CN101574329A - Zolpidem tartrate film agent - Google Patents
Zolpidem tartrate film agent Download PDFInfo
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- CN101574329A CN101574329A CNA2009100530079A CN200910053007A CN101574329A CN 101574329 A CN101574329 A CN 101574329A CN A2009100530079 A CNA2009100530079 A CN A2009100530079A CN 200910053007 A CN200910053007 A CN 200910053007A CN 101574329 A CN101574329 A CN 101574329A
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- zolpidem tartrate
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Abstract
The invention discloses a zolpidem tartrate film agent and a preparation method thereof. The film agent comprises the following components by weight percentage: 1-40 percent of zolpidem tartrate, 40-98 percent of high molecular film-forming material, 0-20 percent of plasticizer, 0-3 percent of titanium dioxide, and 1-30 percent of flavoring agent. The high molecular film-forming material comprises more than one of the following components of hydroxypropyl methylcellulose, hydroxy propyl cellulose, polyvinyl alcohol, polyvinyl pyrrolidone, sodium alginate, polyoxyethylene, bletilla mucilage, cornstarch, or carrageenan. The film agent has rapid dissolving out speed, good stability and rapid absorption, can release medicaments on the surface of a mucosa which then can absorb the medicaments quickly, and avoid the first-pass effect of liver, and has high bioavailability, is convenient in use, quick in effect, good in adaptability, popular by patients, has good formability, can be adhered at the drug administration position after drug administration, keeps the drugs not to be dispersed, can keep the original state to release the drugs continuously, is accurate in dosage, has no dust explosion during the production process, and can solve the problems of labor security and environmental pollution.
Description
Technical field
The present invention relates to a kind of Zolpidemtar Trate preparation.
Background technology
The insomnia is the upset of ortho sleep pattern, shows as can't fall asleep or can not sleep night.Relevant data shows that Chinese adult insomnia rate 38.2% exists the people of sleep disorder a lot.
The medicine of Cure for insomnia at present commonly used has sedative hypnotic, antidepressants, antihistaminic (seldom being used for hypnosis at present) and Chinese medicine.The sedative hypnotic has experienced triple-substituted development so far: first generation sedative hypnotic drug comprises barbiturates, chloral hydrate, mixture tribromide and hydroxyzine (atarax) etc., their therapeutic index is lower, is easy to generate bigger, the median dose of influencing each other between toleration and dependency, the medicine and can suppresses to breathe.Second filial generation sedative hypnotic drug mainly is meant the Benzodiazepines sedative hypnotic, can induce the patient sleeping rapidly, reduce night and awaken number of times, prolong the length of one's sleep and improve sleep quality, but also changed common sleep pattern, made shallow sleep prolongation, the shortening of REM sleeping eyes persistent period, the delay of the time of occurrence of REM sleep first, have a dream minimizing or disappearance.Third generation sedative hypnotic drug mainly is meant non-Benzodiazepines hypnotic, comprises zolpidem, zopiclone and Zaleplon.Zolpidem is such medicine that at first appears on the market, and is developed by French Sythelabo company, and 1988 at France's listing, trade name Synthelabo.China begins the import zolpidem in nineteen ninety-five.
Zolpidemtar Trate is a γ-An Jidingsuan A-benzene phenodiazine receptor stimulating agent, and selectively acting has stronger sedative-hypnotic effect and slight anxiety, of flaccid muscles and anticonvulsant action in the ω of brain 1 benzene phenodiazine receptor subtype.Studies show that γ-An Jidingsuan is one of most important neurotransmitter of central nervous system, the neurotransmitter of about 50% synapse is a γ-An Jidingsuan.Gamma-aminobutyric acid receptor can be divided into γ-An Jidingsuan A and γ-An Jidingsuan B (or ω 1/ ω 2) receptor on the pharmacology.γ-An Jidingsuan A is subjected to physical ability by fly gill fungus and arecaidine excitement, is suppressed by anticonvulsant dicentrine and Picrotoxin.γ-An Jidingsuan B receptor is relevant with chloride channel.Gamma-aminobutyric acid receptor is made up of α, β, γ subunit, and zolpidem acts on alpha subunit, can significantly shorten time for falling asleep, simultaneously can reduce night and awaken number of times, increases total sleep time, improves sleep quality, does not have obvious aftereffect inferior morning.Few " sleeping in the place " phenomenon that produces does not influence the ergasia in time morning and the dexterity of action yet.The no addiction of clothes seldom produces the knock-on aypnia after the drug withdrawal for a long time, and repeated application is seldom gathered, and uses safer.Therefore extensively admitted after the listing, become the standard drug of Cure for insomnia disease, the trend that progressively replaces benzodiazepine is arranged.
