ratio of valaciclovir hydrochlordide and sodium bicarbonate is 1:0.5-0.6.
The preparation method of tablets of vacyclovir hydrochloride agent of the present invention, wherein said filler is selected from one or more in microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch; Described lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
The inventor is dissolved in valaciclovir hydrochlordide in sodium bicarbonate aqueous solution, then usings this aqueous solution as wetting agent, pharmaceutically on acceptable adjuvant, granulate, and drying, tabletting.When carrying out dissolution determination, because sodium bicarbonate and valaciclovir hydrochlordide have become sodium salt, therefore dissolubility is good, the inventor has added a part of sodium bicarbonate in right amount simultaneously, the sodium bicarbonate of this part reacts rapidly with the hydrochloric acid in gastric juice, effervescent effect helps the quick disintegrate of tablet, thus tablet of the present invention not only disintegrate is fast, stripping is also very fast.Compared with prior art, the present invention is without adding disintegrating agent, and tablet is disintegrate stripping rapidly, and preparation technology is simple simultaneously, is applicable to large production requirement.
The specific embodiment
Following examples further describe preparation process of the present invention and beneficial effect, embodiment is only for the purpose of illustration, do not limit the scope of the invention, within the apparent change that those of ordinary skills make according to the present invention simultaneously and modification are also contained in the scope of the invention.
Embodiment 1 tablets of vacyclovir hydrochloride agent and preparation method thereof
Preparation method:
Recipe quantity takes valaciclovir hydrochlordide, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, join recipe quantity and cross on the microcrystalline Cellulose of 100 mesh sieves, granulate, 60 ℃ of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Embodiment 2 tablets of vacyclovir hydrochloride agent and preparation method thereof
Preparation method:
Recipe quantity takes valaciclovir hydrochlordide, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, join recipe quantity and cross on the lactose of 100 mesh sieves, granulate, 50 ℃ of dryings, 20 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Embodiment 3 tablets of vacyclovir hydrochloride agent and preparation method thereof
Preparation method:
Recipe quantity takes valaciclovir hydrochlordide, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, join recipe quantity and cross on the microcrystalline Cellulose of 100 mesh sieves, granulate, 55 ℃ of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Comparative example's 1 tablets of vacyclovir hydrochloride agent and preparation method thereof
Preparation method:
Valaciclovir hydrochlordide, sodium bicarbonate, microcrystalline Cellulose are all crossed 100 mesh sieves, after recipe quantity takes, mix, and add pure water appropriate, 55 ℃ of dryings, and 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Comparative example's 2 tablets of vacyclovir hydrochloride agent and preparation method thereof
Preparation method:
Valaciclovir hydrochlordide was pulverized 100 mesh sieves, recipe quantity takes microcrystalline Cellulose and the low-substituted hydroxypropyl cellulose mix homogeneously of valaciclovir hydrochlordide, lactose, half amount, using 5% PVP K30 50% alcoholic solution as binding agent, granulate, 65 ℃ of dryings, 30 mesh sieve granulate, then mix homogeneously with magnesium stearate and the Aspartane of the microcrystalline Cellulose of surplus and low-substituted hydroxypropyl cellulose, proportional quantities, tabletting.
Comparative example's 3 tablets of vacyclovir hydrochloride agent and preparation method thereof
Preparation method:
Recipe quantity takes valaciclovir hydrochlordide, sodium bicarbonate, joins in pure water, is stirred to dissolve, using this aqueous solution as wetting agent, join recipe quantity and cross on the microcrystalline Cellulose of 100 mesh sieves, granulate, 55 ℃ of dryings, 18 mesh sieve granulate, dry granule is mixed homogeneously with magnesium stearate, tabletting.
Dissolution and the assay of embodiment 4 tablets of vacyclovir hydrochloride
1, dissolution.Get respectively tablets of vacyclovir hydrochloride prepared by embodiment 1-3 and comparative example 1-3, according to dissolution method (appendix X C the second method), the 0.lmol/L hydrochloric acid solution 900ml of take is dissolution medium, rotating speed is per minute 50 to turn, and operation in accordance with the law, in the time of 15 minutes, get solution 10ml, filter, it is appropriate that precision measures subsequent filtrate, with the 0.lmol/L hydrochloric acid solution, quantitatively dilutes and make the solution that approximately contains 10 μ g in every lml.According to UV-VIS spectrophotometry (appendix IV A), measure absorbance at the wavelength place of 254nm immediately; Separately get the valaciclovir hydrochlordide reference substance appropriate, accurately weighed, make with 0.1mol/L dissolve with hydrochloric acid solution quantitative dilution the solution that approximately contains 10 μ g in every lml, be measured in the same method the stripping quantity that the meter grate is every.Limit is 80% of labelled amount, should be up to specification.
2, assay.According to high performance liquid chromatography (appendix V D), measure, chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler; Methanol-water (10:90) is mobile phase; The detection wavelength is 254nm, gets valaciclovir hydrochlordide 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 annotate people's chromatograph of liquid, record chromatogram, the separating degree at valaciclovir hydrochlordide peak and guanine peak should meet the requirements.
Algoscopy: get respectively the about 50mg of tablets of vacyclovir hydrochloride prepared by embodiment 1-3 and comparative example 1-3, accurately weighed, put in the 50ml measuring bottle, adding 0.4% sodium hydroxide solution 5ml makes to dissolve, be diluted with water to scale, shake up, precision measures 2ml, put in the 100ml measuring bottle, be diluted with water to scale, shake up, precision measures 20 μ l, annotate people's chromatograph of liquid, record chromatogram; Separately get the valaciclovir hydrochlordide reference substance appropriate, be measured in the same method.By external standard method, with calculated by peak area, obtain.
