CN105055424A - Anti-infective medicinal cefotiam hydrochloride composition - Google Patents
Anti-infective medicinal cefotiam hydrochloride composition Download PDFInfo
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- CN105055424A CN105055424A CN201510589896.6A CN201510589896A CN105055424A CN 105055424 A CN105055424 A CN 105055424A CN 201510589896 A CN201510589896 A CN 201510589896A CN 105055424 A CN105055424 A CN 105055424A
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- cefotiam hydrochloride
- cefotiam
- sodium chloride
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Abstract
The invention relates to an anti-infective medicinal cefotiam hydrochloride composition, and belongs to the technical field of medicines. The composition consists of cefotiam hydrochloride and sodium chloride; the cefotiam hydrochloride is crystals; an X-ray powder diffraction pattern obtained by measuring the crystals by using Cu-K alpha rays is shown as figure 1. The new crystal form of the cefotiam hydrochloride provided by the invention is different from the crystal form structure in the prior art; through experimental verification, people surprisingly find that the crystal compound is high in purity, high in mobility, high in stability and low in polymer content, and does not have hygroscopicity; after prepared powder-injection is matched with 0.9 percent sodium chloride injection, 5 percent dextrose injection, and 5 percent sodium chloride and dextrose injection and is then placed for 4 hours, the stability of the solution is high.
Description
Technical field
The invention belongs to medical art, relate to a kind of anti-infectives cefotiam hydrochloride compositions.
Background technology
Cefotiam hydrochloride is for apply cephalosporin more widely clinically, because it is in storage process, particularly under the condition of high temperature (> 50 DEG C), often there is degraded and polyreaction, thus cause active constituents of medicine content to reduce, color and luster is strengthened, and polymeric impurities content raises.In addition, cross the cefotiam hydrochloride of effect duration, because the resting period is long, also usually make active constituents of medicine content reduce, darken, polymer content is high especially, and during polymer content height, easily makes human body produce anaphylaxis.
Although prior art to some extent solves its purity problem, but through further studying discovery, because cefotiam hydrochloride is positioned in the process of depositing, particularly under the condition of high temperature (> 50 DEG C), often there is degraded and polyreaction, along with the prolongation of resting period, its high polymer content increases, and the risk making human body produce anaphylactic reaction increases, and prior art is by various mode, as prepared by crystal formation, substantially increase its safety.
But containing unstable beta-lactam nucleus in the structure of cefotiam hydrochloride, easy generation hydrolysis and rearrangement reaction, cause structural damage and lose antibacterial activity, some catabolite may produce anaphylaxis, and therefore the stability of this kind of antibiotic in transfusion should cause extensive attention.
But, document " cefotiam hydrochloridefor inj and the research of three kinds of infusion solutions compatibility stability " [Luo Xiaoru, Wei Liping, Deng. cefotiam hydrochloridefor inj and the research of three kinds of infusion solutions compatibility stability, PLA's Acta Pharmaceutica Sinica [J], 2013,29(4): 354-356] after the stability of cefotiam hydrochloridefor inj and 0.9% sodium chloride injection, 5% glucose injection and 5% Dextrose and Sodium Chloride Inj. compatibility is investigated, under its result shows room temperature condition, cefotiam hydrochloridefor inj is all unstable in above-mentioned 3 kinds of solution.And all unresolved described problem of the crystal compound of prior art.
And the mobility of cefotiam hydrochloride is also poor, make when preparing cefotiam hydrochloridefor inj and the mixing homogeneity of adjuvant poor.The invention provides a kind of cefotiam hydrochloride Anxin crystalline compounds being different from prior art, its purity is high, good fluidity, good stability, polymer content is low, moist without drawing, after the injectable powder made and 0.9% sodium chloride injection, 5% glucose injection, 5% Dextrose and Sodium Chloride Inj. compatibility, room temperature places the good stability of solution after 4h.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of anti-infectives cefotiam hydrochloride compositions.
