CN102552107A - Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof - Google Patents
Two-phase release preparation containing zolpidem or salt of zolpidem and preparation method thereof Download PDFInfo
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- CN102552107A CN102552107A CN2012100095905A CN201210009590A CN102552107A CN 102552107 A CN102552107 A CN 102552107A CN 2012100095905 A CN2012100095905 A CN 2012100095905A CN 201210009590 A CN201210009590 A CN 201210009590A CN 102552107 A CN102552107 A CN 102552107A
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Abstract
The invention discloses a two-phase release preparation containing zolpidem or salt of zolpidem, which is characterized by comprising a normal medicine-containing fast release preparation and enteric fast release preparation and being suitable for respectively releasing zolpidem or salt of zolpidem in two preset periods of time. More than 90% dose of the normal medicine-containing fast release preparation is released within 30 minutes in 0.01M of hydrochloric acid buffer solution at 37 DEG C, and more than 90% dose of the enteric fast release preparation is released within 30 minutes in phosphate buffer solution of 6.8 potential of hydrogen (pH) at 37 DEG C. The two-phase release preparation containing zolpidem or salt of zolpidem is specific to the sleep characteristics of a patient with sleep difficulties and early waking, and has effects on patients with both sleeping difficulties and early waking simultaneously.
Description
Technical field
The present invention relates to the two-phase delivery formulations of a kind of zolpidem or its salt, the invention still further relates to the method for preparing of the two-phase delivery formulations of this zolpidem or its salt.
Background technology
Insomnia is a kind of common sleep disorder, and difficulty falling asleep, the Depth of sleep that causes for a variety of causes is shallow or frequency is too short, early awakening and the length of one's sleep are not enough or of poor quality etc.The common reason that causes having a sleepless night mainly contains environment reason, individual factors, body reason, Nervous and Mental Factors, emotional factor etc.Wherein, early awakening be meant weekly more than four times than the Zao 2-3 of normal condition hour or longer time awakening, and the phenomenon that can not fall asleep once more.The people of insomnia is usually simultaneously with difficulty falling asleep and early awakening.The effective acting time of most of sleeping pill is generally at 4-6h, by taking medicine before the routine sleep, treats difficulty falling asleep simultaneously and the early awakening symptom can't be proved effective, and this also is a blank in the treatment of sleep disorders.
Zolpidem, a kind of Imidazopyridine class sedative hypnotic drug mainly acts on 1 receptor of the ω on the GABA-BZDA subunit in the brain, has stronger sedative-hypnotic effect and slight anxiety, of flaccid muscles and anticonvulsant action.Americanism obstacle diagnosis and statistic handbook the 4th edition are mentioned the choice drug that non-Benzodiazepines hypnotic drug zolpidem can be used as Primary insomnia.This medicine is the earliest by the development of French Sanofi-Aventis company; Be first non-Benzodiazepines sleeping pill, the Zolpidemtar Trate conventional tablet is in Initial Public Offering in 1988, and in December, 1992 is through U.S. FDA audit approval; Be respectively 1993 and 1996 with the Time To Market of China in the U.S.; Successively be widely used,, the trend that progressively replaces benzodiazepine arranged all over the world being widely used as the sedative hypnotic in states such as American and Britain, moral, Switzerland, Spain.Oral zolpidem ordinary preparation, bioavailability are 70%, blood drug level peaking behind the medication 0.5-3h, and mean half-life is 2.4h, the persistent period is less than 6h.Improve slow releasing tablet for this reason, and gone on the market ProductName Ambian CR in 2005 in the U.S..
Zolpidem belongs to fugitive sleeping pill, and its half-life is short, and action time is short.In order to solve short problem of zolpidem half-life.CN1334729A discloses the controlled release preparation of a kind of zolpidem or its salt, and contained drug presents two-phase in can be at the fixed time and discharges in the said preparation, and wherein first is the rapid release phase mutually, and second is the slow release phase mutually.But a large amount of clinical cases find that under the effect of sleeping pill, the patient can sleep peacefully 3-4 hour at least, the early awakening symptom then occurred.Therefore continue medication through slow releasing preparation, the time administration that especially originally can sleep peacefully the patient just seems and there is no need.After 3-4 hour, often because medicine discharged finish do not reach effective drug level and to the early awakening bundle in hopeless.Slow releasing preparation is longer because of its release time simultaneously, because of patient's individual variation, is difficult to the effectively rational blood drug level level of control, causes symptoms such as the most of patients m seq has one's head in the clouds, and influences operate as normal and life.
