CN101396366B - Solid oral preparation containing valsartan and preparation method thereof - Google Patents
Solid oral preparation containing valsartan and preparation method thereof Download PDFInfo
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- CN101396366B CN101396366B CN2007100463836A CN200710046383A CN101396366B CN 101396366 B CN101396366 B CN 101396366B CN 2007100463836 A CN2007100463836 A CN 2007100463836A CN 200710046383 A CN200710046383 A CN 200710046383A CN 101396366 B CN101396366 B CN 101396366B
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- hydrochlorothiazide
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Abstract
The invention discloses an oral solid preparation containing diovan and a preparation method thereof. The invention uses medically acceptable salt and (or) hydrochlorothiazide as active component and prepares for an impacted substance by medical active component by a rolling method; the impacted substance is filtered or ground to obtain a granulated substance; the granulated substance is mixed with medical auxiliary material; and the mixture is transformed into the oral solid preparation. The invention pre-treating the active substance and can ensure the good fluidity of the material, and the invention is characterized by simple technology, low cost and the like and is fit for the industrialized production.
Description
Technical field
The present invention relates to pharmaceutical preparation, be specifically related to a kind of contain valsartan and pharmaceutically acceptable salt thereof and (or) solid orally ingestible of hydrochlorothiazide with and preparation method thereof.
Background technology
The activator of RAAS (RAAS) is vasotonia II, is formed under angiotensin converting enzyme (ACE) effect by vasotonia I.Angiotensin II can with the special receptors bind on the cell membranes in tissue.It has a lot of physiological actions, comprises direct or indirect participation blood pressure regulating.Angiotensin II is a kind of strong vaso-excitor material, can bring into play direct pressor effect, also can promote the heavily absorption of sodium, stimulates the aldosterone secretion.
Valsartan is a kind of angiotensin (AT) II receptor antagonist of orally active high specificity, it optionally acts on the AT1 receptor subtype, the AT1 receptor subtype produces reaction to the known action of Angiotensin II, AT2 receptor subtype and cardiovascular effect are irrelevant, and valsartan is to the activity of AT1 receptor without any partial agonist.Valsartan is stronger 20000 times than AT2 receptor with the affinity of AT1 receptor.
Chinese: valsartan
English name: Valsartan
Chemical name: (S)-N-valeryl-N-{[2 '-(1H-tetrazole-5-yl) [1,1 '-phenylbenzene]-the 4-yl] methyl }-valine,
Molecular formula: C
24H
29N
5O
3
Structural formula:
ACE is converted into Angiotensin II with angiotensin I, and the degraded Kallidin I.Angiotensin ii receptor antagonist one valsartan does not have inhibitory action to ACE, does not cause the retention of Kallidin I and P material, so can not cause cough.Relatively the clinical trial of valsartan and ACE inhibitor confirms that the incidence rate (2.6%) of valsartan group dry cough significantly is lower than ACE inhibitor group (7.9%) (P＜0.05).Find a clinical trial that the patient who once accepted ACE inhibitor treatment back generation dry cough symptom is carried out, the valsartan group, diuretic group, ACEI. group have 19.5%, 19.0%, 68.5% patient cough (P＜0.05) to occur respectively.Valsartan does not have influence to other known hormone receptor or ion channels that play an important role in cardiovascular is regulated.
Hydrochlorothiazide mainly suppresses marrow and mixes the again absorption of ascending branch cortex portion to Na+ and Cl-, thereby promotes kidney that the drainage of sodium chloride is produced diuresis, is middle effect diuretic.It also has the effect of faint inhibition carbonic anhydrase, and therefore HCO3-loses lighter in the urine.Appearance effect in oral back 1 hour reached the peak in about 2 hours, kept 12-18 hour.
Chinese: hydrochlorothiazide
English name: Hydrochlorothiazide
Chemical name: 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide-1,1-dioxide
Molecular formula: C
7H
8CIN
3O
4S
2
Structural formula:
This product also has hypotensive effect, and can strengthen the hypotensive effect of other depressor.Pressure reduction effect is weak but certain, uses as basic depressor and other depressor compatibilities clinically.Also have antidiuretic activity, reduce diabetes insipidus patient's urine amount, but curative effect is not as good as pituitrin.Be used for various edema (with better), each phase hypertension and diabetes insipidus clinically to the cardiac edema curative effect.
