CN1410062A - Sodium rebeilazole for injection use - Google Patents
Sodium rebeilazole for injection use Download PDFInfo
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- CN1410062A CN1410062A CN 02135784 CN02135784A CN1410062A CN 1410062 A CN1410062 A CN 1410062A CN 02135784 CN02135784 CN 02135784 CN 02135784 A CN02135784 A CN 02135784A CN 1410062 A CN1410062 A CN 1410062A
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- sodium
- rabeprazole
- preparation
- rebeilazole
- injection use
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Abstract
A medicine Leibeilazuona for injection contains Leibeilazuona, excipient, pH regulator and antioxidizing agent. It can be used for treating stomach ulcer, duodenal ulcer, erosive gastroesophageal reverse flor disease, pyloric halicobacterium, and zollinger-ellison syndrome. Its advantages are high biological utilization rate and quickly taking its effect.
Description
Technical field:
The present invention relates to the preparation processing field, specifically contain the preparation of RABEPRAZOLE SODIUM.
Background technology:
The chemical constitution of RABEPRAZOLE SODIUM is:
Chemical name: 2-[[[4-(3-methoxy propoxy)-3-methyl-α-pyridine radicals] methyl] sulfinyl-1H-benzimidazole sodium]
RABEPRAZOLE SODIUM (sodium rabeprazole) is a benzimidazole substituent up-to-date behind omeprazole, lansoprazole, potent inhibitor for the most advanced and sophisticated secretion of parietal cell film inner proton pump, RABEPRAZOLE SODIUM suppresses the activity of H+-K+-ATP enzyme specifically, this enzyme is the key enzyme that gastric acid generates, and to basic gastric acid with by the gastric acid secretion that stimulation causes inhibitory action is arranged.RABEPRAZOLE SODIUM is applicable to gastric ulcer, duodenal ulcer, erosive stomach-esophageal reflux disease, helicobacter pylori, zollinger-ellison syndrome.What show clinical practice is sodium rabeprazole enteric-coated and sodium rabeprazole enteric-coated capsule.
RABEPRAZOLE SODIUM is unstable under acidic condition, and is destroyed easily in gastric acid, make enteric coatel tablets or enteric coated capsule after the oral absorption onset slower, and bioavailability is lower.
Summary of the invention
Give full play to for the function that makes RABEPRAZOLE SODIUM treatment gastric ulcer, duodenal ulcer, erosive stomach-esophageal reflux disease, helicobacter pylori, zollinger-ellison syndrome, should select and study and more help the medicine effective ingredient and absorb and accelerate the dosage form that the medicine effective ingredient absorbs.
From pharmacology, pharmacokinetics angle analysis, by muscle or intravenous injection medication, can avoid RABEPRAZOLE SODIUM oral destroyed in gastric acid, can make RABEPRAZOLE SODIUM rapidly by blood absorption or directly enter blood again, improve the concentration of RABEPRAZOLE SODIUM in blood and shorten peak time, utilized by human body rapidly, can reach the purpose of rapid onset and raising bioavailability.But because the character instability of RABEPRAZOLE SODIUM own, in sour environment, destroy easily, its properties of Aqueous Solution is also very unstable, the omeprazole injection of clinical use also often has the variable color situation to take place, because the influence of above factor brings very big difficulty for the formulating and the processing and preparing of such medicine injection preparation, up to the present, the bibliographical information of RABEPRAZOLE SODIUM being processed into injection preparation that success is not also arranged does not more have and can go on the market by practical injection preparation.
In order to make RABEPRAZOLE SODIUM after use, can reach the purpose of rapid onset and raising bioavailability, the invention provides a kind of new preparation that contains RABEPRAZOLE SODIUM, it is active component with the RABEPRAZOLE SODIUM, adding an amount of adjuvant is processed into, can be used for intramuscular injection and intravenous injection, RABEPRAZOLE SODIUM preparation compositions adopted name is---sodium rebeilazole for injection use.
Content of the present invention comprises the prescription and the preparation method of sodium rebeilazole for injection use preparation compositions.
