CN1981769A - Hydrochloride epinastine dispersing tablets and their production - Google Patents
Hydrochloride epinastine dispersing tablets and their production Download PDFInfo
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- CN1981769A CN1981769A CN 200510133746 CN200510133746A CN1981769A CN 1981769 A CN1981769 A CN 1981769A CN 200510133746 CN200510133746 CN 200510133746 CN 200510133746 A CN200510133746 A CN 200510133746A CN 1981769 A CN1981769 A CN 1981769A
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- epinastine hydrochloride
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Abstract
A dispersing tablet of epinastine hydrochloride is prepared proportionally from epinastine hydrochloride, filler, disintegrant, sweetening agent, flavouring and lubricant. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to histamine H
1Epinastine hydrochloride dispersible tablet of receptor antagonist and preparation method thereof.
Background technology
Epinastine hydrochloride is by the exploitation of German Boehringer Ingelheim company, went on the market in Japan in 1991, and in succession in South America, the multinational listing in Asia, existing Boehringer Ingelheim and the cooperation application of Allergan company are gone on the market at U.S., E.U., the tablet of China's Ministry of Public Health approved import this product, domestic existing epinastine hydrochloride capsule, the listing of epinastine hydrochloride sheet.
From first antihistaminic exploitation of nineteen thirty-seven so far, kind of H surplus in the of existing 50
1Receptor antagonist is for clinical practice.Before the eighties was the first generation, and first generation antihistaminic has central inhibitory action and H
1Receptor-selective differs from its further use, especially central inhibitory action clinically of two drawbacks limit, the safety of the anti-resistance of first generation amine medicine is descended, and limited the dosage of treatment.After the eighties is the second filial generation, and second filial generation antihistaminic is to the therapeutic equivalence of allergic diseases such as rhinitis, urticaria, compares with the first generation to have following three advantages: the maincenter side reaction is slight, so the second filial generation is called non-sedative antihistamine medicine (NSA) again; H
1Receptor-selective is strong; Good patient compliance.Owing to have the advantage of above three highly significants, the anti-resistance of second filial generation amine medicine has occupied the market of the antihistaminic overwhelming majority soon.Cause that weight increase, incidence rate are respectively 3.6%, 2%~3%, 1%~2% but still have some medicines such as cetirizine, azelastine, ketotifen then can stimulate appetite in the second filial generation medicine.Since 1986, cardiac event and the death risk report drug-induced about the NSA class increase in succession, caused very big concern, as WHO adverse effect cooperation center received 17 countries, 976 routine antihistaminics altogether in 1986~1996 years untoward reaction report, wherein 99% is NSA.Bring out cardiac toxicity more be terfenadine, secondly be astemizole, loratadine and cetirizine.Other second filial generation antihistaminic, announcement does not so far appear in the newspapers.So far, terfenadine causes dead and sudden death 98 examples of disposition, astemizole 25 examples, loratadine 13 examples, cetirizine 2 examples.Epinastine hydrochloride does not also have above-mentioned side reaction report up to now.
Epinastine hydrochloride is an oral second filial generation antihistaminic, has selectivity and suppresses periphery H
1The effect of receptor, no maincenter sedation and cholinolytic effect.Clinically be used for the treatment of allergic rhinitis more, and symptoms such as urticaria, eczema, dermatitis, skin pruritus, psoriasis, allergic bronchial asthma.
In recent years, disintegrate becomes the dispersible tablet of uniform viscosity suspension rapidly, because its taking convenience absorbs soon, characteristics such as bioavailability height are subjected to people's attention day by day.The kind of this kind dosage form also increases gradually, as: British Pharmacopoeia 1980 editions, 1988 editions, 1993 editions have all been recorded the aspirin dispersible tablet, aspirin codeine dispersible tablet and Sulfamethoxazole Compound dispersible tablet, the narcotine in addition that goes on the market successively in addition, acyclovir, tens kinds such as amoxicillin.The unit of present domestic development dispersible tablet is a lot, declares to form climax, as: roxithromycin dispersing tablet has 23 families to declare, and the clarithromycin dispersible tablet has 27 families to declare.But the development that absorbs the epinastine hydrochloride dispersible tablet fast, that bioavailability is high does not appear in the newspapers.Up to the present, the epinastine hydrochloride peroral dosage form is single both at home and abroad, and tablet, capsule are only arranged, and obviously can not satisfy each age patient's demand.