In addition; Pulse site-specific drug delivery mini-pill when CN101574328 discloses selecting of a kind of zolpidem salt; Its micropill skin is the time lag layer with the hypotonicity acrylic resin coating that contains quaternary ammonium salt group, has controlled intermediate layer medicine and organic acid and has discharged, and the time hysteresis through after a while discharges medicine; The pulse site-specific drug delivery mini-pill is only to the symptom of early awakening during this selecting, the readily good therapeutic effect of difficulty falling asleep that usually is accompanied for the early awakening symptom.
Summary of the invention
The invention provides the two-phase delivery formulations of a kind of zolpidem or its salt; It is characterized in that it is made up of common pastille quick releasing formulation and enteric-coated quick releasing formulation two parts; Discharge zolpidem or its salt respectively in two periods that are adapted at being scheduled to; Common pastille quick releasing formulation in 30min, the discharging more than 90% of its dose in the hydrochloride buffer of 37 ℃ 0.01M, enteric-coated quick releasing formulation in 30min, the discharging more than 90% of its dose in the pH6.8 phosphate buffer.
Preferably, said enteric-coated quick releasing formulation in the hydrochloride buffer of 37 ℃ 0.01M 0-2 hour burst size less than 10%.
More preferably be that total content of dispersion of said zolpidem or its salt is calculated as 6-16mg by zolpidem.
More preferably be that said zolpidem or its salt are Zolpidemtar Trate.
Preferably, said enteric-coated quick releasing formulation comprises zolpidem or its salt, and receivable enteric material on the pharmaceutics.
More preferably be, said enteric material is one or more in crylic acid resin, hydroxypropyl methylcellulose diethyl phthalate, the Hydroxypropyl Methyl Cellulose Phthalate, and its weight accounts for the 60%-90% of whole enteric-coated quick releasing formulation weight.
More preferably be, said enteric-coated quick releasing formulation also comprises plasticizer, and said plasticizer comprises phthalate, one or more in citric acid ester type, Polyethylene Glycol, the stearic acid, and its weight accounts for the 10%-40% of whole enteric-coated quick releasing formulation weight.
More preferably be, said two-phase delivery formulations is a tablet, and its preparation method is following:
A. with medicine and other adjuvant mix homogeneously except that lubricant, the adding mix lubricant is even, makes common pastille quick releasing formulation;
B. with medicine and filler mix homogeneously, add wetting agent system soft material, extrude round as a ball, must rapid release ball core, enteric coated, make enteric-coated quick releasing formulation;
C. with common pastille quick releasing formulation and enteric-coated quick releasing formulation mix homogeneously, tabletting promptly gets.
More preferably be, said two-phase delivery formulations is a powder, and wherein each phase scalable dosage is to realize individual administration.
Perhaps, more preferably be, said two-phase delivery formulations is a capsule, and wherein each phase scalable dosage is to realize individual administration.
