CN1038726C - Analgin nasal drops - Google Patents
Analgin nasal drops Download PDFInfo
- Publication number
- CN1038726C CN1038726C CN94106351A CN94106351A CN1038726C CN 1038726 C CN1038726 C CN 1038726C CN 94106351 A CN94106351 A CN 94106351A CN 94106351 A CN94106351 A CN 94106351A CN 1038726 C CN1038726 C CN 1038726C
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- dipyrone
- nasal drop
- solid chemicals
- stabilizing agent
- buffer solution
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Abstract
The present invention discloses a liquid nose drop. Soluble solid medicine which contains dipyrone is dissolved in buffering solvent, which prepares the liquid nose drop. The nose drop used as febrifuge is used for treating infantile fever. The present invention is realized in a mode that stabilizing agents, thickening agents and bacteriostatic agents are added into a preparation.
Description
The present invention relates to a kind of liquid collunarium medicament that contains dipyrone.
Dipyrone is a kind of pyrazolone antipyretic analgesic that clear and definite curative effect is arranged, and the dosage form that adopts has tablet at present, injection, and enema, nasal drop etc., the nasal drop of dipyrone is used for many years.Since the sixties, some hospitals of China make nasal drop with commercially available injection and use to children's, obtained satisfied effect, after the seventies, all there is employing in hospital in all parts of the country, but existing dipyrone solution instability, when commercially available injection is done the nasal drop application, injection peace bottle is opened the back medicine and can not once be used up, and solution oxide flavescence after several hours can't continue to use.Some hospital adopts following formulation dipyrone nasal drop:
Dipyrone 20g
Sodium citrate 0.4g
Distilled water adds to 100ml " Chinese Hospitals preparation standard ", 1989
By the nasal drop of this formulated, though its stability is good than the normal injection agent, but still can flavescence in 16 hours, for this reason can only matching while using very inconvenient.
The object of the invention is that the soluble solids preparation that provides a kind of usefulness to contain dipyrone is dissolved in the nasal drop of making in the buffering solvent, the soluble solids preparation that will contain the dipyrone of fixed amount during application, be dissolved in the buffering solvent of fixed amount and get final product, this solution contains 10～30% dipyrone, it is long to have stable phase, onset is rapid, and the long characteristics of retention time were once made up a prescription available 7 days on nasal mucosa.
The present invention realizes by following process:
One, contain the preparation of the soluble solids preparation of dipyrone:
With dipyrone, soluble stabilizers, solubility thickening agent or other soluble agents carrier are pulverized the back mixing, make common powder, granule, tablet.
Two, the preparation of buffering solvent:
With the EDTA disodium, the solubility antibacterial is dissolved in the buffer solution, regulates pH value to 3.0～7.0.
Three, above-mentioned soluble solids preparation and the buffering solvent that contains dipyrone packed respectively, and the soluble solids preparation that will contain dipyrone during use is dissolved in the buffering solvent, is made into the solution that contains dipyrone 10～30%, and this solution can be used as nasal drop and uses.
Nasal drop of the present invention is by dipyrone, soluble stabilizers, the solubility thickening agent, the solubility antibacterial, buffer solution or other soluble agents carrier are formed, soluble stabilizers wherein can be 0.01～1% antioxidant as sodium sulfite, sodium sulfite, sodium pyrosulfite, also can be chelating agent as 0.01～0.5% EDTA disodium, antioxidant can be separately or two kinds be used in combination, solubility thickening agent wherein can be 0.1～5% methylcellulose, 0.1～5% sodium carboxymethyl cellulose, 0.1～5.0% hydroxypropyl emthylcellulose, 0.1～5.0% hydroxypropyl cellulose, 1.0～20% polyvinylpyrrolidone, solubility antibacterial wherein can be 0.001～0.01% phenylmercuric nitrate, the clean ethyl ester of 0.05～0.1% Ni Bo, buffer solution wherein can be the phosphate buffer of 0.05～0.5M, the citrate buffer solution of 0.05～0.5M.
Its stability of nasal drop of the present invention and refrigeration function can show by the listed experimental data of following table.
