CN1047077C - Stable, painless piroxicam potassium injectable composition - Google Patents
Stable, painless piroxicam potassium injectable composition Download PDFInfo
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- CN1047077C CN1047077C CN94100686A CN94100686A CN1047077C CN 1047077 C CN1047077 C CN 1047077C CN 94100686 A CN94100686 A CN 94100686A CN 94100686 A CN94100686 A CN 94100686A CN 1047077 C CN1047077 C CN 1047077C
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- piroxicam
- potassium
- injection
- stable
- piroxicam potassium
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Abstract
The present invention relates to a stable and painless piroxicam potassium injectable composition, particularly to a stable and painless piroxicam potassium injectable composition which comprises 2.275 g of piroxicam potassium, 40 ml of triethylene glycol, 1.0 g of lidocaine and enough distilled water for injection, wherein the triethylene glycol is used as a solvent and a stabilizer; the lidocaine is used as painkillers; the piroxicam potassium, the triethylene glycol, the lidocaine and the distilled water for injection make the total volume of the present invention be 100 ml.
Description
The present invention relates to injectable piroxicam potassium compositions.In more detail, the present invention relates to stable and anosis injectable piroxicam potassium compositions, it comprises piroxicam potassium, 2,2'-ethylenedioxybis(ethanol)., lignocaine and distilled water for injection.
Piroxicam is the non-steroid antiinflammatory drug that a class belongs to benzothiazine derivative family, and by suppressing synthetic antiinflammatory, pain relieving and the antipyretic activity of showing of prostaglandin.Therefore and piroxicam is long half time in blood plasma, only just shows enough drug effects by administration daily dose once a day.Yet when the administration of piroxicam oral administration, it shows unwanted side effect such as upper abdomen pain, dyspepsia, puffiness of face or the like.Therefore, develop piroxicam injectable formulation and be used for clinical recently.Yet because piroxicam itself is seldom water-soluble, when with preparation of injectable formulation form and storage piroxicam, this preparation may be easy to become muddiness and piroxicam can be precipitated out from preparation.Therefore, the strong request exploitation does not have the method that can stablize piroxicam under the influence condition and further reduce the pain that becomes intramuscular injection preparation subject matter to the piroxicam pharmacologically active.
The inventor has carried out big quantity research for this method of exploitation, confirm then: if piroxicam not soluble in water is transformed into its potassium salt, can be combined into injectable formulation to piroxicam potassium salt, yet, the inventor also confirms: when injection piroxicam potassium salt, the piroxicam potassium injection causes and has an intense pain, and unstable, therefore some problems are also arranged, and promptly piroxicam may crystallize out from preparation and this preparation may become muddy.
Therefore, the inventor is to stabilizing agent commonly used, the various combination of solvent and analgesic has carried out repeated experiments, so that find out to improving injectable piroxicam preparation stability and reducing the solvent of the pain that may be caused by this preparation of injection, the best of breed of stabilizing agent and analgesic.The result, the inventor confirms, 2,2'-ethylenedioxybis(ethanol). is optimum solvent and stabilizing agent in containing the piroxicam potassium injection solution, the local anaesthetics lignocaine can show only needed analgesic effect and without any unwanted side effect and with the interaction of other component, therefore finish the present invention.
Therefore, the purpose of this invention is to provide stable, painless piroxicam potassium injectable composition.
Another object of the present invention provides stable and painless piroxicam potassium injectable composition, and it comprises the piroxicam potassium as active component, as the 2,2'-ethylenedioxybis(ethanol). of solvent and stabilizing agent, and the tired and distilled water for injection as the benefit card of analgesic.
For understanding following public detailed content of the present invention better and can estimating the contribution of the present invention fully, summarized the more appropriate and important feature of the present invention above to present technique.Person skilled in the art can realize: notion disclosed herein can easily be used as modification with specific embodiments for realization identical purpose of the present invention or design the basis of other structure.And person skilled in the art can recognize: this suitable formation does not break away from scope of the present invention and the essence that proposes in the claims.
The present invention relates to stable and painless injectable piroxicam potassium compositions, it comprises piroxicam potassium, 2,2'-ethylenedioxybis(ethanol)., lignocaine and distilled water for injection.In compositions of the present invention, 2,2'-ethylenedioxybis(ethanol). is as the solvent and the stabilizing agent of piroxicam potassium, and lignocaine is as the pain relieving composition that can reduce the pain that may be caused by this compositions of intramuscular injection.