The present invention is directed to difficulty falling asleep and early awakening patient's sleep characteristics, for simultaneously all effective with the patient of difficulty falling asleep and early awakening.Take two-phase delivery formulations of the present invention before sleeping, wherein common pastille quick releasing formulation is instant performance drug effect in 30 minutes, helps the patient sleeping as early as possible; After after a while, blood drug level reduces, but the patient still can keep sleep; Enteric-coated quick releasing formulation discharged at interval in 2-4 hour once more; Reach treatment blood drug level level rapidly, make the patient when being about to awaken, obtain effective blood drug concentration, thereby prolong patient's the length of one's sleep.Because adopt enteric material, enteric-coated quick releasing formulation is mainly in little intestinal absorption, enteric coating has been avoided the hydrolysis of gastric enzyme, thereby escapes the enzyme barrier, has improved the bioavailability of medicine at enteral.Medicine must could dissolve release through gastric emptying to intestinal, has reduced individual variation, and release time is relatively accurate.Alleviated because of slow releasing preparation longlyer release time simultaneously, and kept certain blood drug level for a long time, brought m seq malaise symptoms such as have one's head in the clouds to the patient.In addition, owing to adopt common pastille powder and the blended micropill pressed-disc technique of enteric-coated quick releasing ball core, it is compared with two release capsules and with double-deck fast slow releasing tablet has more superiority: as realized two delivery formulations that dosage is cut apart; Do not use gelatine capsule shell, the problem of aging that has been prone in having avoided depositing has also avoided capsule to stick to the problem that influence discharges in the esophagus simultaneously when taking medicine.
Description of drawings
Fig. 1 shows according to release graphics in the body of embodiments of the invention.
The specific embodiment
Embodiment 1: the two-phase releasing piece that contains the 10mg Zolpidemtar Trate
Common pastille rapid release powder:
Prescription:
Technology: with Zolpidemtar Trate, lactose/starch mixture, the microcrystalline Cellulose PH102 of recipe quantity, Macrogol 4000, the carboxymethyl starch sodium mix homogeneously, the magnesium stearate of adding recipe quantity, mix homogeneously promptly gets.
The enteric-coated quick releasing micropill
The ball core
Enteric coating
Technology: with Zolpidemtar Trate, the microcrystalline Cellulose PH101 of recipe quantity, low-substituted hydroxypropyl cellulose, sucrose mix homogeneously add 10% starch slurry system soft material, extrude round as a ballly, process rapid release ball core, enteric coating, coating weightening finish 10-15%.
With immediate-release granules for preparing and enteric coated particles mix homogeneously, tabletting promptly gets.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II dissolution in vitro algoscopy, two methods as the phase I release medium, keep 37 ℃ with 900ml0.01M hydrochloric acid, and the slurry method stirs (50rpm), takes a sample respectively at 5min, 15min, 30min, 1h, 2h.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling through measuring 270nm place UV Absorption degree, are confirmed stripping percent.
The result is illustrated in the table 1.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; Remain unchanged in the 15min-2h interval; Explain that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of the hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In the pH6.8 buffer, the enteric coated micropill part discharges in 15min fully.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 1
Embodiment 2: the two-phase releasing piece that contains the 12.5mg Zolpidemtar Trate
Common pastille rapid release powder
Technology: with Zolpidemtar Trate, mannitol, the microcrystalline Cellulose PH200 of recipe quantity, the cross-linking sodium carboxymethyl cellulose mix homogeneously, the calcium stearate of adding recipe quantity, mix homogeneously promptly gets.
The enteric-coated quick releasing micropill
The ball core
Enteric coating
Technology: with Zolpidemtar Trate, the microcrystalline Cellulose PH101 of recipe quantity, low-substituted hydroxypropyl cellulose, lactose mix homogeneously add 0.1% sodium carboxymethyl cellulose system soft material; Extrude (35rpm) round as a ball (600rpm); Process rapid release ball core, enteric coating, coating weightening finish 25-30%.
With immediate-release granules for preparing and enteric coated particles mix homogeneously, tabletting promptly gets.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II dissolution in vitro algoscopy, two methods as the phase I release medium, keep 37 ℃ with 900ml0.01M hydrochloric acid, and the slurry method stirs (50rpm), takes a sample respectively at 5min, 15min, 30min, 1h, 2h.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling are confirmed stripping percent through measuring 270nm place UV Absorption degree.
The result is illustrated in the table 2.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; Remain unchanged in the 15min-2h interval; Explain that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of the hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In the pH6.8 buffer, the enteric coated micropill part discharges in 15min fully.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 2
Embodiment 3: the two-phase releasing piece that contains the 12.5mg Zolpidemtar Trate
Common pastille rapid release powder:
Technology: with Zolpidemtar Trate, lactose, the microcrystalline Cellulose PH102 of recipe quantity, the carboxymethyl starch sodium mix homogeneously, the magnesium stearate of adding recipe quantity, mix homogeneously promptly gets.
