CN1823768A - Cimetidine freeze dried composition - Google Patents
Cimetidine freeze dried composition Download PDFInfo
- Publication number
- CN1823768A CN1823768A CN 200610000608 CN200610000608A CN1823768A CN 1823768 A CN1823768 A CN 1823768A CN 200610000608 CN200610000608 CN 200610000608 CN 200610000608 A CN200610000608 A CN 200610000608A CN 1823768 A CN1823768 A CN 1823768A
- Authority
- CN
- China
- Prior art keywords
- cimetidine
- acid
- injection
- consumption
- mannitol
- 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
Abstract
A freeze-dried powder injection with high solubility and stability contains cimetidine, freeze-dried powder supporting agent and pH regulator.
Description
Technical field
The present invention relates to comprise the pharmaceutical composition of cimetidine, specifically, relate to contain the lyophilized medication composition and method of making the same of cimetidine.
Background technology
Cimetidine has another name called cimetidine, is first kind of bisfentidine.1974 synthetic by Britain Di Langte (Durant), U.S. SmithKline (Smith Kline; French) company's exploitation, listing in 1977, more than 100 countries use is widely used in the treatment ulcer of upper digestive tract in the world, and the existing millions of patient in the whole world obtains satisfied curative effect, also is the medicine of present most widely used treatment Peptic Ulcers.Cimetidine is H
2Receptor blocking agent mainly acts on H on the parietal cell
2Receptor plays the effect of competitive inhibition histamine, suppresses basal gastric acid secretion, also suppresses by gastric acid secretions that stimulation stimulated such as food, histamine gastrin, caffeine and insulins.Injection 300mg after 4～5 hours, suppresses basal gastric acid secretion and can reach 80%, can suppress basal gastric acid secretion and reach 4～5 hours.Be distributed widely in after this product absorbs in the body tissue except that brain, can see through placental barrier, this product concentration can be higher than plasma concentration in the milk.Protein binding rate is 15%～20%, and part is at the liver intracellular metabolite, and metabolite is sulfoxide and methylol cimetidine, mainly through renal excretion.About 75% of injection volume discharges from kidney with original shape after 24 hours; 10% can discharge from feces.Can remove through the blood dialysis.Renal function is t just often
1/2Be 2 hours, creatinine clearance rate was at 20～50ml/ minute person its half-life (t
1/2) be 2.9 hours, be 3.7 hours during＜20ml/ minute person, the renal insufficiency person is 5 hours.Because it uses convenience, low price, the medicine source is abundant, side effect is little, has both become a line clinical application that is used for the treatment of ulcer of upper digestive tract.
The dosage form of present domestic listing has conventional tablet, slow releasing tablet, chewable tablet, capsule, injection (little liquid drugs injection, infusion solutions).Cimetidine is made freeze-dried powder, and its stability is compared with liquid drugs injection and is significantly increased, and is convenient to accumulating, has guaranteed clinical application safety.
Summary of the invention
The present invention gropes through overtesting, is developed into the injection cimetidine, has improved stability of formulation, has guaranteed clinical application safety.
Pharmaceutic adjuvant in the present composition includes but not limited to (cimetidine is by 1 part of calculating):
A. proppant:
Mannitol: consumption is 0～2 part;
Dextran: consumption is 5～15 parts;
Sorbitol: consumption is 8～30 parts;
Glucose: consumption is 0～10 part;
Preferred mannitol, 0～2 part.
The b.pH regulator:
Citric acid: consumption is 0.1～0.5 part;
Lactic acid: consumption is 0.01～0.2 part;
Malic acid: consumption is 0.1～0.3 part;
Gluconic acid: consumption is 0.1～0.5 part;
Succinic acid: consumption is 0.1～0.4 part;
Fumaric acid: consumption is 0.05～0.3 part;
Ascorbic acid: consumption is 0.05～0.4 part;
Optimization citric acid, consumption are 0.1～0.5 part;
The preparation technology of freeze-dried composition of the present invention is: the pH regulator agent of weighing recipe quantity is put in the container, adds the water for injection of 60～80% amounts, stirring and dissolving; The cimetidine and the proppant of recipe quantity are added in the above-mentioned solution, be stirred to dissolving after.Be heated to 60 ℃ of insulations, add the active carbon of 0.2% (g/ml), stirring and evenly mixing, static absorption is after 20 minutes, filter carbon removal, benefit adds to the full amount of water for injection, fine straining, the intermediate sampling, to be detected qualified after, quantitatively (about 3ml) fill in cillin bottle, half moulding plug, the freeze dryer of packing into, lyophilization.After the end to be dried, the intrinsic pressure plug of case, outlet lock aluminium lid, packing is promptly.
Cimetidine freeze dried composition of the present invention is suitable for using clinically.Before use, can add an amount of aseptic medicinal aqueous diluent (for example, water for injection, normal saline, G/W and other known aqueous carriers), be reconstructed into for intramuscular injection or intravenous solution.
Following examples are intended to further specify the present invention, scope of the present invention are not limited.
