CN105125518A - Medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting - Google Patents
Medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting Download PDFInfo
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- CN105125518A CN105125518A CN201510587291.3A CN201510587291A CN105125518A CN 105125518 A CN105125518 A CN 105125518A CN 201510587291 A CN201510587291 A CN 201510587291A CN 105125518 A CN105125518 A CN 105125518A
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Abstract
The invention discloses a medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting, which belongs to the technical field of medicines. The composition is prepared from tropisetron hydrochloride, mannitol, sodium sulfite, carboxymethyl starch sodium, povidone K30, 95 percent ethanol and talc powder, wherein the tropisetron hydrochloride is a new crystalline compound; an X-ray powder diffraction pattern, which is obtained by measurement of Cu-Kalpha rays, of the new crystalline compound, is as shown in figure 1, and the new crystalline compound is tropisetron hydrochloride different from the tropisetron hydrochloride reported in the prior art; tests prove that the new crystalline compound has the advantages of high purity, good flowability, good stability, low content of impurities, low possibility of moisture absorption, and safety and reliability in clinical application; the capsule prepared from the new crystalline compound is high in dissolution rate, good in stability and very suitable for clinical application.
Description
Technical field
The invention belongs to medical art, relate to a kind of medicine Navoban (Soz) composition capsule for the treatment of nausea and vomiting.
Background technology
Navoban (Soz) is selectivity peripheral neurons and central nervous system's 5-hydroxytryptamine receptor antagonist, can selectively block vomiting reflex maincenter, the excitement of peripheral neurons presynaptic 5-hydroxytryptamine receptor, act on the 5-hydroxytryptamine receptor of the vagal activity importing nervus centralis area postrema into, can the nausea and vomiting that caused by chemotherapy of Prevention and Curation, do not cause extrapyramidal system untoward reaction.
In prior art, for the crystal formation of Navoban (Soz), had many research, but the hygroscopicity of impurity content, stability and crystal formation is still undesirable, brings difficulty also to while have impact on self stability the preparation of preparation.
The present invention is through a large amount of experimental studies, and obtained a kind of Navoban (Soz) crystalline compounds being different from prior art, the purity of this Tropiseiron hydrochloride compound is high, good fluidity, good stability, not easily moisture absorption, impurity content is low, preparation for preparation brings conveniently, clinical practice is safe and reliable, and utilize the capsule that this crystal compound is obtained, dissolution is high, good stability, is very suitable for clinical practice.
In prior art, for the crystal formation of Navoban (Soz), had many research, but the hygroscopicity of impurity content, stability and crystal formation is still undesirable, brings difficulty also to while have impact on self stability the preparation of preparation.
The present invention is through a large amount of experimental studies, and obtained a kind of Navoban (Soz) crystalline compounds being different from prior art, the purity of this Tropiseiron hydrochloride compound is high, good fluidity, good stability, not easily moisture absorption, impurity content is low, preparation for preparation brings conveniently, clinical practice is safe and reliable, and utilize the capsule that this crystal compound is obtained, dissolution is high, good stability, is very suitable for clinical practice.
Summary of the invention
Goal of the invention of the present invention is to provide a kind of medicine Navoban (Soz) composition capsule for the treatment of nausea and vomiting.
In order to complete object of the present invention, the technical scheme of employing is:
Treat a medicine Navoban (Soz) composition capsule for nausea and vomiting, described compositions is made up of Navoban (Soz), mannitol, sodium sulfite, carboxymethylstach sodium, PVP K30,95% ethanol, Pulvis Talci; Described Navoban (Soz) is crystal, and the X-ray powder diffraction pattern that the measurement of use Cu-K alpha ray obtains as shown in Figure 1.
Preferably, described compositions is made up of the Navoban (Soz) of 0.5 weight portion, the mannitol of 10.0-10.4 weight portion, the sodium sulfite of 3.3-3.7 weight portion, the carboxymethylstach sodium of 2-4 weight portion, the PVP K30 of 0.3-0.5 weight portion, 95% ethanol of 3-5 weight portion, the Pulvis Talci of 0.2-0.4 weight portion.