The enteric-coated quick releasing micropill:
Enteric coating:
Technology: with Zolpidemtar Trate, the microcrystalline Cellulose PH101 of recipe quantity, polyvinylpolypyrrolidone, ethylmethylcellulose mix homogeneously add 10% pregelatinized Starch slurry system soft material, extrude round as a ballly, process rapid release ball core, enteric coating, coating weightening finish 15-25%.
With immediate-release granules for preparing and enteric coated particles mix homogeneously, tabletting promptly gets.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II dissolution in vitro algoscopy, two methods as the phase I release medium, keep 37 ℃ with 900ml0.01M hydrochloric acid, and the slurry method stirs (50rpm), takes a sample respectively at 5min, 15min, 30min, 1h, 2h.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling through measuring 270nm place UV Absorption degree, are confirmed stripping percent.
The result is illustrated in the table 3.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; Remain unchanged in the 15min-2h interval; Explain that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of the hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In the pH6.8 buffer, the enteric coated micropill part discharges in 15min fully.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 3
Embodiment 4: the two-phase releasing piece that contains the 12.5mg Zolpidemtar Trate
Common pastille rapid release powder:
Technology: with Zolpidemtar Trate, lactose, the microcrystalline Cellulose PH102 of recipe quantity, the carboxymethyl starch sodium mix homogeneously, the magnesium stearate of adding recipe quantity, mix homogeneously promptly gets.
The enteric-coated quick releasing micropill:
Enteric coating:
Technology: with Zolpidemtar Trate, the microcrystalline Cellulose PH101 of recipe quantity, polyvinylpolypyrrolidone, ethylmethylcellulose mix homogeneously add 10% pregelatinized Starch slurry system soft material, extrude round as a ballly, process rapid release ball core, enteric coating, coating weightening finish 15-25%.
With immediate-release granules for preparing and enteric coated particles mix homogeneously, tabletting promptly gets.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II dissolution in vitro algoscopy, two methods as the phase I release medium, keep 37 ℃ with 900ml0.01M hydrochloric acid, and the slurry method stirs (50rpm), takes a sample respectively at 5min, 15min, 30min, 1h, 2h.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling through measuring 270nm place UV Absorption degree, are confirmed stripping percent.
The result is illustrated in the table 4.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; Remain unchanged in the 15min-2h interval; Explain that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of the hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In the pH6.8 buffer, the enteric coated micropill part discharges in 15min fully.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 4
Embodiment 5: the two-phase releasing piece that contains the 4mg Zolpidemtar Trate
Common pastille rapid release powder
Technology: with Zolpidemtar Trate, lactose/starch mixture, the microcrystalline Cellulose PH102 of recipe quantity, Macrogol 4000, the carboxymethyl starch sodium mix homogeneously, the magnesium stearate of adding recipe quantity, mix homogeneously promptly gets.
The enteric-coated quick releasing micropill
The ball core
Enteric coating
Technology: with Zolpidemtar Trate, the microcrystalline Cellulose PH101 of recipe quantity, low-substituted hydroxypropyl cellulose, sucrose mix homogeneously add 10% starch slurry system soft material, extrude round as a ballly, process rapid release ball core, enteric coating, coating weightening finish 10-15%.
With immediate-release granules for preparing and enteric coated particles mix homogeneously, tabletting promptly gets.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II dissolution in vitro algoscopy, two methods as the phase I release medium, keep 37 ℃ with 900ml0.01M hydrochloric acid, and the slurry method stirs (50rpm), takes a sample respectively at 5min, 15min, 30min, 1h, 2h.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling through measuring 270nm place UV Absorption degree, are confirmed stripping percent.