In order to complete object of the present invention, the technical scheme of employing is:
The present invention relates to a kind of anti-infectives cefotiam hydrochloride compositions, consisting of of described compositions: cefotiam hydrochloride 1 weight portion, sodium chloride 0.4-0.8 weight portion; Described cefotiam hydrochloride is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
First optimal technical scheme of the present invention is consisting of of described compositions: cefotiam hydrochloride 1 weight portion, sodium chloride 0.5-0.7 weight portion.
Second optimal technical scheme of the present invention is consisting of of described compositions: cefotiam hydrochloride 1 weight portion, sodium chloride 0.6 weight portion.
3rd optimal technical scheme of the present invention is the dosage form of described compositions is injection, and the preparation method of described injection comprises the following steps:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
The preparation method of the cefotiam hydrochloride crystal in the present composition comprises the following steps:
Get cefotiam hydrochloride crude drug, the volume adding 30 DEG C is that in the mixed solvent A of the water of cefotiam hydrochloride weight 8 times, N-methylacetamide, water, N-methylacetamide volume ratio are 4:1, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.5T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent B that volume is cefotiam hydrochloride weight 5 times of ethanol, isobutanol, ether, the volume ratio of ethanol, isobutanol, ether is 2:3:4; After being added dropwise to complete, be cooled to-3 DEG C, leave standstill 2 hours, filter, washing, vacuum drying, obtains described cefotiam hydrochloride crystal.
The polymorphism of solid chemical is the natural phenomena that a kind of general material exists, this phenomenon refers to that a kind of solid chemical can exist 2 kinds or two or more crystal form state, be also called the polymorphic state of material, the polymorphic state of material is also referred to as " allomorphism " phenomenon.Although its chemical nature of allomorphous solid matter is identical, its physicochemical property may be different.For " allomorphism medicine " that physicochemical property is different, also can show the curative effect of different disease preventing and treating clinically, directly affect application and the clinical effectiveness of medicine.
Because cefotiam hydrochloride is positioned in the process of depositing, particularly under the condition of high temperature (> 50 DEG C), often there is degraded and polyreaction, along with the prolongation of resting period, its high polymer content increases, and the risk making human body produce anaphylactic reaction increases, and prior art is by various mode, as prepared by crystal formation, substantially increase its safety.
But containing unstable beta-lactam nucleus in the structure of cefotiam hydrochloride, easy generation hydrolysis and rearrangement reaction, cause structural damage and lose antibacterial activity, some catabolite may produce anaphylaxis, and therefore the stability of this kind of antibiotic in transfusion should cause extensive attention.
But, document " cefotiam hydrochloridefor inj and the research of three kinds of infusion solutions compatibility stability " [Luo Xiaoru, Wei Liping, Deng. cefotiam hydrochloridefor inj and the research of three kinds of infusion solutions compatibility stability, PLA's Acta Pharmaceutica Sinica [J], 2013,29(4): 354-356] after the stability of cefotiam hydrochloridefor inj and 0.9% sodium chloride injection, 5% glucose injection and 5% Dextrose and Sodium Chloride Inj. compatibility is investigated, under its result shows room temperature condition, cefotiam hydrochloridefor inj is all unstable in above-mentioned 3 kinds of solution.And all unresolved described problem of the crystal compound of prior art.
And the mobility of cefotiam hydrochloride is also poor, make when preparing cefotiam hydrochloridefor inj and the mixing homogeneity of adjuvant poor.The invention provides a kind of cefotiam hydrochloride Anxin crystalline compounds being different from prior art, its purity is high, good fluidity, good stability, polymer content is low, moist without drawing, after the injectable powder made and 0.9% sodium chloride injection, 5% glucose injection, 5% Dextrose and Sodium Chloride Inj. compatibility, room temperature places the good stability of solution after 4h.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction that the cefotiam hydrochloride crystal of the embodiment of the present invention 1 preparation uses the measurement of Cu-K alpha ray to obtain.
