CN1911207A - Oral liquor contg. citalopram hydrobromide and its prepn. method - Google Patents
Oral liquor contg. citalopram hydrobromide and its prepn. method Download PDFInfo
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- CN1911207A CN1911207A CN 200610030979 CN200610030979A CN1911207A CN 1911207 A CN1911207 A CN 1911207A CN 200610030979 CN200610030979 CN 200610030979 CN 200610030979 A CN200610030979 A CN 200610030979A CN 1911207 A CN1911207 A CN 1911207A
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- oral liquid
- citalopram hydrobromate
- plasticizer
- sweeting agent
- citalopram
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Abstract
An oral liquid of citalopram hydrobromate is proportionally prepared from citalopram hydrobromate, sweetening agent, plasticizer, antiseptic, aromatic and solvent. Its preparing process is also disclosed.
Description
Technical field
The present invention relates to the preparation of pharmaceutical formulations field, relate in particular to a kind of citalopram hydrobromate oral liquid and preparation method thereof.
Background technology
The citalopram hydrobromate oral liquid is mainly used in treatment endogenous and non-endogenous depression.Hydrocodone is selective serotonin reuptake inhibitor (SSRI).Can strengthen the neural synapse transmission of 5-hydroxy tryptamine energy, produce antidepressant effect.Its antidepressant effect is generally set up in week at 2-4.Citalopram has high selectivity to the inhibitory action of serotonin reuptake transporter, and to 5-HT1A, 5-HT2A receptor, dopamine D 1, D2 receptor, adrenoreceptor, histamine H1-receptor, γ-GABA receptor, M-cholinoceptor and benzodiazepine receptors do not have affinity or affinity very low.Antagonism to M-cholinoceptor, histamine receptor and adrenoreceptor is considered to relevant with side effect such as some psychoactive drug cholinolytic, calmness and cardiovascular.
It is big that the citalopram hydrobromate oral liquid has a dispersion, absorbs soon, can bring into play drug effect more rapidly; Be easy to divided dose, be specially adapted to the gerontal patient and swallow the inconvenient patient of solid preparation.
In the preparation of citalopram hydrobromate oral liquid, mouthfeel and stability problem the be pharmaceutical work person problem that face of citalopram hydrobromate in preparation.Therefore the mouthfeel of citalopram hydrobromate oral liquid and stability problem are the problems that mainly solves in the commercial production always.
Summary of the invention
The object of the invention is to select suitable adjuvant and preparation technology for use, and the preparation method of the citalopram hydrobromate oral liquid of the good and good stability of a kind of mouthfeel is provided.
The citalopram hydrobromate oral liquid that the present invention is prepared comprises following raw material:
Citalopram hydrobromate 0.01～1wt%
Sweeting agent, plasticizer 12～35wt%
Antiseptic 0.01～0.5wt%
Aromatic 0.005～0.05wt%
Solvent 64～87wt%
The preferred component of the raw material of citalopram hydrobromate oral liquid is:
Citalopram hydrobromate 0.05～0.8wt%
Sweeting agent, plasticizer 15～30wt%
Antiseptic 0.05～0.3wt%
Aromatic 0.008～0.02wt%
Solvent 68～85wt%
Sweeting agent and plasticizer are selected from sorbitol, glycerol, propylene glycol described in the citalopram hydrobromate oral liquid component; Antiseptic is selected from methyl hydroxybenzoate, propylparaben, benzoic acid, sodium benzoate; Aromatic is selected from Herba Menthae essence, fragrant citrus essence and strawberry essence.
The preparation method of citalopram hydrobromate oral liquid may further comprise the steps: water intaking is an amount of, be heated to boiling, add antiseptic and make dissolving, put coldly, get sweeting agent, plasticizer and add mixing, add citalopram hydrobromate, stirring makes dissolving, adds sweeting agent, plasticizer and an amount of aromatic again, and solubilizer is to full dose.
Regulate pH value to 5 ± 1 with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity.By the microvoid membrane filtration, check pH value and content, qualified after, the filtrate fill, gland seals, promptly.
Sweeting agent and plasticizer used in the preparation method are selected from sorbitol, glycerol, propylene glycol; Antiseptic is selected from methyl hydroxybenzoate, propylparaben, benzoic acid, sodium benzoate; Aromatic is selected from Herba Menthae essence, fragrant citrus essence and strawberry essence.
Prescription of the present invention and method prepare the citalopram hydrobromate oral liquid, and the ratio range of each material is more stable through clinical function of proof in the prescription, and side effect is also less, and mouthfeel is better.
Owing to added sweeting agent, plasticizer in suitable solvent, sweet taste is obviously strengthened, bitterness weakens, easier being guaranteed during the suitable common process of mouthfeel; In prescription, added simultaneously the stabilizing agent of medicine, made effective ingredient more stable in the storage life, thereby guaranteed the curative effect of medicine.
