CN103393633B - Pharmaceutical composition of paclitaxel and ranitidine hydrochloride - Google Patents
Pharmaceutical composition of paclitaxel and ranitidine hydrochloride Download PDFInfo
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- CN103393633B CN103393633B CN201310332958.6A CN201310332958A CN103393633B CN 103393633 B CN103393633 B CN 103393633B CN 201310332958 A CN201310332958 A CN 201310332958A CN 103393633 B CN103393633 B CN 103393633B
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- ranitidine hydrochloride
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Abstract
The invention relates to a pharmaceutical composition of paclitaxel and ranitidine hydrochloride, and especially relates to an application product of the pharmaceutical composition, wherein the application product comprises paclitaxel injection and an injection containing ranitidine hydrochloride. Administration comprises following steps, the injection containing ranitidine hydrochloride is applied firstly by intravenous injection, the paclitaxel injection is dissolved and diluted by normal saline or 5% glucose and sodium chloride solution, and then the diluted paclitaxel injection is applied by intravenous drop infusion.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of paclitaxel and ranitidine hydrochloride, be specifically related to the Combination application packaging of a kind of paclitaxel injection and the injection containing ranitidine hydrochloride, belong to medical art.
Background technology
Paclitaxel is novel breast cancer, by promoting tubulin polymerization, suppresses depolymerization, keeps tubulin to stablize, T suppression cell mitosis.Experiment in vitro proves that paclitaxel has significant radiosensitizing effect, may be to make cell terminate in G2 and M phase to radiotherapy sensitivity.
Paclitaxel belongs to mitotic inhibitor or spindle poison (Spindle poison), different with the chemotherapeutic mechanism of action conventional at present, and it is induction and the assembling promoting microtubule.Paclitaxel has polymerization and the effect of stable microtubule, causes the tumor cell of division to be fast firmly fixed at mitotic stages, cancerous cell is copied blocked and dead.
Be applicable to a line and the second line treatment of ovarian cancer and breast carcinoma and NSCLC.Head and neck cancer, the esophageal carcinoma, spermocytoma, recurrence Fei Hejin lymphomas etc.
But the same with other chemotherapeutics, paclitaxel also can cause series of side effects, such as to neural destruction, myalgia, cardiac toxicity, vomiting, alopecia etc., and it is active poor for multidrug resistance (MDR).Thus, development has lower side effect, the pharmacokinetic property of improvement and still keep the cancer therapy drug of anticancer therapeutic to be always the study hotspot of domestic and international pharmaceutical science man for multidrug resistance cell.
But paclitaxel also has significant toxic and side effects, be mainly bone marrow depression and neurotoxicity, arthralgia, myalgia occur for often 2 ~ 3 days after medication, and GPT raises and accounts for 33%, and alopecia sees all patients, often betides and controls latter 12nd ~ 21 days.
Ranitidine hydrochloride is bisfentidine, the imidazole ring of cimetidine is instead of with furan nucleus, to H2 receptor, there is higher selectivity, can significantly suppress normal person and ulcer patient basis and night gastric acid secretion, and the gastric acid secretion that pentagastrin, histamine and dining cause, tiring of its gastric acid secretion inhibiting is 5 ~ 12 times of cimetidine by mol.Quiet note ranitidine hydrochloride can make gastric acid secretion reduce by 90%; Certain inhibitory action is had to the secretion of pepsinogen.Protective effect is had to experimental gastric mucosa injury and acute ulcer.On the secretion of gastrin and gonadal hormone without impact.
Ranitidine hydrochloride be mainly used in 1. digestive ulcerative bleeding, diffusivity gastric mucosal lesion is hemorrhage, stoma ulcer is hemorrhage, it is hemorrhage etc. to prevent after stomach operation again; 2. concurrent during stress state acute gastric mucosal lesion and aspirin caused acute gastric mucosal lesion; Also the generation preventing stress ulcer with bleeding under seriously disease (as cerebral hemorrhage, severe trauma etc.) stress state is usually used in; 3. after general anesthesia or major operation and weak comatose patient prevent from regurgitation of gastric juice from merging inhaling human nature pneumonia.
