CN1883479A - A quantitative drop - Google Patents

A quantitative drop Download PDF

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Publication number
CN1883479A
CN1883479A CN 200510077339 CN200510077339A CN1883479A CN 1883479 A CN1883479 A CN 1883479A CN 200510077339 CN200510077339 CN 200510077339 CN 200510077339 A CN200510077339 A CN 200510077339A CN 1883479 A CN1883479 A CN 1883479A
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CN
China
Prior art keywords
quantitative drop
essence
loratadine
sodium
desloratadine
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN 200510077339
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Chinese (zh)
Inventor
俞正茂
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BEIJING D-VENTURE PHARM T CORP
Original Assignee
BEIJING D-VENTURE PHARM T CORP
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by BEIJING D-VENTURE PHARM T CORP filed Critical BEIJING D-VENTURE PHARM T CORP
Priority to CN 200510077339 priority Critical patent/CN1883479A/en
Publication of CN1883479A publication Critical patent/CN1883479A/en
Pending legal-status Critical Current

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Abstract

The invention relates to a quantitative dripping agent comprising loratadine of pharmaceutical raw material of loratadine, solvent, flavoring agent, preservative agent, stabilizer and coloring agent. The dripping agent can be prepared into syrup or solution.

Description

A kind of quantitative drop
Technical field
The present invention is a kind of quantitative drop of Desloratadine or loratadine, and Gai Zhi Ji Give pharmaceutical quantities accurate science is rationally convenient, and onset time is fast.
Technical background
Desloratadine and loratadine are H 1Receptor antagonist has stronger anti-histamine activity, clinical whole body and the local symptom that is usually used in relieve chronic idiopathic urticaria and catarrhus perennialis.Its specification was that 30~300ml does not wait through the Desloratadine syrup of EMEA approval in the Europe listing in 2002, and concentration is 0.5mg/ml; 2~5 years old one day dosage 1.25mg of child, one day dosage of 6~11 years old child is 2.5mg, be administered once every day.By dosage and specification as can be seen, this syrup dosage can't accurately be controlled, and dosage is greatly unreasonable when causing medication, and the administering mode inconvenience, unhygienic, easily cause cross infection.
The technical measures that carry out an invention
Purpose of the present invention is solution or the inaccurate and antihygienic problem of syrup dosage that solves Desloratadine or loratadine.We adopt the quantitative drop pump of keeping a public place clean, and are to press with certain body weight, have solved dosage and hygienic issues, are easy to passive administration patient's administration simultaneously.
The present invention is directed to the prior art problem, adopt following technical scheme to solve:
Desloratadine or loratadine medicine material and solvent propylene glycol and/or glycerol and/or ethanol and/or Polyethylene Glycol and water and an amount of correctives, stabilizing agent, buffer agent, antiseptic, coloring agent etc. are formulated, and adopt the quantitative drop pump, by mechanical pressing valve medicinal liquid is quantitatively pumped.Medicinal liquid can be the solution or the syrup of Desloratadine or loratadine.Desloratadine or the loratadine content in this preparation is 0.1~2mg/ml, propylene glycol, glycerol, ethanol and the Polyethylene Glycol ratio in this preparation is: propylene glycol 1~30% (W/V), glycerol 1~30% (W/V), ethanol 1~20% (V/V), Polyethylene Glycol 1~30% (W/V), wherein Polyethylene Glycol can be selected from PEG200, PEG300, PEG400, PEG600, preferred PEG400.
Correctives, stabilizing agent, buffer agent, antiseptic, coloring agent etc. include but not limited in the said preparation: sucrose, glucose, stevioside, aspartame, disodium edetate, sodium calcium edetate, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium hydrogen phosphate, benzoic acid, sodium benzoate, sorbitol, strawberry essence, flavoring orange essence, Fructus Citri Limoniae essence, apple essence, grape essence, Oleum menthae, amaranth, lemon yellow, red, the carmine of temptation.
The amount of liquid that quantitative drop is whenever pressed is 0.5~4ml, and Ying You Give medicine is to press with per 1~10 kg body weight.