Epinastine hydrochloride flavor is extremely bitter, thus clinically mostly be coated tablet or capsule, and manufacturer is few.Because this product few side effects, toxicity is low, patient's better tolerance.Be used for 3 years old and above child and adult's medication in Japan more.The present invention adopts the bitterness of cyclodextrin embedding epinastine hydrochloride, makes the dispersible tablet compliance that makes good, be convenient to the patient and accept, and has enriched doctor, patient's dosage form selection leeway.。
Summary of the invention
In order to solve the single shortcoming of prior art epinastine hydrochloride peroral dosage form, improve the bitterness of epinastine hydrochloride, the compliance that makes the epinastine hydrochloride dispersible tablet is well a purpose of the present invention.
Another object of the present invention provides the method for preparing the epinastine hydrochloride dispersible tablet.
The object of the present invention is achieved like this: a kind of epinastine hydrochloride dispersible tablet, every epinastine hydrochloride that contains 2.5-40mg; The pharmaceutic adjuvant that also comprises other comprises filler, disintegrating agent, correctives, sweeting agent and lubricant.
1, prescription: the epinastine hydrochloride dispersible tablet, its prescription is composed as follows: in 1000, wherein contain:
Epinastine hydrochloride 2.5-40.0g
Cyclodextrin 5-50g
Starch lactose 80-150g
Microcrystalline Cellulose 50-100g
Calcium hydrogen phosphate 20-100g
Disintegrating agent 20-50g
Sweeting agent 25-40g
Magnesium stearate 5-20g
Micropowder silica gel 10-20g
Solid essence 15-30g
Pure water 5-20ml
2, preparation method:
Method 1:(a) epinastine hydrochloride is crossed 100 mesh sieves, and used adjuvant is crossed 80 mesh sieves, and is standby; (b) epinastine hydrochloride is standby with a small amount of pure water dissolving back.Take by weighing the cyclodextrin of recipe quantity, add in the pure water, grind evenly, dripping hydrochloric acid epinastine solution fully grinds, after the cold drying promptly; (c) epinastine hydrochloride, calcium hydrogen phosphate, microcrystalline Cellulose, starch lactose, disintegrating agent, sweeting agent, the micropowder silica gel adjuvant with recipe quantity places blender to be mixed to evenly, makes dried granule with rolling stone roller extruding stem method; (d) add magnesium stearate and solid essence, behind the mix homogeneously, tabletting makes dispersible tablet.
Method 2:(a) epinastine hydrochloride is crossed 100 mesh sieves, and used adjuvant is crossed 80 mesh sieves, and is standby; (b) epinastine hydrochloride is standby with a small amount of pure water dissolving back.Take by weighing the cyclodextrin of recipe quantity, add in the pure water, grind evenly, dripping hydrochloric acid epinastine solution fully grinds, after the cold drying promptly; (c) epinastine hydrochloride, calcium hydrogen phosphate, microcrystalline Cellulose, starch lactose, disintegrating agent, sweeting agent, solid essence, micropowder silica gel, the solid essence adjuvant of recipe quantity placed blender be mixed to evenly after, tabletting makes dispersible tablet.
The dispersible tablet purpose according to the present invention, disintegrate becomes granule to require dispersible tablet to meet behind the water as soon as possible, and forms uniform suspension, improves bioavailability of medicament, and reduces the toxic and side effects of medicine, so it designs with the different prescriptions that are embodied in of ordinary tablet maximum.
Compared to existing technology, the present invention has following advantage:
1, absorption is fast, bioavailability is high;
2, being convenient to patient takes, both can directly take, take after also can in water, disperseing, and also can chew or contain to suck and take and do not reduce its bioavailability, can can allow the patient select the convenient easily instructions of taking of pharynx again for the patient provides a kind of effective antihistamine drug according to s own situation;
3, the advantage of this product be have the suitability for industrialized production of being easy to, technology is easy, production technology is identical with common non-coated tablet, does not need special installation, production cost is lower;
4, adopt dry granulation tabletting or direct compression process, the activity of farthest having preserved medicine;
5, the present invention adopts the bitterness of cyclodextrin embedding epinastine hydrochloride, and is fragrant and sweet good to eat after seasoning, is convenient to patient and uses, and compliance is good;
6, it to have solved this product dosage form single, listing at present only has the problem of coated tablet, capsule, enriched doctor, patient's dosage form selection leeway.
The invention will be further described below in conjunction with the specific embodiment.
The specific embodiment
To further illustrate the present invention in following examples, these embodiment only are used to the present invention is described and to the present invention without limits.