Ranitidine, untoward reaction has constipation, nausea and vomiting, inappetence, abnormal pulmonary function, allergy, weak, headache etc.
Prior art instructed paclitaxel can with ranitidine conbined usage, but both share and the clinical application defect of the side effect of unresolved respective existence.。
Summary of the invention
In order to overcome the series of problems existed in prior art, the present inventor has creatively found to adopt the paclitaxel injection of particular excipient and the use in conjunction of ranitidine injection, not only completely solve water solublity and the stability problem of paclitaxel, facilitate clinical application, and because the paclitaxel injection adopting particular excipient to prepare unexpectedly also solves the existing part side effect defect of ranitidine, enhance drug safety.
An object of the present invention, provide the pharmaceutical composition of a kind of paclitaxel and ranitidine hydrochloride, wherein, paclitaxel is selected from the injection of sterile freeze-drying preparation or aseptic parenteral solution, and ranitidine hydrochloride is be selected from the sterile freeze-drying preparation of ranitidine hydrochloride or the injection of aseptic parenteral solution.
An object of the present invention, provide the pharmaceutical composition of a kind of paclitaxel injection and ranitidine hydrochloride, wherein, paclitaxel injection is sterile freeze-drying preparation or aseptic parenteral solution, and ranitidine hydrochloride is sterile freeze-drying preparation containing ranitidine hydrochloride or aseptic parenteral solution.
An object of the present invention, provide the Combination application packaging of a kind of paclitaxel injection and ranitidine hydrochloride, wherein, paclitaxel injection is sterile freeze-drying preparation or aseptic parenteral solution, and ranitidine hydrochloride is sterile freeze-drying preparation containing ranitidine hydrochloride or aseptic parenteral solution.
Combination application provided by the invention packaging, usage is: quiet note ranitidine hydrochloride 50mg before paclitaxel treatment, then by paclitaxel normal saline or 5% glucose saline dissolved dilution, quiet 3 hours.
Combination application packing specification provided by the invention is paclitaxel injection 5ml:30mg or 10ml:60mg or 16.7ml:100mg or 25ml:150mg or 30mg, ranitidine hydrochloride injection 2ml:50mg or 5ml:50mg or 100ml: ranitidine 0.1g and sodium chloride 0.9g or 250ml: ranitidine 0.1g and sodium chloride 2.25g or 50mg or 100mg.
Paclitaxel injection of the present invention, for comprising injection paclitaxel and paclitaxel injection, adds for paclitaxel sterile freeze-drying preparation that appropriate amount of auxiliary materials makes or adds the formulated aseptic parenteral solution of appropriate amount of auxiliary materials.
As one of specific embodiment, the concrete component of paclitaxel injection and consumption as follows:
Present invention also offers a kind of preparation method of paclitaxel injection, concrete steps are:
(1) first in material-compound tank, add recipe quantity propylene glycol, PVP K30 and span 20, be uniformly mixed;
(2) add the paclitaxel of recipe quantity, stirring and dissolving is complete, adds water for injection to 90% of total amount, regulates pH to be 3.0-5.0 with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution;
(3) add total amount 0.05%(g/ml) injection-use activated carbon, add residue water for injection, standardize solution, stirring and adsorbing 30 minutes;
(4) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(5) fill, sealing, sterilizing, obtains paclitaxel injection.
Ranitidine hydrochloride injection of the present invention is sterile freeze-drying preparation containing ranitidine hydrochloride or aseptic parenteral solution.
As one of specific embodiment, the concrete component of Ranitidine hydrochloride injection and consumption as follows:
Present invention also offers a kind of preparation method of Ranitidine hydrochloride injection, concrete steps are:
(1) in material-compound tank, first add the water for injection of recipe quantity 80%;
(2) add ranitidine hydrochloride and other adjuvants of recipe quantity, stirring and dissolving is complete, regulates pH to be 6.8-7.2 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution;
(3) add total amount 0.05%(g/ml) injection-use activated carbon, add residue water for injection, standardize solution, stirring and adsorbing 30 minutes;
(4) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(5) fill, sealing, sterilizing, obtains Ranitidine hydrochloride injection.
