CN102860997A - Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof - Google Patents
Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof Download PDFInfo
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- CN102860997A CN102860997A CN2012103694621A CN201210369462A CN102860997A CN 102860997 A CN102860997 A CN 102860997A CN 2012103694621 A CN2012103694621 A CN 2012103694621A CN 201210369462 A CN201210369462 A CN 201210369462A CN 102860997 A CN102860997 A CN 102860997A
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Abstract
The invention provides an ondansetron oral cavity instant membrane capable of sheltering bad medicine taste and a preparation method thereof. The oral cavity instant membrane comprises active pharmaceutical ingredients for sheltering the bad taste and auxiliary materials suitable for pharmacy, the active pharmaceutical ingredients include ondansetron or salts acceptable in the pharmacy, and the auxiliary materials suitable for the pharmacy comprise a membrane-forming material, a sweetening agent and a filling agent. The oral cavity instant membrane has the advantages that the taste is good, the oral cavity instant membrane can be rapidly dissolved in the oral cavity without water, the bioavailability is high, the usage is convenient, the processing technology is simple, convenient and practical, the related auxiliary materials suitable for the pharmacy are easy to purchase, and good social and economic benefits are achieved.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of ondansetron oral instant membrane that covers the adverse drug taste and preparation method thereof.
Background technology
Oral instant membrane belongs to the membrane in the pharmaceutical dosage form, also is a kind of immediate release oral solid dosage form, and it is the breath freshening thin film evolution from confection and mouth care market, has been applied in over-the-counter drug and the prescription drug abroad at present.Oral instant membrane is a kind of safe and effective dosage form, common product is designed to the size of a stamp, on tongue, can dissolve fast, and swallow with normal swallowing act, the patient can take in the situation that need not to drink water, thereby realizes the quick release of one or more effective ingredients.Oral instant membrane can be implemented in is inconvenient to drink water or does not have in the situation of drinking water supply, take medicine accurately easily and fast,, and compare with common box-packed or bottled medicine, volume is less, be easy to carry, can better meet fast pace, high pressure city crowd's demand, especially be fit to child, old people and critical patient and use.Therefore, pharmaceutical producing enterprise and consumer think that unanimously oral instant membrane is the desirable novel form of a kind of alternative conventional dosage forms such as liquid preparation, tablet and capsule, will have wide marketing advantage.
The chemical name 1,2,3 of ondansetron (Ondansetron), 9-tetrahydrochysene-9-methyl-3-[(2-Methylimidazole .-1-yl) methyl]-4-oxo carbazole, molecular formula is C18H19N3O, what use clinically is its hydrochloride form.Ondansetron Hydrochloride is the high selectivity 5-HT3 receptor antagonist of first listing, is that the neuron 5-HT5 receptor of around being positioned at by antagonism and nervus centralis part is brought into play antiemetic effect.Ondansetron can also suppress because of feeling sick that opium is induced, because its high selectivity effect, thereby does not have the side effect of other Bendectins, such as the extrapyramidal symptoms, excessively calm etc.This product is affirmed by numerous clinicians, and has been become the main flow medication in domestic Bendectin market after the long-term clinical practice of experience.
Patent CN1289085C discloses a kind of nasal spray of taking charge of fine jade class medicine, and it comprises the medicine that is selected from ondansetron, tropisetron and granisetron, osmotic pressure regulator and water.
Patent CN101134024A discloses a kind of hydrochloric acid ondansetron and preparation method thereof, take Ondansetron Hydrochloride as principal agent, adds suitable filler, correctives and makes solution, makes oral cavity disintegration tablet after the lyophilization.Its advantage is: the patient takes, and need not water, is disintegratable below 30 seconds in the oral cavity, and patient is got timely medical treatment.
