CN1640402A - Stable naloxone powder for injection - Google Patents
Stable naloxone powder for injection Download PDFInfo
- 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
Links
- 229960004127 naloxone Drugs 0.000 title claims abstract description 21
- 239000000843 powder Substances 0.000 title claims abstract description 20
- 238000002347 injection Methods 0.000 title claims abstract description 10
- 239000007924 injection Substances 0.000 title claims abstract description 10
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 title abstract 4
- 150000003839 salts Chemical class 0.000 claims abstract description 5
- RGPDIGOSVORSAK-STHHAXOLSA-N naloxone hydrochloride Chemical compound Cl.O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C RGPDIGOSVORSAK-STHHAXOLSA-N 0.000 claims description 24
- 239000002671 adjuvant Substances 0.000 claims description 7
- 229960005250 naloxone hydrochloride Drugs 0.000 claims description 7
- 235000002639 sodium chloride Nutrition 0.000 claims description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
- 230000035479 physiological effects, processes and functions Effects 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 3
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 2
- 229920000858 Cyclodextrin Polymers 0.000 claims description 2
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 2
- 229920002307 Dextran Polymers 0.000 claims description 2
- 229930091371 Fructose Natural products 0.000 claims description 2
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 2
- 239000005715 Fructose Substances 0.000 claims description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims description 2
- 229930195725 Mannitol Natural products 0.000 claims description 2
- 229910019142 PO4 Inorganic materials 0.000 claims description 2
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims description 2
- 235000001014 amino acid Nutrition 0.000 claims description 2
- 150000001413 amino acids Chemical class 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims description 2
- 235000013927 calcium gluconate Nutrition 0.000 claims description 2
- 229960004494 calcium gluconate Drugs 0.000 claims description 2
- 239000004227 calcium gluconate Substances 0.000 claims description 2
- 239000001506 calcium phosphate Substances 0.000 claims description 2
- 235000011010 calcium phosphates Nutrition 0.000 claims description 2
- NEEHYRZPVYRGPP-UHFFFAOYSA-L calcium;2,3,4,5,6-pentahydroxyhexanoate Chemical compound [Ca+2].OCC(O)C(O)C(O)C(O)C([O-])=O.OCC(O)C(O)C(O)C(O)C([O-])=O NEEHYRZPVYRGPP-UHFFFAOYSA-L 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 239000004615 ingredient Substances 0.000 claims description 2
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 2
- 239000008101 lactose Substances 0.000 claims description 2
- 239000000594 mannitol Substances 0.000 claims description 2
- 235000010355 mannitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims description 2
- 150000003904 phospholipids Chemical class 0.000 claims description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 2
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims description 2
- 239000011780 sodium chloride Substances 0.000 claims description 2
- 229930193551 sterin Natural products 0.000 claims description 2
- 239000000811 xylitol Substances 0.000 claims description 2
- 235000010447 xylitol Nutrition 0.000 claims description 2
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims description 2
- 229960002675 xylitol Drugs 0.000 claims description 2
- 230000005764 inhibitory process Effects 0.000 abstract description 6
- 208000026106 cerebrovascular disease Diseases 0.000 abstract description 4
- 201000010099 disease Diseases 0.000 abstract description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract description 4
- 201000006474 Brain Ischemia Diseases 0.000 abstract description 3
- 206010008190 Cerebrovascular accident Diseases 0.000 abstract description 3
- 206010019196 Head injury Diseases 0.000 abstract description 3
- 206010070511 Hypoxic-ischaemic encephalopathy Diseases 0.000 abstract description 3
- 208000006011 Stroke Diseases 0.000 abstract description 3
- 208000030886 Traumatic Brain injury Diseases 0.000 abstract description 3
- 208000007848 Alcoholism Diseases 0.000 abstract description 2
- 206010002091 Anaesthesia Diseases 0.000 abstract description 2
- 230000001154 acute effect Effects 0.000 abstract description 2
- 201000007930 alcohol dependence Diseases 0.000 abstract description 2
- 230000037005 anaesthesia Effects 0.000 abstract description 2
- 206010010071 Coma Diseases 0.000 abstract 1
- 230000001939 inductive effect Effects 0.000 abstract 1
- 239000000463 material Substances 0.000 abstract 1
- 230000000241 respiratory effect Effects 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 7
- 238000004108 freeze drying Methods 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 230000029058 respiratory gaseous exchange Effects 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 3
- 230000036592 analgesia Effects 0.000 description 3
- 230000008485 antagonism Effects 0.000 description 3
- 238000001914 filtration Methods 0.000 description 3
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical class O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 description 3
- 238000012856 packing Methods 0.000 description 3
- 230000002980 postoperative effect Effects 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 208000010513 Stupor Diseases 0.000 description 2
- OROGSEYTTFOCAN-DNJOTXNNSA-N codeine Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)=C[C@H](O)[C@@H]1OC1=C2C3=CC=C1OC OROGSEYTTFOCAN-DNJOTXNNSA-N 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 208000001286 intracranial vasospasm Diseases 0.000 description 2
- 239000002994 raw material Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- 206010003497 Asphyxia Diseases 0.000 description 1
- GVGLGOZIDCSQPN-PVHGPHFFSA-N Heroin Chemical compound O([C@H]1[C@H](C=C[C@H]23)OC(C)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4OC(C)=O GVGLGOZIDCSQPN-PVHGPHFFSA-N 0.000 description 1
- XADCESSVHJOZHK-UHFFFAOYSA-N Meperidine Chemical compound C=1C=CC=CC=1C1(C(=O)OCC)CCN(C)CC1 XADCESSVHJOZHK-UHFFFAOYSA-N 0.000 description 1
- 241001597008 Nomeidae Species 0.000 description 1
- 102000003840 Opioid Receptors Human genes 0.000 description 1
- 108090000137 Opioid Receptors Proteins 0.000 description 1
- 208000005374 Poisoning Diseases 0.000 description 1
- 208000013200 Stress disease Diseases 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
- 229960004126 codeine Drugs 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 229960002069 diamorphine Drugs 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 description 1
- WVLOADHCBXTIJK-YNHQPCIGSA-N hydromorphone Chemical compound O([C@H]1C(CC[C@H]23)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O WVLOADHCBXTIJK-YNHQPCIGSA-N 0.000 description 1
- 229960001410 hydromorphone Drugs 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 229960005181 morphine Drugs 0.000 description 1
- 230000003533 narcotic effect Effects 0.000 description 1
- 230000036407 pain Effects 0.000 description 1
- 229960000482 pethidine Drugs 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 238000010298 pulverizing process Methods 0.000 description 1
- 230000035939 shock Effects 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
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
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.
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)
| 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 |
-
2004
- 2004-01-02 CN CN 200410000003 patent/CN1640402A/en active Pending
Cited By (10)
| 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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