As one of specific embodiment, the concrete component of hydrochloride for injection ranitidine and consumption as follows:
Present invention also offers a kind of preparation method of hydrochloride for injection ranitidine, concrete steps are:
(1) in material-compound tank, first add the water for injection of recipe quantity 80%;
(2) add ranitidine hydrochloride and other adjuvants of recipe quantity, stirring and dissolving is complete, regulates pH to be 6.8-7.2 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution;
(3) add total amount 0.05%(g/ml) injection-use activated carbon, add residue water for injection, standardize solution, stirring and adsorbing 30 minutes;
(4) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(5) fill, lyophilization, obtains hydrochloride for injection ranitidine.
The Combination application that present invention also offers a kind of paclitaxel injection and ranitidine hydrochloride injection is packaged in a line and the second line treatment of ovarian cancer and breast carcinoma and NSCLC, head and neck cancer, the esophageal carcinoma, spermocytoma, the application in recurrence Fei Hejin lymphomas etc.Paclitaxel plus ranitidine hydrochloride uses, and can prevent anaphylaxis occurs.
Detailed description of the invention
embodiment 1the preparation of paclitaxel injection
Prescription:
Preparation process
(1) first add 2000ml propylene glycol, 250ml PVP K30 and 30g span 20 in a reservoir, be uniformly mixed;
(2) add 30g paclitaxel, stirring and dissolving is complete, adds water for injection to 4500ml, regulates pH to be 4.6 with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution;
(3) add 2.5g injection-use activated carbon, add residue water for injection, be settled to 5000ml, stirring and adsorbing 30 minutes;
(4) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(5) fill, 5ml/ props up, and sealing, sterilizing, obtains paclitaxel injection
comparative example 1the preparation of paclitaxel injection
Prescription:
Preparation process
(1) first add 2000ml ethanol, 250ml PEG400 and 30g Tween 80 in a reservoir, be uniformly mixed;
(2) add 30g paclitaxel, stirring and dissolving is complete, adds water for injection to 4500ml, regulates pH to be 4.6 with 1mol/L sodium hydroxide solution or 1mol/L hydrochloric acid solution;
(3) add 2.5g injection-use activated carbon, add residue water for injection, be settled to 5000ml, stirring and adsorbing 30 minutes;
(4) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(5) fill, 5ml/ props up, and sealing, sterilizing, obtains paclitaxel injection.
embodiment 3the preparation of Ranitidine hydrochloride injection
Prescription:
Preparation process
(1) first 1600ml water for injection is added in a reservoir; Add 50g ranitidine hydrochloride and 11.32g sodium hydrogen phosphate and 6.44g sodium dihydrogen phosphate, stirring and dissolving is complete, regulates pH to be 6.9 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution; Add 1.0g injection-use activated carbon, add residue water for injection, be settled to 2000ml, stirring and adsorbing 30 minutes; Solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters; Fill, 2ml/ props up, and sealing, sterilizing, obtains Ranitidine hydrochloride injection.
(2) first 4000ml water for injection is added in a reservoir; Add 50g ranitidine hydrochloride and 11.32g sodium hydrogen phosphate and 6.44g sodium dihydrogen phosphate, stirring and dissolving is complete, regulates pH to be 7.0 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution; Add 2.5g injection-use activated carbon, add residue water for injection, be settled to 5000ml, stirring and adsorbing 30 minutes; Solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters; Fill, 5ml/ props up, and sealing, sterilizing, obtains Ranitidine hydrochloride injection.
(3) first in Agitation Tank, 80L water for injection is added; Add 100g ranitidine hydrochloride, 900g sodium chloride and 22.64g sodium hydrogen phosphate and 12.88g sodium dihydrogen phosphate, stirring and dissolving is complete, regulates pH to be 6.8 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution; Add 50g injection-use activated carbon, add residue water for injection, be settled to 100L, stirring and adsorbing 30 minutes; Solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters; Fill, 100ml/ bottle, sealing, sterilizing, obtains Ranitidine hydrochloride injection.
(4) first in Agitation Tank, 200L water for injection is added; Add 100g ranitidine hydrochloride, 2250g sodium chloride and 22.64g sodium hydrogen phosphate and 12.88g sodium dihydrogen phosphate, stirring and dissolving is complete, regulates pH to be 7.1 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution; Add 125g injection-use activated carbon, add residue water for injection, be settled to 250L, stirring and adsorbing 30 minutes; Solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters; Fill, 250ml/ bottle, sealing, sterilizing, obtains Ranitidine hydrochloride injection.
embodiment 4the preparation of hydrochloride for injection ranitidine
Prescription:
Preparation process
(1) first 4800ml water for injection is added in a reservoir;
(2) add 150g ranitidine hydrochloride, 450g mannitol, 33.96g sodium hydrogen phosphate and 19.32g sodium dihydrogen phosphate, stirring and dissolving is complete, regulates pH to be 7.0 with 1mol/L sodium hydroxide solution or 1mol/L phosphoric acid solution;
(3) add 3g injection-use activated carbon, add residue water for injection, standardize solution 6000ml, stirring and adsorbing 30 minutes;
(4) solution coarse filtration takes off charcoal, through 0.45 μm of cartridge filter coarse filtration, then uses 0.22 μm of microporous filter membrane aseptic filtration qualified to visible foreign matters;
(5) fill, 2ml/ bottle or 4ml/ bottle, lyophilization, obtains hydrochloride for injection ranitidine.
embodiment 5the preparation of assembly packaging medicine
Combination 1: paclitaxel injection 5ml:30mg and Ranitidine hydrochloride injection 2ml:50mg.
Combination 2: paclitaxel injection 5ml:30mg and Ranitidine hydrochloride injection 5ml:50mg.
Combination 3: paclitaxel injection 5ml:30mg and Ranitidine hydrochloride injection 100ml:0.1g.
Combination 4: paclitaxel injection 5ml:30mg and Ranitidine hydrochloride injection 250ml:0.1g.
Combination 5: paclitaxel injection 5ml:30mg and hydrochloride for injection ranitidine freeze-dried powder 50mg.
Combination 6: paclitaxel injection 5ml:30mg and hydrochloride for injection ranitidine freeze-dried powder 100mg.
Test example 1 pharmacology irritant test
Get the New Zealand Journal of Health Physical Education doe 24 of body weight 2.0-2.5kg, be divided into six groups at random.New zealand rabbit is placed in holder, first group of abdominal part hypodermic embodiment of the present invention 5 combines the medicine of 1, second group of abdominal part hypodermic embodiment of the present invention 5 combines the medicine of 2, 3rd group of abdominal part hypodermic embodiment of the present invention 5 combines the medicine of 5, 4th group of abdominal part hypodermic embodiment of the present invention 5 combines the medicine of 6, the injection paclitaxel of the 5th group of same specification of the abdominal part hypodermic embodiment of the present invention 1, the paclitaxel injection of the 6th group of same specification of the abdominal part hypodermic embodiment of the present invention 2, every new zealand rabbit injection 3ml, during injection and after injection, note observing injection site with or without redness, congested, the stimulation such as hemorrhage and downright bad.In last administration after 24 hours, by sacrifice of animal, drawn materials in injection site, carry out histopathologic examination.
Result of the test:
Perusal: six groups all do not occur the irritant reaction such as obvious redness, hyperemia, necrosis.
Pathological examination: six groups of skin texture are normal, and epidermis is without thickening, and subcutaneous tissue has no the morphological changes such as hyperemia, edema, has no the changes such as inflammatory cell infiltration.
Conclusion: assembly packaging product of the present invention relative to the effect of one-component application of stimulus without obvious increase.
Test example 2 clinical effect trial
Choose patient 160 example of certain hospital's breast cancer treatment, be divided into eight groups at random, often organize 20 examples.
