CN103285470A - Metoclopramide nasal spray - Google Patents
Metoclopramide nasal spray Download PDFInfo
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- CN103285470A CN103285470A CN2012100399794A CN201210039979A CN103285470A CN 103285470 A CN103285470 A CN 103285470A CN 2012100399794 A CN2012100399794 A CN 2012100399794A CN 201210039979 A CN201210039979 A CN 201210039979A CN 103285470 A CN103285470 A CN 103285470A
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Abstract
The invention provides a metoclopramide nasal spray. A used spraying device comprises a spray bottle and a spray head, and is characterized in that the spray bottle comprises a casing (1) and a liner (2) with 3.0 ml volume; the liner of the spray bottle is in a shape of a cylinder, the combination of a cylinder and a conoidcone, or the combination of a cylinder, a conoidcone and a cylinder with a smaller diameter; the casing of the spray bottle is provided with the same shape, size and interface part with a spray bottle of a 10 ml spraying agent device sold in the market presently; and the spray head adopts a spray head of the 10 ml spraying agent device sold in the market presently. The metoclopramide nasal spray provided by the invention has the advantages of few residues, high safety and multiple times of effective spraying, the production cost can be reduced, and the medicine waste is prevented.
Description
Technical field:
The present invention relates to a kind of metoclopramide nasal spray, specifically relate to the metoclopramide nasal spray that a kind of employing has the spray bottle of volume 3.0ml inner bag.
Background technology:
Metoclopramide is dopamine D
2Receptor antagonist also has 5-HT simultaneously
4The receptor agonism effect is to 5-HT
3Receptor has slight inhibitory action.Can act on dopamine receptor in the oblongata chemoreceptor trigger zone (CTZ) and improve the threshold value of CTZ, have powerful central antiemetic effect.This medicine mainly acts on upper digestive tract, promotes the motion of stomach and top intestinal segment; Improve the sphincteral tension force of quiescent condition gastrointestinal tract, increase the tension force of lower esophageal sphincter and the amplitude of contraction, lower esophageal pressure is increased, retardance stomach-esophageal reflux, strengthen the harmonization of the stomach esophageal peristalsis, and strengthen the ability of cleaning up to esophageal contents, promote the emptying of stomach; Promote the lax of pylorus, duodenum and top jejunum, form the orthofunction between gastric antrum, body of stomach and top small intestinal.These effects also can strengthen the antiemetic effect of this medicine.
Go on the market abroad the earliest metoclopramide be injection by (1979), the former producer of grinding: BAXTER, specification; 5mg/ml (2,10,30ml), trade name: REGLAN.1980 by ANI PHARMS in U.S.'s tablet that gone on the market, specification: 5,10mg, trade name: REGLAN.Injection is mainly used in nausea and vomiting, the diabetic gastroparesis that postoperative and chemotherapy cause.Oral formulations is mainly used in treating diseases such as gastroesophageal reflux, diabetic gastroparesis.Metoclopramide injection and oral formulations have gone on the market for many years, and antiemetic effect has obtained affirming of multinomial clinical trial.Shortcoming: injection administration inconvenience, patient tolerability is poor.Tablet: onset is slow.Injection and tablet all may cause tardive dyskinesia (a kind of serious dyskinesia, irreversible usually), total the danger of generation increases with the course for the treatment of and cumulative dose, FDA has the warning that adds black surround on its description.Injection and tablet administration time all can not surpass for 12 weeks.
Crinos in 1999 is at Italy's metoclopramide nasal spray that gone on the market, specification: 10,20mg/ spray (2,4ml), trade name: Pramidin.The advantage of nasal spray: compare with injection: it is suitable to cause curative effect and the injection of telling the acute vomiting that chemotherapeutics causes in the control moderate, but nasal spray is non-invasive therapy, convenient drug administration.Compare with tablet: nasal spray is rapid-action, good patient compliance, toxic and side effects are little, is the dosage form of suitable clinical use.
Crinos is at the metoclopramide nasal spray of Italy's listing, be with liquid medicine filling in common spray bottle, because the spray bottle volume is bigger, the medicinal liquid of smaller size smaller (2.0ml) exists only in the bottom of spray bottle, liquid level is lower, the degree of depth deficiency of submergence pipette, cause medicinal liquid to draw not exclusively, cause effectively spray inferior less, residual many, waste is big, though can solve effective hydrojet number of times defect of insufficient by the fill amount that strengthens medicinal liquid, but further strengthened the waste of expensive medicinal liquid, caused drug price high, strengthened patient's financial burden.
