CN102283815B - Benidipine hydrochloride dispersing tablet and preparation method thereof - Google Patents
Benidipine hydrochloride dispersing tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a benidipine hydrochloride dispersing tablet, which comprises the following components in percentage by weight: 0.5-2% of benidipine hydrochloride used as an active ingredient as well as 40-62.8% of auxiliary material A, 35-55% of auxiliary material B, 1.0-5.0% of auxiliary material C, 0.5-6.0% of auxiliary material D and 0.2-5.0% of auxiliary material E used as a mixed auxiliary material. The method also discloses a preparation method of the benidipine hydrochloride dispersing tablet. The dispersing tablet disclosed by the invention has the advantages of short disintegration time, good dispersion state, rapid drug dissolution, definite curative effect, high bioavailability and convenience in administration, and can be administered by swallowing and can also be administered after being dispersed in water. The preparation process comprises production equipment and process for common tablets, and has the advantages of no need for special production process and equipment, simple production process and low cost.
Description
Technical field
The present invention relates to a kind of benidipine hydrochloride dispersing tablet and preparation method thereof, belong to the synthetic preparing technical field that reaches of medicine.
Background technology
Hypertension can be divided into essential hypertension and secondary hypertension.Essential hypertension accounts for 90%, is under various factors impact, due to the blood pressure regulating functional disorder; Secondary hypertension accounts for 5%～10%.Show according to the China's Statistical data, in 35～74 years old crowd of China, hypertensive sickness rate is up to approximately 27%, and patient's number is near 100,013,000, and is annual newly-increased more than 3,000,000.Hypertension can cause the damage of the organs such as the heart, brain, kidney, the serious threat mankind's health and lives.Therefore, the protection heart, brain, kidney, control heart failure, renal failure and apoplexy have become the important goal of hypertension therapeutic.
KW-3049 is a kind of novel, long-acting, second filial generation dihydropyridine calcium ion antagonist, is used for the treatment of clinically essential hypertension.1991 by Japan consonance fermentation company in Japanese Initial Public Offering, afterwards in the listing of many countries.KW-3049 combines with dihydropyridine (DHP) binding site of cell membrane potential dependent calcium channel, suppresses flow of calcium ions, thus coronary artery dilator and peripheral blood vessel.In addition, this product is more in the distribution of cell membrane, is mainly to enter in cell to combine with the DHP binding site.In addition, shrink inhibitory action and DHP binding site affinity etc. by the research myocardium vessel, prove that the associativity of this product and DHP binding site is strong and the speed of dissociating is very slow, thus the lasting pharmacological action of demonstration, and with the blood drug level non-correlation.KW-3049 has following effect: 1, hypotensive effect: give KW-3049 to spontaneous hypertensive rat, DOCA-Sal Hypertensive Rats, renal hypertension dog per os, show slowly and the hypotensive effect that continues.Long term administration does not produce drug resistance.During primary hypertension patient 1 time on the oral 1st, do not affect the daily variation of blood pressure, showed stable antihypertensive effect in 24 hours.2, Antianginal effect: to experimental angina pectoris model (rat) and Canis familiaris L. coronary artery ligation again the Lower cardiac function, the ischemic cardiac electrograph that cause of perfusion change the effect that is significantly improved.When giving the angina pectoris patient oral, show that KW-3049 changes (ECG ST section reduction) to the caused ischemic of sports load and has the improvement effect.3, renal function protecting effect: when giving KW-3049 to the continuous per os of renal insufficiency model (nephrectomy 5/6) spontaneous hypertensive rat, improve renal function when showing hypotensive effect.When primary hypertension patient was oral, can see renal blood flow significantly increased.After the patient of hypertensive patients chronic renal insufficiency was oral, creatinine clearance rate and urea nitrogen clearance significantly increased, and showed the protecting renal function effect.4, suppress vascular remodeling; protective effect this product to blood vessel endothelium increases the NO generation by activating endothelial NO synzyme (eNOS) and strengthening eNOS gene expression; and suppress the NO deactivation by its antioxidation; the final NO biological activity that enlarges; thereby the inhibition vascular remodeling plays protective effect to blood vessel endothelium.