Embodiment 1:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (2.5mg specification in 1000) wherein contains:
Epinastine hydrochloride 2.5g
Cyclodextrin 5g
Starch lactose 100g
Microcrystalline Cellulose 60g
Calcium hydrogen phosphate 20g
Carboxymethylstach sodium 25g
Steviosin 25g
Magnesium stearate 5g
Micropowder silica gel 10g
Solid essence 15g
Pure water 8ml
2, method 1: epinastine hydrochloride dispersible tablet preparation method is as follows:
(a) epinastine hydrochloride is crossed 100 mesh sieves, and used adjuvant is crossed 80 mesh sieves, and is standby; (b) epinastine hydrochloride is standby with a small amount of pure water dissolving back.Take by weighing the cyclodextrin of recipe quantity, add in the pure water, grind evenly, dripping hydrochloric acid epinastine solution fully grinds, after the cold drying promptly; (c) epinastine hydrochloride, calcium hydrogen phosphate, microcrystalline Cellulose, starch lactose, carboxymethylstach sodium, steviosin, the micropowder silica gel adjuvant with recipe quantity places blender to be mixed to evenly, makes dried granule with rolling stone roller extruding stem method; (d) add magnesium stearate and solid essence, behind the mix homogeneously, tabletting makes dispersible tablet.
Sampling, all meets the relevant drug standard of using at detection level, dissolution and dispersing uniformity and disintegration then.Dispersible tablet can be answered disintegrate fully in the 3min with reference to the British Pharmacopoeia requirement in the time of in 19~21 ℃ of water except that need meet the quality standard of ordinary tablet.The uniformity or the suspension ability of tackling simultaneously after the disintegrate detect: get 2 of dispersible tablets, put among 20 ℃ of water 100ml, to being poured on the screen cloth in 710mm aperture after the disintegrate fully, discrete particles can pass through screen cloth fully.
Method 2: epinastine hydrochloride dispersible tablet preparation method is as follows:
(a) epinastine hydrochloride is crossed 100 mesh sieves, and used adjuvant is crossed 80 mesh sieves, and is standby; (b) epinastine hydrochloride is standby with a small amount of pure water dissolving back.Take by weighing the cyclodextrin of recipe quantity, add in the pure water, grind evenly, dripping hydrochloric acid epinastine solution fully grinds, after the cold drying promptly; (c) epinastine hydrochloride, calcium hydrogen phosphate, microcrystalline Cellulose, starch lactose, carboxymethylstach sodium, steviosin, solid essence, micropowder silica gel, the solid essence adjuvant of recipe quantity placed blender be mixed to evenly after, tabletting makes dispersible tablet.
Sampling, all meets relevant drug standard at detection level, dissolubility and dispersing uniformity and disintegration then.Dispersible tablet can be answered disintegrate fully in the 3min with reference to the British Pharmacopoeia requirement in the time of in 19~21 ℃ of water except that need meet the quality standard of ordinary tablet.The uniformity or the suspension ability of tackling simultaneously after the disintegrate detect: get 2 of dispersible tablets, put among 20 ℃ of water 100ml, to being poured on the screen cloth in 710mm aperture after the disintegrate fully, discrete particles can pass through screen cloth fully.
Embodiment 2:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (5mg specification in 1000) wherein contains:
Epinastine hydrochloride 5g
Cyclodextrin 10g
Starch lactose 100g
Microcrystalline Cellulose 60g
Calcium hydrogen phosphate 20g
Carboxymethylstach sodium 25g
Steviosin 25g
Magnesium stearate 5g
Micropowder silica gel 10g
Solid essence 15g
Pure water 10ml
2, preparation method: epinastine hydrochloride dispersible tablet preparation method is with embodiment 1.
Embodiment 3:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (10mg specification in 1000) wherein contains:
Epinastine hydrochloride 10g
Cyclodextrin 15g
Starch lactose 90g
Microcrystalline Cellulose 60g
Calcium hydrogen phosphate 20g
Carboxymethylstach sodium 25g
Steviosin 25g
Magnesium stearate 5g
Micropowder silica gel 10g
Solid essence 15g
Pure water 15ml
2, preparation method: epinastine hydrochloride dispersible tablet preparation method is with embodiment 1.
Embodiment 4:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (20mg specification in 1000) wherein contains:
Epinastine hydrochloride 20g
Cyclodextrin 20g
Starch lactose 110g
Microcrystalline Cellulose 70g
Calcium hydrogen phosphate 30g
Carboxymethylstach sodium 30g
Steviosin 27g
Magnesium stearate 7g
Micropowder silica gel 10g
Solid essence 18g
Pure water 20ml
2, preparation method: epinastine hydrochloride dispersible tablet preparation method is with embodiment 1.
