CN101559042A - Compound double-layer tablet containing telmisartan and hydrochlorothiazide - Google Patents
Compound double-layer tablet containing telmisartan and hydrochlorothiazide Download PDFInfo
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- CN101559042A CN101559042A CNA2008101041573A CN200810104157A CN101559042A CN 101559042 A CN101559042 A CN 101559042A CN A2008101041573 A CNA2008101041573 A CN A2008101041573A CN 200810104157 A CN200810104157 A CN 200810104157A CN 101559042 A CN101559042 A CN 101559042A
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- hydrochlorothiazide
- layer tablet
- solid dispersion
- compound double
- telmisartan
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Abstract
The invention discloses a compound double-layer tablet containing telmisartan and hydrochlorothiazide and a preparation method thereof. The preparation method comprises the following steps: preparing the hydrochlorothiazide into solid dispersoid, and then, mixing the solid dispersoid with the telmisartan to obtain the compound double-layer tablet containing telmisartan and hydrochlorothiazide. The compound double-layer tablet improves the solubility of main medicines, promotes the rapid disintegration of medicines, prevents the stripping influence of meglumine on the hydrochlorothiazide, and increases the bioavailability of the main medicines simultaneously. The compound double-layer tablet containing telmisartan and hydrochlorothiazide has good effect on treating hypertension.
Description
Technical field
The invention discloses a kind of compound double-layer tablet that contains telmisartan and hydrochlorothiazide and preparation method thereof, particularly relate to a kind of method of making double-layer tablet behind the solid dispersion again with telmisartan that hydrochlorothiazide partly is prepared into.
Background technology
Telmisartan is a kind of receptor antagonist of Angiotensin II, medically is being mainly used in the treatment hypertension symptom.Hydrochlorothiazide be a kind of oral administration be used for the treatment of edema and hypertensive thiazide diuretic.Conventional using method is that meglumine and telmisartan are united use, telmisartan is had good effect, but meglumine is unfavorable for the stripping of hydrochlorothiazide.Telmisartan and hydrochlorothiazide unite use, demonstrated good synergism in the treatment aspect hypertension.In order promptly to satisfy the synergism that two kinds of active component are united use, solve the influence of meglumine simultaneously to hydrochlorothiazide, improve the dissolubility of principal agent, promote the quick disintegrate of medicine, increase the bioavailability of principal agent simultaneously, be the subject matter that will solve.
Two pieces of patents of CN1615123A, CN101080225A disclose respectively and have adopted two one-tenth chip technologies and two kinds of medicine various combination method prepared preparation.Because the poorly water-soluble of hydrochlorothiazide, and meglumine has considerable influence to the stripping of hydrochlorothiazide.More than two pieces of preparation method prepared preparation that patent provided, do not mention by adopting method solution meglumine prepare solid dispersion that the stripping of hydrochlorothiazide is influenced problem, promote the dissolving of hydrochlorothiazide simultaneously, accelerate the disintegration rate of medicine, thus problems such as raising bioavailability.The applicant finds by a large amount of experiments, poorly soluble, meglumine that the hydrochlorothiazide solid dispersion system that adopts PVP-K30, the husky nurse of POLO, PEG6000 to form efficiently solves hydrochlorothiazide influence problems such as hydrochlorothiazide stripping, improved the dissolubility of medicine, improve bioavailability of medicament, also increased the stability of principal agent simultaneously.
Summary of the invention
The invention provides a kind of compound double-layer tablet that contains telmisartan and hydrochlorothiazide and preparation method thereof, described double-layer tablet is made with telmisartan after hydrochlorothiazide partly is prepared into solid dispersion again.
Compound double-layer tablet of the present invention, described hydrochlorothiazide solid dispersion carrier are the mixture that PVP-K30, poloxamer and PEG6000 form.
Compound double-layer tablet of the present invention, acceptable auxiliary is one or more in lactose, microcrystalline Cellulose, sodium carboxymethylstarch, Brilliant blue aluminum lake, magnesium stearate and the xylitol on the described hydrochlorothiazide solid dispersion Chinese materia medica.
Solid dispersion of the present invention, the weight percentage of described PVP-K30 are 1%～15%.
Solid dispersion of the present invention, the weight percentage of the husky nurse of described POLO is 1%～10%.
Solid dispersion of the present invention, the weight percentage of described PEG6000 are 5%～30%.
Solid dispersion of the present invention, the weight percentage of described various adjuvants are 0%～50%.
Compound double-layer tablet of the present invention, described compound double-layer tablet has good action effect to treatment hypertension.
The specific embodiment
The present invention is described in further detail below in conjunction with embodiment, but be not limited to following embodiment.Wherein " % " is meant " percentage by weight ".
Embodiment 1
This embodiment is for directly making tablet
Preparation technology: take by weighing hydrochlorothiazide, telmisartan, PEG6000, the husky nurse of POLO, PVP-K30, microcrystalline Cellulose, meglumine and starch by recipe quantity, polyvidone alcoholic solution with 5% is a binding agent, stirring makes it dissolving, 30 order wet granulations, 60 ℃ of oven dry.26 order granulate are measured moisture, after adding magnesium stearate and Pulvis Talci mix, and 60～80N tabletting.
Embodiment 2
This embodiment is pressed into double-layer tablet with telmisartan then for earlier hydrochlorothiazide being pressed into ordinary tablet.
