CN109028765A - A kind of drying means of tirofiban hydrochloride - Google Patents
A kind of drying means of tirofiban hydrochloride Download PDFInfo
- Publication number
- CN109028765A CN109028765A CN201810707944.0A CN201810707944A CN109028765A CN 109028765 A CN109028765 A CN 109028765A CN 201810707944 A CN201810707944 A CN 201810707944A CN 109028765 A CN109028765 A CN 109028765A
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- China
- Prior art keywords
- drying
- tirofiban hydrochloride
- highefficientfluidbeddrier
- wet product
- tirofiban
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B3/00—Drying solid materials or objects by processes involving the application of heat
- F26B3/02—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air
- F26B3/06—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried
- F26B3/08—Drying solid materials or objects by processes involving the application of heat by convection, i.e. heat being conveyed from a heat source to the materials or objects to be dried by a gas or vapour, e.g. air the gas or vapour flowing through the materials or objects to be dried so as to loosen them, e.g. to form a fluidised bed
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/06—Controlling, e.g. regulating, parameters of gas supply
- F26B21/10—Temperature; Pressure
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B21/00—Arrangements or duct systems, e.g. in combination with pallet boxes, for supplying and controlling air or gases for drying solid materials or objects
- F26B21/06—Controlling, e.g. regulating, parameters of gas supply
- F26B21/12—Velocity of flow; Quantity of flow, e.g. by varying fan speed, by modifying cross flow area
Abstract
The present invention provides a kind of drying means of tirofiban hydrochloride, carry out fluidized drying to tirofiban hydrochloride wet product using HighefficientFluidbeddrier；Wherein, the drying temperature in HighefficientFluidbeddrier is 40~50 DEG C, and drying time is 10~20 minutes, 30~70m of air mass flow3/h.Moisture content in tirofiban hydrochloride obtained by drying means using a kind of disclosed tirofiban hydrochloride is lower, appearance is in off-white powder, meet the requirement for preparing tirofiban hydrochloride sodium chloride injection, and has the advantages that prevented from caking and impurity content is lower.
Description
Technical field
The present invention relates to chemical pharmacy field more particularly to a kind of drying means of tirofiban hydrochloride.
Background technique
Tirofiban hydrochloride, Tirofiban Hydrochloride, chemical name: N- (normal-butyl sulfonyl)-O- [4- (4-
Piperidyl) butyl]-l-tyrosine hydrochloride monohydrate, molecular formula: C22H36N2O5S·HCl·H2O, molecular weight 495.08.
The compound at product-tirofiban before salt be a kind of non-peptides II b/ of platelet glycoprotein, III a receptor invertibity it is short of money
Anti-agent has crosslinking and blood platelet by preventing fibrinogen from reaching blocking platelet in conjunction with glycoproteinⅱb/ⅲa
The pharmacological activity of aggregation.
Tirofiban hydrochloride is suitable for unstable angina pectoris or non-q wave myocardial infarction patient etc..It can prevent heart to lack
Blood event, while being also applied for coronary ischemic syndrome patient and carrying out patch resection in Coronary angioplasty or coronary artery, with
Prevent and controlled coronary artery to occlude related heart ischemia complication suddenly.Tirofiban hydrochloride is obtained because of its good pharmacological activity
The concern of more and more researchers is obtained, corresponding document report is more, the optimization of bulk pharmaceutical chemicals synthesis route is related generally to, with
And the improvement of preparation prescription technique.Currently, being had not been reported about tirofiban hydrochloride drying means.
Although to similar medicines such as tirofiban hydrochlorides, there are air drying methods and boulton process to do in the prior art
Dry means.But applicant have observed that usually there is appearance not in the dry tirofiban hydrochloride wet product of air drying method, boulton process
Good disadvantage, while there is also the disadvantages that moisture is higher and impurity is more.In view of this, it is necessary to drying in the prior art
The method of tirofiban hydrochloride is improved, to solve the above problems.
Summary of the invention
It is an object of the invention to disclose a kind of drying means of tirofiban hydrochloride, to reduce tirofiban hydrochloride
Moisture content, and the tirofiban hydrochloride after drying is avoided yellowing phenomenon occur, overcome the impurity in tirofiban hydrochloride on the high side
Defect.