Preferably, described compositions is made up of the Navoban (Soz) of 0.5 weight portion, the mannitol of 10.2 weight portions, the sodium sulfite of 3.5 weight portions, the carboxymethylstach sodium of 3 weight portions, the PVP K30 of 0.4 weight portion, 95% ethanol of 4 weight portions, the Pulvis Talci of 0.3 weight portion.
The preparation method of described composition capsule comprises the following steps:
1) weigh according to technology preparation amount;
2) supplementary material process: sieve the Navoban (Soz) of recipe quantity and mannitol 100 orders;
3) premixing: the Navoban (Soz) of recipe quantity and mannitol are mixed with equal increments method;
4) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
5) mixing granulation: the Navoban (Soz) of recipe quantity, mannitol, sodium sulfite, carboxymethylstach sodium are added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 alcoholic solution prepared, wet mixing 60-90 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
6) dry: arranging boiling drier inlet temperature is 55 DEG C, is dried to moisture < 3.5%, select 24 order nylon wires to be arranged on granulate in oscillating granulator after dry;
7) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
8) select suitable glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
9) pack.
The preparation method of the crystal of described Navoban (Soz) comprises the following steps:
Get Navoban (Soz) crude drug, the volume adding 30 DEG C is that in the mixed solvent A of the water of Navoban (Soz) weight 8 times, acetone, N-methylacetamide, water, acetone, N-methylacetamide volume ratio are 4:1:0.5, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.7T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent B of ethanol that volume is Navoban (Soz) weight 5 times, isobutanol, ether, the volume ratio of ethanol, isobutanol, ether is 2:4:3; After being added dropwise to complete, be cooled to-3 DEG C, leave standstill 2 hours, filter, washing, vacuum drying, obtains described Navoban (Soz) 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.
Accompanying drawing explanation
Fig. 1 is the X-ray powder diffraction that the Navoban (Soz) 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 Navoban (Soz) crystal
Get Navoban (Soz) crude drug, the volume adding 30 DEG C is that in the mixed solvent A of the water of Navoban (Soz) weight 8 times, acetone, N-methylacetamide, water, acetone, N-methylacetamide volume ratio are 4:1:0.5, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.7T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent B of ethanol that volume is Navoban (Soz) weight 5 times, isobutanol, ether, the volume ratio of ethanol, isobutanol, ether is 2:4:3; After being added dropwise to complete, be cooled to-3 DEG C, leave standstill 2 hours, filter, washing, vacuum drying, obtains described Navoban (Soz) 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 Navoban (Soz) crystal prepared uses the measurement of Cu-K alpha ray to obtain.
embodiment 2:the preparation of vitro Dissolution of Tropisetron Hydrochloride Capsules
Prescription: with parts by weight as table 1
Table 1 Navoban (Soz) composition prescription
Preparation method:
1) weigh according to technology preparation amount;
2) supplementary material process: sieve the Navoban (Soz) of recipe quantity and mannitol 100 orders;
3) premixing: the Navoban (Soz) of recipe quantity and mannitol are mixed with equal increments method;
4) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
5) mixing granulation: the Navoban (Soz) of recipe quantity, mannitol, sodium sulfite, carboxymethylstach sodium are added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 alcoholic solution prepared, wet mixing 60-90 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
6) dry: arranging boiling drier inlet temperature is 55 DEG C, is dried to moisture < 3.5%, select 24 order nylon wires to be arranged on granulate in oscillating granulator after dry;
7) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
8) select suitable glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
9) pack.
embodiment 3:the preparation of vitro Dissolution of Tropisetron Hydrochloride Capsules
Prescription: with parts by weight as table 2
Table 2 Navoban (Soz) composition prescription
Preparation method:
1) weigh according to technology preparation amount;
2) supplementary material process: sieve the Navoban (Soz) of recipe quantity and mannitol 100 orders;
3) premixing: the Navoban (Soz) of recipe quantity and mannitol are mixed with equal increments method;
4) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
5) mixing granulation: the Navoban (Soz) of recipe quantity, mannitol, sodium sulfite, carboxymethylstach sodium are added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 alcoholic solution prepared, wet mixing 60-90 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
6) dry: arranging boiling drier inlet temperature is 55 DEG C, is dried to moisture < 3.5%, select 24 order nylon wires to be arranged on granulate in oscillating granulator after dry;
7) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
8) select suitable glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
9) pack.
