CN103285473A - Oxytocin nasal spray - Google Patents

Oxytocin nasal spray Download PDF

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Publication number
CN103285473A
CN103285473A CN2012100399972A CN201210039997A CN103285473A CN 103285473 A CN103285473 A CN 103285473A CN 2012100399972 A CN2012100399972 A CN 2012100399972A CN 201210039997 A CN201210039997 A CN 201210039997A CN 103285473 A CN103285473 A CN 103285473A
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China
Prior art keywords
spray
cylinder
bottle
inner bag
oxytocin
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CN2012100399972A
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Chinese (zh)
Inventor
姜庆伟
衣伟锋
吕玉珠
唐亚坤
刘俊轶
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Beijing Tianheng Pharmaceutical Research Institute Co. Ltd.
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BEIJING TIANHENG MEDICINE INST
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Abstract

The invention provides an oxytocin nasal spray. A spraying device comprises a spraying bottle and a spraying head, and is characterized in that the spraying bottle comprises a casing (1) and a liner (2) with the volume of 6.0 ml; the liner of the spraying bottle is in a shape of a cylinder, the combination of a cylinder and an eggplant shape, or the combination of a cylinder, a sphere and a cylinder with a smaller diameter; the casing of the spraying bottle has the same appearance, size and connector part as those of a conventional 10 ml spray sold in the market; and the spraying head adopts a praying head of the conventional 10 ml spray sold in the market. The oxytocin nasal spray has the advantages of few residues, high safety and multiple effective spraying times, the production cost can be reduced, and the medicine waste is prevented.

