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CN1640402A - Stable naloxone powder for injection - Google Patents

Stable naloxone powder for injection Download PDF

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Publication number
CN1640402A
CN1640402A CN 200410000003 CN200410000003A CN1640402A CN 1640402 A CN1640402 A CN 1640402A CN 200410000003 CN200410000003 CN 200410000003 CN 200410000003 A CN200410000003 A CN 200410000003A CN 1640402 A CN1640402 A CN 1640402A
Authority
CN
China
Prior art keywords
naloxone
powder
injection
injectable powder
stable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN 200410000003
Other languages
Chinese (zh)
Inventor
孔庆文
杨春玮
刘军
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
QIFANG PHARMACEUTICAL CO Ltd GUANGDONG PROVINCE
Original Assignee
QIFANG PHARMACEUTICAL CO Ltd GUANGDONG PROVINCE
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by QIFANG PHARMACEUTICAL CO Ltd GUANGDONG PROVINCE filed Critical QIFANG PHARMACEUTICAL CO Ltd GUANGDONG PROVINCE
Priority to CN 200410000003 priority Critical patent/CN1640402A/en
Publication of CN1640402A publication Critical patent/CN1640402A/en
Pending legal-status Critical Current

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Abstract

The present invention relates to a stable naloxone powder injection. The naloxone powder injection described by said invention is formed from naloxone or its physiologically-aceptable salt and pharmacologically-allowable injection auxiliary material. It can be extensively used for curing various diseases of acute alcoholism, cerebrovascular accident, ischemic encephalopathy, coma, craniocerebral injury and imminent serious diseases, and can be used for removing respiratory inhibition and inducing awavening after combined anesthesia and operation.

Description

A kind of stable naloxone injectable powder
Technical field
The invention belongs to medical technical field, relate to that a kind of stable being used to eased pain and the medicine of the special form of antagonism respiration inhibition medicine.
Background technology
Naloxone was synthesized in nineteen sixty, was hydroxyl (two) hydromorphone derivant.Naloxone is the clinical excessive and poisoning treatment that is used for the analgesia medicine of opiate receptor pure antagonist.The clinical position person is except that being used for the drug-induced respiration inhibition of antagonism morphine class, and stress diseases such as non-narcotic overdose (ethanol, stable), shock, cerebral infarction, asphyxia of newborn syndrome are tried out, obtain better therapeutic effect, caused domestic and international doctor's very big interest.Naloxone has antagonism to analgesia and the respiration inhibition that analgesia medicine heroin, morphine, codeine, Pethidine etc. cause.Wide clinical application in cerebrovascular accident, ischemic encephalopathy, various stupor, respiration inhibition, craniocerebral injury, various severe crisis, art with diseases such as postoperative cerebral vasospasm.At present China has ratified the listing of naloxone hydrochloride injection, but along with output constantly enlarges, quality problems also occur now and then, and aqueous injection freezes in the north winter, and inconvenience is used, transportation breakage rate height, and these all be to enlarge use to be provided with obstacle.
Summary of the invention
Innovation of the present invention is to overcome the deficiencies in the prior art, provides a kind of convenient transportation, storage period long, stable naloxone injectable powder.
Naloxone injectable powder of the present invention is made up of acceptable injection supplementary material on receivable salt and the pharmacology on naloxone or its physiology, and the content of every bottle of injectable powder naloxone is 0.1mg-10mg (containing end points), and adjuvant is 5mg-40g (containing end points).
The main effective ingredient of this powder pin is a receivable salt on naloxone or its physiology, such as naloxone hydrochloride.
Pharmaceutic adjuvant of the present invention is: the mixture of one or more of aminoacid, glucose, lactose, fructose, maltose, xylitol, phospholipid, sterin, cyclodextrin or derivatives thereof, mannitol, polyvinylpyrrolidone, dextran, sodium chloride, calcium gluconate or phosphate etc.
The present invention is achieved in that the naloxone of getting recipe quantity or naloxone hydrochloride, adjuvant, after the water for injection dissolving, adjusts pH to 3-7, is sub-packed in behind the standardize solution in the lyophilizing bottle, and freeze drying process makes the powder pin routinely.Also can adopt method to obtain aseptic powder earlier, through the aseptic subpackaged finished product that obtains by lyophilization; Perhaps the method with lyophilization or solvent crystal makes sterile bulk drug, mixes the back packing again with aseptic adjuvant and obtains finished product.
Injectable powder convenient transportation of the present invention, storage period is long, and than the aqueous injection good stability of products, the quality height can be mass-produced.
Injectable powder of the present invention can be applied to combined anesthesia medicine postoperative remove respiration inhibition and waken, in the acute alcoholism, cerebrovascular accident, ischemic encephalopathy, stupor, craniocerebral injury, various severe crisis, art with disease such as postoperative cerebral vasospasm.
Embodiment
Further specify the present invention below by specific embodiment, but be not limited to following examples:
1. get naloxone hydrochloride, the adjuvant of recipe quantity, with the water for injection dissolving, adjusting pH is 3.0-7.0, standardize solution, solution through aseptic filtration, is distributed into the solution of every bottle of hydrochloric naloxone 0.4mg or 1mg or 2mg or 4mg in 100 grades of workshops, make the freeze-dried powder finished product by freeze-drying.
At 100 grades being raw material with the naloxone hydrochloride in going to the workshop, add an amount of water, adjuvant, adjusting pH is 3.0-7.0, solution is through aseptic filtration, make aseptic powder by freeze-drying, be distributed into every bottle of hydrochloric naloxone 0.4mg or 1mg or 2mg or 4mg after the pulverizing, roll lid, packing gets product.
3. get naloxone hydrochloride, under 100 grades of conditions, separate out its crystallization with the solvent method, sucking filtration, dry, promptly get the powder pin with aseptic raw material (also available spray drying method), add an amount of aseptic adjuvant, be distributed into every bottle of hydrochloric naloxone 0.4mg or 1mg or 2mg or 4mg behind the mix homogeneously, roll lid, packing gets product.