Patent CN1209108C discloses a kind of antiemetic composition that transmits through skin, (a) a kind of base material, the hydrophilic organic solvent that contains (1) 20%-80% percentage by weight, (2) by the Tegin L 90 of 1%-5% percentage by weight and the N of 1%-5% percentage by weight, the skin penetration intensifier that the N-diethyl-meta-toluamide forms, and the water of (3) 15%-80% percentage by weight; (b) according to the weight of base material, a kind of antiemetic of 1%-15% percentage by weight, antiemetic is from tropisetron, ondansetron is selected in the family that granisetron and their acceptable salt aspect pharmacy form.
Patent CN1833641A discloses a kind of Ondansetron Hydrochloride oral administration solution and preparation method thereof, citric acid, sodium citrate, sorbitol, stevioside, sodium benzoate are dissolved in the distilled water in proportion with after Ondansetron Hydrochloride mixes, get clear and bright solution behind stirring, the fine straining, again packing gets product after sterilization.
More than the ondansetron of several patent disclosures and the formulation products of hydrochlorate thereof certain inferior position is all arranged in clinical practice, the indication of ondansetron is for to be used for: the 1. nausea and vomiting that causes of cytotoxic chemotherapy and radiotherapy; 2. prevent and treat postoperative pernicious vomiting.And the tumor patient that need to carry out radiation and chemotherapy mostly is weakly bed patient, especially late period and critical patient, may be also due to illness feelings worsen and can't normally take food, for this type of patient, the use of above-mentioned transdermal absorption formulation, oral administration solution and nasal spray all may face certain difficulty and inconvenience, thereby greatly reduces the compliance of patient's medication.Although oral cavity disintegration tablet can dissolve rapidly in the oral cavity, use the freeze-dry process preparation, higher manufacturing cost must cause higher drug price, can increase to a certain extent patient's financial burden.
The oral instant membrane type of ondansetron (ondansetron Rapid Film) that SciClone drugmaker produces is in the Europe listing, is used for the treatment of by feeling sick of causing of radiotherapy, chemotherapy or surgical operation, vomiting etc.Its contained adjuvant is dibenzylatiooluene, calcium carbonate, and colloidal silica, erythritol, hydroxypropyl emthylcellulose, ammonium glycyrrhizinate, poly(ethylene oxide), sodium bicarbonate etc., different with adjuvant used in the present invention and preparation technology.
Ondansetron has stronger bitterness, to hide this bitterness fully certain technical difficulty is arranged, the oral formulations of at present list marketing comprises tablet, capsule and oral cavity disintegration tablet, mouthfeel is not ideal, and extensive patients especially child patient is badly in need of preparation good mouthfeel, that can effectively cover the adverse drug taste.Technical problem to be solved by this invention is, utilizes the applicable adjuvant of pharmacy, and by simple and easy to do preparation process, the medicine ondansetron that will have poor taste is prepared into the oral instant membrane with good taste, thereby remedies the deficiency of present listing product.
Summary of the invention
The invention provides a kind of ondansetron oral instant membrane and preparation method thereof of covered adverse drug taste of innovation.
One of purpose of the present invention provides that a kind of taste is good, drug releasing rate is very fast, is conducive to the ondansetron oral instant membrane of rapid onset.
Another object of the present invention provides the simple and easy preparation technology of ondansetron oral instant membrane, and the oral instant membrane that makes has higher mechanical strength and wearability, can guarantee that it is packing, transports, do not breaking when taking, and keeps good appearance.
The present invention adopts the polacrilin potassium resin to be combined with ondansetron for the bitterness of sheltering ondansetron, makes this pharmaceutical composition taste pleasant, and the oral solid formulation mouthfeel of preparation is good, is conducive to improve the compliance of patient's medication.
The present invention adopts sodium carboxymethyl cellulose and xanthan gum combination as filmogen, adds simultaneously microcrystalline Cellulose as the composition that promotes dissolving, and this oral instant membrane can be dissolved rapidly in the oral cavity.