Use clinically at present contain valsartan and pharmaceutically acceptable salt thereof and (or) the topmost dosage form of these one or both medicines of hydrochlorothiazide is tablet and capsule.
Tablet and capsule are one of dosage forms that is most widely used in the modern medicines preparation, and it has, and dosage is accurate, and medicament contg difference is less, and steady quality is convenient to store and carry, and advantages such as convenient drug administration mainly supply oral.
The method that AU2006202999 has introduced by non-slurry pelletizing prepares the valsartan sheet, with valsartan and microcrystalline Cellulose, polyvinylpolypyrrolidone, micropowder silica gel, mixing such as magnesium stearate.Overstock by cylinder, after sieve and make granule, add material again, mix the back tabletting.This patent has also been introduced the method that adopts fluidized bed prilling to prepare granule encapsulated simultaneously.
US6858228, US6485745 have introduced the preparation method of valsartan and Hydrochlorothiade sheet, with valsartan, and hydrochlorothiazide and microcrystalline Cellulose, polyvinylpolypyrrolidone, the part magnesium stearate mixes.Adopt drum extrusion, the method for sieving makes granule, and mixes tabletting with remaining magnesium stearate.
WO2005/082329 has introduced the preparation method of valsartan sheet.With valsartan, polyvinylpolypyrrolidone, carboxymethylcellulose calcium, sodium carboxymethyl cellulose, microcrystalline Cellulose, starch, micropowder silica gel, mixing such as magnesium stearate.Adopt the rolling process non-slurry pelletizing, granule and microcrystalline Cellulose, polyvinylpolypyrrolidone, micropowder silica gel, magnesium stearate mixes.Tabletting obtains the valsartan sheet.
EP1410797, WO97/49394 have introduced the preparation method of valsartan and Hydrochlorothiade sheet, also are to adopt dry method granulation processes.
Direct compression process or often because the flowability of powder body is not good, perhaps tablet machine equipment is not suitable for direct compression technology.In addition, carry out capsule after material directly mixed and fill and also exist, and cause problems such as capsular content uniformity is defective to be unfavorable for suitability for industrialized production because material fluidity is not good.
Summary of the invention
The technical problem to be solved in the present invention be research design be fit to contain valsartan and pharmaceutically acceptable salt thereof and (or) hydrochlorothiazide solid orally ingestible and industrial method.
The invention provides a kind of contain valsartan and pharmaceutically acceptable salt thereof and (or) solid orally ingestible of hydrochlorothiazide.
Column weight amount proportioning is pressed in the constituent of said preparation:
The raw material weight ratio
Valsartan and pharmaceutically acceptable salt thereof: 40～60%
Hydrochlorothiazide: 0～20%
Filler: 20～60%
Disintegrating agent: 0～15%
Fluidizer: 0～3%
Lubricant: 0.1～2%
Wherein said preparation by valsartan and (or) hydrochlorothiazide forms as active constituents of medicine and pharmaceutic adjuvant, pharmaceutic adjuvant is a starch, pregelatinized Starch, dextrin, microcrystalline Cellulose, optimization type microcrystalline Cellulose, sugar part, lactose, calcium hydrogen phosphate, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, micropowder silica gel, Pulvis Talci, the composition of one or more in magnesium stearate or the stomach dissolved film coating pre-mix dose.
Another object of the present invention be provide contain valsartan and pharmaceutically acceptable salt thereof and (or) preparation method of the solid orally ingestible of hydrochlorothiazide, this method comprises the following steps:
(1) active constituents of medicine is obtained compact with the roll-in method compacting;
(2) compact is sieved or grind and obtain granulate;
(3) again the material of " (2) " and pharmaceutic adjuvant are mixed, obtain compounding substances;
(4) with the mixture of " (3) " compacting in flakes or fill become capsule.