KW-3049 is almost insoluble in water, the dosage form of domestic listing only has tablet, the disintegration of tablet time is long, absorption difference in body, bioavailability is low, instructions of taking is single, and dysphagia patients is difficult to take, when drug dose, when specification is larger or once take the sheet number when more this problem particularly outstanding.
Summary of the invention
The present invention is directed to the deficiency that the KW-3049 tablet exists, its dosage form is improved, a kind of benidipine hydrochloride dispersing tablet is provided, it has overcome the deficiency of tablet, and disintegration time is short, and dissolution is high, taking convenience.
The present invention also provides the method for preparing this dispersible tablet, and its method is simple, and is easy to implement.
The concrete technical scheme of the present invention is as follows:
A kind of benidipine hydrochloride dispersing tablet is characterized in that: comprise KW-3049 effective ingredient and mixed accessories, each composition weight proportion is as follows:
KW-3049 0.5～2%
Auxiliary material A 40～62.8%
Auxiliary material B 35～55%
Adjuvant C 1～5%
Adjuvant D 0.5～6.0%
Adjuvant E 0.2%～5.0%;
Described auxiliary material A is at least a in microcrystalline Cellulose, lactose, starch and pregelatinized Starch, auxiliary material B is at least a in carboxymethylstach sodium, Extra Sodium Carboxylmethyl Starch, hyprolose, polyvinylpolypyrrolidone and cross-linked carboxymethyl cellulose sodium, adjuvant C is at least a in hypromellose and PVP K30, adjuvant D is at least a in saccharin sodium, sucrose and aspartame, and adjuvant E is at least a in magnesium stearate and micropowder silica gel.Above-mentioned adjuvant plays the effect of disintegrating agent, binding agent, lubricant, filler.
Above various adjuvant can produce a lot of formulas when selecting, through verification experimental verification, the alone effect of auxiliary material A is effective not as share, and is best with microcrystalline Cellulose, lactose and pregelatinized Starch effect; In auxiliary material B, the dispersion effect of every kind of adjuvant is all variant, preferred carboxymethylstach sodium, polyvinylpolypyrrolidone and cross-linked carboxymethyl cellulose sodium; In adjuvant C, PVP K30 help solubilization, preferred PVP K30, and adjuvant D is preferably aspartame, and adjuvant E is preferably magnesium stearate.
The performance of the different dispersible tablets of each composition consumption has difference, can reach the pharmacopeia requirement according to the dispersible tablet of mentioned component proportioning, and when preparing dispersible tablet according to following proportioning, disintegration and the dissolution of dispersible tablet are better, and optimization formula is:
KW-3049 0.8～1%
Auxiliary material A 45～55%
Auxiliary material B 40～50%
Adjuvant C 1.5～3%
Adjuvant D 2～5.5%
Adjuvant E 1.5%～5.0%.
When certainly, taking at the same time preferred adjuvant and preferred proportioning, the performance of gained dispersible tablet is best.
The present invention also provides the preparation method of benidipine hydrochloride dispersing tablet, it is characterized in that comprising the following steps: each composition is crossed the 80-100 mesh sieve, and with the composition mix homogeneously except adjuvant E, add ethanol to make soft material, then cross 14～30 mesh sieves and granulate, 45～75 ℃ of dryings, after 14～24 mesh sieve granulate, add at last adjuvant E, mixing, tabletting and get final product.
In said method, during the preparation soft material, the volumetric concentration of described ethanol is 20～85%.Make that contained humidity is 2～7wt% after particle drying.
The present invention has carried out reselecting, making up to adjuvant, through a large amount of research and experiments, optimized suitable accessory formula and with the amount ratio of effective ingredient, obtained containing filler, disintegrating agent, binding agent, lubricant in auxiliary material A, B, C, D, E than the better tablet formulation of existing tablet, improved medicine body internal absorption factor, solved the problem that it is difficult that the patient takes medicine, dispersible tablet in the 100ml water of 20 ℃ ± 1 ℃, jolting 3min, all disintegrates and by No. 2 sieves.