embodiment 4:the preparation of vitro Dissolution of Tropisetron Hydrochloride Capsules
Prescription: with parts by weight as table 3
Table 3 Navoban (Soz) composition prescription
Preparation method:
1) weigh according to technology preparation amount;
2) supplementary material process: sieve the Navoban (Soz) of recipe quantity and mannitol 100 orders;
3) premixing: the Navoban (Soz) of recipe quantity and mannitol are mixed with equal increments method;
4) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
5) mixing granulation: the Navoban (Soz) of recipe quantity, mannitol, sodium sulfite, carboxymethylstach sodium are added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 alcoholic solution prepared, wet mixing 60-90 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
6) dry: arranging boiling drier inlet temperature is 55 DEG C, is dried to moisture < 3.5%, select 24 order nylon wires to be arranged on granulate in oscillating granulator after dry;
7) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
8) select suitable glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
9) pack.
experimental example 1:fluidity test
The mobility of this experimental example to the Navoban (Soz) 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 Navoban (Soz)s (batch: 1,2,3,4,5 and 6), sample from 6 batches of obtained Navoban (Soz)s respectively, adopt fixed funnel method, funnel is placed in the suitable height on graph paper, Navoban (Soz) 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 Navoban (Soz) accumulation horizon.The results are shown in Table 4:
The fluidity test result of table 4 Navoban (Soz)
From the interpretation of table 4, the mobility of Navoban (Soz) crystal of the present invention is fine.
experimental example 2:influence factor tests
1, hot test
The Navoban (Soz) 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 Navoban (Soz) 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 Navoban (Soz) 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 5:
Table 5 influence factor result of the test
Result shows: the Navoban (Soz) 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 Navoban (Soz) crystalline compounds that Example 1 prepares 3 batches and marketable material, 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 6.
Table 6 accelerated test result
Result shows: the Navoban (Soz) crystalline compounds that the present invention prepares, known through accelerated test result, its good stability, 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 7:
Table 7 hygroscopicity test results
According to above-mentioned experiment, the hygroscopicity of Navoban (Soz) crystalline compounds prepared by the present invention is low, good stability.
experimental example 5:dissolution Rate Testing
According to literature procedure (" research of Navoban (Soz) sheet dissolution method ", Gao Lijun etc., science and technology and engineering, 12nd volume, 30th phase, in October, 2012) capsule for preparing embodiments of the invention 2 and commercially available vitro Dissolution of Tropisetron Hydrochloride Capsules agent do Dissolution experiments at identical conditions.The experimental result obtained is as shown in table 8:
Table 8 dissolution test result
According to above-mentioned experiment, the dissolution of the capsule that the Navoban (Soz) crystalline compounds adopting the present invention to obtain prepares is higher than prior art.Identical experiment is carried out to other embodiments, has obtained analog result.
Claims (5)
1. treat a medicine Navoban (Soz) composition capsule for nausea and vomiting, it is characterized in that: described compositions is made up of Navoban (Soz), mannitol, sodium sulfite, carboxymethylstach sodium, PVP K30,95% ethanol, Pulvis Talci; Described Navoban (Soz) 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. the medicine Navoban (Soz) composition capsule for the treatment of nausea and vomiting according to claim 1, is characterized in that: described compositions is made up of the Navoban (Soz) of 0.5 weight portion, the mannitol of 10.0-10.4 weight portion, the sodium sulfite of 3.3-3.7 weight portion, the carboxymethylstach sodium of 2-4 weight portion, the PVP K30 of 0.3-0.5 weight portion, 95% ethanol of 3-5 weight portion, the Pulvis Talci of 0.2-0.4 weight portion.
3. the medicine Navoban (Soz) composition capsule for the treatment of nausea and vomiting according to claim 2, is characterized in that: described compositions is made up of the Navoban (Soz) of 0.5 weight portion, the mannitol of 10.2 weight portions, the sodium sulfite of 3.5 weight portions, the carboxymethylstach sodium of 3 weight portions, the PVP K30 of 0.4 weight portion, 95% ethanol of 4 weight portions, the Pulvis Talci of 0.3 weight portion.