The invention provides a kind of oral instant membrane that covers the adverse drug taste, this oral instant membrane comprises active constituents of medicine and the applicable adjuvant of pharmacy that hides flavor, the active constituents of medicine of described screening flavor comprises active constituents of medicine and is used for hiding the adjuvant of flavor that the applicable adjuvant of described pharmacy comprises filmogen, sweeting agent, filler etc.
Described active constituents of medicine is: ondansetron or its pharmaceutically acceptable salt comprise in hydrochlorate, sulfate, phosphate, the maleate one or more mixture.
Described adjuvant for hiding flavor is ion exchange resin, and preferred version is the polacrilin potassium resin, and the weight ratio of itself and Ondansetron Hydrochloride is 2: 1-1: 3, and preferred version is 1: 1.The polacrilin potassium resin is to be formed by methacrylic acid and divinylbenzene copolymerization, with potassium hydroxide neutralization and get final product, can be used for disintegrating agent, stabilizing agent, the slow releasing preparation of pharmaceutical preparation and covers the medicine taste.Polacrilin resin used in the present invention belongs to the AMBERLITE of Luo Shi chemical company
TMSeries of products are a kind of insoluble weak acid hydrogen type cation exchange resins, are the porous copolymers that methacrylic acid and divinylbenzene are polymerized, and are used for the carrier of some drugs and related substances thereof, also can be used for covering the uncomfortable taste of some drugs.
Described filmogen for this oral instant membrane is selected from one or more mixture of gelatin, arabic gum, xanthan gum, agar, sodium alginate, polyvinyl alcohol, Kollicoat IR, hypromellose, methylcellulose, sodium carboxymethyl cellulose and hydroxypropyl cellulose, preferably carboxymethyl cellulose sodium and xanthan gum.
Described sweeting agent for this oral instant membrane is selected from one or more mixture of aspartame, stevioside, glycyrrhizin, sucralose, fructose, sucrose and maltose.
Described filler for this oral instant membrane is selected from one or more mixture of mannitol, lactose, sorbitol, microcrystalline Cellulose, pregelatinized Starch, dextrin and starch.
According to a preferred version of the present invention, described active constituents of medicine is Ondansetron Hydrochloride, described adjuvant for hiding flavor is the polacrilin potassium resin, contain Ondansetron Hydrochloride 8mg in the every ondansetron oral instant membrane, polacrilin potassium resin 8mg, the applicable adjuvant content of described pharmacy is respectively sucralose 2mg, microcrystalline Cellulose 2mg, Carboxymethyl cellulose sodium 6mg, 0.3% xanthan gum solution 240g, mannitol 8mg, 0.3% kermes cellulose solution 4mg, 30% glycerite 8mg, fruity flavor liquid 4mg.
Another object of the present invention has provided a kind of preparation method of covering the ondansetron oral instant membrane of adverse drug taste:
A. prepare medicated resin: take by weighing Ondansetron Hydrochloride, use water dissolution, stirring and dissolving under the room temperature adds the polacrilin potassium resin, stirs 1 hour under the room temperature, carries out ion exchange, obtains Ondansetron Hydrochloride medicated resin suspension;
B. always mixed: add sucralose, microcrystalline Cellulose and sodium carboxymethyl cellulose in the prepared suspension of step a, the limit edged stirs, swelling 1 hour, add again xanthan gum solution, mannitol, kermes cellulose solution and glycerol, fully stir, left standstill 1 hour;
C. after leaving standstill 10 minutes under 60 ℃ of conditions, smear, drying;
D. cut packing.
Ondansetron oral instant membrane technical parameter according to the present invention's preparation is respectively: taste is good, and outward appearance and melting meet the requirements.
The polacrilin potassium resin that the present invention uses can directly use the polacrilin potassium resin, also can be prepared from by the polacrilin resin.
Polacrilin potassium process for preparing resins: take by weighing polacrilin resin 20g, add 1mol/l potassium hydroxide solution 100ml, low rate mixing 2 hours left standstill 4-10 hour, removed alkali liquor, wash with water until aqueous solution pH=6-7, sucking filtration, drying is 1 hour under 60 ℃ of freeze-day with constant temperature conditions, pulverizes 200 orders, namely get the polacrilin potassium resin, for subsequent use.