The kind of drugs approved by FDA listing has tablet (specification 5mg and 10mg), oral sustained release sheet (specification 6.25mg and 12.5mg) and oral cavity disintegration tablet (specification 5mg and 10mg).In the document relevant for the report of Sublingual tablet, oral spray and slow release microgranule.The kind of domestic listing has tablet (specification 5mg and 10mg) and dispersible tablet (specification 10mg); Declare clinical kind capsule, granule, slow releasing tablet, oral cavity disintegration tablet and mouthful molten etc. are arranged; In addition relevant for the patent of zolpidem nasal-cavity administration and controlled release form.
The zolpidem liver metabolism is mainly drained in urine (about 60%) and feces (about 40%), and its Excreta is nonactive metabolite.For the insomniac, sleeping immediately after total hope is taken medicine; And it is reported that the first pass effect of Zolpidem Tartrate agent liver is 35%, this has influenced the performance of Zolpidemtar Trate drug effect to a certain extent, thus be badly in need of a kind of quick acting, avoid first pass effect, preparation that bioavailability is high.
Summary of the invention
The object of the present invention is to provide a kind of Zolpidem tartrate film, to overcome the above-mentioned defective that prior art exists.
Zolpidem tartrate film of the present invention comprises following components in weight percentage:
Macromolecule filming material 40～98%
Described macromolecule filming material comprises more than one in hydroxypropyl emthylcellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), sodium alginate, polyoxyethylene (PEO), Pseudobulbus Bletillae (Rhizoma Bletillae) glue, corn starch or the carrageenan;
Described plasticizer comprises more than one in PEG, glycerol or the Tween 80;
Described correctives comprises more than one in sweeting agent, acidic flavoring agent, aromatic, gummy macromolecular material, lecithin, cephalin or the phosphatidic acid;
Described sweeting agent such as sucrose, xylitol, leaf dulcin, Radix Glycyrrhizae ester glycosides, stevioside, saccharin sodium, aspartame, acesulfame potassium or cyclamate etc.;
Described acidic flavoring agent such as citric acid, citric acid, tartaric acid, malic acid, ascorbic acid or glycine etc.;
Described aromatic such as Eucalyptus oil, oleum Citri sinensis, Oleum menthae, Oleum menthae, L-menthol or vanillin etc.;
Described gummy macromolecular material such as xanthan gum, guar gum, tragakanta, cover in its glue, locust bean gum or the Radix Acaciae senegalis etc. more than one;
Preferably, described Zolpidem tartrate film also comprises other adjuvant, and described other adjuvant comprises more than one in pigment, antioxidant or the antiseptic etc.;
Preferably, Zolpidem tartrate film comprises following components in weight percentage:
Macromolecule filming material 40～98%
Preferably, described Zolpidem tartrate film comprises following components in weight percentage:
Macromolecule filming material 56～89%
Correctives 6～20%
Preferably, described Zolpidem tartrate film comprises following components in weight percentage:
Zolpidemtar Trate 10～20%
Macromolecule filming material 46～56%
Plasticizer 12～15%
Correctives 18～20%.
Preferably, described membrane surface has decorative pattern.