Three kinds of dipyrone nasal drop stability relatively
* commercially available dipyrone injection is opened mouth and is at room temperature placed measurement result.The dipyrone nasal drop that * records for " Chinese Hospitals preparation standard ".It is that nearly tablet is dissolved in the buffering solvent and makes that * * nasal drop of the present invention system contains.
| Time (h) optical density kind | 0 | 6 | 16 | 40 | 65 | 90 | 113 | 138 | 168 |
| * commercially available injection | 0.010 | 0.040 | 0.136 | 0.606 | 0.684 | ||||
| * hospital nasal drop | 0.033 | 0.071 | 0.118 | 0.177 | 0.209 | 0.217 | 0.232 | ||
| * * nasal drop of the present invention | 0.035 | 0.036 | 0.037 | 0.039 | 0.043 | 0.049 | 0.051 | 0.058 | 0.062 |
The dipyrone nasal drop compares the refrigeration function of rabbit
(the continuous table of going up)
Annotate: 1.*P＜0.05 * * P＜0.01
| Group | Number of animals | Dosage mg/kg | Normal body temperature ℃ | Back body temperature ℃ heats up | Body temperature changes after the administration | |||
| 10′ | 20′ | 30′ | 40′ | |||||
| Blank hospital nasal drop nasal drop of the present invention | 6 6 6 | 150 150 | 38.8±0.25 38.7±0.21 38.8±0.31 | 39.5±0.38 39.9±0.49 40.1±0.54 | 39.4±0.06 39.9±0.36 39.4±0.5 | 39.5±0.15 39.8±0.30 39.36±0.48 | 39.6±0.35 39.7±0.29 39.3±0.57 | 39.65±0.24 39.6±0.24 39.2±0.51 |
| Body temperature changes after the administration | ||||||
| 1h | 1.5h | 2h | 3h | 4h | 5h | 6h |
| 39.7±0.40 * 39.4±0.19 ** 39.1±0.51 | 39.7±0.47 * 39.1±0.25 ** 39.0±0.45 | 39.6±0.65 ** 39.0±0.22 ** 38.9±0.44 | 39.5±0.50 ** 38.9±0.31 ** 38.8±0.46 | 39.5±0.41 * 38.9±0.34 ** 38.78±0.52 | 39.5±0.34 * 39.0±0.34 ** 38.7±0.55 | 39.6±0.44 * 39.2±0.46 ** 38.8±0.62 |
2. newly develop nasal drop 10 ' onset, lasting 6hr still has the highly significant cooling effect, and just there is the significant hypothermal effect in hospital with nasal drop 1hr,
And cooling extent is little.
From effect experiment, nasal drop of the present invention, 10 minutes existing highly significant drug effects behind the collunarium, drug effect highly significant all in 6 hours, and hospital's nasal drop just has remarkable drug effect after 1 hour, just occur the highly significant drug effect after 2 hours.The former prolongs drug effect retention time on nasal mucosa because contain thickening agent, and it is quick-acting and efficient that absorbtivity increases generation.
From stability experiment, existing nasal drop promptly improve more than 1 times through 6 hours its optical density, and 168 hours optical density of nasal drop of the present invention does not also improve 1 times, and showing has fabulous stability.
Nasal drop of the present invention can prepare by the following example:
Embodiment 1
1. dipyrone 800mg writes out a prescription
Sodium sulfite 4mg
Hypromellose 40mg
2. EDTA disodium 0.4mg
Phenylmercuric nitrate 0.14mg
Phosphate buffer (PH4.0) 4ml
Method for making: 1. dipyrone, sodium sulfite are pulverized, and mix.The hypromellose wiring solution-forming is added in the compound as binding agent, the system soft material, the system, be dried to granule, be sub-packed in the bottle.With the granule tabletting, be sub-packed in the bottle.
2. EDTA disodium, phenylmercuric nitrate are dissolved in the pH4.0 phosphate buffer, make solvent.
Embodiment 2
1. dipyrone 1.5g writes out a prescription
Sodium sulfite 8mg
Hypromellose 120mg
2. EDTA disodium 30mg
The clean ethyl ester 6mg of Ni Bo
Phosphate buffer (pH5.0) 6ml
Method for making: 1. dipyrone, sodium sulfite are pulverized, are mixed.The hypromellose wiring solution-forming is made binding agent, and be added on and make granule in the compound, drying, bottling becomes the soluble particles agent.The granule tabletting is fuse.