Description

The oxytocin nasal spray
Technical field:
The present invention relates to a kind of oxytocin nasal spray, specifically relate to the oxytocin nasal spray that a kind of employing has the spray bottle of volume 6.0ml inner bag.
Background technology:
Oxytocin is to contain the peptide chain that 9 aminoacid of disulfide bond are formed, be the peptide hormone uterotonic, the main mechanism of action is to promote uterine smooth muscle to shrink, be hasten parturition clinically at present, the choice drug of induced labor, also be used in addition: 1, lactogenic, promote that puerperal, milk was discharged, improve breastfeeding rate, improve the milk output; 2, promote that puerperal, body recovered and the minimizing human milk silt, prevention mastitis and enclosed mass take place.
Oxytocin (1980) dosage form of going on the market abroad the earliest is injection, and the former producer of grinding is Novartis, trade name: Syntocinon, specification: 10 units/ml.The advantage of this injection: rapid-action (3.5 minutes) have the effect of significant contracting palace.Shortcoming: the pain of injection site makes many patients be difficult to accept after the administration.Because untoward reaction such as the feeling sick of pain stimulation, vomiting increase, patient's compliance is poor.
For overcoming the above-mentioned shortcoming of oxytocin inj, Novartis in 1980 is in U.S.'s oxytocin nasal spray that gone on the market, trade name: Syntocinon, specification: 40 units/ml.The Nasal Mucosa Absorption area is big, blood flow abundant, nasal spray passes through nasal mucosa medicine administration, has following advantage: can absorb blood and cerebrospinal fluid rapidly, medication is convenient, absorb fully, quantitatively accurately, absorb fast, damage is little, untoward reaction is little, safe ready, be easy to be accepted by the patient, thereby can be bigger the compliance of raising patient medication, so the oxytocin nasal spray is the dosage form of suitable clinical use.The mucosa delivery approach of peptide medicament comes into one's own just day by day at present.
The oxytocin nasal spray that Novartis produces, be with liquid medicine filling in common spray bottle, because the spray bottle volume is bigger, the medicinal liquid of smaller size smaller (5.0ml) is filled in the 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 oxytocin nasal spray, guarantee its safety and effectiveness simultaneously.Therefore, the invention provides the oxytocin nasal spray that a kind of employing has the spray bottle of volume 6.0ml inner bag.
For achieving the above object, basic design of the present invention be with the oxytocin 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 10ml, and preferred 6.0ml is used for splendid attire 5.0ml oxytocin medicinal liquid, 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 oxytocin 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, in the accompanying drawing 1 inner bag be shaped as cylinder, 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; The structure of inner bag is cylinder+eggplant shape inner bag in the accompanying drawing 2, with accompanying drawing about in the of 1 the consistent cylinder of diameter compare, termination one eggplant shape part under accompanying drawing 2 cylinders, fill need not accurate location except can be guaranteed the time, beyond the same easy operation with the common spray bottle of fill, be the oxytocin medicinal liquid of 5.0ml for fill volume, the top of the eggplant shape of accompanying drawing 2 bottleneck cylinder lower ends is the bigger hemisphere of diameter, the liquid level that can guarantee to load behind the medicinal liquid is unlikely to too near bottleneck, in order to avoid in the pouring process because the vibration of filling apparatus, cause medicinal liquid to spill, guarantee that fill dosage is accurate; Simultaneously tighten up eggplant shape inner bag lower end, even can guarantee spray through 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+spheroid+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, except the advantage with accompanying drawing 2 inner bags, the cylinder that its underpart diameter is littler 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 oxytocin 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 oxytocin 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 oxytocin nasal spray of the present invention.Oxytocin pine 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+eggplant shape from top to bottom, the inner bag shape of accompanying drawing 5 spray bottles is followed successively by cylinder+sphere+cylinder from top to bottom, wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
Oxytocin nasal spray of the present invention, described sprayer unit is compared with the common spray device of existing commercially available 10ml, only be to have 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 oxytocin 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+eggplant shape.
Fig. 3 is shaped as the littler cylindrical inner bag of cylinder+spheroid+diameter.
Fig. 4 adopts the oxytocin nasal spray of the inner bag that is shaped as cylinder+eggplant shape.
Fig. 5 adopts the oxytocin nasal spray that is shaped as the littler cylindrical inner bag of cylinder+spheroid+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 (0.1ml/ spray) of the common spray device of domestic commercially available 10ml, and the inner bag volume is 6.0ml.
The comparative example:
(trade name: Syntocinon, manufacturer: Novartis), specification is 40 units/ml to oxytocin nasal spray commercially available product, 0.1ml/ spray, 5ml/ bottle.
Effectively hydrojet number of times and hydrojet residual rate test
Test method: get one of oxytocin nasal spray commercially available product, straight perpendicular holding, press shower nozzle examination spray and make its activation 4 times, clean nozzle, the accurate title, decide, continuous injection for several times (each injection interval 5 seconds) again, stop after the obvious minimizing of discharge rate, all clean nozzle and accurate the title after every spray once and decide installation weight, it is poor to calculate every spray front and back installation weight, be every spray discharge rate (mg), the hydrojet number of times before discharge rate obviously reduces is effective hydrojet number of times; Residue medicinal liquid in the spray bottle is taken out, and accurate the title, decide, and is the hydrojet residual quantity.
Computing formula:
Spray bottle herb liquid total amount=hydrojet residual quantity+each time discharge rate
Hydrojet residual rate=(hydrojet residual quantity/spray bottle herb liquid total amount) * 100%
Result of the test such as following table:
Table 1 comparative example hydrojet experimental result table
Figure BSA00000673109500041
As follows according to above-mentioned formula result calculated:
Spray bottle herb liquid total amount=5362.6mg
Hydrojet residual rate=26.5%
Result of the test shows that 1~36 hydrojet weight of oxytocin nasal spray commercially available product is about 110mg, and the 37th time hydrojet weight obviously reduces, and is 72.4mg, thus its effectively spray time be 36 times, but the hydrojet residual rate is bigger, wastes more serious.
Embodiments of the invention
Embodiment 1
One, prescription (in 1000 bottles, the 0.1ml/ spray)
Figure BSA00000673109500042
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, namely.
2. fill: to the spray bottle shown in the accompanying drawing 2, every bottle of fill 5.0ml screws fog-spray nozzle (0.1ml/ spray) with the oxytocin aqueous solution fill of above-mentioned preparation, that is, final finished is seen accompanying drawing 4.
Three, effectively hydrojet number of times and hydrojet residual rate test
Test method: same comparative example
Computing formula: same comparative example
Result of the test such as following table:
Table 2 embodiment 1 hydrojet experimental result table
Figure BSA00000673109500051
As follows according to above-mentioned formula result calculated:
Spray bottle herb liquid total amount=5380.8mg
Hydrojet residual rate=6.3%
Result of the test shows, 1~46 hydrojet weight of oxytocin nasal spray of embodiment 1 preparation is about 110mg, the 47th time hydrojet weight obviously reduces, be 68.6mg, therefore its effectively spray time be 46 times, under the situation of the medicinal liquid of comparative example's commercially available product fill equal volume, be higher than 36 times of commercially available product, the hydrojet residual rate is more much lower than commercially available product simultaneously, therefore greatly reduces patient's financial burden.
Embodiment 2
One, prescription (in 1000 bottles, the 0.1ml/ spray)
Figure BSA00000673109500061
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, namely.
2. fill: to the spray bottle shown in the accompanying drawing 3, every bottle of fill 5.0ml screws fog-spray nozzle (0.1ml/ spray) with the oxytocin aqueous solution fill of above-mentioned preparation, that is, final finished is seen accompanying drawing 5.
Three, effectively hydrojet number of times and hydrojet residual rate test
Test method: same comparative example
Computing formula: same comparative example
Result of the test such as following table:
Table 3 embodiment 2 hydrojet experimental result tables
Figure BSA00000673109500062
As follows according to above-mentioned formula result calculated:
Spray bottle herb liquid total amount=5391.9mg
Hydrojet residual rate=2.4%
Result of the test shows, 1~48 hydrojet weight of oxytocin nasal spray of embodiment 1 preparation is about 110mg, the 49th time hydrojet weight obviously reduces, be 64.3mg, therefore its effectively spray time be 48 times, under the situation of the medicinal liquid of comparative example's commercially available product fill equal volume, be higher than 36 times of commercially available product, the hydrojet residual rate is more much lower than commercially available product simultaneously, has reduced patient's financial burden.

Claims (10)

1. an oxytocin 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 6.0ml.
2. oxytocin 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+eggplant shape from top to bottom.
3. oxytocin 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+sphere+cylinder from top to bottom, and wherein the cylinder of hypomere is littler than epimere body diameter.
4. oxytocin nasal spray as claimed in claim 1, the inner bag that it is characterized in that described spray bottle is shaped as cylinder+eggplant shape as shown in Figure 2.
5. oxytocin nasal spray as claimed in claim 1, the inner bag that it is characterized in that described spray bottle is shaped as cylinder+sphere+cylinder as shown in Figure 3, and wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
6. oxytocin 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. oxytocin nasal spray as claimed in claim 6, the inner bag shape of described spray bottle is followed successively by cylinder+eggplant shape from top to bottom.
8. oxytocin nasal spray as claimed in claim 6, the inner bag shape of described spray bottle is followed successively by cylinder+sphere+cylinder from top to bottom, and wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
9. oxytocin 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+eggplant shape from top to bottom.
10. oxytocin 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+sphere+cylinder from top to bottom, and wherein the cylinder of hypomere is littler than epimere body diameter, and end portion is hemisphere.
CN2012100399972A 2012-02-22 2012-02-22 Oxytocin nasal spray Pending CN103285473A (en)

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Citations (7)

* Cited by examiner, † Cited by third party
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
WO2009115200A1 (en) * 2008-03-17 2009-09-24 Boehringer Ingelheim International Gmbh Reservoir and nebulizer
WO2010040979A1 (en) * 2008-10-08 2010-04-15 Archimedes Development Ltd. A device for administering liquid analgesics

Patent Citations (7)

* Cited by examiner, † Cited by third party
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
WO2009115200A1 (en) * 2008-03-17 2009-09-24 Boehringer Ingelheim International Gmbh Reservoir and nebulizer
WO2010040979A1 (en) * 2008-10-08 2010-04-15 Archimedes Development Ltd. A device for administering liquid analgesics

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Application publication date: 20130911