The specific embodiment
Embodiment 1
Citalopram hydrobromate 2g
Glycerol, sorbitol 200g
Methyl hydroxybenzoate 3g
Fragrant citrus essence 0.1g
Water 796g
Water intaking is an amount of, be heated to boiling, add antiseptic methyl hydroxybenzoate 3g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 100g adds, mixing, add principal agent 2g, stir and make dissolving, add sweeting agent, plasticizer sorbitol 100g and fragrant citrus essence aromatic 100mg again, solubilizer 796g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 2
Citalopram hydrobromate 2g
Glycerol, sorbitol 160g
Propylparaben 2g
Strawberry essence 0.1g
Water 836g
Water intaking is an amount of, be heated to boiling, add antiseptic propylparaben 2g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 90g adds, mixing, add principal agent 2g, stir and make dissolving, add sweeting agent, plasticizer sorbitol 70g and strawberry essence aromatic 100mg again, solubilizer water 836g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 3
Citalopram hydrobromate 2g
Glycerol, propylene glycol 340g
Benzoic acid 1.5g
Fragrant citrus essence 0.1g
Water 656g
Water intaking is an amount of, be heated to boiling, add preservative benzoic acid 1.5g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 140g adds, mixing, add principal agent 2g, stir and make dissolving, add sweeting agent, plasticizer propylene glycol 200g and fragrant citrus essence aromatic 100mg again, solubilizer 656g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 4
Citalopram hydrobromate 0.5g
Glycerol, sorbitol 150g
Nipalgin propanoic acid 0.5g
Strawberry essence 0.08g
Water 846g
Water intaking is an amount of, be heated to boiling, add antiseptic nipalgin propanoic acid 0.5g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 90g adds, mixing, add principal agent 0.5g, stir and make dissolving, add sweeting agent, plasticizer sorbitol 60g and strawberry essence aromatic 80mg again, solubilizer 846g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 5
Citalopram hydrobromate 7.5g
Glycerol, sorbitol 290g
Nipalgin propanoic acid 2.8g
Strawberry essence 0.18g
Water 680g
Water intaking is an amount of, be heated to boiling, add antiseptic nipalgin propanoic acid 2.8g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 140g adds, mixing, add principal agent 0.5g, stir and make dissolving, add sweeting agent, plasticizer sorbitol 150g and strawberry essence aromatic 180mg again, solubilizer 846g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 6
Citalopram hydrobromate 0.1g
Glycerol, propylene glycol 120g
Benzoic acid 0.1g
Fragrant citrus essence 0.05g
Water 780g
Water intaking is an amount of, be heated to boiling, add preservative benzoic acid 0.1g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 60g adds, mixing, add principal agent 0.1g, stir and make dissolving, add sweeting agent, plasticizer propylene glycol 60g and fragrant citrus essence aromatic 50mg again, solubilizer 780g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 7
Citalopram hydrobromate 0.1g
Glycerol, propylene glycol 300g
Benzoic acid 4g
Fragrant citrus essence 0.4g
Water 600g
Water intaking is an amount of, be heated to boiling, add preservative benzoic acid 4g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 140g adds, mixing, add principal agent 0.1g, stir and make dissolving, add sweeting agent, plasticizer propylene glycol 160g and fragrant citrus essence aromatic 400mg again, solubilizer 600g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 8
Citalopram hydrobromate 9g
Glycerol, propylene glycol 100g
Benzoic acid 0.1g
Fragrant citrus essence 0.05g
Water 650g
Water intaking is an amount of, be heated to boiling, add preservative benzoic acid 0.1g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 60g adds, mixing, add principal agent 9g, stir and make dissolving, add sweeting agent, plasticizer propylene glycol 40g and fragrant citrus essence aromatic 50mg again, solubilizer 650g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 9
Citalopram hydrobromate 9g
Glycerol, sorbitol 300g
Propylparaben 4g
Strawberry essence 0.4g
Water 600g
Water intaking is an amount of, be heated to boiling, add antiseptic propylparaben 4g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 140g adds, mixing, add principal agent 9g, stir and make dissolving, add sweeting agent, plasticizer sorbitol 160g and strawberry essence aromatic 400mg again, solubilizer water 600g, regulating pH value with 0.1mol/L acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
Embodiment 10
Citalopram hydrobromate 8g
Glycerol, sorbitol 300g
Propylparaben 0.1g
Strawberry essence 0.4g
Water 600g
Water intaking is an amount of, be heated to boiling, add antiseptic propylparaben 0.1g and make dissolving, put coldly, get sweeting agent, plasticizer glycerol 140g adds, mixing, add principal agent 8g, stir and make dissolving, add sweeting agent, plasticizer sorbitol 160g and strawberry essence aromatic 400mg again, solubilizer water 600g, regulating pH value with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution in case of necessity is 5 ± 1.By the microvoid membrane filtration, check pH and content, qualified after, the filtrate fill, gland seals, promptly.