The specific embodiment
Below in conjunction with specific embodiment the present invention is described in further detail, but scope of the present invention is not limited to these embodiment.So, under method prerequisite of the present invention, simple modifications of the present invention is all belonged to the scope of protection of present invention.
Embodiment 1
Every hydrochloric ondansetron 4mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process is as follows:
Take by weighing Ondansetron Hydrochloride, sucralose, microcrystalline Cellulose, mannitol, after the dispersion of 30% glycerite, add 3% hydroxypropyl methylcellulose solution, the limit edged stirs, approximately stir after 15 minutes, add the sodium carboxymethyl cellulose swelling after 1 hour, 0.3% pigment solution mixes 5 minutes again, degassed, above-mentioned Ondansetron Hydrochloride suspendible glue is coated on the flat board uniformly, air blast, heat drying, heating-up temperature is 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and pliability is good, and the entrance dissolving is slow, and bitter in the mouth is limited to 35s when dissolving.
Embodiment 2
Every hydrochloric ondansetron 4mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process is as follows:
Take by weighing Ondansetron Hydrochloride, sucralose, microcrystalline Cellulose, after disperseing with 30% glycerite, add 10% pulullan polysaccharide aqueous solution, the limit edged stirs, approximately stir after 15 minutes, added the sodium carboxymethyl cellulose swelling 1 hour, add again 0.3% pigment solution and mix 5 minutes, degassed, above-mentioned Ondansetron Hydrochloride suspendible glue is coated on the flat board uniformly, air blast, heat drying, heating-up temperature is 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and pliability is general, and entrance is dissolved with improvement, and bitter in the mouth is limited to 25s when dissolving.
Embodiment 3
Every hydrochloric ondansetron 4mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process:
Take by weighing Ondansetron Hydrochloride 4g, water 500ml dissolving, add polacrilin potassium resin 4g under the room temperature after the stirring and dissolving, continuous stirring was carried out ion exchange 1 hour, namely got Ondansetron Hydrochloride medicated resin solution, added sucralose again, microcrystalline Cellulose, mannitol, stirring is uniformly dispersed it, add xanthan gum solution, the limit edged stirs, approximately stir 15 minutes after, glycerol adding, pigment solution mixes 5 minutes, and is degassed, is coated in uniformly above-mentioned Ondansetron Hydrochloride suspendible glue on the flat board, air blast, heat drying, heating-up temperature is 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and toughness is better, and the entrance dissolving is fast, and mouthfeel also is improved, solution time 20s.
Embodiment 4
Every hydrochloric ondansetron 8mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process:
Take by weighing Ondansetron Hydrochloride, sucralose, microcrystalline Cellulose, mannitol, after the dispersion of 30% glycerite, add 3% hydroxypropyl methylcellulose solution, the limit edged stirs, approximately stir after 15 minutes, 0.3% pigment solution mixes 5 minutes again, and is degassed, is coated in uniformly above-mentioned Ondansetron Hydrochloride suspendible glue on the flat board, air blast, heat drying, heating-up temperature is 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and pliability is good, and the entrance dissolving is slow, and bitter in the mouth is limited to 35s when dissolving.
Embodiment 5
Every hydrochloric ondansetron 8mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process:
Take by weighing Ondansetron Hydrochloride 8g, water 1000ml dissolving, add polacrilin potassium resin 8g under the room temperature after the stirring and dissolving, continuous stirring was carried out ion exchange 1 hour, namely get Ondansetron Hydrochloride medicated resin solution, add again sucralose, microcrystalline Cellulose, mannitol, sodium carboxymethyl cellulose swelling 1 hour and it is uniformly dispersed after, add 0.3% xanthan gum solution, the limit edged stirs, approximately stir 15 minutes after, add again 30% glycerite, 0.3% pigment solution mixes 5 minutes, and is degassed, is coated in uniformly above-mentioned Ondansetron Hydrochloride suspendible glue on the flat board, air blast, heat drying, heating-up temperature is 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and toughness is better, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 18s.