The hydrochlorothiazide part
The telmisartan part
Preparation technology: take by weighing hydrochlorothiazide, lactose, xylitol, sodium carboxymethylstarch, Brilliant blue aluminum lake and microcrystalline Cellulose by recipe quantity, the polyvidone alcoholic solution with 5% is a binding agent, 30 order wet granulations, 60 ℃ of oven dry.26 order granulate are measured moisture, and after the adding magnesium stearate was mixed, tabletting was standby.Take by weighing telmisartan, sodium hydroxide, mannitol alcohol, meglumine and starch by recipe quantity, the alcohol granulation with 95%, 30 order wet granulations, 60 ℃ of oven dry.26 order granulate are measured moisture, after the adding Pulvis Talci mixes, are pressed into double-layer tablet with hydrochlorothiazide tablet at 40～60N.
Embodiment 3
This embodiment is pressed into double-layer tablet with telmisartan then for earlier hydrochlorothiazide being prepared into the solid dispersion sheet.
The hydrochlorothiazide part
The telmisartan part
Preparation technology: take by weighing hydrochlorothiazide, PEG6000 by recipe quantity, the polyvidone alcoholic solution with 5% is a binding agent, adds the husky nurse of PVP-K30 and POLO, 60 order wet granulations.50 ℃ of oven dry grind the back and make it dissolving, 30 order wet granulations, 60 ℃ of oven dry with sodium carboxymethylstarch, Brilliant blue aluminum lake, microcrystalline Cellulose and stirring.26 order granulate are measured moisture, after the adding magnesium stearate is mixed, are prepared into solid dispersion, and are standby behind the tabletting.Take by weighing telmisartan, sodium hydroxide, sorbitol, meglumine and starch by recipe quantity, the alcohol granulation with 95%, 30 order wet granulations, 60 ℃ of oven dry.26 order granulate are measured moisture, after the adding Pulvis Talci mixes, are pressed into double-layer tablet with hydrochlorothiazide tablet at 40～60N.
Embodiment 1, embodiment 2 and embodiment 3 are carried out dissolution determination.
Assay method: according to the determination of dissolution rate method, promptly " 2005 editions two appendix XC dissolution determination methods of Chinese pharmacopoeia, first method is a release medium with 900mL water, temperature (37.5 ± 0.5) ℃, 100 rev/mins of rotating speeds.The results are shown in following table:
Hydrochlorothiazide stripping result
Telmisartan stripping result
By hydrochlorothiazide is made solid dispersion, make double-layer tablet with telmisartan again, increase the water solublity of principal agent, the disintegration rate of medicine is fast, and stripping is complete, and bioavailability improves.
Claims (8)
1. a compound double-layer tablet that contains telmisartan and hydrochlorothiazide active component is characterized in that hydrochlorothiazide and the prepared solid dispersion of acceptable accessories in this compound double-layer tablet, and then makes double-layer tablet with telmisartan.
2. compound double-layer tablet according to claim 1 is characterized in that described hydrochlorothiazide solid dispersion carrier is the mixture that PVP-K30, poloxamer and PEG6000 form.
3. compound double-layer tablet according to claim 1 is characterized in that acceptable auxiliary on the described hydrochlorothiazide solid dispersion Chinese materia medica is one or more in lactose, microcrystalline Cellulose, sodium carboxymethylstarch, Brilliant blue aluminum lake, magnesium stearate and the xylitol.
4. solid dispersion according to claim 2, the weight percentage that it is characterized in that described PVP-K30 is 1%～15%.
5. solid dispersion according to claim 2 is characterized in that the weight percentage of the husky nurse of described POLO is 1%～10%.
6. solid dispersion according to claim 2, the weight percentage that it is characterized in that described PEG6000 is 5%～30%.
7. solid dispersion according to claim 3, the weight percentage that it is characterized in that described various adjuvants is 0%～50%.
8. compound double-layer tablet according to claim 1 is characterized in that described double-layer tablet has good action effect to treatment hypertension.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101041573A CN101559042A (en) | 2008-04-16 | 2008-04-16 | Compound double-layer tablet containing telmisartan and hydrochlorothiazide |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101041573A CN101559042A (en) | 2008-04-16 | 2008-04-16 | Compound double-layer tablet containing telmisartan and hydrochlorothiazide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101559042A true CN101559042A (en) | 2009-10-21 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2008101041573A Pending CN101559042A (en) | 2008-04-16 | 2008-04-16 | Compound double-layer tablet containing telmisartan and hydrochlorothiazide |
Country Status (1)
| Country | Link |
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| CN (1) | CN101559042A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103006566A (en) * | 2012-12-27 | 2013-04-03 | 惠州市九惠制药股份有限公司 | Osmotic pump controlled release tablet of losartan potassium and hydrochlorothiazide solid dispersion or inclusion compound |
| CN103479643A (en) * | 2013-10-10 | 2014-01-01 | 沈阳药科大学 | Preparation method of compound preparation for treating high blood pressure |
-
2008
- 2008-04-16 CN CNA2008101041573A patent/CN101559042A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103006566A (en) * | 2012-12-27 | 2013-04-03 | 惠州市九惠制药股份有限公司 | Osmotic pump controlled release tablet of losartan potassium and hydrochlorothiazide solid dispersion or inclusion compound |
| CN103479643A (en) * | 2013-10-10 | 2014-01-01 | 沈阳药科大学 | Preparation method of compound preparation for treating high blood pressure |
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| PB01 | Publication | ||
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| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20091021 |