The preparation method of Zolpidem tartrate film of the present invention comprises the steps:
(1) with Zolpidemtar Trate hydrochloric acid solution or pulverous Zolpidemtar Trate and plasticizer, add weight content and be the aqueous solution of 10～35% macromolecule filming material, disperse;
The concentration of hydrochloric acid is 0.1～0.5mol/L
The content of Zolpidemtar Trate in described hydrochloric acid solution is 0.02～0.1g/mL;
(2) add titanium dioxide and correctives then, disperse,, then place the vacuum defoamation of spending the night if produce bubble in the solution;
(3) then with above-mentioned solution extension on stainless steel band, glass plate or plastic sheeting, drying, the knurling rolls embossing, cut into certain size again after, peel off from stainless steel band, glass plate or plastic sheeting, pack promptly.
Preferably, in step (1), also can add other adjuvant; If water soluble components in distress in the prescription is dissolvable in water hydrophilic solvents such as ethanol, be added into again in the macromolecule filming material aqueous solution.
Described process for dispersing is conventional, installs high-speed stirred dispersion etc. as dispersed with stirring, employing emulsification pretreatment blender etc., for those skilled in the art, is to select easily.
Test method
(1) dissolving the time limit gets 6 of membrane, each clip becomes the thin film of 1cm * 1cm size, the stainless steel silk that is 2.0mm with two-layer sieve aperture internal diameter presss from both sides respectively, check according to the method (two appendix XA of Chinese Pharmacopoeia version in 2005) under the disintegration inspection technique tablet item, observe and record membrane off-bottom and the time by screen cloth.
(2) dissolution test
Get 6 of membrane, clamp with paperclip respectively, adopt dissolution method (two appendix XC of Chinese Pharmacopoeia version in 2005 three therapeutic methods of traditional Chinese medicine) device, 0.1mol/L hydrochloric acid with 100ml is dissolution medium, rotating speed is that per minute 150 changes, from test sample contact dissolution medium, timing immediately, respectively in the time of 10 seconds, 20 seconds, 30 seconds, 1 minute, 2 minutes, 3 minutes, 5 minutes, get solution 5ml, filter, get subsequent filtrate and measure trap and calculate every stripping quantity according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2005 A).
Zolpidem tartrate film of the present invention can be used for Cure for insomnia disease, and can stick in the oral cavity, and the method that the through port transmucosal absorbs applies and the patient who needs treatment, and using method is as follows: unpack, take out membrane, put into mouth and get final product.Dosage is generally 5mg～10mg/ time, the usefulness that is taken at bed time, and maximum dose level must not surpass 10mg on 1st, and generally be no more than 7-10 days the course of treatment.Specifically can determine by the doctor according to state of an illness of patient etc.
The present invention is by the investigation to the performance of the excipient substance of various different sizes, comform multiple medicines with grope in the adjuvant to have selected filming performance good, can dissolve, be difficult for the moisture absorption and the stable adjuvant of chemical property rapidly.The smooth membrane that the present invention will make is suppressed decorative pattern with knurling rolls, increases the surface area of membrane, accelerates the dissolution rate of medicine, further reaches the purpose of rapid release.And can design the knurling rolls of different pattern as required, and suppress various decorative patterns, improve the aesthetic feeling of product, or strengthen false proof, protection trade mark.
The present invention is film like, adopts unit dose package, and good looking appearance is easy to carry; Take simply, need not drink water and to take, be applicable to the old man and the child of dysphagia; And infiltration rate is fast, bioavailability height, good effect; Production technology is simple, and production cost is low, the added value of product height.
Zolpidem tartrate film stripping of the present invention is rapid, good stability, and pelliculae pro cavo oris is thin and soft, medicine can be directly released into mucomembranous surface, fast Absorption; The oral cavity rapid release membrane is easy to use, and is rapid-action, can avoid the first pass effect of liver, has good biological effectiveness; Compliance is good, welcome by the patient; Formability is good, can directly attach to medicine-feeding part after the administration, can not disperse, and the lasting release that can maintain the original state, thereby dosage is accurate; Several in process of production no dust from flying may solve labor protection and problem of environmental pollution.
Description of drawings
Fig. 1 is the dissolution curve.
Fig. 2 is external pig oral mucosa test.