To achieve the above object, the present invention provides a kind of drying means of tirofiban hydrochloride, dry using efficient boiling
Dry machine carries out fluidized drying to tirofiban hydrochloride wet product；
Wherein, the drying temperature in HighefficientFluidbeddrier is 40~50 DEG C, and drying time is 10~20 minutes, air stream
Measure 30~70m3/h。
As a further improvement of the present invention, the drying temperature in HighefficientFluidbeddrier is 45 ± 4 DEG C, and drying time is
12~18 minutes, 40~60m of air mass flow3/h。
As a further improvement of the present invention, the drying temperature in HighefficientFluidbeddrier is 45 ± 2 DEG C, and drying time is
12~18 minutes, 40~60m of air mass flow3/h。
As a further improvement of the present invention, the drying temperature in HighefficientFluidbeddrier is 45 ± 1 DEG C, and drying time is
15 minutes, 45~55m of air mass flow3/h。
As a further improvement of the present invention, the drying temperature in HighefficientFluidbeddrier is 45 DEG C, drying time 15
Minute, air mass flow 50m3/h。
As a further improvement of the present invention, the moisture content of the tirofiban hydrochloride wet product is 8.55%.
Compared with prior art, the beneficial effects of the present invention are: using a kind of disclosed tirofiban hydrochloride
Drying means obtained by moisture content in tirofiban hydrochloride it is lower, appearance is in off-white powder, meets and prepares hydrochloric acid and replace
The requirement of Rofe class sodium chloride injection, and have the advantages that prevented from caking and impurity content is lower.
Detailed description of the invention
Fig. 1 is the high-efficient liquid phase chromatogram of tirofiban hydrochloride made from atmosphere pressure desiccation；
Fig. 2 is the high-efficient liquid phase chromatogram of tirofiban hydrochloride made from boulton process；
Fig. 3 is the high-efficient liquid phase chromatogram of tirofiban hydrochloride made from freeze-drying；
Fig. 4 is using the height for inventing tirofiban hydrochloride made from a kind of revealed drying means of tirofiban hydrochloride
Effect liquid phase chromatogram figure.
Specific embodiment
The present invention is described in detail for each embodiment shown in reference to the accompanying drawing, but it should be stated that, these
Embodiment is not limitation of the present invention, those of ordinary skill in the art according to these embodiments made by function, method,
Or equivalent transformation or substitution in structure, all belong to the scope of protection of the present invention within.
The drying means for inventing a kind of revealed tirofiban hydrochloride uses fluidized drying in HighefficientFluidbeddrier
Method carries out fluidized drying to tirofiban hydrochloride wet product, and states clearly specific embodiment.
Embodiment 1
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
44 DEG C of drying temperature, drying time 10 minutes, air mass flow 70m3/h。
Embodiment 2
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
41 DEG C of drying temperature, drying time 12 minutes, air mass flow 60m3/h。
Embodiment 3
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
43 DEG C of drying temperature, drying time 15 minutes, air mass flow 45m3/h。
Embodiment 4
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
46 DEG C of drying temperature, drying time 18 minutes, air mass flow 30m3/h。
Embodiment 5
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
47 DEG C of drying temperature, drying time 20 minutes, air mass flow 55m3/h。
Embodiment 6
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
Drying temperature in HighefficientFluidbeddrier is 49 DEG C, drying time 12 minutes, air mass flow 70m3/h。
Embodiment 7
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
Drying temperature in HighefficientFluidbeddrier is 42 DEG C, drying time 15 minutes, air mass flow 60m3/h。
Embodiment 8
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
Drying temperature in HighefficientFluidbeddrier is 40 DEG C, drying time 20 minutes, air mass flow 50m3/h。
Embodiment 9
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
Drying temperature in HighefficientFluidbeddrier is 48 DEG C, drying time 12 minutes, air mass flow 60m3/h。
Embodiment 10
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
Drying temperature in HighefficientFluidbeddrier is 48 DEG C, drying time 15 minutes, air mass flow 50m3/h。
Embodiment 11
Take tirofiban hydrochloride wet product appropriate, the moisture content of tirofiban hydrochloride wet product is 8.55%.Using efficient boiling
Drying machine carries out fluidized drying, the power 2.3kw of HighefficientFluidbeddrier to tirofiban hydrochloride wet product.Its process conditions are as follows:
Drying temperature in HighefficientFluidbeddrier is 50 DEG C, and drying time is 20 minutes, air mass flow 50m3/h。
Tirofiban hydrochloride used in the present invention is tirofiban into sample undried after salt, white pulpous state.