Embodiment 6
Every hydrochloric ondansetron 8mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process:
Take by weighing Ondansetron Hydrochloride 8g, water 1000ml dissolving, add polacrilin potassium resin 4g under the room temperature after the stirring and dissolving, continuous stirring was carried out ion exchange 1 hour, namely get Ondansetron Hydrochloride medicated resin solution, add again sucralose, microcrystalline Cellulose, mannitol, sodium carboxymethyl cellulose swelling 1 hour and it is uniformly dispersed after, add 0.3% xanthan gum solution, the limit edged stirs, approximately stir after 15 minutes, add 30% glycerite again, 0.3% pigment solution mixes 5 minutes, degassed, above-mentioned Ondansetron Hydrochloride suspendible glue is coated on the flat board air blast uniformly, heat drying, heating-up temperature are 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and toughness is better, and entrance dissolves rapidly dispersion, and mouthfeel is general, and flavor a bit point is bitter, solution time 20s.
Embodiment 7
Every hydrochloric ondansetron 8mg, the consisting of of 1000 Ondansetron Hydrochloride oral instant membranes:
Specific operation process:
Take by weighing Ondansetron Hydrochloride 8g, water 1000ml dissolving, add polacrilin potassium resin 16g under the room temperature after the stirring and dissolving, continuous stirring was carried out ion exchange 1 hour, namely get Ondansetron Hydrochloride medicated resin solution, add again sucralose, microcrystalline Cellulose, mannitol, sodium carboxymethyl cellulose swelling 1 hour and it is uniformly dispersed after, add 0.3% xanthan gum solution, the limit edged stirs, approximately stir after 15 minutes, add 30% glycerite again, 0.3% pigment solution mixes 5 minutes, degassed, above-mentioned Ondansetron Hydrochloride suspendible glue is coated on the flat board air blast uniformly, heat drying, heating-up temperature are 60 ℃, cutting (2cm * 2cm), namely get the Ondansetron Hydrochloride oral instant membrane.
This membrane outward appearance is good, and toughness is better, and entrance dissolves rapidly dispersion, good mouthfeel, and it is sweet to distinguish the flavor of, solution time 20s.
Claims (8)
1. the Ang Dan that can cover the adverse drug taste is with the fine jade oral instant membrane, it is characterized in that described oral instant membrane comprises active constituents of medicine and the applicable adjuvant of pharmacy that hides flavor, the active constituents of medicine of described screening flavor comprises active constituents of medicine and is used for hiding the adjuvant of flavor.
2. the active constituents of medicine of described screening flavor according to claim 1, it is characterized in that: described active constituents of medicine is ondansetron or its pharmaceutically acceptable salt, comprise in hydrochlorate, sulfate, phosphate, the maleate mixture of one or more, preferred version is Ondansetron Hydrochloride.
3. the active constituents of medicine of described screening flavor according to claim 1, it is characterized in that: described adjuvant for hiding flavor is ion exchange resin, preferred version of the present invention is the polacrilin potassium resin, and the weight ratio of itself and Ondansetron Hydrochloride is 2: 1-1: 3, and preferred version is 1: 1.
4. the applicable adjuvant of described pharmacy according to claim 1 comprises filmogen, sweeting agent and filler.
5. filmogen according to claim 4 is selected from gelatin, arabic gum, xanthan gum, agar, sodium alginate, polyvinyl alcohol, Kollicoat IR, hypromellose, methylcellulose, sodium carboxymethyl cellulose, the hydroxypropyl cellulose mixture of one or more, preferably carboxymethyl cellulose sodium and xanthan gum.
6. sweeting agent according to claim 4 is selected from aspartame, stevioside, glycyrrhizin, sucralose, fructose, sucrose, the maltose mixture of one or more, preferred sucralose.