Detailed description of the invention
Below by specific embodiment, summary of the invention of the present invention is described in further detail, but does not therefore limit content of the present invention.
embodiment 1:the preparation of cefotiam hydrochloride crystal
Get cefotiam hydrochloride crude drug, the volume adding 30 DEG C is that in the mixed solvent A of the water of cefotiam hydrochloride weight 8 times, N-methylacetamide, water, N-methylacetamide volume ratio are 4:1, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.5T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent B that volume is cefotiam hydrochloride weight 5 times of ethanol, isobutanol, ether, the volume ratio of ethanol, isobutanol, ether is 2:3:4; After being added dropwise to complete, be cooled to-3 DEG C, leave standstill 2 hours, filter, washing, vacuum drying, obtains described cefotiam hydrochloride crystal.
As shown in Figure 1, its purity of high-performance liquid chromatogram determination is 99.9% to the X-ray powder diffraction pattern that the cefotiam hydrochloride crystal prepared uses the measurement of Cu-K alpha ray to obtain.
embodiment 2:the preparation of cefotiam hydrochloride compositions
Consist of: cefotiam hydrochloride crystal 1 weight portion prepared by the present invention, sodium chloride 0.4 weight portion.
Preparation method is:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
embodiment 3:the preparation of cefotiam hydrochloride compositions
Consist of: cefotiam hydrochloride crystal 1 weight portion prepared by the present invention, sodium chloride 0.5 weight portion.
Preparation method is:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
embodiment 4:the preparation of cefotiam hydrochloride compositions
Consist of: cefotiam hydrochloride crystal 1 weight portion prepared by the present invention, sodium chloride 0.6 weight portion.
Preparation method is:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
embodiment 5:the preparation of cefotiam hydrochloride compositions
Consist of: cefotiam hydrochloride crystal 1 weight portion prepared by the present invention, sodium chloride 0.7 weight portion.
Preparation method is:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
embodiment 6:the preparation of cefotiam hydrochloride compositions
Consist of: cefotiam hydrochloride crystal 1 weight portion prepared by the present invention, sodium chloride 0.8 weight portion.
Preparation method is:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
experimental example 1, fluidity test
The mobility of this experimental example to the cefotiam hydrochloride crystal that the embodiment of the present invention 1 obtains detects.
Method: according to the embodiment of the present invention 1 method continuous production 6 batches of cefotiam hydrochlorides (batch: 1,2,3,4,5 and 6), respectively from 6 batches of obtained cefotiam hydrochloride regulating the spleen and stomach samplings, adopt fixed funnel method, funnel is placed in the suitable height on graph paper, cefotiam hydrochloride crystal is freely flowed down from bell mouth, until the cone top formed contacts with bell mouth, measure hypotenuse and the horizontal angle (θ angle of repose) of cefotiam hydrochloride accumulation horizon.The results are shown in Table 1:
The fluidity test result of table 1 cefotiam hydrochloride
From the interpretation of table 1, the mobility of cefotiam hydrochloride crystal of the present invention is fine.
experimental example 2: influence factor tests
1, hot test
The cefotiam hydrochloride crystalline compounds that Example 1 prepares, simulation listing packaging, puts in sealing clean container, place 10 days at 40 ± 2 DEG C of temperature, in the 5th day and sampling in the 10th day, detect by stability high spot reviews project, result of the test compared with 0 day.
2, high humility test
The cefotiam hydrochloride crystalline compounds that Example 1 prepares, simulation listing packaging, put in sealing clean container, place 10 days under the condition of 25 ± 2 DEG C of relative humiditys 90% ± 5%, in the 5th day and sampling in the 10th day, detect by stability high spot reviews project, result of the test compared with 0 day.