Medicine of the present invention proves through pharmacological testing, and its determined curative effect absorbs rapidly, the bioavailability height, and the dosage accurate science is rationally convenient simultaneously, has avoided leaning on clinically the shortcoming of experience administration.Mouthfeel is good, is easy to be accepted by patients such as childs.Solve dosage and hygienic issues simultaneously, and be easy to passive administration patient's administration.
Embodiment
The present invention is described in further detail below in conjunction with embodiment.
Specify the present invention in conjunction with the embodiments, but be not limited to following embodiment.
Embodiment 1
Prescription:
Desloratadine or loratadine 0.5g
Citric acid 3g
Sodium citrate 20g
Disodium edetate 0.5g
Sodium benzoate 1g
Sorbitol 10g
Propylene glycol 70g
Strawberry essence 3g
Sucrose 650g
Lemon yellow 0.04g
Carmine 0.007g
Add water to 1000ml
Preparation technology:
1, Desloratadine or loratadine, sodium citrate pulverize separately are crossed 100 mesh sieves.
2, take by weighing the 450g purified water, be heated to little boiling, add recipe quantity sucrose, be heated to little boiling, add recipe quantity sodium benzoate, citric acid, sodium citrate, sorbitol while hot, stir and make dissolving.It is standby that syrup is chilled to room temperature.
3, take by weighing the purified water that 5g boiled, add the disodium edetate of recipe quantity, stir and make dissolving.Solution adds in the syrup, stirs evenly.
4, take by weighing in the Desloratadine or loratadine adding 50g propylene glycol of recipe quantity, stir and make dissolving, solution adds in the syrup, with residue propylene glycol clean container, in the cleanout fluid adding syrup, stirs evenly.
5, lemon yellow, the carmine that takes by weighing recipe quantity is dissolved in the purified water of boiling on a small quantity, adds syrup, stirs evenly.
6, take by weighing the strawberry essence adding syrup of recipe quantity, stir evenly.
7, syrup filters with 200 mesh sieves, adds the purified water of boiling to 1000ml.
8, quality inspection is sub-packed in the drop bottle every bottled medicinal liquor 100ml after qualified.
Embodiment 2
Prescription:
Desloratadine or loratadine 0.25g
Citric acid 10g
Sodium citrate 10g
Sodium calcium edetate 0.05g
Sodium benzoate 3g
Sorbitol 20g
Glycerol 50g
Grape essence 3g
Sucrose 650g
Lure red 0.01g
Add water to 1000ml
Preparation technology:
1, Desloratadine or loratadine, sodium citrate pulverize separately are crossed 100 mesh sieves.
2, take by weighing the 450g purified water, be heated to little boiling, add recipe quantity sucrose, be heated to little boiling, add recipe quantity sodium benzoate, citric acid, sodium citrate, sorbitol while hot, stir and make dissolving.It is standby that syrup is chilled to room temperature.
3, take by weighing the purified water that 5g boiled, add the sodium calcium edetate of recipe quantity, stir and make dissolving.Solution adds in the syrup, stirs evenly.
4, take by weighing in the Desloratadine or loratadine adding 30g glycerol of recipe quantity, stir and make dissolving, solution adds in the syrup, with residue glycerol clean container, in the cleanout fluid adding syrup, stirs evenly.
5, take by weighing red being dissolved in the purified water of boiling on a small quantity of temptation of recipe quantity, add syrup, stir evenly.
6, take by weighing the grape essence adding syrup of recipe quantity, stir evenly.
7, syrup filters with 200 mesh sieves, adds the purified water of boiling to 1000ml.
8, quality inspection is sub-packed in the drop bottle every bottled medicinal liquor 100ml after qualified.
Embodiment 3
Prescription:
Desloratadine or loratadine 1g
Tartaric acid 20g
Sodium tartrate 10g
Sodium calcium edetate 0.025g
Benzoic acid 2g
Sorbitol 15g
Propylene glycol 50g
Ethanol 20ml
Apple essence 3.5g
Sucrose 650g
Lemon yellow 0.007g
Carmine 0.01g
Add water to 1000ml
Preparation technology:
1, Desloratadine or loratadine were pulverized 100 mesh sieves.
2, take by weighing the 450g purified water, be heated to little boiling, add recipe quantity sucrose, be heated to little boiling, add recipe quantity benzoic acid, tartaric acid, sodium tartrate, sorbitol while hot, stir and make dissolving.It is standby that syrup is chilled to room temperature.
3, take by weighing the purified water that 5g boiled, add the sodium calcium edetate of recipe quantity, stir and make dissolving.Solution adds in the syrup.Stir evenly.
4, with after propylene glycol and the ethanol mixing, the Desloratadine or the loratadine that take by weighing recipe quantity add in 30g propylene glycol and the alcoholic acid mixed liquor, stir and make dissolving, solution adds in the syrup, with residue propylene glycol and alcoholic acid mixed liquor clean container, cleanout fluid adds in the syrup, stirs evenly.