The specific embodiment
Recipe quantity is 2000 (specification 5mg) or 1000 (specification 10mg)
Zolpidemtar Trate 10g
HPMC 56g
Glycerol 10g
Titanium dioxide 2g
Aspartame 15g
Glycine 5g
Get HPMC adding distil water 300g dissolving, cross 80 mesh sieves, remove insoluble matter, add glycerol, tween 80 and glycine subsequently, stir and make dissolving;
Zolpidemtar Trate is added in the film forming serosity with the 0.1mol/L dissolve with hydrochloric acid solution of 100mL.Get levigated titanium dioxide and aspartame again and add in the slurry, stir, place the vacuum defoamation of spending the night.
Again with the extension of film liquid on stainless steel band, 80 ℃ of dryings, embossing is cut into certain size, peels off from stainless steel band, packs promptly.
The recipe quantity of embodiment 2 is 6000 (specification 5mg) or 3000 (specification 10mg)
Zolpidemtar Trate 30g
HPMC 51.9g
PEG400 5g
Titanium dioxide 3g
Acesulfame potassium 5g
Aspartame 5g
Sunset yellow 60 0.1g
Get HPMC adding distil water 300g dissolving, cross 80 mesh sieves, remove insoluble matter, add PEG400, acesulfame potassium, aspartame and sunset yellow 60 subsequently, stir and make dissolving.
Get levigated titanium dioxide and Zolpidemtar Trate again and add in the slurry, stir, place the vacuum defoamation of spending the night.
Again with the extension of film liquid on glass plate, 80 ℃ of dryings, embossing is cut into certain size, peels off from glass plate, packs promptly.
Embodiment 3
The recipe quantity of embodiment 3 is 4000 (specification 5mg) or 2000 (specification 10mg)
Zolpidemtar Trate 20g
PVA 46g
Glycerol 15g
Titanium dioxide 1g
Saccharin sodium 15g
Citric acid 2g
Oleum Citri sinensis 1g
Get PVA adding distil water 100g dissolving, cross 80 mesh sieves, remove insoluble matter, add glycerol, saccharin sodium and citric acid subsequently, stir and make dissolving.
Zolpidemtar Trate is crossed 200 mesh sieves, carries out adding in the serosity behind the comminution by gas stream with fluid energy mill.Oleum Citri sinensis is dissolved in the ethanol, is added into film forming with in the serosity.Get levigated titanium dioxide again and add in the slurry, stir, place the vacuum defoamation of spending the night.
Again with the extension of film liquid on plastic sheeting, 80 ℃ of dryings, embossing is cut into certain size, peels off from plastic sheeting, packs promptly.
Embodiment 4
The recipe quantity of embodiment 4 is 1000 (specification 5mg) or 500 (specification 10mg).
Zolpidemtar Trate 5g
PEO 89g
Cyclamate 5g
L-menthol 1g
Get PEO adding distil water 500g dissolving, cross 80 mesh sieves, remove insoluble matter, add cyclamate subsequently, fully stir and make dissolving.Zolpidemtar Trate is the dissolve with hydrochloric acid solution of 0.1mol/L with 250mL concentration, is added in the serosity.The L-menthol is dissolved in the ethanol, is added into film forming with in the serosity, stirs, and places the vacuum defoamation of spending the night.Again with the extension of film liquid on stainless steel band, 80 ℃ of dryings, embossing is cut into certain size, packs promptly.
The time limit of dissolving of embodiment 1～4 is respectively 60 ± 10s, 50 ± 10s, 30 ± 5s, 45 ± 5s.
The dissolution curve as shown in Figure 1, four prescriptions are in 1 minute all more than the stripping about 90% or 90%.
Embodiment 6
Tensile property test (adopting the membrane of embodiment 1)
Get without the Zolpidem tartrate film of cutting in right amount, cut 5 on the sample of 150mm * 15mm size, the sample edge must be level and smooth, non-notch and damage.Sample is placed more than 4 hours in (23 ± 2) ℃, (50 ± 5) % relative humidity environment, and carried out the tensile property test with this understanding.