The tight device of roll-in is a kind of conventional equipment, and hydraulic means can push roller to the material that passes between the roller by the screw rod transmission system.The roller rotating speed is 3～5rpm.After extruding, can or grind the compact screening and form granulate.After by above-mentioned technology active substance being handled, make it have good mobility, again active substance is mixed with unclassified stores, can direct compression or fill capsule.
The present invention by to active substance through pretreatment, can guarantee that material has good mobility and be fit to above-mentioned production technology.This technology is for other technologies, and it is simple to have technology.Characteristics such as cost is low are fit to suitability for industrialized production.If active substance is not carried out non-slurry pelletizing, and directly mix the back direct compression with adjuvant, can be because problems such as flowability cause production to encounter difficulties.When adopting the Fette high speed tablet press to carry out tabletting, its main pinch roller pressure divergence surpasses 5%, has exceeded the limit of machine self, and the autostop phenomenon takes place.And adopting method of the present invention, its main pinch roller pressure divergence to meet the set point of equipment less than 5%, production process is normal.
According to quality standard the sample that adopts the present invention to produce is detected, every index is all up to specification.
The specific embodiment
By following object lesson, understanding the present invention that can be more concrete, but the present invention is not limited to following example.
Embodiment 1: the preparation of valsartan sheet
The preparation label: the valsartan crude drug adopts non-slurry pelletizing machine (Alexandria WP120V) to carry out pelletize, obtains valsartan crude drug granule.Pressure: 40bar, roller rotating speed: 3rpm.This granule and optimization type microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix the back and adopt high speed tablet press to carry out tabletting.Various material's proportion see Table 1 in the label.And to the hardness of plain sheet, weight differential, detect disintegration.The results are shown in Table 2.
Table 1, material proportion of composing
| Name of material | Every content (mg) |
| Valsartan crude drug granule optimization type microcrystalline Cellulose polyvinylpolypyrrolidone magnesium stearate | 80 62.4 16 1.6 |
| Gross weight | 160 |
Table 2, the plain sheet testing result of valsartan
| Average sheet is heavy | Hardness is qualified | Weight differential | Disintegration |
| 160mg | Qualified | ＜3％ | ＜1min |
The preparation coated tablet:
Coating powder is mixed with coating solution, plain sheet is carried out coating.Up to the slice, thin piece weightening finish is 2～5%, and the every index of coated tablet meets relevant regulations.
Embodiment 2: the preparation of valsartan sheet
The preparation label: the valsartan crude drug adopts non-slurry pelletizing machine (Alexandria WP120V) to carry out pelletize, obtains valsartan crude drug granule.Pressure: 60bar, drum rotation speed: 3rpm.This granule and valsartan (not pelletize), optimization type microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix the back and adopt high speed tablet press to carry out tabletting.And coating.Various material's proportion see Table 3 in the label.And to the hardness of plain sheet, weight differential, detect disintegration.The results are shown in Table 4.
Table 3, material proportion of composing
| Name of material | Every content (mg) |
| Valsartan crude drug granule valsartan optimization type microcrystalline Cellulose polyvinylpolypyrrolidone magnesium stearate | 40 40 62.4 16 1.6 |
| Gross weight | 160 |
Table 4, the plain sheet testing result of valsartan
| Average sheet is heavy | Hardness is qualified | Weight differential | Disintegration |
| 160mg | Qualified | ＜3％ | ＜1min |
The preparation coated tablet:
Coating powder is mixed with coating solution, plain sheet is carried out coating.Up to the slice, thin piece weightening finish is 2～5%, and the every index of coated tablet meets relevant regulations.
Embodiment 3: the preparation of valsartan sheet
The preparation label: the valsartan crude drug adopts non-slurry pelletizing machine (Alexandria WP120V)
Carry out pelletize, obtain valsartan crude drug granule.Pressure: 60bar, drum rotation speed: 3rpm.This granule and optimization type microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix the back and adopt high speed tablet press to carry out tabletting.And coating.Various material's proportion see Table 5 in the label.And to the hardness of plain sheet, weight differential, detect disintegration.The results are shown in Table 6.