The specific embodiment
Embodiment 1:
(1) prescription
Cimetidine 400g
Mannitol 40g
Malic acid 150g
Water for injection adds to 3000ml
1000 bottles
(2) preparation method
The malic acid of weighing recipe quantity is put in the container, adds the water for injection of 80% amount, stirring and dissolving; The cimetidine and the mannitol of recipe quantity are added in the above-mentioned solution, be stirred to dissolving after.Be heated to 60 ℃ of insulations, add the active carbon of 0.2% (g/ml), stirring and evenly mixing, static absorption is after 20 minutes, filter carbon removal, benefit adds to the full amount of water for injection, fine straining, the intermediate sampling, to be detected qualified after, quantitatively (about 3m1) fill in cillin bottle, half moulding plug, the freeze dryer of packing into, lyophilization.After the end to be dried, the intrinsic pressure plug of case, outlet lock aluminium lid, packing is promptly.
Embodiment 2:
(1) prescription
Cimetidine 400g
Citric acid 130g
Water for injection adds to 3000ml
1000 bottles
(2) preparation method
The citric acid of weighing recipe quantity is put in the container, and it is about 70% to add the injection water, stirring and dissolving; The cimetidine of recipe quantity is added in the above-mentioned solution, be stirred to cimetidine dissolving after.Be heated to 60 ℃ of insulations, add the active carbon of 0.2% (g/ml), stirring and evenly mixing, static absorption is after 20 minutes, filter carbon removal, benefit adds to the full amount of water for injection, fine straining, the intermediate sampling, to be detected qualified after, quantitatively (about 3ml) fill in cillin bottle, half moulding plug, the freeze dryer of packing into, lyophilization.After the end to be dried, the intrinsic pressure plug of case, outlet lock aluminium lid, packing is promptly.
Embodiment 3:
(1) prescription
Cimetidine 400g
Mannitol 10g
Citric acid 100g
Water for injection adds to 3000ml
1000 bottles
(2) preparation method
The citric acid of weighing recipe quantity is put in the container, adds the water for injection of 80% amount, stirring and dissolving; The cimetidine and the mannitol of recipe quantity are added in the above-mentioned solution, be stirred to dissolving after.Be heated to 60 ℃ of insulations, add the active carbon of 0.2% (g/ml), stirring and evenly mixing, static absorption is after 20 minutes, filter carbon removal, benefit adds to the full amount of water for injection, fine straining, the intermediate sampling, to be detected qualified after, quantitatively (about 3ml) fill in cillin bottle, half moulding plug, the freeze dryer of packing into, lyophilization.After the end to be dried, the intrinsic pressure plug of case, outlet lock aluminium lid, packing is promptly.
More than described the preferred embodiment for the present invention, so it is not in order to limit the present invention.Those skilled in the art can not depart from the improvement of category of the present invention and spirit to embodiment disclosed herein.
Claims (4)
1, a kind of injection freeze-drying medicinal composition is comprising cimetidine and lyophilized powder proppant and pH regulator agent.The parts by weight of each component are 1 part of cimetidine, 0～30 part of lyophilized powder proppant, 0.01～1 part of pH regulator agent.
2, compositions as claimed in claim 1, wherein the lyophilized powder proppant is selected from: mannitol, sorbitol, dextran, glucose, preferred mannitol, by 1 part, the consumption of mannitol is 0～2 part to its consumption in cimetidine.
3, compositions as claimed in claim 1, wherein the pH regulator agent is selected from: contain citric acid, lactic acid, malic acid, gluconic acid, succinic acid, fumaric acid, ascorbic acid in the present composition, by 1 part, the consumption of citric acid is 0.1～0.5 part in cimetidine for optimization citric acid, its consumption.