Dispersible tablet disintegration time of the present invention is short, good dispersing state, drug-eluting rapidly, high, the taking convenience of determined curative effect, bioavailability, both can swallow, take after can disperseing in water again.Preparation technology is production equipment and the technique of conventional tablet, need not the special producing technology and equipment, and production technology is simple, and cost is low.
The specific embodiment
The invention will be further described below in conjunction with concrete experimental example, but be not restricted to following examples.
The present invention's supplementary material used is commercially available, and ethanol used is that volumetric concentration is 20～85%.
Embodiment 1
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 20g, lactose 10, pregelatinized Starch 25g, Extra Sodium Carboxylmethyl Starch 16g, cross-linked carboxymethyl cellulose sodium 23g, hypromellose 1g, aspartame 0.5g, magnesium stearate 0.2g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, Extra Sodium Carboxylmethyl Starch, cross-linked carboxymethyl cellulose sodium, hypromellose, aspartame by formula sieves, mix homogeneously, with appropriate 50% alcoholic solution soft material processed, crossing 18 mesh sieves granulates, 50 ℃ of dryings 4 hours, 18 mesh sieve granulate add the magnesium stearate mix homogeneously, tabletting and get final product, the heavy 0.1g of sheet.
Embodiment 2
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 30g, lactose 15g, carboxymethylstach sodium 30g, cross-linked carboxymethyl cellulose sodium 19g, hypromellose 2g, saccharin sodium 1g, magnesium stearate 1g.
Getting KW-3049, microcrystalline Cellulose, lactose, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium, hypromellose, saccharin sodium by formula sieves, mix homogeneously, with appropriate 60% alcoholic solution soft material processed, crossing 20 mesh sieves granulates, 60 ℃ of dryings 4 hours, 20 mesh sieve granulate add the magnesium stearate mix homogeneously, tabletting and get final product.
Embodiment 3
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 20g, pregelatinized Starch 44g, polyvinylpolypyrrolidone 50g, hypromellose 3g, PVP K30 1g, aspartame 4g, magnesium stearate 2g.
Getting KW-3049, microcrystalline Cellulose, pregelatinized Starch, polyvinylpolypyrrolidone, hypromellose, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 75% alcoholic solution soft material processed, crossing 20 mesh sieves granulates, 65 ℃ of dryings 4 hours, 20 mesh sieve granulate add the magnesium stearate mix homogeneously, tabletting and get final product.
Embodiment 4
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 30g, lactose 35g, pregelatinized Starch 30g, carboxymethylstach sodium 50g, polyvinylpolypyrrolidone 10g, PVP K30 5g, aspartame 5g, magnesium stearate 2g, micropowder silica gel 1g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, polyvinylpolypyrrolidone, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 60% alcoholic solution soft material processed, crossing 24 mesh sieves granulates, 70 ℃ of dryings 4 hours, 24 mesh sieve granulate add magnesium stearate, micropowder silica gel mix homogeneously, tabletting and get final product.
Embodiment 5
The dispersible tablet formula consists of: KW-3049 2g, lactose 40g, pregelatinized Starch 50g, Extra Sodium Carboxylmethyl Starch 60g, polyvinylpolypyrrolidone 42g, hypromellose 2g, PVP K30 4g, aspartame 4g, micropowder silica gel 6g.
Getting KW-3049, lactose, pregelatinized Starch, Extra Sodium Carboxylmethyl Starch, polyvinylpolypyrrolidone, hypromellose, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 70% alcoholic solution soft material processed, crossing 16 mesh sieves granulates, 75 ℃ of dryings 3 hours, 16 mesh sieve granulate add the micropowder silica gel mix homogeneously, tabletting and get final product.
Embodiment 6
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 40g, lactose 20g, pregelatinized Starch 30g, carboxymethylstach sodium 30g, polyvinylpolypyrrolidone 30g, cross-linked carboxymethyl cellulose sodium 30g, PVP K30 4g, aspartame 4g, magnesium stearate 3g, micropowder silica gel 7g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose sodium, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 80% alcoholic solution soft material processed, crossing 18 mesh sieves granulates, 65 ℃ of dryings 3 hours, 18 mesh sieve granulate add magnesium stearate, micropowder silica gel mix homogeneously, tabletting and get final product.
Embodiment 7
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 45g, lactose 30g, pregelatinized Starch 54g, Extra Sodium Carboxylmethyl Starch 84g, cross-linked carboxymethyl cellulose sodium 16g, PVP K30 5g, aspartame 8g, magnesium stearate 6g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, Extra Sodium Carboxylmethyl Starch, cross-linked carboxymethyl cellulose sodium, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 85% alcoholic solution soft material processed, crossing 20 mesh sieves granulates, 60 ℃ of dryings 3 hours, 20 mesh sieve granulate add magnesium stearate.
Embodiment 8
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 30g, lactose 70g, pregelatinized Starch 20g, carboxymethylstach sodium 50g, polyvinylpolypyrrolidone 20g, cross-linked carboxymethyl cellulose sodium 40g, hypromellose 2g, PVP K30 2g, aspartame 10g, magnesium stearate 2g, micropowder silica gel 2g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium, polyvinylpolypyrrolidone, hypromellose, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 80% alcoholic solution soft material processed, crossing 18 mesh sieves granulates, 70 ℃ of dryings 2 hours, 18 mesh sieve granulate add magnesium stearate, micropowder silica gel mix homogeneously, tabletting and get final product.
Embodiment 9
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 35g, lactose 48g, pregelatinized Starch 30g, carboxymethylstach sodium 60g, cross-linked carboxymethyl cellulose sodium 49g, PVP K30 5g, aspartame 15g, magnesium stearate 2g, micropowder silica gel 4g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium, PVP K30, aspartame by formula sieves, mix homogeneously, with appropriate 85% alcoholic solution soft material processed, crossing 20 mesh sieves granulates, 75 ℃ of dryings 2 hours, 20 mesh sieve granulate add magnesium stearate, micropowder silica gel mix homogeneously, tabletting and get final product.
Embodiment 10
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 50g, lactose 55g, pregelatinized Starch 65g, carboxymethylstach sodium 65g, cross-linked carboxymethyl cellulose sodium 46g, PVP K30 6g, saccharin sodium 9g, magnesium stearate 2g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium, PVP K30, saccharin sodium by formula sieves, mix homogeneously, with appropriate 55% alcoholic solution soft material processed, crossing 24 mesh sieves granulates, 70 ℃ of dryings 3 hours, 24 mesh sieve granulate add the magnesium stearate mix homogeneously, tabletting and get final product.
Embodiment 11
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 40g, lactose 40g, pregelatinized Starch 70g, carboxymethylstach sodium 50g, Extra Sodium Carboxylmethyl Starch 40g, polyvinylpolypyrrolidone 40g, cross-linked carboxymethyl cellulose sodium 48g, PVP K30 7g, aspartame 5g, saccharin sodium 5g, magnesium stearate 3g, micropowder silica gel 1g.
Getting KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, Extra Sodium Carboxylmethyl Starch, cross-linked carboxymethyl cellulose sodium, polyvinylpolypyrrolidone, PVP K30, saccharin sodium, aspartame by formula sieves, mix homogeneously, with appropriate 65% alcoholic solution soft material processed, crossing 18 mesh sieves granulates, 75 ℃ of dryings 3 hours, 18 mesh sieve granulate add the micropowder silica gel mix homogeneously, tabletting and get final product.
Embodiment 12
The dispersible tablet formula consists of: KW-3049 2g, microcrystalline Cellulose 60g, lactose 40g, pregelatinized Starch 50g, carboxymethylstach sodium 60g, Extra Sodium Carboxylmethyl Starch 40g, polyvinylpolypyrrolidone 50g, cross-linked carboxymethyl cellulose sodium 61g, PVP K30 12g, aspartame 11g, saccharin sodium 8g, micropowder silica gel 6g.
By formula get KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, pre-carboxymethylstach sodium, Extra Sodium Carboxylmethyl Starch, polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose sodium PVP K30, aspartame, saccharin sodium sieves, mix homogeneously, with appropriate 85% alcoholic solution soft material processed, crossing 24 mesh sieves granulates, 75 ℃ of dryings 3 hours, 24 mesh sieve granulate add the micropowder silica gel mix homogeneously, tabletting and get final product.
Experimental example
Detect explanation beneficial effect of the present invention below by test: benidipine hydrochloride dispersing tablet of the present invention is take domestic listing product KW-3049 sheet as contrast, carried out in vitro tests, benidipine hydrochloride dispersing tablet in experimental example 1～12 has been carried out dispersing uniformity test and dissolution in vitro test, and its test method and result are as follows:
1, dissolution in vitro test
Test method: according to dissolution method (two appendix XC three therapeutic methods of traditional Chinese medicine of Chinese Pharmacopoeia version in 2010), take hydrochloric acid solution (9 → 1000) 200ml as dissolution medium, rotating speed is per minute 100 to turn, measure in accordance with the law, respectively at 5,10 and 60min to get solution appropriate, filter, get filter filtrate, according to ultraviolet visible spectrophotometry (two appendix IV A of Chinese Pharmacopoeia version in 2010), the place measures absorbance at the 240nm wavelength; Another precision takes the KW-3049 reference substance stock solution 5ml under the assay item, puts in the 200ml measuring bottle, adds hydrochloric acid solution (9 → 1000) to scale, shakes up, and measures with method, calculates dissolution.Result of the test sees Table 1:
Result of the test shows, the dissolution rate in vitro of benidipine hydrochloride dispersing tablet of the present invention obviously is better than existing KW-3049 sheet on the domestic market.
2, dispersing uniformity test
Test method: get 2 of benidipine hydrochloride dispersing tablets, shine dispersing uniformity inspection technique (two appendix I A of Chinese Pharmacopoeia version in 2010) in the 100ml water of 20 ℃ ± 1 ℃, jolting 3min, all disintegrate is also by No. 2 sieves.Result of the test sees Table 2.
Result of the test shows, benidipine hydrochloride dispersing tablet of the present invention in the 100ml water of 20 ℃ ± 1 ℃, jolting 3min, all disintegrates and by No. 2 sieves, result all meets " the requirement of dispersing uniformity in dispersible tablet in Chinese pharmacopoeia.When selecting adjuvant, the alone effect of auxiliary material A is effective not as share, and is best with microcrystalline Cellulose, lactose and pregelatinized Starch effect; In auxiliary material B, the dispersion effect of every kind of adjuvant is all variant, preferred carboxymethylstach sodium, polyvinylpolypyrrolidone and cross-linked carboxymethyl cellulose sodium; In adjuvant C, PVP K30 help solubilization, and when the supplementary product consumption of its adhesive effect was large, dispersible tablet obviously extended disintegration.
Claims (5)
1. benidipine hydrochloride dispersing tablet, it is characterized in that: its formula consists of: KW-3049 2g, microcrystalline Cellulose 20g, lactose 10g, pregelatinized Starch 25g, Extra Sodium Carboxylmethyl Starch 16g, cross-linked carboxymethyl cellulose sodium 23g, hypromellose 1g, aspartame 0.5g, magnesium stearate 0.2g; Preparation method is: get KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, Extra Sodium Carboxylmethyl Starch, cross-linked carboxymethyl cellulose sodium, hypromellose, aspartame by formula and sieve, mix homogeneously, with appropriate 50% alcoholic solution soft material processed, crossing 18 mesh sieves granulates, 50 ℃ of dryings 4 hours, 18 mesh sieve granulate add the magnesium stearate mix homogeneously, tabletting and get final product, the heavy 0.1g of sheet.