5, lemon yellow and the carmine that takes by weighing recipe quantity is dissolved in the purified water of boiling on a small quantity, adds syrup, stirs evenly.
6, take by weighing the apple essence adding syrup of recipe quantity, stir evenly.
7, syrup filters with 200 mesh sieves, adds the purified water of boiling to 1000ml.
8, quality inspection is sub-packed in the drop bottle every bottled medicinal liquor 100ml after qualified.
Embodiment 4
Prescription:
Desloratadine or loratadine 2g
Citric acid 3g
Sodium citrate 20g
Disodium edetate 0.5g
Sodium benzoate 15g
Sorbitol 10g
Propylene glycol 40g
Ethanol 20ml
PEG400 200g
Strawberry essence 3g
Aspartame 5g
Lemon yellow 0.007g
Carmine 0.01g
Add water to 1000ml
Preparation technology:
1, Desloratadine or loratadine were pulverized 100 mesh sieves.
2, take by weighing recipe quantity propylene glycol, ethanol, PEG400 and water 100g, mix homogeneously takes by weighing the Desloratadine or the loratadine of recipe quantity, adds in the mixed solution, dissolve solution I.
3, take by weighing sodium benzoate, citric acid, sodium citrate, disodium edetate, sorbitol, the aspartame of recipe quantity, add suitable quantity of water, stir and make dissolving, get solution II.
4, lemon yellow and the carmine that takes by weighing recipe quantity is dissolved in low amounts of water, solution III.
5, with solution I, solution II, solution III mix homogeneously, add strawberry essence, add water to full dose, stir, get solution IV.
6, solution IV filters with 200 mesh sieves.
7, quality inspection is sub-packed in the drop bottle every bottled medicinal liquor 100ml after qualified.
Embodiment 5
Prescription:
Desloratadine or loratadine 1g
Tartaric acid 10g
Sodium tartrate 30g
Sodium calcium edetate 0.25g
Sodium benzoate 10g
Sorbitol 10g
Propylene glycol 50g
PEG600 300g
Grape essence 3g
Glucose 200g
Oleum menthae 2g
Lemon yellow 0.007g
Carmine 0.01g
Add water to 1000ml
Preparation technology:
1, Desloratadine or loratadine were pulverized 100 mesh sieves.
2, take by weighing recipe quantity propylene glycol, PEG600 and water 150g, mix homogeneously takes by weighing the Desloratadine or the loratadine of recipe quantity, adds in the mixed solution, dissolve solution I.
3, take by weighing glucose, sodium benzoate, tartaric acid, sodium tartrate, sodium calcium edetate, the sorbitol of recipe quantity, add suitable quantity of water, stir and make dissolving, get solution II.
4, lemon yellow and the carmine that takes by weighing recipe quantity is dissolved in low amounts of water, solution III.
5, with solution I, solution II, solution III mix homogeneously, add grape essence, add water to full dose, stir, get solution IV.
6, solution IV filters with 200 mesh sieves.
7, quality inspection is sub-packed in the drop bottle every bottled medicinal liquor 100ml after qualified.
Embodiment 6
Prescription:
Desloratadine or loratadine 0.5g
Citric acid 15g
Sodium citrate 20g
Disodium edetate 0.05g
Sodium benzoate 15g
Sorbitol 10g
Propylene glycol 40g
PEG300 200g
Apple essence 2g
Stevioside 5g
Oleum menthae 2g
Lure red 0.01g
Add water to 1000ml
Preparation technology:
1, Desloratadine or loratadine were pulverized 100 mesh sieves.
2, take by weighing recipe quantity propylene glycol, PEG300 and water 100g, mix homogeneously takes by weighing the Desloratadine or the loratadine of recipe quantity, adds in the mixed solution, dissolve solution I.
3, take by weighing stevioside, sodium benzoate, citric acid, sodium citrate, disodium edetate, the sorbitol of recipe quantity, add suitable quantity of water, stir and make dissolving, get solution II.
4, take by weighing the red low amounts of water that is dissolved in of temptation of recipe quantity, get solution III.
5, with solution I, solution II, solution III mix homogeneously, add apple essence, add water to full dose, stir, get solution IV.
6, solution IV filters with 200 mesh sieves.
7, quality inspection is sub-packed in the drop bottle every bottled medicinal liquor 100ml after qualified.
As described above, according to the Desloratadine of the present invention's preparation or the syrup or the solution of loratadine, it is simple for process, and favorable reproducibility, equipment cost are not high.The amount of liquid that quantitative drop is whenever pressed is 0.5~4ml, and Ying You Give medicine is that a Qin , Give pharmaceutical quantities accurate science is rationally convenient with per 1~10 kg body weight.