With upper and lower two sides is that planar precision is the gage measuring sample thickness of 0.001mm, and the thickness of each sample should be measured 3 points, gets arithmetic mean of instantaneous value.Sample is placed two anchor clamps of universal testing machine, the sample longitudinal axis and the upper and lower anchor clamps line of centres are coincided, the anchor clamps degree of tightness is suitable, to prevent the sample slippage or to rupture that the spacing of two anchor clamps is 60mm in anchor clamps.Speed with 100 ± 10mm/min is started testing machine, after the sample fracture, reads hot strength and elongation at break.
Test result sees Table 1.
Embodiment 7
External pig oral mucosa test (adopting the membrane of embodiment 1 and embodiment 3)
Take off position, cheek chamber immediately from the pig's head of just having slaughtered, carefully strip oral mucosa, with normal saline flushing 1～2 time, constant temperature (37 ± 1) is ℃ standby.
Adopt the vertical diffusion cell of Franz to carry out external oral mucosa and see through test.With diffusion cell the pig oral mucosa is fixedly clamped, slick mucosa skin is towards supply pool, and the mucosa internal layer that fold is arranged is towards reception tank.Bath temperature (37 ± 1) ℃, mixing speed 500rpm, saturating mucosa area 0.785cm
2, reception tank volume 1.5ml, receiving liquid is the normal saline solution of 0.1mol/L hydrochloric acid.
Zolpidem tartrate film is placed on the pig oral mucosa, timing sampling 1ml, and replenish 37 ℃ of homothermic blank liquid that receive.Sample adopts high performance liquid chromatography to analyze.The results are shown in Figure 2.
Claims (9)
1. Zolpidem tartrate film is characterized in that, comprises following components in weight percentage:
Zolpidemtar Trate 1～40%
Macromolecule filming material 40～98%
Plasticizer 0～20%
Titanium dioxide 0～3%
Correctives 1～30%
Described macromolecule filming material comprises more than one in hydroxypropyl emthylcellulose (HPMC), hydroxypropyl cellulose (HPC), polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP), sodium alginate, polyoxyethylene (PEO), Pseudobulbus Bletillae (Rhizoma Bletillae) glue, corn starch or the carrageenan.
2. Zolpidem tartrate film according to claim 1 is characterized in that described plasticizer comprises more than one in PEG, glycerol or the Tween 80;
Described correctives comprises more than one in sweeting agent, acidic flavoring agent, aromatic, gummy macromolecular material, lecithin, cephalin or the phosphatidic acid;
Described sweeting agent is selected from sucrose, xylitol, leaf dulcin, Radix Glycyrrhizae ester glycosides, stevioside, saccharin sodium, aspartame, acesulfame potassium or cyclamate;
Described acidic flavoring agent is selected from citric acid, citric acid, tartaric acid, malic acid, ascorbic acid or glycine;
Described aromatic is selected from Eucalyptus oil, oleum Citri sinensis, Oleum menthae, Oleum menthae, L-menthol or vanillin;
Described gummy macromolecular material such as xanthan gum, guar gum, tragakanta, cover in its glue, locust bean gum or the Radix Acaciae senegalis more than one.
3. Zolpidem tartrate film according to claim 1 is characterized in that, described Zolpidem tartrate film also comprises other adjuvant, and described other adjuvant comprises more than one in pigment, antioxidant or the antiseptic.
4. Zolpidem tartrate film according to claim 3 is characterized in that, comprises following components in weight percentage:
Zolpidemtar Trate 1～40%
Macromolecule filming material 40～98%
Plasticizer 0～20%
Titanium dioxide 0～3%
Correctives 1～30%
Other adjuvant 0～1%.
5. Zolpidem tartrate film according to claim 3 is characterized in that, comprises following components in weight percentage:
Zolpidemtar Trate 5～30%
Macromolecule filming material 56～89%
Plasticizer 0～12%
Titanium dioxide 0～3%
Correctives 6～20%
Other adjuvant 0～0.1%.
6. Zolpidem tartrate film according to claim 3 is characterized in that, comprises following components in weight percentage:
Zolpidemtar Trate 10～20%
Macromolecule filming material 46～56%
Plasticizer 12～15%
Titanium dioxide 1～2%
Correctives 18～20%.