Embodiment 5:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (40mg specification in 1000) wherein contains:
Epinastine hydrochloride 40g
Cyclodextrin 60g
Starch lactose 90g
Microcrystalline Cellulose 80g
Calcium hydrogen phosphate 40g
Carboxymethylstach sodium 40g
Steviosin 28g
Magnesium stearate 8g
Micropowder silica gel 15g
Solid essence 20g
Pure water 30ml
2, preparation method: epinastine hydrochloride dispersible tablet preparation method is with embodiment 1.
Embodiment 6:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (10mg specification in 1000) wherein contains:
Epinastine hydrochloride 10g
Cyclodextrin 15g
Starch lactose 100g
Microcrystalline Cellulose 60g
Calcium hydrogen phosphate 20g
Carboxymethylstach sodium 15g
Cross-linked carboxymethyl cellulose sodium 20g
Saccharin sodium 28g
Magnesium stearate 5g
Micropowder silica gel 10g
Solid essence 15g
Pure water 15ml
2, preparation method: epinastine hydrochloride dispersible tablet preparation method is with embodiment 1.
Embodiment 7:
1, prescription: the prescription of epinastine hydrochloride dispersible tablet is composed as follows: (10mg specification in 1000) wherein contains:
Epinastine hydrochloride 10g
Cyclodextrin 15g
Starch lactose 100g
Microcrystalline Cellulose 60g
Calcium hydrogen phosphate 20g
Carboxymethylstach sodium 15g
Crospolyvinylpyrrolidone 15g
Aspartame 27g
Magnesium stearate 5g
Micropowder silica gel 10g
Solid essence 15g
Pure water 15ml
2, preparation method: epinastine hydrochloride dispersible tablet preparation method is with embodiment 1.
Claims (8)
1, a kind of epinastine hydrochloride dispersible tablet is characterized in that: every epinastine hydrochloride that contains 2.5-40mg; The pharmaceutic adjuvant that also comprises other comprises filler, disintegrating agent, correctives, sweeting agent and lubricant.
2, epinastine hydrochloride dispersible tablet as claimed in claim 1 is characterized in that described disintegrating agent is: carboxymethylstach sodium, cross-linked carboxymethyl cellulose sodium or crospolyvinylpyrrolidone.
3, epinastine hydrochloride dispersible tablet as claimed in claim 1 is characterized in that described sweeting agent is: steviosin, aspartame or saccharin sodium.
4, as arbitrary epinastine hydrochloride dispersible tablet of claim 1 to 3, its prescription is composed as follows: in 1000, wherein contain
Epinastine hydrochloride 2.5-40.0g
Cyclodextrin 5-50g
Starch lactose 80-150g
Microcrystalline Cellulose 50-100g
Calcium hydrogen phosphate 20-100g
Disintegrating agent 20-50g
Sweeting agent 25-40g
Magnesium stearate 5-20g
Micropowder silica gel 10-20g
Solid essence 15-30g
Pure water 5-20ml
5, as the consumption of the described sweeting agent of claim 1 to 4, when being 1000, recipe quantity must be not less than 25 grams, and optimum amount is the 25-30 gram.
6,, it is characterized in that every dosage that contains described epinastine hydrochloride is 2.5mg, 5mg, 10mg, 20mg or 40mg as the described epinastine hydrochloride dispersible tablet of claim 1 to 4.
7, the preparation method of epinastine hydrochloride dispersible tablet is characterized in that comprising the steps:
(a) epinastine hydrochloride is crossed 100 mesh sieves, and used adjuvant is crossed 80 mesh sieves, and is standby;
(b) epinastine hydrochloride is standby with a small amount of pure water dissolving back.Take by weighing the cyclodextrin of recipe quantity, add in the pure water, grind evenly, dripping hydrochloric acid epinastine solution fully grinds, after the cold drying promptly;
(c) epinastine hydrochloride, calcium hydrogen phosphate, microcrystalline Cellulose, starch lactose, disintegrating agent, sweeting agent, the micropowder silica gel adjuvant with recipe quantity places blender to be mixed to evenly, makes dried granule with rolling stone roller extruding stem method;
(d) add magnesium stearate and solid essence, behind the mix homogeneously, tabletting makes dispersible tablet.