Table 5, material proportion of composing
| Name of material | Every content (mg) |
| Valsartan crude drug granule optimization type microcrystalline Cellulose polyvinylpolypyrrolidone magnesium stearate | 40 49 10 1 |
| Gross weight | 100 |
Table 6, the plain sheet testing result of valsartan
| Average sheet is heavy | Hardness is qualified | Weight differential | Disintegration |
| 100mg | Qualified | ＜3％ | ＜1min |
The preparation coated tablet:
Coating powder is mixed with coating solution, plain sheet is carried out coating.Up to the slice, thin piece weightening finish is 2～5%, and the every index of coated tablet meets relevant regulations.
Embodiment 4: the preparation of valsartan sheet
The preparation label: the valsartan crude drug adopts non-slurry pelletizing machine (Alexandria WP120V)
Carry out pelletize, obtain valsartan crude drug granule.Pressure: 60bar, drum rotation speed: 3rpm.This granule and optimization type microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix the back and adopt high speed tablet press to carry out tabletting.And coating.Various material's proportion see Table 7 in the label.And to the hardness of plain sheet, weight differential, detect disintegration.The results are shown in Table 8.
Table 7, material proportion of composing
| Name of material | Every content (mg) |
| Valsartan crude drug granule optimization type microcrystalline Cellulose polyvinylpolypyrrolidone magnesium stearate | 40 19 6 1 |
| Gross weight | 66 |
Table 8, the plain sheet testing result of valsartan
| Average sheet is heavy | Hardness is qualified | Weight differential | Disintegration |
| 100mg | Qualified | ＜3％ | ＜1min |
The preparation coated tablet:
Coating powder is mixed with coating solution, plain sheet is carried out coating.Up to the slice, thin piece weightening finish is 2～5%, and the every index of coated tablet meets relevant regulations.
Embodiment 5: the preparation of valsartan and Hydrochlorothiade sheet
The preparation label: the valsartan crude drug adopts non-slurry pelletizing machine (Alexandria WP120V)
Carry out pelletize, obtain valsartan crude drug granule.Pressure: 60bar, drum rotation speed: 3rpm.This granule and hydrochlorothiazide, optimization type microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix the back and adopt high speed tablet press to carry out tabletting.And coating.Various material's proportion see Table 9 in the label.And to the hardness of plain sheet, weight differential, detect disintegration.The results are shown in Table 10.
Table 9, material proportion of composing
| Name of material | Every content (mg) |
| Valsartan crude drug granule hydrochlorothiazide optimization type microcrystalline Cellulose polyvinylpolypyrrolidone magnesium stearate | 160 25 71.5 40 3.5 |
| Gross weight | 300 |
Table 10, the plain sheet testing result of valsartan
| Average sheet is heavy | Hardness is qualified | Weight differential | Disintegration |
| 300mg | Qualified | ＜3％ | ＜1min |
The preparation coated tablet:
Coating powder is mixed with coating solution, plain sheet is carried out coating.Up to the slice, thin piece weightening finish is 2～5%, and the every index of coated tablet meets relevant regulations.
Embodiment 6: the preparation of valsartan and Hydrochlorothiade sheet
The preparation label: the valsartan crude drug adopts non-slurry pelletizing machine (Alexandria WP120V)
Carry out pelletize, obtain valsartan crude drug granule.Pressure: 60bar, drum rotation speed: 3rpm.This granule and hydrochlorothiazide, optimization type microcrystalline Cellulose, polyvinylpolypyrrolidone, magnesium stearate mix the back and adopt high speed tablet press to carry out tabletting.And coating.Various material's proportion see Table 11 in the label.And to the hardness of plain sheet, weight differential, detect disintegration.The results are shown in Table 12.
Table 11, material proportion of composing
| Name of material | Every content (mg) |
| Valsartan crude drug granule hydrochlorothiazide optimization type microcrystalline Cellulose polyvinylpolypyrrolidone magnesium stearate | 160 12.5 84 40 3.5 |
| Gross weight | 300 |
Table 12, the plain sheet testing result of valsartan
| Average sheet is heavy | Hardness is qualified | Weight differential | Disintegration |
| 300mg | Qualified | ＜3％ | ＜1min |
The preparation coated tablet:
Coating powder is mixed with coating solution, plain sheet is carried out coating.Up to the slice, thin piece weightening finish is 2～5%, and the every index of coated tablet meets relevant regulations.