The prescription of the preparation compositions of sodium rebeilazole for injection use of the present invention is as follows:
The active component RABEPRAZOLE SODIUM
Adjuvant comprises excipient
The pH regulator agent
Antioxidant
Each components contents scope of above-mentioned prescription is as follows:
RABEPRAZOLE SODIUM (1～50) part (parts by weight, as follows)
Excipient (10～500) part
PH regulator agent (1～50) part
Antioxidant (1～50) part
Through stability experiment and clinical pharmacology experimental verification, its preferred content range is:
RABEPRAZOLE SODIUM (5～20) part (parts by weight, as follows)
Excipient (50～300) part
PH regulator agent (2～20) part
Antioxidant (1～20) part
Its optimum content scope is:
RABEPRAZOLE SODIUM (8～12) part (parts by weight, as follows)
Excipient (100～200) part
PH regulator agent (4～8) part
Antioxidant (1～10) part
Because RABEPRAZOLE SODIUM is at sour environment or have under the situation that water exists unstable, cause the loss of decomposing rotten and drug effect easily, the inventor thinks after through research, and it is to control mutual usage ratio of RABEPRAZOLE SODIUM and pH regulator agent and the residual moisture of controlling the said preparation dried frozen aquatic products well that thunder injection shellfish of the present invention is drawn the key of azoles preparation of sodium composite formula.
After stability experiment and the research of clinical pharmacology experiment screening, the inventor confirms that in aforementioned sodium rebeilazole for injection use pharmaceutical formulation, the consumption between active component RABEPRAZOLE SODIUM and the pH regulator agent should be controlled at following part by weight:
Its preferred weight ratio is:
RABEPRAZOLE SODIUM: pH regulator agent=(0.25～10): 1
The optimum weight ratio is:
RABEPRAZOLE SODIUM: pH regulator agent=(1～3): 1
The method of moisture is controlled parameters such as cryodesiccated temperature, time and vacuum and is implemented in the control sodium rebeilazole for injection use preparation in preparation process.Sodium rebeilazole for injection use of the present invention, its dried frozen aquatic products moisture Control is≤2.0%.
Its preferred moisture controlling index is≤1.0%.
Its optimum moisture controlling index is≤0.5%.
The said excipient of the prescription of sodium rebeilazole for injection use preparation compositions of the present invention, can select the sodium chloride that is common to the medicine injectable dosage forms, mannitol, dextran etc. for use, through blood vessel irritation experiment and clinical pharmacodynamic experiment and stability experiment, preferred sodium chloride and the mannitol of using, analysis-by-synthesis is the best to select mannitol for use.
The said pH regulator agent of the prescription of sodium rebeilazole for injection use preparation compositions of the present invention, can select the sodium hydroxide, sodium hydrogen phosphate, sodium dihydrogen phosphate, sodium phosphate, the sodium citrate that are common to the medicine injectable dosage forms for use, through blood vessel irritation experiment and clinical pharmacodynamic experiment and stability experiment, preferred sodium hydrogen phosphate, sodium dihydrogen phosphate or the sodium phosphate of using, analysis-by-synthesis is the best to select sodium hydrogen phosphate for use.
The said antioxidant of the prescription of sodium rebeilazole for injection use preparation compositions of the present invention, can select the sodium sulfite, sodium sulfite, sodium metabisulfite, sodium thiosulfate, sodium formaldehyde sulphoxylate, sodium dithionite, 2-hydroxy-2-propane-sulfonic acid sodium salt, the hydroxyl methane sodium sulfate that are common to the medicine injectable dosage forms for use, through blood vessel irritation experiment and clinical pharmacodynamic experiment and stability experiment, preferred sodium sulfite, sodium sulfite and sodium thiosulfate, analysis-by-synthesis is the best to select sodium sulfite for use.
The preparation method of sodium rebeilazole for injection use of the present invention is as follows:
Take by weighing a certain amount of active component RABEPRAZOLE SODIUM by the aforementioned formula consumption, excipient, the pH regulator agent, antioxidant, it is dissolved in the sterile water for injection that is equivalent to 2～10 times of said components gross weights, filtering with microporous membrane through 0.22 μ m, be sub-packed in the vial by the preparation specification requirement, under aseptic condition, carry out lyophilization, pre-freeze-40 ℃～-35 ℃ 5～7 hours, slowly heat up then, and startup vacuum pump, keep vacuum 0.15mmHg in the freeze dryer, about 28～32 hours of low-temperature vacuum drying to the temperature to 0 of freeze dryer shelf ℃, continues to be warming up to 10 ℃ again, continue to keep vacuum 0.1mmHg in the freeze dryer, dry about 2.5～3.5 hours of high-temperature vacuum makes the moisture of dried frozen aquatic products reach standard-required, promptly obtains sodium rebeilazole for injection use.