7. according to each described Zolpidem tartrate film of claim 1～6, it is characterized in that described membrane surface has decorative pattern.
8. according to the preparation method of each described Zolpidem tartrate film of claim 1～7, comprise the steps:
(1) with Zolpidemtar Trate hydrochloric acid solution or pulverous Zolpidemtar Trate and plasticizer, add weight content and be the aqueous solution of 10～35% macromolecule filming material, disperse;
(2) add titanium dioxide and correctives then, disperse,, then place the vacuum defoamation of spending the night if produce bubble in the solution;
(3) then with above-mentioned solution extension on stainless steel band, glass plate or plastic sheeting, drying, the knurling rolls embossing, cut into certain size again after, peel off from stainless steel band, glass plate or plastic sheeting, pack promptly.
9. method according to claim 8 is characterized in that, in step (1), adds other adjuvant; If water soluble components in distress in the prescription is dissolvable in water hydrophilic solvents such as ethanol, be added into again in the macromolecule filming material aqueous solution.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100530079A CN101574329A (en) | 2009-06-12 | 2009-06-12 | Zolpidem tartrate film agent |
| CN2010101898146A CN101849926B (en) | 2009-06-12 | 2010-05-19 | Zolpidem tartrate film |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100530079A CN101574329A (en) | 2009-06-12 | 2009-06-12 | Zolpidem tartrate film agent |
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| CN101574329A true CN101574329A (en) | 2009-11-11 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNA2009100530079A Pending CN101574329A (en) | 2009-06-12 | 2009-06-12 | Zolpidem tartrate film agent |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102028672A (en) * | 2010-09-29 | 2011-04-27 | 上海现代药物制剂工程研究中心有限公司 | Microporous spongy film preparation and preparation method thereof |
| CN102641258A (en) * | 2012-04-24 | 2012-08-22 | 上海现代药物制剂工程研究中心有限公司 | Spongy dextromethorphan hydrobromide film agent with micro-pore and preparation method thereof |
| CN102670570A (en) * | 2012-05-04 | 2012-09-19 | 上海现代药物制剂工程研究中心有限公司 | Microporous spongy ondansetron hydrochloride film agent and preparation method thereof |
| CN104523689A (en) * | 2014-11-19 | 2015-04-22 | 山东大学 | Oral cavity gel and preparation method thereof |
-
2009
- 2009-06-12 CN CNA2009100530079A patent/CN101574329A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102028672A (en) * | 2010-09-29 | 2011-04-27 | 上海现代药物制剂工程研究中心有限公司 | Microporous spongy film preparation and preparation method thereof |
| CN102028672B (en) * | 2010-09-29 | 2012-08-29 | 上海现代药物制剂工程研究中心有限公司 | Microporous spongy film preparation and preparation method thereof |
| CN102641258A (en) * | 2012-04-24 | 2012-08-22 | 上海现代药物制剂工程研究中心有限公司 | Spongy dextromethorphan hydrobromide film agent with micro-pore and preparation method thereof |
| CN102641258B (en) * | 2012-04-24 | 2013-04-24 | 上海现代药物制剂工程研究中心有限公司 | Spongy dextromethorphan hydrobromide film agent with micro-pore and preparation method thereof |
| CN102670570A (en) * | 2012-05-04 | 2012-09-19 | 上海现代药物制剂工程研究中心有限公司 | Microporous spongy ondansetron hydrochloride film agent and preparation method thereof |
| CN102670570B (en) * | 2012-05-04 | 2013-06-05 | 上海现代药物制剂工程研究中心有限公司 | Microporous spongy ondansetron hydrochloride film agent and preparation method thereof |
| CN104523689A (en) * | 2014-11-19 | 2015-04-22 | 山东大学 | Oral cavity gel and preparation method thereof |
| CN104523689B (en) * | 2014-11-19 | 2016-09-14 | 山东大学 | A kind of mouth gels and preparation method thereof |
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Open date: 20091111 |