3, strong illumination test
The cefotiam hydrochloride crystalline compounds that Example 1 prepares, simulation listing packaging, puts in sealing clean container, being placed in illumination is place 10 days under the condition of 4500lx, in the 5th day and sampling in the 10th day, detect by stability high spot reviews project, result compared with 0 day.The results are shown in Table 2
Table 2 influence factor result of the test
Result shows: the cefotiam hydrochloride crystalline compounds that the present invention prepares, and its stability is good, and under high temperature, high humidity, high light conditions, equal retention is stablized.
experimental example 3: Acceleration study
The cefotiam hydrochloride crystalline compounds that Example 1 prepares, simulation listing packaging, put in sealing clean container, in 40 DEG C ± 2 DEG C, place 6 months under relative humidity 70% ± 5% condition, at duration of test respectively at 1,2,3,6 sampling at the end of month once, each stability high spot reviews project is tested.The results are shown in Table 3.
Table 3 accelerated test result
Result shows: the cefotiam hydrochloride crystalline compounds that the present invention prepares, known through accelerated test result, its good stability, and polymer content is low, and total assorted content is low.
experimental example 4: wettability test
1 instrument
PL203 electronic balance, LRH-250-S constant temperature and humidity incubator, HH-400SD testing chamber for medicine stability;
2 methods
Get the glass desicator (for ensureing that saline solution is saturated, excessive salt should be had bottom exsiccator to exist) that bottom fills salt supersaturated solution, the built-in weighing botle of exsiccator, places 48h to constant humidity in calorstat.Sample thief is about 2g, puts in weighing botle, accurately weighed, bottle cap is opened, puts into exsiccator top, put in 25 DEG C of constant temperature and humidity incubators or 20 DEG C of stability test casees by different temperatures requirement and preserve, operation repetitive 3 parts, weighs respectively at different time, calculates the hydroscopicity of different time.
Computing formula: hydroscopicity=(medicated powder weight after moisture absorption-moisture absorption prodrug grain weight amount)/moisture absorption prodrug grain weight amount × 100%.Result is as table 4:
Table 4 hygroscopicity test results
According to above-mentioned experiment, the hygroscopicity of cefotiam hydrochloride crystalline compounds prepared by the present invention is low, good stability.
experimental example 4: compatibility stability is tested
This experimental example has investigated the stability of different cefotiam hydrochloridefor inj and three kinds of infusion solutions compatibilities.
Sample:
Test specimen: the cefotiam hydrochloridefor inj that the embodiment of the present invention 4 is obtained;
Control sample 1: prepare cefotiam hydrochloridefor inj according to the prescription of invention formulation embodiment 4 and preparation method, difference is cefotiam hydrochloride used is according to the obtained cefotiam hydrochloride of the method for CN102659818A embodiment 1;
Control sample 2: prepare cefotiam hydrochloridefor inj according to the prescription of invention formulation embodiment 4 and preparation method, difference is cefotiam hydrochloride used is according to the obtained cefotiam hydrochloride of the method for CN103232477A embodiment 1;
Compatibility stability test method: according to " cefotiam hydrochloridefor inj and the research of three kinds of infusion solutions compatibility stability " [Luo Xiaoru, Wei Liping, Deng. cefotiam hydrochloridefor inj and the research of three kinds of infusion solutions compatibility stability, PLA's Acta Pharmaceutica Sinica [J], 2013, method 29(4): 354-356] has investigated test specimen, control sample 1 and control sample 2 and 0.9% sodium chloride injection, 5% glucose injection, the stability of 5% Dextrose and Sodium Chloride Inj. compatibility, adopt HPLC method, place 0 at ambient temperature, 1, 2, 4h, measure the change of each sample related substance and content.The results are shown in Table shown in 5 and table 6.
Table 5 cefotiam hydrochloride is positioned on assay result in different medium
Table 6 cefotiam hydrochloride is positioned on determination of related substances result in different medium
As can be seen from above-mentioned result of the test, control sample 1 and control sample 2 are along with the prolongation of standing time, and the main constituent content of each sample all declines, and total impurities significantly increases, impurity number also showed increased, show room temperature place 4h after solution all unstable; Compare with control sample 2 with control sample 1, cefotiam hydrochloridefor inj of the present invention is along with the prolongation of standing time, its main constituent content changes hardly, total impurities is without significant change, impurity number is also without significant change, show under the condition that prescription is identical with preparation method, after after the cefotiam hydrochloridefor inj adopting cefotiam hydrochloride trihydrate crystal of the present invention to obtain and 0.9% sodium chloride injection, 5% glucose injection, 5% Dextrose and Sodium Chloride Inj. compatibility, room temperature places 4h, solution has good stability.