2. benidipine hydrochloride dispersing tablet, it is characterized in that: its formula consists of: KW-3049 2g, microcrystalline Cellulose 30g, lactose 35g, pregelatinized Starch 30g, carboxymethylstach sodium 50g, polyvinylpolypyrrolidone 10g, PVP K30 5g, aspartame 5g, magnesium stearate 2g, micropowder silica gel 1g; Preparation method is: get KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, polyvinylpolypyrrolidone, PVP K30, aspartame by formula and sieve, mix homogeneously, with appropriate 60% alcoholic solution soft material processed, crossing 24 mesh sieves granulates, 70 ℃ of dryings 4 hours, 24 mesh sieve granulate add magnesium stearate, micropowder silica gel mix homogeneously, tabletting and get final product.
3. benidipine hydrochloride dispersing tablet, it is characterized in that: its formula consists of: KW-3049 2g, lactose 40g, pregelatinized Starch 50g, Extra Sodium Carboxylmethyl Starch 60g, polyvinylpolypyrrolidone 42g, hypromellose 2g, PVP K30 4g, aspartame 4g, micropowder silica gel 6g; Preparation method is: get KW-3049, lactose, pregelatinized Starch, Extra Sodium Carboxylmethyl Starch, polyvinylpolypyrrolidone, hypromellose, PVP K30, aspartame by formula and sieve, mix homogeneously, with appropriate 70% alcoholic solution soft material processed, crossing 16 mesh sieves granulates, 75 ℃ of dryings 3 hours, 16 mesh sieve granulate add the micropowder silica gel mix homogeneously, tabletting and get final product.
4. benidipine hydrochloride dispersing tablet, it is characterized in that: its formula consists of: KW-3049 2g, microcrystalline Cellulose 40g, lactose 20g, pregelatinized Starch 30g, carboxymethylstach sodium 30g, polyvinylpolypyrrolidone 30g, cross-linked carboxymethyl cellulose sodium 30g, PVP K30 4g, aspartame 4g, magnesium stearate 3g, micropowder silica gel 7g; Preparation method is: get KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, carboxymethylstach sodium, polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose sodium, PVP K30, aspartame by formula and sieve, mix homogeneously, with appropriate 80% alcoholic solution soft material processed, crossing 18 mesh sieves granulates, 65 ℃ of dryings 3 hours, 18 mesh sieve granulate add magnesium stearate, micropowder silica gel mix homogeneously, tabletting and get final product.
5. benidipine hydrochloride dispersing tablet, it is characterized in that: its formula consists of: KW-3049 2g, microcrystalline Cellulose 60g, lactose 40g, pregelatinized Starch 50g, carboxymethylstach sodium 60g, Extra Sodium Carboxylmethyl Starch 40g, polyvinylpolypyrrolidone 50g, cross-linked carboxymethyl cellulose sodium 61g, PVP K30 12g, aspartame 11g, saccharin sodium 8g, micropowder silica gel 6g; Preparation method is: by formula get KW-3049, microcrystalline Cellulose, lactose, pregelatinized Starch, pre-carboxymethylstach sodium, Extra Sodium Carboxylmethyl Starch, polyvinylpolypyrrolidone, cross-linked carboxymethyl cellulose sodium PVP K30, aspartame, saccharin sodium sieves, mix homogeneously, with appropriate 85% alcoholic solution soft material processed, crossing 24 mesh sieves granulates, 75 ℃ of dryings 3 hours, 24 mesh sieve granulate add the micropowder silica gel mix homogeneously, tabletting and get final product.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1827114A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Pharmaceutical composition using efonidipine as active ingredient, its preparation method and use |
| CN1827111A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Pharmaceutical composition using benazepril hydrochloride amlodipine besylate as active ingredients, its preparation method and use |
| CN101156851A (en) * | 2007-09-27 | 2008-04-09 | 刘全胜 | Nicardipine hydrochloride dispersion piece and method for making same |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1827114A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Pharmaceutical composition using efonidipine as active ingredient, its preparation method and use |
| CN1827111A (en) * | 2006-04-14 | 2006-09-06 | 北京润德康医药技术有限公司 | Pharmaceutical composition using benazepril hydrochloride amlodipine besylate as active ingredients, its preparation method and use |
| CN101156851A (en) * | 2007-09-27 | 2008-04-09 | 刘全胜 | Nicardipine hydrochloride dispersion piece and method for making same |
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