CN102552116B - Preparation method of ephedrine and furacilin nasal drops - Google Patents
Preparation method of ephedrine and furacilin nasal drops Download PDFInfo
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- CN102552116B CN102552116B CN201010605242.5A CN201010605242A CN102552116B CN 102552116 B CN102552116 B CN 102552116B CN 201010605242 A CN201010605242 A CN 201010605242A CN 102552116 B CN102552116 B CN 102552116B
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- nasal drops
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- ephedrine
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- furacilin nasal
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Abstract
The invention discloses a preparation method of ephedrine and furacilin nasal drops, and particularly relates to a method for adjusting the pH value of the nasal drops in the production process of ephedrine and furacilin nasal drops. The method is characterized in that: during preparation of the ephedrine and furacilin nasal drops, a pH value buffering agent is added, and the pH value is adjusted to a required range. The falling value of the pH value of finished ephedrine and furacilin nasal drops prepared with the method is small, the pH value tends to keep stable in a falling process, and product quality is good.
Description
Technical field
The invention belongs to medical art, be specifically related to produce the method adjusting this nasal drop pH value in compound furacilin nasal drops process.
Background technology
The principle active component of compound furacilin nasal drops is ephedrine hydrochloride and nitrofural, for nose then collapsible nasal mucosa blood vessel, therefore can be used as nose Decongestant, alleviates nasal mucosa hyperemia, edema, nasal obstruction.
Nitrofural can disturb the carbohydrate metabolism process of antibacterial and oxidase system and play antibacterial or bactericidal action, the glycometabolic commitment of main interference antibacterial, causes bacterial metabolism disorderly and dead.Its antimicrobial spectrum is comparatively wide, has antibacterial action, also have effect to anaerobe to multiple Grain-positive and negative bacterium, to bacillus pyocyaneus and Diplococcus pneumoniae power weak, have drug resistance, to fungus to Pseudomonas and Proteus, mycete is invalid, but still has suitable effect to because of mould microbial bacteriological infection.Be 13 ~ 20ug/ml to the bacteriocidal concentration of sensitive organism, Mlc is 5 ~ 10ug/ml.
Ephedrine can directly act on α, β two kinds of receptors, plays adrenomimetic drug effect, adrenergic nerve tip also can be impelled to discharge chemical mediator, indirectly plays adrenomimetic drug effect.Compare with epinephrine, the feature of ephedrine is stable in properties, effectively oral, and act on weak and lasting, central excitation effect is more remarkable.There is the effects such as loose bronchial smooth muscle, excited heart, vasoconstrictive, raising blood pressure.The clinical hypotension that causes for bronchial asthma, subarachnoid anesthesia or epidural anesthesia and remove nasal decongestion, edema.
But compound furacilin nasal drops pH within storage period has the ground trend that constantly declines, and is unfavorable for control and the keeping of product quality.
Summary of the invention
The present invention mainly for above-mentioned pH value decline problem, proposes the method for adjusted to ph in a kind of compound furacilin nasal drops production process
During preparation compound furacilin nasal drops, add pH value buffer agent, adjusted to ph is to the scope required.
Adding pH buffer agent can after adding antiseptic.
Described pH buffer agent is a kind of arbitrary composition of or above-mentioned four kinds of materials of sodium acetate, sodium citrate, sodium hydrogen phosphate, sodium dihydrogen phosphate.
The quality adding pH buffer agent accounts for 0.001% ~ 0.3% (g/ml) of compound furacilin nasal drops cumulative volume.
The quality adding pH buffer agent accounts for 0.01% ~ 0.2% (g/ml) of compound furacilin nasal drops cumulative volume.
By adding pH buffer agent, form the stability cushioned the pH value improving compound furacilin nasal drops with the pH adjusting agent in prescription, the situation that the pH value of compound furacilin nasal drops is declined improves significantly, and product quality has significantly improved.
Detailed description of the invention:
Embodiment 1: in the compound furacilin nasal drops preparation liquid adding antiseptic; Add the sodium acetate of 0.03% (g/ml) and make it fully dissolve, measure pH value, then adjust ph is to 6.0 ~ 7.5, adds and adds to the full amount of water for injection, and stirs evenly, and filters, embedding and get final product.