The result is illustrated in the table 5.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; Remain unchanged in the 15min-2h interval; Explain that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of the hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In the pH6.8 buffer, the enteric coated micropill part discharges in 15min fully.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 5
Embodiment 6: the two-phase releasing piece that contains the 16mg Zolpidemtar Trate
Common pastille rapid release powder
Technology: with Zolpidemtar Trate, lactose/starch mixture, the microcrystalline Cellulose PH102 of recipe quantity, Macrogol 4000, the carboxymethyl starch sodium mix homogeneously, the magnesium stearate of adding recipe quantity, mix homogeneously promptly gets.
The enteric-coated quick releasing micropill
The ball core
Enteric coating
Technology: with Zolpidemtar Trate, the microcrystalline Cellulose PH101 of recipe quantity, low-substituted hydroxypropyl cellulose, sucrose mix homogeneously add 10% starch slurry system soft material, extrude round as a ballly, process rapid release ball core, enteric coating, coating weightening finish 10-15%.
With immediate-release granules for preparing and enteric coated particles mix homogeneously, tabletting promptly gets.
Adopt Chinese Pharmacopoeia (version in 2010) appendix II dissolution in vitro algoscopy, two methods as the phase I release medium, keep 37 ℃ with 900ml0.01M hydrochloric acid, and the slurry method stirs (50rpm), takes a sample respectively at 5min, 15min, 30min, 1h, 2h.Release medium is adjusted to pH6.8, and respectively at 5min, 15min, 30min and 45min sampling through measuring 270nm place UV Absorption degree, are confirmed stripping percent.
The result is illustrated in the table 6.Show that common pastille quick releasing formulation was complete stripping in 15 minutes; Remain unchanged in the 15min-2h interval; Explain that enteric coating well protected rapid release ball core in acid medium, avoid it in acid medium, to discharge, the final stripping of the hydrochloric acid of 0.1M is not as the hydrochloric acid solution of 0.01M.In the pH6.8 buffer, the enteric coated micropill part discharges in 15min fully.Whole release profiles is stepped, two-phase rapid release characteristic.
Table 6
More than be that tabletting makes tablet with immediate-release granules for preparing and enteric coated particles mix homogeneously.Can also immediate-release granules and enteric coated particles be prepared as the powder or the capsule of comparting packaging, the patient can according to the reduced dose personalized medicine of particulate volume, repeat no more at this according to the sleep characteristics of oneself with to the tolerance degree of medicine.
Although embodiment of the present invention are open as above; But it is not restricted to listed utilization in description and the embodiment; It can be applied to various suitable the field of the invention fully, for being familiar with those skilled in the art, can easily realize other modification; Therefore under the general concept that does not deviate from claim and equivalency range and limited, the legend that the present invention is not limited to specific details and illustrates here and describe.
Claims (10)
1. the two-phase delivery formulations of a zolpidem or its salt; It is characterized in that it is made up of common pastille quick releasing formulation and enteric-coated quick releasing formulation two parts; Discharge zolpidem or its salt respectively in two periods that are adapted at being scheduled to; Common pastille quick releasing formulation in 30min, the discharging more than 90% of its dose in the hydrochloride buffer of 37 ℃ 0.01M, enteric-coated quick releasing formulation in 30min, the discharging more than 90% of its dose in the pH6.8 phosphate buffer.
2. the two-phase delivery formulations of zolpidem as claimed in claim 1 or its salt is characterized in that, said enteric-coated quick releasing formulation in the hydrochloride buffer of 37 ℃ 0.01M 0-2 hour burst size less than 10%.
3. the two-phase delivery formulations of zolpidem as claimed in claim 2 or its salt is characterized in that, total content of dispersion of said zolpidem or its salt is calculated as 6-16mg by zolpidem.
4. the two-phase delivery formulations of zolpidem as claimed in claim 3 or its salt is characterized in that, said zolpidem or its salt are Zolpidemtar Trate.
5. like the two-phase delivery formulations of arbitrary described zolpidem or its salt among the claim 1-4, it is characterized in that said enteric-coated quick releasing formulation comprises zolpidem or its salt, and receivable enteric material on the pharmaceutics.
6. the two-phase delivery formulations of zolpidem as claimed in claim 5 or its salt; It is characterized in that; Said enteric material is one or more in crylic acid resin, hydroxypropyl methylcellulose diethyl phthalate, the Hydroxypropyl Methyl Cellulose Phthalate, and its weight accounts for the 60%-90% of whole enteric-coated quick releasing formulation weight.