The dissolution of table 1 embodiment tablets of vacyclovir hydrochloride, assay result
| Sample source | 5min dissolution (%) | 15min dissolution (%) | Content (%) |
| Embodiment 1 | 93.8 | 99.3 | 99.5 |
| Embodiment 2 | 99.1 | 99.6 | 99.8 |
| Embodiment 3 | 99.4 | 100.3 | 99.9 |
| The comparative example 1 | 37.3 | 72.9 | 99.1 |
| The comparative example 2 | 22.8 | 75.8 | 99.3 |
| The comparative example 3 | 25.9 | 76.2 | 99.4 |
It can be seen from the table, tablets of vacyclovir hydrochloride stripping prepared by embodiment of the present invention 1-3 is quick, the complete stripping of 5min; Comparative example 1 only mixes sodium bicarbonate with valaciclovir hydrochlordide, valaciclovir hydrochlordide is salify not, therefore stripping is slow; Comparative example 2 adopts prior art, and stripping is slow; Comparative example 3 has reduced the sodium bicarbonate consumption, although valaciclovir hydrochlordide and sodium bicarbonate salify, because sodium bicarbonate does not have unnecessary amount, so stripping can not play the effervescent effect while measuring, therefore disintegration of tablet is slow, and the drug slow stripping.
Claims (9)
1. a tablets of vacyclovir hydrochloride agent is characterized in that: using the aqueous solution of valaciclovir hydrochlordide and sodium bicarbonate as wetting agent, formed by wet granulation tabletting by the component that comprises following weight portion:
2. tablets of vacyclovir hydrochloride agent according to claim 1 is characterized in that: using the aqueous solution of valaciclovir hydrochlordide and sodium bicarbonate as wetting agent, formed by wet granulation tabletting by the component of following weight portion:
3. tablets of vacyclovir hydrochloride agent according to claim 1 and 2 is characterized in that: the weight ratio of valaciclovir hydrochlordide and sodium bicarbonate is 1:0.5-0.6.
4. tablets of vacyclovir hydrochloride agent according to claim 1 and 2, it is characterized in that: described filler is selected from one or more in microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch.
5. tablets of vacyclovir hydrochloride agent according to claim 1 and 2 is characterized in that: described lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
6. the preparation method of a tablets of vacyclovir hydrochloride agent according to claim 2, is characterized in that comprising the steps: valaciclovir hydrochlordide is dissolved in sodium bicarbonate aqueous solution, take this solution as wetting agent, on filler, granulate, drying, then even with mix lubricant, tabletting.
7. the preparation method of tablets of vacyclovir hydrochloride agent according to claim 6, it is characterized in that: the weight ratio of valaciclovir hydrochlordide and sodium bicarbonate is 1:0.5-0.6.
8. the preparation method of tablets of vacyclovir hydrochloride agent according to claim 6, it is characterized in that: described filler is selected from one or more in microcrystalline Cellulose, lactose, mannitol, starch and pregelatinized Starch.
9. the preparation method of tablets of vacyclovir hydrochloride agent according to claim 6, it is characterized in that: described lubricant is one or more in magnesium stearate, micropowder silica gel and sodium stearyl fumarate.
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| CN201310430502.3ACN103462918B (en) | 2013-09-22 | 2013-09-22 | A kind of Valaciclovir hydrochloride tablet and preparation method thereof |
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| CN201310430502.3ACN103462918B (en) | 2013-09-22 | 2013-09-22 | A kind of Valaciclovir hydrochloride tablet and preparation method thereof |
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| CN112168791A (en)* | 2020-09-23 | 2021-01-05 | 药大制药有限公司 | Valacyclovir hydrochloride liposome tablet and preparation method thereof |
| CN113274356A (en)* | 2021-05-25 | 2021-08-20 | 丽珠集团丽珠制药厂 | Valaciclovir hydrochloride granules and preparation method thereof |
| CN114621227A (en)* | 2022-02-28 | 2022-06-14 | 海南久常制药有限公司 | Valaciclovir hydrochloride, preparation and preparation method thereof |
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|---|---|---|---|---|
| CN104188928A (en)* | 2014-09-17 | 2014-12-10 | 山东新时代药业有限公司 | Valaciclovir hydrochloride tablet and preparation method thereof |
| CN110279667A (en)* | 2019-07-30 | 2019-09-27 | 珠海润都制药股份有限公司 | A kind of tablets of vacyclovir hydrochloride and preparation method thereof |
| CN110279667B (en)* | 2019-07-30 | 2023-02-10 | 珠海润都制药股份有限公司 | Valaciclovir hydrochloride tablet and preparation method thereof |
| CN112168791A (en)* | 2020-09-23 | 2021-01-05 | 药大制药有限公司 | Valacyclovir hydrochloride liposome tablet and preparation method thereof |
| CN112168791B (en)* | 2020-09-23 | 2022-04-22 | 药大制药有限公司 | Valacyclovir hydrochloride liposome tablet and preparation method thereof |
| CN113274356A (en)* | 2021-05-25 | 2021-08-20 | 丽珠集团丽珠制药厂 | Valaciclovir hydrochloride granules and preparation method thereof |
| CN114621227A (en)* | 2022-02-28 | 2022-06-14 | 海南久常制药有限公司 | Valaciclovir hydrochloride, preparation and preparation method thereof |
| CN115212206A (en)* | 2022-08-15 | 2022-10-21 | 江苏知原药业股份有限公司 | Medicinal composition containing pirfenidone and preparation method thereof |
| CN115212206B (en)* | 2022-08-15 | 2023-04-18 | 江苏知原药业股份有限公司 | Medicinal composition containing pirfenidone and preparation method thereof |
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| CN103462918B (en) | 2015-12-02 |
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