4. the medicine Navoban (Soz) composition capsule for the treatment of nausea and vomiting according to claim 1, it is characterized in that, the preparation method of described composition capsule comprises the following steps:
1) weigh according to technology preparation amount;
2) supplementary material process: sieve the Navoban (Soz) of recipe quantity and mannitol 100 orders;
3) premixing: the Navoban (Soz) of recipe quantity and mannitol are mixed with equal increments method;
4) prepare PVP K30 ethanol: 95% ethanol of recipe quantity is placed in stainless steel cask, adds the PVP K30 of recipe quantity while stirring, be stirred to all dissolvings for subsequent use;
5) mixing granulation: the Navoban (Soz) of recipe quantity, mannitol, sodium sulfite, carboxymethylstach sodium are added in wet mixing pelletizer, open stirring motor and be dry mixed 5 minutes, add the PVP K30 alcoholic solution prepared, wet mixing 60-90 soft material second, 24 order nylon wires are arranged in oscillating granulator granulates;
6) dry: arranging boiling drier inlet temperature is 55 DEG C, is dried to moisture < 3.5%, select 24 order nylon wires to be arranged on granulate in oscillating granulator after dry;
7) always mix: the Pulvis Talci of the dry granule after granulate and recipe quantity is joined in mixer, motor rotation frequency 200r/min is set, open mixer and mix 15 minutes;
8) select suitable glue shell, use capsule filling machine fill, content uniformity conforms with the regulations;
9) pack.
5. the medicine Navoban (Soz) composition capsule for the treatment of nausea and vomiting according to claim 1, it is characterized in that, the preparation method of the crystal of described Navoban (Soz) comprises the following steps:
Get Navoban (Soz) crude drug, the volume adding 30 DEG C is that in the mixed solvent A of the water of Navoban (Soz) weight 8 times, acetone, N-methylacetamide, water, acetone, N-methylacetamide volume ratio are 4:1:0.5, obtain solution; Then in the horizontal direction of the liquid level of gained solution, the stationary magnetic field that magnetic field intensity is 0.7T is applied, and under the condition of this stationary magnetic field, in solution, dripping the mixed solvent B of ethanol that volume is Navoban (Soz) weight 5 times, isobutanol, ether, the volume ratio of ethanol, isobutanol, ether is 2:4:3; After being added dropwise to complete, be cooled to-3 DEG C, leave standstill 2 hours, filter, washing, vacuum drying, obtains described Navoban (Soz) crystal.
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| CN201510587291.3A CN105125518A (en) | 2015-09-16 | 2015-09-16 | Medicinal tropisetron hydrochloride composition capsule for treating nausea and vomiting |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106432281A (en) * | 2016-09-23 | 2017-02-22 | 临沂草之美医药科技有限公司 | Preparation method of pharmaceutical ceftazidime crystal compound for treating surgical infection |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2672500A (en) * | 1999-02-18 | 2000-09-04 | Novartis Ag | Systemic use of 5-ht3 receptor antagonists against rheumatic inflammatory processes |
| US20020032149A1 (en) * | 1997-08-28 | 2002-03-14 | Kenneth Kensey | In vivo delivery methods and compositions |
| CN102351857A (en) * | 2011-08-23 | 2012-02-15 | 天津市汉康医药生物技术有限公司 | Tropiseiron hydrochloride compound |
| CN103073543A (en) * | 2013-01-25 | 2013-05-01 | 回音必集团抚州制药有限公司 | Preparation method and application of tropisetron citrate crystal form I |
-
2015
- 2015-09-16 CN CN201510587291.3A patent/CN105125518A/en not_active Withdrawn
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020032149A1 (en) * | 1997-08-28 | 2002-03-14 | Kenneth Kensey | In vivo delivery methods and compositions |
| AU2672500A (en) * | 1999-02-18 | 2000-09-04 | Novartis Ag | Systemic use of 5-ht3 receptor antagonists against rheumatic inflammatory processes |
| CN102351857A (en) * | 2011-08-23 | 2012-02-15 | 天津市汉康医药生物技术有限公司 | Tropiseiron hydrochloride compound |
| CN103073543A (en) * | 2013-01-25 | 2013-05-01 | 回音必集团抚州制药有限公司 | Preparation method and application of tropisetron citrate crystal form I |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106432281A (en) * | 2016-09-23 | 2017-02-22 | 临沂草之美医药科技有限公司 | Preparation method of pharmaceutical ceftazidime crystal compound for treating surgical infection |
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