7. the two-phase delivery formulations of zolpidem as claimed in claim 6 or its salt; It is characterized in that; Said enteric-coated quick releasing formulation also comprises plasticizer; Said plasticizer comprises phthalate, one or more in citric acid ester type, Polyethylene Glycol, the stearic acid, and its weight accounts for the 10%-40% of whole enteric-coated quick releasing formulation weight.
8. the two-phase delivery formulations of zolpidem as claimed in claim 7 or its salt is characterized in that, said two-phase delivery formulations is a tablet, and its preparation method is following:
A. with medicine and other adjuvant mix homogeneously except that lubricant, the adding mix lubricant is even, makes common pastille quick releasing formulation;
B. with medicine and filler mix homogeneously, add wetting agent system soft material, extrude round as a ball, must rapid release ball core, enteric coated, make enteric-coated quick releasing formulation;
C. with common pastille quick releasing formulation and enteric-coated quick releasing formulation mix homogeneously, tabletting promptly gets.
9. the two-phase delivery formulations of zolpidem as claimed in claim 7 or its salt is characterized in that, said two-phase delivery formulations is a powder, and wherein each phase scalable dosage is to realize individual administration.
10. the two-phase delivery formulations of zolpidem as claimed in claim 7 or its salt is characterized in that, said two-phase delivery formulations is a capsule, and wherein each phase scalable dosage is to realize individual administration.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107961227A (en) * | 2017-12-19 | 2018-04-27 | 河南中帅医药科技股份有限公司 | A kind of preparation method and application of double releasing micropills of Chinese medicinal formulae |
| CN115707455A (en) * | 2021-08-18 | 2023-02-21 | 越洋医药开发(广州)有限公司 | Tablet allowing sleep regulation type drug to be released in stages and preparation method thereof |
| CN115919806A (en) * | 2022-12-22 | 2023-04-07 | 南京乐韬生物科技有限公司 | A kind of preparation method of GABA sustained release capsule |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1334729A (en) * | 1998-12-04 | 2002-02-06 | 圣诺菲-合成实验室公司 | Controlled-release dosage forms comprising zolpidem or salt thereof |
| CN101574328A (en) * | 2009-06-18 | 2009-11-11 | 中国药科大学 | Timing pulsed release micro-pill of zolpidem salt |
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2012
- 2012-01-12 CN CN201210009590.5A patent/CN102552107B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1334729A (en) * | 1998-12-04 | 2002-02-06 | 圣诺菲-合成实验室公司 | Controlled-release dosage forms comprising zolpidem or salt thereof |
| CN101574328A (en) * | 2009-06-18 | 2009-11-11 | 中国药科大学 | Timing pulsed release micro-pill of zolpidem salt |
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| 谢齐昂等: "酒石酸唑吡坦双脉冲控释微丸的研制", 《中国药学杂志》, vol. 44, no. 17, 30 September 2009 (2009-09-30) * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107961227A (en) * | 2017-12-19 | 2018-04-27 | 河南中帅医药科技股份有限公司 | A kind of preparation method and application of double releasing micropills of Chinese medicinal formulae |
| CN115707455A (en) * | 2021-08-18 | 2023-02-21 | 越洋医药开发(广州)有限公司 | Tablet allowing sleep regulation type drug to be released in stages and preparation method thereof |
| CN115707455B (en) * | 2021-08-18 | 2025-03-14 | 越洋医药开发(广州)有限公司 | Tablets allowing segmented release of sleep-regulating drugs and preparation method thereof |
| CN120154581A (en) * | 2021-08-18 | 2025-06-17 | 越洋医药开发(广州)有限公司 | Tablets allowing segmented release of sleep regulating drugs and preparation method thereof |
| CN115919806A (en) * | 2022-12-22 | 2023-04-07 | 南京乐韬生物科技有限公司 | A kind of preparation method of GABA sustained release capsule |
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| CN102552107B (en) | 2014-02-26 |
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