4, the preparation method of injection freeze-dried composition as claimed in claim 1 is characterized by: the pH regulator agent of weighing recipe quantity is put in the container, adds the water for injection of 60～80% amounts, stirring and dissolving; The cimetidine and the proppant of recipe quantity are added in the above-mentioned solution, be stirred to dissolving after.Be heated to 60 ℃ of insulations, add the active carbon of 0.2% (g/ml), stirring and evenly mixing, static absorption is after 20 minutes, filter carbon removal, benefit adds to the full amount of water for injection, fine straining, the intermediate sampling, to be detected qualified after, quantitatively (about 3ml) fill in cillin bottle, half moulding plug, the freeze dryer of packing into, lyophilization.After the end to be dried, the intrinsic pressure plug of case, outlet lock aluminium lid, packing is promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610000608 CN1823768A (en) | 2006-01-09 | 2006-01-09 | Cimetidine freeze dried composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610000608 CN1823768A (en) | 2006-01-09 | 2006-01-09 | Cimetidine freeze dried composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1823768A true CN1823768A (en) | 2006-08-30 |
Family
ID=36934711
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610000608 Pending CN1823768A (en) | 2006-01-09 | 2006-01-09 | Cimetidine freeze dried composition |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1823768A (en) |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102349895A (en) * | 2011-09-28 | 2012-02-15 | 海南良方医药有限公司 | Cimetidine composition for injection and preparation method thereof |
| CN102670496A (en) * | 2012-05-25 | 2012-09-19 | 鼎正动物药业（天津）有限公司 | Cimetidine injection and preparation process |
| CN103330707A (en) * | 2013-06-27 | 2013-10-02 | 海南卫康制药(潜山)有限公司 | Cimetidine composition for injection |
| CN109431982A (en) * | 2018-11-27 | 2019-03-08 | 山西诺成制药有限公司 | A kind of cimetidine in sodium chloride injection production method preventing contaminant overstandard |
| CN110623923A (en) * | 2019-10-22 | 2019-12-31 | 江苏恒丰强生物技术有限公司 | Cimetidine sodium chloride injection for dogs and preparation method thereof |
| JP2020203956A (en) * | 2013-09-11 | 2020-12-24 | イーグル バイオロジクス， インコーポレイテッド | Liquid protein formulations containing viscosity-lowering agents |
| CN112353799A (en) * | 2021-01-06 | 2021-02-12 | 福安药业集团湖北人民制药有限公司 | Cimetidine composition for injection and preparation method and application thereof |
-
2006
- 2006-01-09 CN CN 200610000608 patent/CN1823768A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102349895A (en) * | 2011-09-28 | 2012-02-15 | 海南良方医药有限公司 | Cimetidine composition for injection and preparation method thereof |
| CN102349895B (en) * | 2011-09-28 | 2013-04-10 | 海南良方医药有限公司 | Cimetidine composition for injection and preparation method thereof |
| CN102670496A (en) * | 2012-05-25 | 2012-09-19 | 鼎正动物药业（天津）有限公司 | Cimetidine injection and preparation process |
| CN103330707A (en) * | 2013-06-27 | 2013-10-02 | 海南卫康制药(潜山)有限公司 | Cimetidine composition for injection |
| JP2020203956A (en) * | 2013-09-11 | 2020-12-24 | イーグル バイオロジクス， インコーポレイテッド | Liquid protein formulations containing viscosity-lowering agents |
| JP7214697B2 (en) | 2013-09-11 | 2023-01-30 | イーグル バイオロジクス， インコーポレイテッド | Liquid protein formulation containing a viscosity-lowering agent |
| CN109431982A (en) * | 2018-11-27 | 2019-03-08 | 山西诺成制药有限公司 | A kind of cimetidine in sodium chloride injection production method preventing contaminant overstandard |
| CN110623923A (en) * | 2019-10-22 | 2019-12-31 | 江苏恒丰强生物技术有限公司 | Cimetidine sodium chloride injection for dogs and preparation method thereof |
| CN112353799A (en) * | 2021-01-06 | 2021-02-12 | 福安药业集团湖北人民制药有限公司 | Cimetidine composition for injection and preparation method and application thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN1823768A (en) | Cimetidine freeze dried composition | |
| CN101095942B (en) | Formulation of the Exendin injection medicine containing stabilizing agent | |
| CN102525963B (en) | Netilmicin sulfate lyophiled powder injection and preparation method thereof | |
| CN1259041C (en) | Bromhexine Hydrochloride aseptic freeze-drying formulation for injection and its preparation method | |
| CN1830440A (en) | Metronidazule injection and its preparation method and use | |
| CN109481459B (en) | Compound electrolyte glucose injection and preparation method thereof | |
| CN1429558A (en) | Mannosan peptide injection and its preparation and use method | |
| CN1526404A (en) | Antitumor ginsenoside C-K injection and its prepn process | |
| CN1864666A (en) | Lyophilized powder injection of levofloxacin mesylate and preparation method thereof | |
| CN1903846B (en) | Ornidazole derivative used for therapy, its preparation method and use | |
| CN112353799A (en) | Cimetidine composition for injection and preparation method and application thereof | |
| CN1679542A (en) | Frozen powder injection of silybin and its preparing method | |
| CN103083322A (en) | Medicinal composition containing injection cefmenoxime hydrochloride and compound amino acid injection | |
| CN101269215B (en) | Glucoprotein incretion composition | |
| CN1176658C (en) | Aseptic freeze-dried prostaglandin injection and its preparing method and use | |
| CN102813631B (en) | Method for preparing phentolamine mesilate freeze-drying powder injection | |
| CN1442138A (en) | Fukangzuo injection fluid and its preparation method | |
| CN1730014A (en) | Novel drug administration route of semen armeniacae amarum injection, its preparation process and new indications | |
| CN1565446A (en) | Freeze-drying fluconazole injection and its preparation method | |
| CN1850097A (en) | Scutellarin injection preparation and its preparing method | |
| CN1895253A (en) | Lomesaline hydrochloride eye drops and preparation thereof | |
| CN1839811A (en) | Lomustine liposome freeze-drying powder injection and its preparation method | |
| CN102757471A (en) | Novel active cytidine disodium triphosphate compound and pharmaceutical composition thereof | |
| CN103315970A (en) | Ranitidine hydrochloride powder injection for injection | |
| CN1526407A (en) | Antitumor protopanoxadiol injection and its prepn process |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |