CN101590014A - Process for preparing naloxone hydrochloride injection - Google Patents
Process for preparing naloxone hydrochloride injection Download PDFInfo
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- CN101590014A CN101590014A CNA2009100160813A CN200910016081A CN101590014A CN 101590014 A CN101590014 A CN 101590014A CN A2009100160813 A CNA2009100160813 A CN A2009100160813A CN 200910016081 A CN200910016081 A CN 200910016081A CN 101590014 A CN101590014 A CN 101590014A
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- naloxone hydrochloride
- hydrochloride injection
- naloxone
- technology
- injection
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
The preparation technology of naloxone hydrochloride injection provided by the invention; by strict control pH scope aborning; can make naloxone hydrochloride injection pH in put procedure constant; adopt the method for inert gas shielding in producing simultaneously; reduce to the oxygen content that reaches in the ampoule in the medicinal liquid minimum; prevent the oxidation deterioration of naloxone hydrochloride injection, reduced related substance.Guaranteed product quality greatly by above two technology.
Description
Technical field
The invention belongs to medical technical field, particularly relate to a kind of process for preparing naloxone hydrochloride injection.
Background technology
Naloxone hydrochloride is pure opiate receptor antagonistic, no intrinsic activity own.But each opioid receptor of energy competitive antagonism has very strong affinity to the μ receptor.Naloxone comes into force rapidly, and antagonism is strong.Naloxone reverses all effects of opiate agonist simultaneously, comprises analgesia.It also has and the incoherent analepsia effect of antagonism opiate receptor in addition.Can reverse the respiration inhibition that the opium analgesic causes rapidly, can cause fever, make cardiovascular function hyperfunction.Naloxone hydrochloride still has Antishock function.Do not produce dependency, withdrawal symptom and the respiration inhibition of morphine sample.
Naloxone hydrochloride is the widest opiate receptor antagonistic of present clinical practice.Be mainly used in: 1. save the narcosis analgesic acute poisoning, the respiration inhibition of this class medicine of antagonism, and patient is revived.2. the residual action of antagonism narcosis analgesic.Neonate is influenced by narcosis analgesic in its parent and causes respiration inhibition, available this product antagonism.3. rescue acute alcoholism: quiet notes naloxone 0.4～0.6mg can make the patient clear-headed.4. be the narcosis analgesic addict to doubting, quiet notes 0.2～0.4mg can excite withdrawal symptom, and diagnostic value is arranged.5. the short effect of waking up may activate physiological awakening system by the cholinergic effect and make patient clear-headed, is used for that general anesthesia wakens and shock and some coma patient.
Naloxone is because liver first-pass effect is big, tablet is oral invalid substantially, use dosage form that injection and 2 kinds of dosage forms of Sublingual tablet are arranged at present clinically, but Sublingual tablet has certain difficulty for patient's medication critical or stupor, and the loss of saliva influence bioavailability during owing to containing.So the exploitation injection more helps patient's medication.
Chinese patent CN200410022077.5 provides a kind of powder injection formulation and the preparation method of naloxone hydrochloride, and CN200510050479.5 provides a kind of naloxone hydrochloride injection and production method thereof of new packing.But they all can not prevent the oxidation deterioration of product.
Summary of the invention
The preparation technology of naloxone hydrochloride injection provided by the invention,, it is characterized in that:
A. control the PH of medicinal liquid
B. filling with inert gas in the ampoule
By strict control PH scope aborning; can make its PH in put procedure constant, adopt the method for inert gas shielding in producing simultaneously, reduce to the oxygen content that reaches in the ampoule in the medicinal liquid minimum; prevent the oxidation deterioration of naloxone hydrochloride injection, reduced related substance.Guaranteed product quality greatly by above two technology.
The specific embodiment
Embodiment 1
Specification 10ml:4mg; by strict control PH scope aborning at 3.0-4.0; can make its PH in put procedure constant; adopt the method for inert gas shielding in producing simultaneously; reduce to the oxygen content that reaches in the ampoule in the medicinal liquid minimum; prevent the oxidation deterioration of naloxone hydrochloride injection, reduced related substance.Guaranteed product quality greatly by above two technology.
Embodiment 2
Specification 1ml:1mg; by strict control PH scope aborning at 3.0-4.0; can make its PH in put procedure constant; adopt the method for inert gas shielding in producing simultaneously; reduce to the oxygen content that reaches in the ampoule in the medicinal liquid minimum; prevent the oxidation deterioration of naloxone hydrochloride injection, reduced related substance.Guaranteed product quality greatly by above two technology.
Claims (2)
1, a kind of process for preparing naloxone hydrochloride injection is characterized in that:
A. control the PH of medicinal liquid;
B. filling with inert gas in the ampoule.
2, process for preparing naloxone hydrochloride injection according to claim 1 is characterized in that described pH value is 3.0-4.0.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100160813A CN101590014A (en) | 2009-06-24 | 2009-06-24 | Process for preparing naloxone hydrochloride injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009100160813A CN101590014A (en) | 2009-06-24 | 2009-06-24 | Process for preparing naloxone hydrochloride injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101590014A true CN101590014A (en) | 2009-12-02 |
Family
ID=41405017
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2009100160813A Pending CN101590014A (en) | 2009-06-24 | 2009-06-24 | Process for preparing naloxone hydrochloride injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101590014A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103877016A (en) * | 2014-04-11 | 2014-06-25 | 成都苑东药业有限公司 | Pharmaceutical composition of naloxone hydrochloride injection and preparation method thereof |
| CN105503888A (en) * | 2016-02-03 | 2016-04-20 | 郭琨 | Naloxone hydrochloride crystal form compound |
| CN105596210A (en) * | 2016-01-05 | 2016-05-25 | 江西高大生物医疗科技有限公司 | Automatic detection type oxygen removal blood bag preparation device and method |
| CN106727293A (en) * | 2016-12-12 | 2017-05-31 | 河南润弘制药股份有限公司 | A kind of Nalmefene hydrochloride injection and preparation method thereof |
-
2009
- 2009-06-24 CN CNA2009100160813A patent/CN101590014A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103877016A (en) * | 2014-04-11 | 2014-06-25 | 成都苑东药业有限公司 | Pharmaceutical composition of naloxone hydrochloride injection and preparation method thereof |
| CN105596210A (en) * | 2016-01-05 | 2016-05-25 | 江西高大生物医疗科技有限公司 | Automatic detection type oxygen removal blood bag preparation device and method |
| CN105596210B (en) * | 2016-01-05 | 2018-05-25 | 江西高大生物医疗科技有限公司 | A kind of automatic detection formula deoxygenation blood bag preparation facilities and method |
| CN105503888A (en) * | 2016-02-03 | 2016-04-20 | 郭琨 | Naloxone hydrochloride crystal form compound |
| CN105503888B (en) * | 2016-02-03 | 2016-07-06 | 郭琨 | A kind of naloxone hydrochloride crystal-form compound |
| CN106727293A (en) * | 2016-12-12 | 2017-05-31 | 河南润弘制药股份有限公司 | A kind of Nalmefene hydrochloride injection and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20091202 |