2. EDTA disodium, ethyl hydroxybenzoate are dissolved in the phosphate buffer of pH5.0 solvent.Embodiment 3
1. dipyrone 1.2g writes out a prescription
Sodium sulfite 40mg
Methylcellulose 320mg
2. EDTA disodium 40mg
Phenylmercuric nitrate 0.8mg
Phosphate buffer (pH6.5) 8ml
Method for making: with embodiment 1.Embodiment 4
1. dipyrone 1g writes out a prescription
Sodium sulfite 100mg
Carboxymethyl cellulose sodium 300mg
2. EDTA disodium 10mg
Ethyl hydroxybenzoate 20mg
Citrate buffer (pH4.0) 10ml
Method for making: with embodiment 2.Embodiment 5
1. dipyrone 250mg writes out a prescription
Sodium sulfite 30mg
Polyvinylpyrrolidone 500mg
2. EDTA disodium 10mg
Phenylmercuric nitrate 2.5mg
Citrate acid buffer (pH6.0) 5ml
Method for making: with embodiment 1 embodiment 6
Prescription: 1. dipyrone 800mg
Sodium pyrosulfite 16mg
The polyethylene pyrrole is alkane ketone 240mg slightly
2. EDTA disodium 2mg
The clean ethyl ester 4mg of Ni Bo
Citrate buffer (pH6.5) 4ml
Method for making: with embodiment 1
Nasal drop of the present invention, its soluble solids preparation that contains dipyrone can a certain amount ofly be packaged in the dry sterile vials, its buffering solvent can a certain amount ofly be packaged in the other dry sterile vials, the solid preparation that the breakdown bottle will contain dipyrone during use is dissolved in that mixing gets final product in the buffering solvent, and mixed nasal drop can use 7 days continuously.
Nasal drop of the present invention, through with normally used Metamizole nasal drip agent good stability being arranged relatively, the solution thermal velocity is fast, and effect is strong, is suitable for suitability for industrialized production and characteristics easy to use.
Claims (6)
1, a kind of dipyrone nasal drop, it is characterized in that: this nasal drop is to be dissolved in the buffering solvent with the solid chemicals that contains dipyrone to make, the described solid chemicals that contains dipyrone is made up of dipyrone, stabilizing agent thickening agent and other pharmaceutical carriers, described its pH value of buffering solvent is 3.0～7.0, is made up of buffer solution, stabilizing agent, antibacterial.
2, by the described nasal drop of claim 1, it is characterized in that: the described solid chemicals that contains dipyrone, stabilizing agent wherein is one or more bonded antioxidant, comprise: sodium sulfite, sodium sulfite, sodium pyrosulfite, thickening agent wherein are one or more blended following materials: methylcellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, polyvinylpyrrolidone, described buffering solvent, buffer solution wherein is phosphate buffered solution, citrate buffer solution, and antibacterial wherein is a phenylmercuric nitrate, the clean ethyl ester of Ni Bo, stabilizing agent are the EDTA disodiums.
3, by the described nasal drop of claim 1, it is characterized in that: the described solid chemicals that contains dipyrone is the tablet of solubility, granule, powder.
4, by the described nasal drop of claim 1, it is characterized in that: the preparation of this nasal drop is directly to be dissolved in the described buffering solvent with the solid chemicals that contains dipyrone in use.
5, by the described nasal drop of claim 1, it is characterized in that: contain 10%～30% dipyrone in this nasal drop.
6, by the described nasal drop of claim 1, it is characterized in that: the described solid chemicals that contains dipyrone, stabilizing agent dosage wherein is 0.01～1%, thickening agent consumption wherein is 0.1～20%, described buffering solvent, the concentration of buffer solution wherein is 0.05～0.5M, and the concentration of antibacterial wherein is 0.001～0.1%.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94106351A CN1038726C (en) | 1994-06-14 | 1994-06-14 | Analgin nasal drops |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94106351A CN1038726C (en) | 1994-06-14 | 1994-06-14 | Analgin nasal drops |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1103292A CN1103292A (en) | 1995-06-07 |
| CN1038726C true CN1038726C (en) | 1998-06-17 |
Family
ID=5032499
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN94106351A Expired - Fee Related CN1038726C (en) | 1994-06-14 | 1994-06-14 | Analgin nasal drops |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1038726C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107028877B (en) * | 2017-04-24 | 2020-10-27 | 浙江大飞龙动物保健品股份有限公司 | Veterinary long-acting analgin injection and preparation method thereof |
-
1994
- 1994-06-14 CN CN94106351A patent/CN1038726C/en not_active Expired - Fee Related
Non-Patent Citations (3)
| Title |
|---|
| 《药剂学》 1990.1.1 人民卫生出版社 * |
| 《药剂学》 1990.1.1 人民卫生出版社;奚念朱，顾学裘主编;《中国医院制剂规范》 1989.1.1 * |
| 奚念朱，顾学裘主编;《中国医院制剂规范》 1989.1.1 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1103292A (en) | 1995-06-07 |
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