To contain antiseptic, stabilizing agent in the prescription and two lot number sample room temperature placements that do not contain antiseptic, stabilizing agent after 12 months, sample is checked according to microbial process under the Chinese Pharmacopoeia version item in 2000 and related substance HPLC, the sample total number of bacteria, fungi count, pathogenic bacterium, the related substance that contain antiseptic, stabilizing agent in result's prescription are all qualified, the sample total number of bacteria that does not contain antiseptic surpasses required standard, the sample related substance that does not contain stabilizing agent, related substance total impurities peak area surpasses contrast solution main constituent peak area (1.0%).Show and contain antiseptic in the prescription obviously than stable when not containing antiseptic in the prescription.
With containing sweeting agent, aromatic in the prescription and not containing two lot number samples of sweeting agent, aromatic, repay examination through 5 volunteers, the result contains sweeting agent, the aromatic mouthfeel is obviously improved, and is felt as gas fragrance, and it is sweet to distinguish the flavor of, little hardship.Do not contain sweeting agent, aromatic and all feel sense of discomfort is slightly arranged the mouthfeel bitterness.
Claims (10)
1. citalopram hydrobromate oral liquid is characterized in that comprising following raw material:
Citalopram hydrobromate 0.01～1wt%
Sweeting agent, plasticizer 12～35wt%
Antiseptic 0.01～0.5wt%
Aromatic 0.005～0.05wt%
Solvent 64～87wt%.
2. citalopram hydrobromate oral liquid as claimed in claim 1 is characterized in that the component of raw material is:
Citalopram hydrobromate 0.05～0.8wt%
Sweeting agent, plasticizer 15～30wt%
Antiseptic 0.05～0.3wt%
Aromatic 0.008～0.02wt%
Solvent 68～85wt%.
3. citalopram hydrobromate oral liquid as claimed in claim 1 is characterized in that: described sweeting agent and plasticizer are selected from sorbitol, glycerol, propylene glycol.
4. citalopram hydrobromate oral liquid as claimed in claim 1 is characterized in that: described antiseptic is selected from methyl hydroxybenzoate, propylparaben, benzoic acid, sodium benzoate.
5. citalopram hydrobromate oral liquid as claimed in claim 1 is characterized in that: described aromatic is selected from Herba Menthae essence, fragrant citrus essence and strawberry essence.
6. the preparation method of citalopram hydrobromate oral liquid as claimed in claim 1 or 2, it is characterized in that may further comprise the steps: water intaking is an amount of, is heated to boiling, adds antiseptic and makes dissolving, put cold, get sweeting agent, plasticizer adding, mixing adds citalopram hydrobromate, stirring makes dissolving, add sweeting agent, plasticizer and an amount of aromatic again, solubilizer filters to full dose.
7. the preparation method of citalopram hydrobromate oral liquid as claimed in claim 6 is characterized in that also comprising: regulate pH value to 5 ± 1 with 0.1mol/L hydrochloric acid solution or 0.1mol/L sodium hydroxide solution.
8. the preparation method of citalopram hydrobromate oral liquid as claimed in claim 6 is characterized in that: described sweeting agent and plasticizer are selected from sorbitol, glycerol, propylene glycol.
9. the preparation method of citalopram hydrobromate oral liquid as claimed in claim 6 is characterized in that: described antiseptic is selected from methyl hydroxybenzoate, propylparaben, benzoic acid, sodium benzoate.
10. the preparation method of citalopram hydrobromate oral liquid as claimed in claim 6 is characterized in that: described aromatic is selected from Herba Menthae essence, fragrant citrus essence and strawberry essence.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610030979 CN1911207A (en) | 2006-09-08 | 2006-09-08 | Oral liquor contg. citalopram hydrobromide and its prepn. method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610030979 CN1911207A (en) | 2006-09-08 | 2006-09-08 | Oral liquor contg. citalopram hydrobromide and its prepn. method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1911207A true CN1911207A (en) | 2007-02-14 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610030979 Pending CN1911207A (en) | 2006-09-08 | 2006-09-08 | Oral liquor contg. citalopram hydrobromide and its prepn. method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1911207A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102415992A (en) * | 2011-11-24 | 2012-04-18 | 福格森（武汉）生物科技有限公司 | Escitalopram oral liquid preparation |
| CN106491521A (en) * | 2016-09-22 | 2017-03-15 | 北京万全德众医药生物技术有限公司 | A kind of oral liquor of escitalopram oxalate |
-
2006
- 2006-09-08 CN CN 200610030979 patent/CN1911207A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102415992A (en) * | 2011-11-24 | 2012-04-18 | 福格森（武汉）生物科技有限公司 | Escitalopram oral liquid preparation |
| CN106491521A (en) * | 2016-09-22 | 2017-03-15 | 北京万全德众医药生物技术有限公司 | A kind of oral liquor of escitalopram oxalate |
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