The cefotiam hydrochloridefor inj obtained to other embodiments of the invention has also carried out above-mentioned test, and its result obtained is similar.
Claims (5)
1. an anti-infectives cefotiam hydrochloride compositions, is characterized in that: described compositions consist of cefotiam hydrochloride 1 weight portion, sodium chloride 0.4-0.8 weight portion; Described cefotiam hydrochloride is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
2. anti-infectives cefotiam hydrochloride compositions according to claim 1, is characterized in that: described compositions consist of cefotiam hydrochloride 1 weight portion, sodium chloride 0.5-0.7 weight portion.
3. anti-infectives cefotiam hydrochloride compositions according to claim 2, is characterized in that: described compositions consist of cefotiam hydrochloride 1 weight portion, sodium chloride 0.6 weight portion.
4. anti-infectives cefotiam hydrochloride compositions according to claim 1, is characterized in that: the dosage form of described compositions is injection, and the preparation method of described injection comprises the following steps:
(1) take cefotiam hydrochloride crystal and sodium chloride in proportion, fully mix;
(2) to divide in the cillin bottle after being filled to sterilizing and to jump a queue.
5. anti-infectives cefotiam hydrochloride compositions according to claim 1, is characterized in that, the crystal preparation method of described cefotiam hydrochloride is:
Get cefotiam hydrochloride crude drug, the volume adding 30 DEG C is that in the mixed solvent A of the water of cefotiam hydrochloride weight 8 times, N-methylacetamide, water, N-methylacetamide volume ratio are 4:1, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.5T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent B that volume is cefotiam hydrochloride weight 5 times of ethanol, isobutanol, ether, the volume ratio of ethanol, isobutanol, ether is 2:3:4; After being added dropwise to complete, be cooled to-3 DEG C, leave standstill 2 hours, filter, washing, vacuum drying, obtains described cefotiam hydrochloride crystal.
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| CN201510589896.6A CN105055424A (en) | 2015-09-17 | 2015-09-17 | Anti-infective medicinal cefotiam hydrochloride composition |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780040A (en) * | 2010-03-24 | 2010-07-21 | 海南美大制药有限公司 | Cefotiam hydrochloride/natrium carbonicum calcinatum medicine composition lipidosome injection |
| CN101912361A (en) * | 2010-07-29 | 2010-12-15 | 陶灵刚 | Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof |
| CN102424687A (en) * | 2011-11-01 | 2012-04-25 | 湖南方盛制药股份有限公司 | Preparation method of cefotiam hexetil hydrochloride |
| CN105085548A (en) * | 2015-09-10 | 2015-11-25 | 青岛蓝盛洋医药生物科技有限责任公司 | Pharmaceutical cefotiam composition for treating infectious diseases |
-
2015
- 2015-09-17 CN CN201510589896.6A patent/CN105055424A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101780040A (en) * | 2010-03-24 | 2010-07-21 | 海南美大制药有限公司 | Cefotiam hydrochloride/natrium carbonicum calcinatum medicine composition lipidosome injection |
| CN101912361A (en) * | 2010-07-29 | 2010-12-15 | 陶灵刚 | Cefotiam hydrochloride/anhydrous sodium carbonate medicinal composition suspension injection and new use thereof |
| CN102424687A (en) * | 2011-11-01 | 2012-04-25 | 湖南方盛制药股份有限公司 | Preparation method of cefotiam hexetil hydrochloride |
| CN105085548A (en) * | 2015-09-10 | 2015-11-25 | 青岛蓝盛洋医药生物科技有限责任公司 | Pharmaceutical cefotiam composition for treating infectious diseases |
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Application publication date: 20151118 |