Claims (4)

1. stable naloxone injectable powder is characterized by and contains the injection supplementary material that receivable salt and pharmacology allow on naloxone or its physiology and form.
2. according to claim 1 described injectable powder, wherein every bottle of powder pin contains the 0.1-10mg naloxone of (containing end points), the adjuvant of 5mg-40g (containing end points).
3. according to claim 1,2 described injectable powder, main effective ingredient is a receivable salt on naloxone or its physiology, such as naloxone hydrochloride.
4. according to claim 1,2 described injectable powder, described injection supplementary material is one or more a mixture of aminoacid, glucose, lactose, fructose, maltose, xylitol, phospholipid, sterin, cyclodextrin or derivatives thereof, mannitol, polyvinylpyrrolidone, dextran, sodium chloride, calcium gluconate or phosphate etc.
CN 200410000003 2004-01-02 2004-01-02 Stable naloxone powder for injection Pending CN1640402A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200410000003 CN1640402A (en) 2004-01-02 2004-01-02 Stable naloxone powder for injection

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 200410000003 CN1640402A (en) 2004-01-02 2004-01-02 Stable naloxone powder for injection

Publications (1)

Publication Number Publication Date
CN1640402A true CN1640402A (en) 2005-07-20

Family

ID=34866593

Family Applications (1)

Application Number Title Priority Date Filing Date
CN 200410000003 Pending CN1640402A (en) 2004-01-02 2004-01-02 Stable naloxone powder for injection

Country Status (1)

Country Link
CN (1) CN1640402A (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10653690B1 (en) 2019-07-09 2020-05-19 Orexo Ab Pharmaceutical composition for nasal delivery
US10729687B1 (en) 2019-07-09 2020-08-04 Orexo Ab Pharmaceutical composition for nasal delivery
US11737980B2 (en) 2020-05-18 2023-08-29 Orexo Ab Pharmaceutical composition for drug delivery
US11957647B2 (en) 2021-11-25 2024-04-16 Orexo Ab Pharmaceutical composition comprising adrenaline
US12303472B2 (en) 2021-11-25 2025-05-20 Orexo Ab Pharmaceutical device for use in intranasal administration

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10653690B1 (en) 2019-07-09 2020-05-19 Orexo Ab Pharmaceutical composition for nasal delivery
US10729687B1 (en) 2019-07-09 2020-08-04 Orexo Ab Pharmaceutical composition for nasal delivery
US10898480B1 (en) 2019-07-09 2021-01-26 Orexo Ab Pharmaceutical composition for nasal delivery
US11883392B2 (en) 2019-07-09 2024-01-30 Orexo Ab Pharmaceutical composition for nasal delivery
US12268684B2 (en) 2019-07-09 2025-04-08 Orexo Ab Pharmaceutical composition for nasal delivery
US11737980B2 (en) 2020-05-18 2023-08-29 Orexo Ab Pharmaceutical composition for drug delivery
US12357573B2 (en) 2020-05-18 2025-07-15 Orexo Ab Pharmaceutical composition for drug delivery
US11957647B2 (en) 2021-11-25 2024-04-16 Orexo Ab Pharmaceutical composition comprising adrenaline
US12303472B2 (en) 2021-11-25 2025-05-20 Orexo Ab Pharmaceutical device for use in intranasal administration
US12472154B2 (en) 2021-11-25 2025-11-18 Orexo Ab Pharmaceutical composition comprising adrenaline

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