8, the preparation method of epinastine hydrochloride dispersible tablet is characterized in that comprising the steps:
(a) epinastine hydrochloride is crossed 100 mesh sieves, and used adjuvant is crossed 80 mesh sieves, and is standby;
(b) epinastine hydrochloride is standby with a small amount of pure water dissolving back.Take by weighing the cyclodextrin of recipe quantity, add in the pure water, grind evenly, dripping hydrochloric acid epinastine solution fully grinds, after the cold drying promptly;
(c) epinastine hydrochloride, calcium hydrogen phosphate, microcrystalline Cellulose, starch lactose, disintegrating agent, sweeting agent, solid essence, micropowder silica gel, the solid essence adjuvant of recipe quantity placed blender be mixed to evenly after, tabletting makes dispersible tablet.
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Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101229174B (en) * | 2008-01-25 | 2010-12-15 | 广东一品红药业有限公司 | Antianaphylaxis compound containing epinastine hydrochloride |
CN103222955A (en) * | 2013-05-22 | 2013-07-31 | 北京科源创欣科技有限公司 | Stable solution containing epinastine or hydrochloride of epinastine |
CN103356616A (en) * | 2013-06-29 | 2013-10-23 | 北京万全德众医药生物技术有限公司 | Bilastine-containing pharmaceutical composition and preparation method thereof |
CN104546731A (en) * | 2013-10-09 | 2015-04-29 | 重庆安格龙翔医药科技有限公司 | Epinastine hydrochloride granules and preparation method thereof |
CN105708840A (en) * | 2014-12-01 | 2016-06-29 | 重庆安格龙翔医药科技有限公司 | Epinastine hydrochloride composition |
CN105708808A (en) * | 2014-12-01 | 2016-06-29 | 重庆安格龙翔医药科技有限公司 | Epinastine hydrochloride granule, and preparation method thereof |
CN105708807A (en) * | 2014-12-01 | 2016-06-29 | 重庆安格龙翔医药科技有限公司 | Preparation method of epinastine hydrochloride fine granule |
CN105769883A (en) * | 2014-12-17 | 2016-07-20 | 康普药业股份有限公司 | Compound sulfamethoxazole dispersible tablet and preparation method thereof |
CN117427042A (en) * | 2023-12-20 | 2024-01-23 | 泊诺(天津)创新医药研究有限公司 | Preparation method of epinastine hydrochloride tablet |
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2005
- 2005-12-16 CN CN200510133746A patent/CN100594904C/en not_active Expired - Fee Related
Cited By (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101229174B (en) * | 2008-01-25 | 2010-12-15 | 广东一品红药业有限公司 | Antianaphylaxis compound containing epinastine hydrochloride |
CN103222955A (en) * | 2013-05-22 | 2013-07-31 | 北京科源创欣科技有限公司 | Stable solution containing epinastine or hydrochloride of epinastine |
CN103356616A (en) * | 2013-06-29 | 2013-10-23 | 北京万全德众医药生物技术有限公司 | Bilastine-containing pharmaceutical composition and preparation method thereof |
CN104546731A (en) * | 2013-10-09 | 2015-04-29 | 重庆安格龙翔医药科技有限公司 | Epinastine hydrochloride granules and preparation method thereof |
CN105708840A (en) * | 2014-12-01 | 2016-06-29 | 重庆安格龙翔医药科技有限公司 | Epinastine hydrochloride composition |
CN105708808A (en) * | 2014-12-01 | 2016-06-29 | 重庆安格龙翔医药科技有限公司 | Epinastine hydrochloride granule, and preparation method thereof |
CN105708807A (en) * | 2014-12-01 | 2016-06-29 | 重庆安格龙翔医药科技有限公司 | Preparation method of epinastine hydrochloride fine granule |
CN105708808B (en) * | 2014-12-01 | 2018-11-27 | 重庆安格龙翔医药科技有限公司 | A kind of epinastine hydrochloride granule and preparation method thereof |
CN105708807B (en) * | 2014-12-01 | 2018-11-27 | 重庆安格龙翔医药科技有限公司 | A kind of preparation method of epinastine hydrochloride granula subtilis |
CN105769883A (en) * | 2014-12-17 | 2016-07-20 | 康普药业股份有限公司 | Compound sulfamethoxazole dispersible tablet and preparation method thereof |
CN117427042A (en) * | 2023-12-20 | 2024-01-23 | 泊诺(天津)创新医药研究有限公司 | Preparation method of epinastine hydrochloride tablet |
CN117427042B (en) * | 2023-12-20 | 2024-03-05 | 泊诺(天津)创新医药研究有限公司 | Preparation method of epinastine hydrochloride tablet |
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