Summary of the invention:
Purpose of the present invention: overcome the defective that prior art exists, reduced waste, reduced the cost of metoclopramide nasal spray, guarantee its safety and effectiveness simultaneously.Therefore, the invention provides the metoclopramide nasal spray that a kind of employing has the spray bottle of volume 3ml inner bag.
For achieving the above object, basic design of the present invention be with the metoclopramide liquid medicine filling in the spray bottle of an inner bag with less volume, described spray bottle comprises inside and outside two parts, and inner bag (2) is namely arranged in shell (1); Specifically see accompanying drawing 1,2,3.Shell (1) is all identical with profile, interface, the size of the spray bottle of prior art, thereby reaches the compatibility with existing fog-spray nozzle and filling production lines, need not to customize fog-spray nozzle and newly purchases production line, saves cost greatly; And inner bag (2) has smaller volume, is generally less than 5.0ml, and preferred 3.0ml for the metoclopramide medicinal liquid of splendid attire volume 2.5ml, guarantees that dosage is accurate, residual little, safe, stops drug waste.
As the technical scheme that realizes the present invention's design, wherein be used for the spray bottle of fill metoclopramide medicinal liquid, comprise shell and inner bag two parts, its structure is referring to accompanying drawing 1,2,3, preferably adopts accompanying drawing 2,3 inner bag shape, most preferably the inner bag shape of accompanying drawing 3.Wherein, inner bag is shaped as cylinder in the accompanying drawing 1, being shaped as under the cylinder of inner bag connects cone in the accompanying drawing 2, with in the accompanying drawing 1 up and down the consistent cylinder of diameter compare, have characteristics wide at the top and narrow at the bottom, the cylinder of bottle mouth position is wideer, need not accurate location in the time of can guaranteeing fill, the same easy operation with the common spray bottle of fill; Simultaneously, the cone hypomere that narrows down gradually can guarantee: even spray is through after using, the residue medicine liquid volume hour, it is enough dark that the height of medicinal liquid liquid level still can submergence suction pipe entrance, thus medicinal liquid can be fully used.The inner-tube structure of accompanying drawing 3 is cylinder+circular cone+cylinder, wherein the hypomere cylinder of inner bag is the cylinder littler than epimere body diameter, further the hypomere cylinder of preferred inner bag partly is hemisphere near the cylinder tip at the bottle end, compare with the inner bag of accompanying drawing 2, advantage is that the littler cylinder of lower diameter can further improve the height of hour medicinal liquid liquid level of residue medicine liquid volume, and reduce the dead volume under the suction pipe entrance, can further improve the utilization rate of medicinal liquid.
The employed spray bottle of metoclopramide nasal spray of the present invention, material can adopt general spray bottle commonly used medicinal plastics or glass, and processing mode both can inner bag and the shell one-shot forming of spray bottle, formation integral type spray bottle; Also can process inner bag separately, be shell with the common spray bottle of existing commercially available 10ml then, and the two is assembled into novel spray bottle of the present invention.A kind of processing mode in preferred back, reason be through industrially scalable repeatedly repeat research, we find preceding a kind of method (the shell one-shot forming that is inner bag and spray bottle is the integral type spray bottle) having relatively high expectations to mould, comparatively speaking, then there is not this problem in the processing inner bag separately, the inner bag mould structure is simple, required precision is identical with common medicine bottle, general conventional process operation can meet the demands, and can be as the common spray bottle of existing commercially available 10ml of shell, the producer of domestic capable production is numerous, in large supply, super quality and competitive price are lower on cost.
The employed spray bottle of metoclopramide nasal spray of the present invention, its shell preferably has identical profile and size with the spray bottle of the common spray device of domestic commercially available 10ml, especially the interface section that is connected with sprayer unit (being commonly called as fog-spray nozzle), identical with the spray bottle interface of the high common spray device of 10ml of domestic market occupation rate, can pass through screw thread, bayonet socket or roll connecting devices commonly used such as mouthful aluminum cover and be connected with the fog-spray nozzle of the common spray device of domestic existing commercially available 10ml, thereby guarantee that container is airtight, medicinal liquid can not evaporate or leak, thereby makes metoclopramide nasal spray of the present invention.Metoclopramide nasal spray of the present invention with above-mentioned feature, its concrete embodiment can be referring to accompanying drawing 4 and accompanying drawing 5, fog-spray nozzle and spray bottle adopt screw thread to spin, wherein the inner bag shape of accompanying drawing 4 spray bottles is followed successively by cylinder+circular cone from top to bottom, the inner bag shape of accompanying drawing 5 spray bottles is followed successively by cylinder+circular cone+cylinder from top to bottom, wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
Metoclopramide nasal spray of the present invention, described sprayer unit is compared with the common spray device of existing commercially available 10ml, only increased the inner bag part in common spray bottle inside, so when manufacturing except the mould part slight change, still can continue to use material and process equipment and the technology of original common spray device, need not special change.The fog-spray nozzle that this product adopts and the manufacturer of spray bottle is numerous, shipment amount is very big, thereby processing technique maturation, steady sources, low price, reliable in quality, pharmacy producer can obtain the cheap and good-quality source of goods; Simultaneously, the occupation rate of pharmacy producer is also quite high at home for the supporting common spray production line of 10ml with it, pharmacy producer can directly use the filling production lines of 10ml common aerosol to produce, need not to buy again new low capacity filling production lines, reduce the filling apparatus requirement of metoclopramide nasal spray, saved cost.