Claims (7)
1. a preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide is characterized in that this preparation method comprises the following steps:
The raw material weight ratio
Valsartan and pharmaceutically acceptable salt thereof: 40～60%
Hydrochlorothiazide: 0～20%
Filler: 20～60%
Disintegrating agent: 0～15%
Fluidizer: 0～3%
Lubricant: 0.1～2%
Method:
(1) active constituents of medicine is obtained compact with the roll-in method compacting;
(2) compact is sieved or grind and obtain granulate;
(3) again the material of " (2) " and pharmaceutic adjuvant are mixed, obtain compounding substances;
(4) with the mixture of " (3) " compacting in flakes or fill become capsule.
2. a kind of preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide according to claim 1, it is characterized in that wherein said active substance is valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide.
4. a kind of preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide according to claim 1, it is characterized in that wherein said active substance comprises the valsartan of 10～400mg and the hydrochlorothiazide of pharmaceutically acceptable salt and/or 10～80mg thereof.
5. a kind of preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide according to claim 1, it is characterized in that, wherein said pharmaceutic adjuvant is a starch, pregelatinized Starch, dextrin, microcrystalline Cellulose, optimization type microcrystalline Cellulose, sugar part, lactose, calcium hydrogen phosphate, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, micropowder silica gel, Pulvis Talci, the composition of one or more in magnesium stearate or the stomach dissolved film coating pre-mix dose.
6. a kind of preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide according to claim 1 is characterized in that, wherein said step (1) is to adopt tight method of roll-in or preloading method to carry out.
7. a kind of preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide according to claim 1 is characterized in that the tight roller rotating speed of wherein said step (1) roll-in is 3～5rpm.
8. a kind of preparation method that contains the solid orally ingestible of valsartan and pharmaceutically acceptable salt and/or hydrochlorothiazide according to claim 2 is characterized in that, wherein said step (2) is undertaken by screening or grinding compact.
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| CN2007100463836A CN101396366B (en) | 2007-09-25 | 2007-09-25 | Solid oral preparation containing valsartan and preparation method thereof |
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|---|---|---|---|
| CN2007100463836A CN101396366B (en) | 2007-09-25 | 2007-09-25 | Solid oral preparation containing valsartan and preparation method thereof |
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| CN101396366A CN101396366A (en) | 2009-04-01 |
| CN101396366B true CN101396366B (en) | 2010-10-13 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526062A (en) * | 2011-10-27 | 2012-07-04 | 浙江华海药业股份有限公司 | Valsartan and hydrochlorothiazide oral solid preparation with high medicament loading capacity |
| CN102631357B (en) * | 2012-04-13 | 2013-04-17 | 重庆康刻尔制药有限公司 | Composite tablet of valsartan and hydrochlorothiazide and preparation method thereof |
| CN102846579B (en) * | 2012-09-24 | 2014-05-14 | 石药集团中诺药业（石家庄）有限公司 | Valsartan medicinal capsule and preparation method thereof |
| CN110478327A (en) * | 2019-09-19 | 2019-11-22 | 苏州东瑞制药有限公司 | A kind of oral preparation and preparation method thereof containing amber love song Ge Lieting |
| CN115721019A (en) * | 2022-12-02 | 2023-03-03 | 南通市常海食品添加剂有限公司 | Dry granulation method for folic acid |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6858228B2 (en) * | 1996-06-27 | 2005-02-22 | Novartis Ag | Solid oral dosage forms of valsartan |
| CN1628106A (en) * | 2002-02-04 | 2005-06-15 | 诺瓦提斯公司 | Salts of valsartan |
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2007
- 2007-09-25 CN CN2007100463836A patent/CN101396366B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6858228B2 (en) * | 1996-06-27 | 2005-02-22 | Novartis Ag | Solid oral dosage forms of valsartan |
| CN1628106A (en) * | 2002-02-04 | 2005-06-15 | 诺瓦提斯公司 | Salts of valsartan |
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