Implementation column 2: in the compound furacilin nasal drops preparation liquid adding antiseptic; Add the sodium citrate of 0.05% (g/ml) and make it fully dissolve, measure pH value, then adjust ph is to 6.0 ~ 7.5, adds and adds to the full amount of water for injection, and stirs evenly, and filters, embedding and get final product.
Implementation column 3: in the compound furacilin nasal drops preparation liquid adding antiseptic; Add the sodium hydrogen phosphate of 0.06% (g/ml) and make it fully dissolve, measure pH value, then adjust ph is to 6.0 ~ 7.5, adds and adds to the full amount of water for injection, and stirs evenly, and filters, embedding and get final product.
Implementation column 4: in the compound furacilin nasal drops preparation liquid adding antiseptic; Add the sodium dihydrogen phosphate of the sodium hydrogen phosphate and 0.04% (g/ml) of 0.06% (g/ml) and make it fully dissolve, measure pH value, then adjust ph is to 6.0 ~ 7.5, adds and adds to the full amount of water for injection, and stirs evenly, and filters, embedding and get final product.
Claims (2)
1. the preparation method of a compound furacilin nasal drops, it is characterized in that, in the compound furacilin nasal drops preparation liquid adding antiseptic, add pH buffer agent, then regulate pH value to 6. 0 ~ 7. 5, add and add to the full amount of water for injection, stir evenly, filter, embedding and get final product, wherein said pH buffer agent is the combination in any of a kind of or above-mentioned four kinds of materials in sodium acetate, sodium citrate, sodium hydrogen phosphate, sodium dihydrogen phosphate, and the quality of pH buffer agent accounts for 0.001% ~ 0.3% of compound furacilin nasal drops cumulative volume, and unit is g/ml.
2. according to the method described in claim 1, it is characterized in that, the quality adding pH buffer agent accounts for 0.01% ~ 0.2% of compound furacilin nasal drops cumulative volume, and unit is g/ml.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010605242.5A CN102552116B (en) | 2010-12-24 | 2010-12-24 | Preparation method of ephedrine and furacilin nasal drops |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201010605242.5A CN102552116B (en) | 2010-12-24 | 2010-12-24 | Preparation method of ephedrine and furacilin nasal drops |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102552116A CN102552116A (en) | 2012-07-11 |
| CN102552116B true CN102552116B (en) | 2015-07-22 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201010605242.5A Active CN102552116B (en) | 2010-12-24 | 2010-12-24 | Preparation method of ephedrine and furacilin nasal drops |
Country Status (1)
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| CN (1) | CN102552116B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109999020A (en) * | 2019-05-23 | 2019-07-12 | 无锡济民可信山禾药业股份有限公司 | A kind of nasal spray and preparation method thereof for alleviating rhinitis snuffles symptom |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1524584A (en) * | 2003-02-27 | 2004-09-01 | 华中科技大学同济医学院附属同济医院 | Sterilization method of furacillin solutions |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007095039A2 (en) * | 2006-02-09 | 2007-08-23 | Schering Corporation | Pharmaceutical formulations |
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2010
- 2010-12-24 CN CN201010605242.5A patent/CN102552116B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1524584A (en) * | 2003-02-27 | 2004-09-01 | 华中科技大学同济医学院附属同济医院 | Sterilization method of furacillin solutions |
Non-Patent Citations (3)
| Title |
|---|
| 呋麻滴鼻液的制备及临床应用;郭温迎等;《海峡药学》;20041231;第16卷(第1期);第35-37页 * |
| 复方呋喃西林滴鼻凝胶剂的制备;肖克来提等;《中国医院药学杂志》;20071231;第27卷(第4期);第545页 * |
| 孙璋等.复方呋喃西林滴鼻液.《实用医院制剂手册》.山东大学出版社,2002,(第1版),第130页第1-3段. * |
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|---|---|
| CN102552116A (en) | 2012-07-11 |
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Address after: 214028 Changjiang South Road, new Wu District, Wuxi, Jiangsu Province, No. 12 Patentee after: Wuxi Jiyu Shanhe Pharmaceutical Co., Ltd Address before: 214028 No. 12 Changjiang South Road, New District, Jiangsu, Wuxi Patentee before: WUXI JIMIN KEXIN SHANHE PHARMACEUTICAL Co.,Ltd. |