7. filler according to claim 4 is selected from mannitol, lactose, sorbitol, microcrystalline Cellulose, pregelatinized Starch, dextrin, the starch mixture, preferably microcrystalline cellulose and the mannitol of one or more.
8. described a kind of preparation method of covering the ondansetron oral instant membrane of adverse drug taste according to claim 1 is characterized in that the method may further comprise the steps:
A. prepare medicated resin: take by weighing Ondansetron Hydrochloride, use water dissolution, stirring and dissolving under the room temperature adds the polacrilin potassium resin, stirs 1 hour under the room temperature, carries out ion exchange, obtains Ondansetron Hydrochloride medicated resin suspension;
B. always mixed: add sucralose, microcrystalline Cellulose and sodium carboxymethyl cellulose in the prepared suspension of step a, the limit edged stirs, swelling 1 hour, add again xanthan gum solution, mannitol, kermes cellulose solution and glycerol, fully stir, left standstill 1 hour;
C. after leaving standstill 10 minutes under 60 ℃ of conditions, smear, drying;
D. cut packing.
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| Application Number | Priority Date | Filing Date | Title |
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| CN2012103694621A CN102860997A (en) | 2012-09-28 | 2012-09-28 | Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof |
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| CN2012103694621A CN102860997A (en) | 2012-09-28 | 2012-09-28 | Ondansetron oral cavity instant membrane capable of sheltering taste and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107921045A (en) * | 2015-07-23 | 2018-04-17 | 雅典娜药品配送方案私人有限公司 | Zolpidem composition and preparation method thereof |
| CN109833311A (en) * | 2017-11-24 | 2019-06-04 | 江苏恒瑞医药股份有限公司 | A kind of molten film composition of mouth |
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| WO2011090694A1 (en) * | 2009-12-28 | 2011-07-28 | Monosol Rx, Llc | Orally administrable film dosage forms containing ondansetron |
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| CN102333526A (en) * | 2009-06-25 | 2012-01-25 | Cha生物&Diostech株式会社 | Fast-dissolving oral film for effectively concealing unpleasant tastes |
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| CN1419441A (en) * | 2000-03-23 | 2003-05-21 | 沃尼尔·朗伯公司 | Fast dissolving orally consumable films containing an ion exchange resin as a taste masking agent |
| US20090004254A1 (en) * | 2007-06-19 | 2009-01-01 | Todd Maibach | Film comprising active drugs |
| CN102333526A (en) * | 2009-06-25 | 2012-01-25 | Cha生物&Diostech株式会社 | Fast-dissolving oral film for effectively concealing unpleasant tastes |
| WO2011090694A1 (en) * | 2009-12-28 | 2011-07-28 | Monosol Rx, Llc | Orally administrable film dosage forms containing ondansetron |
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| CN107921045A (en) * | 2015-07-23 | 2018-04-17 | 雅典娜药品配送方案私人有限公司 | Zolpidem composition and preparation method thereof |
| CN107921045B (en) * | 2015-07-23 | 2021-03-09 | 雅典娜制药股份有限公司 | Zolpidem composition and preparation method thereof |
| CN109833311A (en) * | 2017-11-24 | 2019-06-04 | 江苏恒瑞医药股份有限公司 | A kind of molten film composition of mouth |
| CN109833311B (en) * | 2017-11-24 | 2022-06-21 | 江苏恒瑞医药股份有限公司 | Oral dissolving film composition |
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Address after: 300384 Tianjin Huayuan Industrial Zone Haitai development six road 6 C Haitai green industry base 502 Applicant after: Tianjin City Juxing Kanghua Medical Science & Technology Co., Ltd. Address before: Three road 300384 Tianjin Haitai Huayuan Industrial Zone Xiqing District Branch No. 1 Building 2 901 4 Applicant before: Tianjin City Juxing Kanghua Medical Science & Technology Co., Ltd. |
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Application publication date: 20130109 |