RABEPRAZOLE SODIUM also can be replaced with the rabeprazole potassio in the above-mentioned prescription.
The sodium rebeilazole for injection use that uses prescription provided by the present invention and preparation method to make can be used for intramuscular injection and intravenous injection.
Rabeprazole sodium powder injection of the present invention has good stability, and can reach the shelf-life more than 2 years, and has avoided the destruction of gastric acid to RABEPRAZOLE SODIUM, has improved bioavailability, has shortened peak time.
Sodium rebeilazole for injection use of the present invention is compared with the enteric coatel tablets (or enteric coated capsule) of prior art, has the following advantages:
1, sodium rebeilazole for injection use of the present invention is rapid-action.RABEPRAZOLE SODIUM 10mg is used in general intravenous injection, RABEPRAZOLE SODIUM blood drug level in the blood reaches peak concentration rapidly, sodium rebeilazole for injection use 10mg is used in intramuscular injection, the peak time of blood drug level is 0.5 hour, is 2 hours and use the peak time of sodium rabeprazole enteric-coated blood drug level of Isodose.
2, sodium rebeilazole for injection use bioavailability height of the present invention, sodium rebeilazole for injection use 10mg is used in general intravenous injection, rabeprazole natremia peak concentration of drug in the blood is 421ug/L, and uses sodium rabeprazole enteric-coated blood drug level peak value of Isodose can only reach 293ug/L.
3, sodium rebeilazole for injection use of the present invention is rapid-action, general intravenous injection uses sodium rebeilazole for injection use 10mg can alleviate the pain that ulcer causes rapidly, general injection back got final product onset in 5～10 minutes, sodium rebeilazole for injection use 10mg is used in intramuscular injection, general injection got final product onset in back 20 minutes, and use sodium rabeprazole enteric-coated of Isodose, just can obviously feel the alleviating of pain after general half an hour.For patients with peptic ulcer, alleviate the pain that ulcer brings rapidly and be very important.
4, sodium rebeilazole for injection use of the present invention is faster to the healing speed of patients with peptic ulcer, and cure rate is also higher.In 1 week, the cure rate of sodium rebeilazole for injection use is 61%, and use sodium rabeprazole enteric-coated cure rate of Isodose is 13%, when 2 weeks, the cure rate of RABEPRAZOLE SODIUM powder pin is 84%, and sodium rabeprazole enteric-coated cure rate is 48%, when 4 weeks, the cure rate of RABEPRAZOLE SODIUM powder pin is 93%, and sodium rabeprazole enteric-coated cure rate is 69%.
5, this preparation is the injection freeze-dried product, and moisture is low, and acid or alkali environment is constant, and stability of formulation improves.The ratio of catabolite is less than 1% in two years.
6, this preparation production technique is simple, and quality is controlled easily.
7, this preparation is easy to carry, stores and transports.
The specific embodiment:
Now the specific embodiment of the present invention is described, sees table 1 for details with embodiment:
Table 1 sodium rebeilazole for injection use embodiment table
| Sequence number | Each constituent content | Moisture (%) | Using dosage (in RABEPRAZOLE SODIUM) | Effect | ||||||||||
| Active component | Excipient | The PH regulator | Antioxidant | 3 months shared percentage ratio of catabolite of accelerated tests | Blood peak concentration of drug (μ g/L) | Cure rate (%) in 2 weeks | ||||||||
| RABEPRAZOLE SODIUM | Sodium chloride | Mannitol | Sodium phosphate | Sodium hydrogen phosphate | Sodium dihydrogen phosphate | Sodium sulfite | Sodium thiosulfate | Sodium sulfite | ||||||
| ??1 | ????5mg | ??50mg | ??—— | ??10mg | ??—— | ?—— | ??—— | ??5mg | ?—— | ????1.7 | ????10mg | ?????3.74 | ?????—— | ????—— |
| ??2 | ????10mg | ??—— | ??100mg | ??—— | ??5mg | ?—— | ??15mg | ??—— | ?—— | ????1.2 | ????10mg | ?????1.44 | ?????—— | ????—— |