Claims (7)

1. quantitative drop, it is syrup or the solution that certain medicine material and certain adjuvant are mixed with, and employing quantitative drop pump, by mechanical force pressing valve medicinal liquid is quantitatively pumped, it is characterized in that: (1) Desloratadine or the loratadine content in this preparation is 0.1~2mg/ml; (2) selected solvent is propylene glycol and/or glycerol and/or ethanol and/or Polyethylene Glycol and water; (3) amount of liquid whenever pressed of quantitative drop is 0.5~4ml, and Ying You Give medicine is to press with per 1~10 kg body weight.
2. quantitative drop as claimed in claim 1 is characterized in that described medicine is selected from Desloratadine, loratadine.
3. quantitative drop as claimed in claim 1 is characterized in that its solvent is selected from: propylene glycol and/or glycerol and/or ethanol and/or Polyethylene Glycol and water.
4. quantitative drop as claimed in claim 1, it is characterized in that: propylene glycol, glycerol, ethanol and the Polyethylene Glycol ratio in this preparation is: propylene glycol 1~30% (W/V), glycerol 1~30% (W/V), ethanol 1~20% (V/V), Polyethylene Glycol 1~30% (W/V).
5. quantitative drop as claimed in claim 1 is characterized in that described Polyethylene Glycol is selected from PEG200, PEG300, PEG400, PEG600, preferred PEG400.
6. quantitative drop as claimed in claim 1 is characterized in that containing other adjuvant commonly used.
7. as claim 1 and the described quantitative drop of claim 6, it is characterized in that adjuvant commonly used includes but not limited to: sucrose, glucose, stevioside, aspartame, disodium edetate, sodium calcium edetate, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium hydrogen phosphate, benzoic acid, sodium benzoate, sorbitol, strawberry essence, flavoring orange essence, Fructus Citri Limoniae essence, apple essence, grape essence, Oleum menthae, amaranth, lemon yellow, red, the carmine of temptation.
CN 200510077339 2005-06-22 2005-06-22 A quantitative drop Pending CN1883479A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
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Publications (1)

Publication Number Publication Date
CN1883479A true CN1883479A (en) 2006-12-27

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102670488A (en) * 2011-12-09 2012-09-19 东莞达信生物技术有限公司 Rupatadine syrup composition and preparation method thereof
CN106265665A (en) * 2016-08-22 2017-01-04 申洪波 A kind of preparation with antipruritic function and preparation method
CN106491522A (en) * 2016-09-24 2017-03-15 北京万全德众医药生物技术有限公司 A kind of levo-cetirizine hydrochloride Oral drops and preparation method thereof
CN106619504A (en) * 2016-11-10 2017-05-10 北京万全德众医药生物技术有限公司 Oral desloratadine drops and preparation method thereof
CN110301648A (en) * 2019-07-24 2019-10-08 杭州海王生物工程有限公司 A kind of minerals class drops and preparation method thereof
CN110638750A (en) * 2019-10-28 2020-01-03 深圳市贝美药业有限公司 Preparation method of desloratadine medicine and preparation thereof
CN114588106A (en) * 2022-03-21 2022-06-07 哈尔滨圣泰生物制药有限公司 Desloratadine oral solution preparation and preparation production process thereof
CN114788809A (en) * 2022-01-25 2022-07-26 江苏广承药业有限公司 Loratadine liquid preparation

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102670488A (en) * 2011-12-09 2012-09-19 东莞达信生物技术有限公司 Rupatadine syrup composition and preparation method thereof
CN106265665A (en) * 2016-08-22 2017-01-04 申洪波 A kind of preparation with antipruritic function and preparation method
CN106491522A (en) * 2016-09-24 2017-03-15 北京万全德众医药生物技术有限公司 A kind of levo-cetirizine hydrochloride Oral drops and preparation method thereof
CN106619504A (en) * 2016-11-10 2017-05-10 北京万全德众医药生物技术有限公司 Oral desloratadine drops and preparation method thereof
CN110301648A (en) * 2019-07-24 2019-10-08 杭州海王生物工程有限公司 A kind of minerals class drops and preparation method thereof
CN110638750A (en) * 2019-10-28 2020-01-03 深圳市贝美药业有限公司 Preparation method of desloratadine medicine and preparation thereof
CN110638750B (en) * 2019-10-28 2021-08-27 深圳市贝美药业有限公司 Preparation method of desloratadine medicine and preparation thereof
CN114788809A (en) * 2022-01-25 2022-07-26 江苏广承药业有限公司 Loratadine liquid preparation
CN114588106A (en) * 2022-03-21 2022-06-07 哈尔滨圣泰生物制药有限公司 Desloratadine oral solution preparation and preparation production process thereof

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Open date: 20061227