In more detail, at first be dissolved in the distilled water for injection according to piroxicam potassium of the present invention.Respectively, lignocaine is dissolved in the 2,2'-ethylenedioxybis(ethanol). to obtain lignocaine solution.As above the piroxicam solution of gained therewith lignocaine solution mix, the mixture pH value is adjusted to is about 8.5 then.In this mixture, add enough volume required distilled water for injection to obtain the stable intramuscular injection solution of piroxicam potassium of the present invention.In piroxicam potassium injectable composition of the present invention, preferably use 30 to arrive 80ml 2,2'-ethylenedioxybis(ethanol). and 0.5 to the 1.5g lignocaine for 2.0 to 3.0g piroxicam potassium.Preferablely be, for the 2.275g piroxicam potassium, 2,2'-ethylenedioxybis(ethanol). and lignocaine mix with the ratio of 40ml and 1.0g respectively, and to add in the gained mixture to obtain cumulative volume be the injection solution of 100ml to distilled water for injection then.
The present invention will be described more specifically by following embodiment.Yet, be appreciated that the present invention in no case is subjected to the restriction of these embodiment.
Embodiment 1: the preparation of piroxicam potassium
The 10g piroxicam is suspended in the 83g methanol.In 15 to 20 ℃ add 1.95g85%KOH in this suspension.Stirred gained solution 30 minutes under uniform temp, filter, methanol is removed in evaporation.By adding 74.2g isopropyl alcohol dissolving residue, stirred gained solution one hour at 20 to 25 ℃ then, be cooled to 0 ℃ then with the precipitated solid product.Filter the gained solid, wash with the 24.7g isopropyl alcohol, vacuum drying obtains the piroxicam potassium of 9.4g (productive rate 84%) then.
Embodiment 2: the preparation of piroxicam potassium ejection preparation
2.275g piroxicam potassium is dissolved in (piroxicam potassium solution) in the 40ml distilled water for injection fully.
Respectively, the 1.0g lignocaine is dissolved in (lignocaine solution) in the 40ml 2,2'-ethylenedioxybis(ethanol). fully.
Slowly add in the lignocaine solution to obtain mixture along with stirring the piroxicam potassium solution.Wash the container that contains the piroxicam potassium solution with the distilled water for injection of small size, this washing liquid also is added in this mixture then.
Regulate this mixed solution to PH8.5 with normal potassium hydroxide or normal hydrochloric acid, the distilled water for injection adding wherein makes cumulative volume accurately be 100ml then, subsequently according in Korea's pharmacopeia, the preparation ejection preparation method of describing in the preparation general provisions is handled this mixture, with the intramuscular injection preparation of preparation piroxicam potassium.
Though the present invention with its to a certain degree the optimal way of particularity be described, but the skilled person in the present technique field realizes: optimal way disclosure of the present invention is only finished by embodiment and the formation of each several part, and a large amount of variations in the detailed content of combination and permutation can be thought and do not break away from the spirit and scope of the invention.
Claims (3)
1. injectable compositions, it comprises 2.0 to the 3.0g piroxicam potassium, 0.5 to the 1.5g lignocaine, 30 to 80ml 2,2'-ethylenedioxybis(ethanol). and 40 to the 80ml distilled water for injection.
2. according to the Injectable composition of claim 1, it comprises 2.275g piroxicam potassium, 40ml 2,2'-ethylenedioxybis(ethanol)., 1.0g lignocaine and 60ml distilled water for injection.
3. according to the Injectable composition of claim 1, it comprises 2.275g piroxicam potassium, 40ml 2,2'-ethylenedioxybis(ethanol)., 1.0g lignocaine, a certain amount of potassium hydroxide and hydrochloric acid, and to make final volume be 100ml to regulate pH to 8.5 and distilled water.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94100686A CN1047077C (en) | 1994-01-15 | 1994-01-15 | Stable, painless piroxicam potassium injectable composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN94100686A CN1047077C (en) | 1994-01-15 | 1994-01-15 | Stable, painless piroxicam potassium injectable composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1105241A CN1105241A (en) | 1995-07-19 |
| CN1047077C true CN1047077C (en) | 1999-12-08 |
Family
ID=5029780
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN94100686A Expired - Lifetime CN1047077C (en) | 1994-01-15 | 1994-01-15 | Stable, painless piroxicam potassium injectable composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1047077C (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0336200A1 (en) * | 1988-04-01 | 1989-10-11 | CHIESI FARMACEUTICI S.p.A. | Pharmaceutical compositions of piroxicam in aqueous solutions and process for their preparation |
-
1994
- 1994-01-15 CN CN94100686A patent/CN1047077C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0336200A1 (en) * | 1988-04-01 | 1989-10-11 | CHIESI FARMACEUTICI S.p.A. | Pharmaceutical compositions of piroxicam in aqueous solutions and process for their preparation |
Non-Patent Citations (1)
| Title |
|---|
| 《药理学》第二版 1986.10.1 江明性,人民卫生出版社 * |
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| Publication number | Publication date |
|---|---|
| CN1105241A (en) | 1995-07-19 |
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Free format text: CORRECT: PATENTEE; FROM: JIN RONG TO: JIN YUANGUI |
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Expiration termination date: 20140115 Granted publication date: 19991208 |