| ??3 | ????20mg | ??200mg | ??—— | ??—— | ??10mg | ?—— | ??—— | ??—— | ?20mg | ????1.9 | ????10mg | ?????2.03 | ?????—— | ????—— |
| ??4 | ????8mg | ??—— | ??300mg | ??—— | ??—— | ?5mg | ??—— | ??5mg | ?—— | ????1.5 | ????10mg | ?????1.90 | ?????—— | ????—— |
| ??5 | ????12mg | ??—— | ??200mg | ??—— | ??—— | ?10mg | ??—— | ??—— | ?10mg | ????0.7 | ????10mg | ?????1.97 | ?????—— | ????—— |
| ??6 | ????10mg | ??—— | ??100mg | ??20mg | ??—— | ?—— | ??—— | ??15mg | ?—— | ????0.8 | ????10mg | ?????2.21 | ?????—— | ????—— |
| ??7 | ????10mg | ??—— | ??150mg | ??—— | ??5mg | ?—— | ??10mg | ??—— | ?—— | ????0.3 | ????10mg | ?????0.94 | ?????—— | ????—— |
| ??8 | ????10mg | ??100mg | ??—— | ??—— | ??—— | ?5mg | ??—— | ??15mg | ?—— | ????1.3 | ????10mg | ?????1.57 | ?????—— | ????—— |
| ??9 | ????10mg | ??—— | ??200mg | ??—— | ??5mg | ?—— | ??5mg | ??—— | ?—— | ????0.3 | ????10mg | ?????0.99 | ?????421 | ????84 |
| ??10 | ????10mg | ??—— | ??300mg | ??—— | ??4mg | ?—— | ??3mg | ??—— | ?—— | ????1.2 | ????10mg | ?????1.5 | ?????—— | ????—— |
| ??11 | ????5mg | ??—— | ??300mg | ??—— | ??18mg | ?—— | ??18mg | ??—— | ?—— | ????1.0 | ????10mg | ?????1.2 | ?????—— | ????—— |
| ??12 | ????10mg | ??—— | ??200mg | ??—— | ??10mg | ?—— | ??10mg | ??—— | ?—— | ????0.5 | ????10mg | ?????1.1 | ?????—— | ????—— |
| ??13 | ????10mg | ??—— | ??400mg | ??—— | ??1mg | ?—— | ??2mg | ??—— | ?—— | ????1.5 | ????10mg | ?????1.0 | ?????—— | ????—— |
| Enteric coatel tablets | ??—— | ??—— | ??—— | ??—— | ?—— | ??—— | ??—— | ?—— | ????—— | ????10mg | ?????—— | ?????293 | ????48 | |
| Contrast | Losec (injection) | ??—— | ??—— | ??—— | ??—— | ?—— | ??—— | ??—— | ?—— | ????—— | ????40mg | ?????—— | ?????—— | ????68 |
Claims (13)
1, a kind of preparation that contains RABEPRAZOLE SODIUM is characterized in that with the RABEPRAZOLE SODIUM being active component, can be used for muscle and intravenous sodium rebeilazole for injection use preparation compositions.
2, the preparation that contains RABEPRAZOLE SODIUM according to claim 1 is characterized in that the prescription of said sodium rebeilazole for injection use preparation compositions is as follows:
Active component: RABEPRAZOLE SODIUM
Adjuvant comprises: excipient
The pH regulator agent
Antioxidant
3, the preparation that contains RABEPRAZOLE SODIUM according to claim 1 and 2 is characterized in that each components contents scope of prescription of said sodium rebeilazole for injection use preparation compositions is as follows:
RABEPRAZOLE SODIUM (1～50) part (parts by weight, as follows)
Excipient (10～500) part
PH regulator agent (1～50) part
Antioxidant (1～50) part
4, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that the preferred content scope of each component of prescription of said sodium rebeilazole for injection use preparation compositions is as follows:
RABEPRAZOLE SODIUM (5～20) part (parts by weight, as follows)
Excipient (50～300) part
PH regulator agent (2～20) part
Antioxidant (1～20) part
5, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that the optimum content scope of each component of prescription of said sodium rebeilazole for injection use preparation compositions is as follows:
RABEPRAZOLE SODIUM (8～12) part (parts by weight, as follows)
Excipient (100～200) part
PH regulator agent (4～8) part
Antioxidant (1～10) part
6, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that the preferable amount ratio of RABEPRAZOLE SODIUM and pH regulator agent is in the prescription of said sodium rebeilazole for injection use preparation compositions:
RABEPRAZOLE SODIUM: pH regulator agent=(0.25～10): 1 (part by weight)
7, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that the optimum amount ratio of RABEPRAZOLE SODIUM and pH regulator agent is in the prescription of said sodium rebeilazole for injection use preparation compositions:
RABEPRAZOLE SODIUM: pH regulator agent=(1～3): 1 (part by weight)
8, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that its excipient is selected mannitol or sodium chloride for use in the prescription of said sodium rebeilazole for injection use preparation compositions, with mannitol the best.
9, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that its pH regulator agent is sodium hydrogen phosphate, sodium dihydrogen phosphate or sodium phosphate in the prescription of said sodium rebeilazole for injection use preparation compositions, with sodium hydrogen phosphate the best.
10, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that its antioxidant is sodium sulfite, sodium sulfite or sodium thiosulfate in the prescription of said sodium rebeilazole for injection use preparation compositions, with sodium sulfite the best.
11, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that moisture Control in the said sodium rebeilazole for injection use preparation compositions≤2%, and its selection indicators is≤1%, and optimal parameter is≤0.5%.
12, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that the preparation method of sodium rebeilazole for injection use is as follows:
Take by weighing a certain amount of active component RABEPRAZOLE SODIUM, excipient, pH regulator agent, antioxidant by the prescription consumption, it is dissolved in the sterile water for injection, filtering with microporous membrane through 0.22 μ m, be sub-packed in the vial by the preparation specification requirement, under aseptic condition, carry out lyophilization, pre-freeze-40 ℃～-35 ℃ 5～7 hours, slowly heat up then, about 25～32 hours of low-temperature vacuum drying, continue to be warming up to 10 ℃ again, dry about 2.5～3.5 hours of high-temperature vacuum makes the moisture of dried frozen aquatic products reach standard-required, promptly obtains sodium rebeilazole for injection use.
13, the rabeprazole preparation of sodium that contains according to claim 1 and 2 is characterized in that its active component RABEPRAZOLE SODIUM can replace with the rabeprazole potassio.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02135784 CN1410062A (en) | 2002-11-12 | 2002-11-12 | Sodium rebeilazole for injection use |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02135784 CN1410062A (en) | 2002-11-12 | 2002-11-12 | Sodium rebeilazole for injection use |
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| CN1410062A true CN1410062A (en) | 2003-04-16 |
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| CN 02135784 Pending CN1410062A (en) | 2002-11-12 | 2002-11-12 | Sodium rebeilazole for injection use |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101627996A (en) * | 2009-08-20 | 2010-01-20 | 山东罗欣药业股份有限公司 | Rabeprazole sodium composition and preparation method thereof |
| CN102440967A (en) * | 2010-10-15 | 2012-05-09 | 菏泽步长制药有限公司 | Rabeprazole sodium for injection as well as preparation method and detection method thereof |
| CN102552179A (en) * | 2012-01-13 | 2012-07-11 | 山东罗欣药业股份有限公司 | Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof |
| CN102106829B (en) * | 2009-12-25 | 2013-01-02 | 北京四环科宝制药有限公司 | Sodium rabeprazole freeze-dried powder injection for injection, preparation method thereof and detection method thereof |
-
2002
- 2002-11-12 CN CN 02135784 patent/CN1410062A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101627996A (en) * | 2009-08-20 | 2010-01-20 | 山东罗欣药业股份有限公司 | Rabeprazole sodium composition and preparation method thereof |
| CN101627996B (en) * | 2009-08-20 | 2013-03-27 | 山东罗欣药业股份有限公司 | Rabeprazole sodium composition and preparation method thereof |
| CN102106829B (en) * | 2009-12-25 | 2013-01-02 | 北京四环科宝制药有限公司 | Sodium rabeprazole freeze-dried powder injection for injection, preparation method thereof and detection method thereof |
| CN102440967A (en) * | 2010-10-15 | 2012-05-09 | 菏泽步长制药有限公司 | Rabeprazole sodium for injection as well as preparation method and detection method thereof |
| CN102552179A (en) * | 2012-01-13 | 2012-07-11 | 山东罗欣药业股份有限公司 | Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof |
| CN102552179B (en) * | 2012-01-13 | 2013-06-19 | 山东罗欣药业股份有限公司 | Rabeprazole sodium composite lyophilized injectable powder and preparation method thereof |
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