Description of drawings
Fig. 1 is shaped as the inner bag of cylinder.
Fig. 2 is shaped as the inner bag of cylinder+circular cone.
Fig. 3 is shaped as the littler cylindrical inner bag of cylinder+circular cone+diameter.
Fig. 4 adopts the metoclopramide nasal spray that is shaped as cylinder+circular cone inner bag.
Fig. 5 adopts the metoclopramide nasal spray of the inner bag that is shaped as the littler cylinder of cylinder+circular cone+diameter.
Wherein, Reference numeral is respectively: (1) shell, (2) inner bag
The specific embodiment
Following instantiation is illustrating of the specific embodiment of the invention, limits scope of the present invention but be not used in, and any embodiment that is equal to it is all within protection scope of the present invention.Wherein, except the comparative example, the spray bottle shell of embodiments of the invention all adopts with the spray bottle of the common spray device of domestic commercially available 10ml has identical profile and size and interface section, fog-spray nozzle all adopts the fog-spray nozzle (50 μ l/ spray) of the common spray device of domestic commercially available 10ml, and the inner bag volume is 3.0ml.
The comparative example:
Metoclopramide nasal spray commercially available product (trade name: Pramidin, Italian Crinos company produces), specification is the 2.0ml/ bottle, the 10mg/ spray.
Effectively hydrojet number of times, spraying uniformity and the test of hydrojet residual rate:
Every spray drug content:
Get one bottle of metoclopramide nasal spray commercially available product, straight perpendicular holding, press shower nozzle examination spray and make its activation 4 times, clean nozzle, continuous injection for several times again, after obviously reducing, discharge rate stops, before each the injection 200ml measuring bottle is inverted on the nozzle, collects every spraying liquid, should remove measuring bottle after the injection rapidly and it is directly placed vertically and put (avoiding damage), washing down nozzle with a spot of 0.1mol/L hydrochloric acid simultaneously incorporates in the measuring bottle, add mobile phase again and be diluted to scale, shake up, as need testing solution, measure according to method under the assay item, be every spray drug content.
The reference substance solution preparation:
Precision takes by weighing the about 20mg of metoclopramide reference substance, puts in the 50ml measuring bottle, adds 0.1mol/L hydrochloric acid solution 5ml, and jolting makes dissolving, is diluted to scale with mobile phase, shakes up, and precision is measured 3ml, puts in the 25ml measuring bottle, is diluted to scale with mobile phase, shakes up, namely.
Residual drug content in the bottle:
Debris in the spray bottle is all taken out, be diluted in the 200ml measuring bottle with mobile phase, shake up, precision is measured 1ml and is put in the 10ml measuring bottle again, is diluted to scale with mobile phase, shakes up, and measures according to method under the assay item, is a bottle interior residual drug content.
Assay: with reference to high performance liquid chromatography (2010 editions two appendix V D of Chinese Pharmacopoeia).
Chromatographic condition and system suitability test are filler with octadecylsilane chemically bonded silica; (regulating pH value to 4.0 with triethylamine)-acetonitrile (81: 19) is mobile phase with the 0.02mol/L phosphoric acid solution; The detection wavelength is 275nm.Number of theoretical plate calculates by the metoclopramide peak and is not less than 4000.
Precision is measured need testing solution and each 20 μ l of reference substance solution, annotates people's chromatograph of liquid, and the record chromatogram is pressed external standard method with calculated by peak area, namely.
Computing formula:
The effective hydrojet number of times=hydrojet number of times of every spray drug content in the 80%-120% of labelled amount scope
The relative standard deviation (RSD) * 100% of the drug content of hydrojet uniformity=each time hydrojet of every spray drug content in the 80%-120% of labelled amount scope
Hydrojet residual rate=(principal agent total amount in the interior residual drug content/spray bottle of bottle) * 100%
Wherein, residual drug content+each sprays time drug content in principal agent total amount=bottle in the spray bottle
Result of the test such as following table:
Table 1 comparative example hydrojet experimental result table
As follows according to above-mentioned formula result of calculation:
Effective hydrojet number of times=40 times
Hydrojet uniformity: RSD=2.1%
Metoclopramide total amount=502.9mg in the spray bottle
Hydrojet residual rate=19.9%
Result of the test shows that this nasal spray can carry out 40 effectively sprayings, and its uniformity is better, but the hydrojet residual rate is bigger, wastes more serious.According to the macroanalysis of metoclopramide in the spray bottle, its actual fill volume is about 2.5ml simultaneously.That is to say it is to reach 40 effectively sprayings by many liquid drug, increased patient's financial burden.
Embodiments of the invention
One, prescription (in 1000 bottles, 50 μ l/ spray, 10mg/ spray)
Two, preparation technology:
1. dosing: take by weighing in the water of supplementary material to 95% recipe quantity of recipe quantity, stir, make its dissolving, add the water standardize solution again, namely.
2. fill: to the spray bottle shown in the accompanying drawing 2, every bottle of fill 2.5ml screws fog-spray nozzle (50 μ l/ spray, 10mg/ spray) with the metoclopramide aqueous solution fill of above-mentioned preparation, that is, final finished is seen accompanying drawing 4.
Three, effectively hydrojet number of times, spraying uniformity and the test of hydrojet residual rate
Every spray drug content: same comparative example
Reference substance solution preparation: same comparative example
Residual drug content in the bottle:
Debris in the spray bottle is all taken out, be diluted in the 50ml measuring bottle with mobile phase, shake up, precision is measured 1ml and is put in the 10ml measuring bottle again, is diluted to scale with mobile phase, shakes up, and measures according to method under the assay item.
Assay: same comparative example
Computing formula: same comparative example
Result of the test such as following table:
Table 2 embodiment 1 hydrojet experimental result table
As follows according to above-mentioned formula result of calculation:
Effective hydrojet number of times=46 times
Hydrojet uniformity: RSD=1.4%
Metoclopramide total amount=498.4mg in the spray bottle
Hydrojet residual rate=6.4%
Result of the test shows, the metoclopramide nasal spray of embodiment 1 preparation is all under the situation of 2.5ml in the commercially available product fill amount with the comparative example, can carry out 46 effectively sprayings, be higher than 40 times of commercially available product, its hydrojet uniformity of while and commercially available product indifference, but the hydrojet residual rate is more much lower than commercially available product.
One, prescription (in 1000 bottles, the 10mg/ spray)
Two, preparation technology:
1. dosing: take by weighing in the water of supplementary material to 95% recipe quantity of recipe quantity, stir, make its dissolving, add the water standardize solution again, namely.
2. fill: to the spray bottle shown in the accompanying drawing 3, every bottle of fill 2.5ml screws fog-spray nozzle (50 μ l/ spray, 10mg/ spray) with the metoclopramide aqueous solution fill of above-mentioned preparation, that is, final finished is seen accompanying drawing 5.
Three, effectively hydrojet number of times, spraying uniformity and the test of hydrojet residual rate
Every spray drug content: same comparative example
Reference substance solution preparation: same comparative example
Residual drug content in the bottle:
Debris in the spray bottle is all taken out, be diluted in the 250ml measuring bottle with mobile phase, shake up, measure according to method under the assay item.
Assay: same comparative example
Computing formula: same comparative example
Result of the test such as following table:
Table 3 embodiment 2 hydrojet experimental result tables
As follows according to above-mentioned formula result of calculation:
Effective hydrojet number of times=48 times
Hydrojet uniformity: RSD=1.3%
Metoclopramide total amount=500.2mg in the spray bottle
Hydrojet residual rate=2.9%
Result of the test shows, the metoclopramide nasal spray of embodiment 2 is all under the situation of 2.5ml in the commercially available product fill amount with the comparative example, can carry out 48 effectively sprayings, is higher than 40 effectively sprayings of commercially available product, the residual rate of embodiment 2 is lower simultaneously, has reduced patient's financial burden; Compare with embodiment 1, both do not have significant difference.
Claims (10)
1. a metoclopramide nasal spray comprises medicinal liquid and sprayer unit, and used sprayer unit comprises spray bottle and fog-spray nozzle, it is characterized in that described spray bottle comprises the inner bag (2) of shell (1) and volume 3.0ml.
2. metoclopramide nasal spray as claimed in claim 1 is characterized in that the inner bag of described spray bottle is shaped as cylinder or is followed successively by cylinder+cone from top to bottom.
3. metoclopramide nasal spray as claimed in claim 1, the inner bag that it is characterized in that described spray bottle is shaped as and is followed successively by cylinder+cone+cylinder from top to bottom, and wherein the cylinder of hypomere is littler than epimere body diameter.
4. metoclopramide nasal spray as claimed in claim 1, the inner bag that it is characterized in that described spray bottle is shaped as cylinder+cone as shown in Figure 2.
5. metoclopramide nasal spray as claimed in claim 1, the inner bag that it is characterized in that described spray bottle is shaped as cylinder+cone+cylinder as shown in Figure 3, and wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
6. metoclopramide nasal spray as claimed in claim 1, described sprayer unit comprises spray bottle and fog-spray nozzle, the shell that it is characterized in that described spray bottle has profile, size and the interface section identical with the spray bottle of existing commercially available 10ml spray device, and fog-spray nozzle adopts the fog-spray nozzle of existing commercially available 10ml spray device.
7. metoclopramide nasal spray as claimed in claim 6, the inner bag shape of described spray bottle is followed successively by cylinder+cone from top to bottom.
8. metoclopramide nasal spray as claimed in claim 6, the inner bag shape of described spray bottle is followed successively by cylinder+cone+cylinder from top to bottom, and wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
9. metoclopramide nasal spray as claimed in claim 6 is characterized in that sprayer unit as shown in Figure 4, and the inner bag shape of spray bottle is followed successively by cylinder+cone from top to bottom.
10. metoclopramide nasal spray as claimed in claim 6, it is characterized in that described sprayer unit as shown in Figure 5, the inner bag shape of spray bottle is followed successively by cylinder+cone+cylinder from top to bottom, and wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100399794A CN103285470A (en) | 2012-02-22 | 2012-02-22 | Metoclopramide nasal spray |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100399794A CN103285470A (en) | 2012-02-22 | 2012-02-22 | Metoclopramide nasal spray |
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| CN103285470A true CN103285470A (en) | 2013-09-11 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2012100399794A Pending CN103285470A (en) | 2012-02-22 | 2012-02-22 | Metoclopramide nasal spray |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104606136A (en) * | 2015-01-06 | 2015-05-13 | 中国人民解放军军事医学科学院毒物药物研究所 | Metoclopramide nasal spray, as well as preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001089984A1 (en) * | 2000-05-23 | 2001-11-29 | Carter-Wallace, Inc. | Dispensing container |
| CN2495380Y (en) * | 2001-08-09 | 2002-06-19 | 田霞 | Sprayer |
| CN2687018Y (en) * | 2003-12-10 | 2005-03-23 | 袁航宇 | Bottle with bottle cap |
| CN2707631Y (en) * | 2004-05-24 | 2005-07-06 | 巢晓峰 | Internal bladder tube made glass bottle |
| CN2915696Y (en) * | 2005-12-15 | 2007-06-27 | 云南盘龙云海药业有限公司 | Packaging bottle |
| CN101977693A (en) * | 2008-03-17 | 2011-02-16 | 贝林格尔.英格海姆国际有限公司 | Reservoir and nebulizer |
| CN102176942A (en) * | 2008-10-08 | 2011-09-07 | 阿基米德开发有限公司 | A device for administering liquid analgesics |
-
2012
- 2012-02-22 CN CN2012100399794A patent/CN103285470A/en active Pending
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001089984A1 (en) * | 2000-05-23 | 2001-11-29 | Carter-Wallace, Inc. | Dispensing container |
| CN2495380Y (en) * | 2001-08-09 | 2002-06-19 | 田霞 | Sprayer |
| CN2687018Y (en) * | 2003-12-10 | 2005-03-23 | 袁航宇 | Bottle with bottle cap |
| CN2707631Y (en) * | 2004-05-24 | 2005-07-06 | 巢晓峰 | Internal bladder tube made glass bottle |
| CN2915696Y (en) * | 2005-12-15 | 2007-06-27 | 云南盘龙云海药业有限公司 | Packaging bottle |
| CN101977693A (en) * | 2008-03-17 | 2011-02-16 | 贝林格尔.英格海姆国际有限公司 | Reservoir and nebulizer |
| CN102176942A (en) * | 2008-10-08 | 2011-09-07 | 阿基米德开发有限公司 | A device for administering liquid analgesics |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104606136A (en) * | 2015-01-06 | 2015-05-13 | 中国人民解放军军事医学科学院毒物药物研究所 | Metoclopramide nasal spray, as well as preparation method and application thereof |
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