First group of intravenous injection injection paclitaxel 30mg, once a day;
Second group of intravenous injection paclitaxel injection 5ml:30mg, once a day;
3rd group of intravenous injection injection paclitaxel 30mg+ Ranitidine hydrochloride injection 5ml:50mg, once a day;
4th group of intravenous injection paclitaxel injection 5ml:30mg+ Ranitidine hydrochloride injection 5ml:50mg, once a day;
5th group of intravenous injection injection paclitaxel 30mg+ hydrochloride for injection ranitidine 50mg, once a day;
6th group of intravenous injection paclitaxel injection 5ml:30mg+ hydrochloride for injection ranitidine 50mg, once a day;
The paclitaxel injection 5ml:30mg(Zhejiang Province Jiuxu Pharmaceutical Co., Ltd that 7th group of intravenous injection is commercially available, lot number 120102)+hydrochloride for injection ranitidine 50mg, once a day;
Paclitaxel injection 5ml:30mg+ hydrochloride for injection ranitidine 50mg prepared by the 8th group of intravenous injection comparative example 1, once a day;
Continuous use 6 days.Efficacy result is as following table:
The clinical effectiveness of table 1 eight groups of patients
| Group | Number of cases | Effective | Effectively | Invalid | Total effective rate |
| First group | 20 | 10 | 2 | 8 | 60% |
| Second group | 20 | 9 | 3 | 8 | 60% |
| 3rd group | 20 | 13 | 5 | 2 | 90% |
| 4th group | 20 | 12 | 4 | 4 | 80% |
| 5th group | 20 | 13 | 4 | 3 | 85% |
| 6th group | 20 | 15 | 2 | 3 | 85% |
| 7th group | 20 | 11 | 3 | 6 | 70% |
| 8th group | 20 | 12 | 3 | 5 | 75% |
The untoward reaction of table 2 eight groups of patients
| Group | Number of cases | Arthralgia, myalgia | Constipation | Nausea and vomiting | Amount to |
| First group | 20 | 8 | 3 | 4 | 15 |
| Second group | 20 | 9 | 2 | 5 | 16 |
| 3rd group | 20 | 2 | 3 | 2 | 7 |
| 4th group | 20 | 3 | 2 | 1 | 6 |
| 5th group | 20 | 2 | 2 | 3 | 7 |
| 6th group | 20 | 1 | 3 | 2 | 6 |
| 7th group | 20 | 4 | 2 | 3 | 9 |
| 8th group | 20 | 3 | 5 | 2 | 10 |
Can be found out by above result, the total effective rate the 3rd group to the 6th group of eight groups of patients is apparently higher than first group, second group, the 7th group and the 8th group, and untoward reaction the 3rd group to the 6th group is starkly lower than first group, second group, the 7th group and the 8th group; The paclitaxel injection of particular excipient proportioning of the present invention is described and ranitidine hydrochloride share the better efficacy than the combination being used alone other paclitaxel injections and ranitidine hydrochloride in paclitaxel injection and prior art and side effect is lower.
Claims (2)
1. pack containing the Combination application of paclitaxel aseptic parenteral solution and ranitidine hydrochloride aseptic parenteral solution for one kind, it is characterized in that,
Wherein, paclitaxel aseptic parenteral solution is made up of following composition:
Wherein, ranitidine hydrochloride aseptic parenteral solution is made up of following composition:
2. one kind contains the Combination application packaging of the sterile freeze-drying preparation of paclitaxel aseptic parenteral solution and ranitidine hydrochloride, and it is characterized in that: wherein, paclitaxel aseptic parenteral solution is made up of following composition:
Wherein, the sterile freeze-drying preparation of ranitidine hydrochloride is made up of following composition:
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101485652A (en) * | 2009-02-25 | 2009-07-22 | 北京世纪博康医药科技有限公司 | Composition of taxone compound, and preparation method and application thereof |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101485652A (en) * | 2009-02-25 | 2009-07-22 | 北京世纪博康医药科技有限公司 | Composition of taxone compound, and preparation method and application thereof |
Non-Patent Citations (2)
| Title |
|---|
| 《周剂量紫杉醇同步放疗治疗中晚期贲门癌》;潘雪峰 张凤祥;《实用医学杂志》;20101031;第27卷(第10期);第903页左栏第1.2节 * |
| 系本刊资料,无作者.《紫杉醇注射液(紫素)》.《中国药学杂志》.1996,第31卷(第8期),第505页. * |
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