Tirofiban hydrochloride drying means used in the present invention, is got by screening, is further illustrated below by way of experiment.
Screening experiment
By character, the moisture, related its drying mode of screening substances of investigating tirofiban hydrochloride.Character is seen by visual method
It examines；Moisture is measured by karl Fischer moisture teller；Related substance is detected with high performance liquid chromatograph.Wherein, have
The degradation closed in starting material, intermediate, by-product and the storage that substance mainly introduces in process of production produces
Object.In brief, that is, refer to the organic impurities other than principal component (i.e. tirofiban hydrochloride).
Material and equipment
Material: tirofiban hydrochloride is prepared at the slurry after salt by Wuxi Fu Ze pharmaceutcal corporation, Ltd.
Equipment: SD101-1 electric drying oven with forced convection (Shanghai Su Da laboratory apparatus Co., Ltd)；DZF-6050 vacuum drying
Case (Shanghai Yiheng Scientific Instruments Co., Ltd)；FG-100 HighefficientFluidbeddrier (the strong granulation limited public affairs of drying equipment of Changzhou power
Department)；LYO-2.0 freeze drier (Shanghai Dong Fulong freezing equipment factory)；Agilet1100 high performance liquid chromatograph (Agilent section
Skill)；The full-automatic karl Fischer moisture teller (Shanghai Hegong Scientific Instrument Co., Ltd.) of AKF-2010V.
Experimental method
Chromatographic condition: being filler with octadecylsilane chemically bonded silica；With mobile phase A: 0.025mol/L biphosphate
Potassium (with phosphorus acid for adjusting pH to 2.3)-acetonitrile (volume ratio of potassium dihydrogen phosphate and acetonitrile is 90:10)；Mobile phase B: acetonitrile is pressed
Table carries out gradient elution；Detection wavelength is 227nm；Flow velocity: 1.0ml/min；Column temperature: 35 DEG C.The following table of gradient elution process
Shown in one.
Table one
The preparation of test solution: precision weighs tirofiban hydrochloride sample about 10mg, is placed in 20ml measuring bottle, with 50%
Acetonitrile solution sample dissolution, and it is diluted to scale.
Measuring method: precision measures 10 μ L of test solution, injects high performance liquid chromatograph, chromatogram is recorded, by peak area
Normalization method calculates impurity content.
In order to prove disclosed tirofiban hydrochloride drying means existing other compared with the existing technology
The technical effect of similar drying means, is tested as follows.
(1) atmosphere pressure desiccation:
About 100g tirofiban hydrochloride wet product is taken, air dry oven temperature is set as 50 DEG C, it dries for 24 hours, investigation sample property,
Water content, related substance.
(2) boulton process:
Vacuum oven temperature is set as 40 DEG C, after temperature is stablized, is put into sample, and close chamber door, vacuumizes, work as vacuum
Degree, which reaches when technique requires, starts timing, and drying time is for 24 hours.
(3) freeze-drying:
About 100g sample is taken, is put into pallet, for pre-freeze to -35 DEG C, rate is 0.5~0.6 DEG C/min, is opened after keeping 4h
Vacuum pump, when vacuum degree reaches 20Pa or less, distillation 20h to dry terminal.
(4) fluid-bed drying (a kind of drying means of tirofiban hydrochloride i.e. of the invention):
About 100g tirofiban hydrochloride wet product is taken, is placed in barrel, HighefficientFluidbeddrier drying temperature is set as 45 DEG C, does
The dry time is set as 15 minutes, air mass flow 50m3/h。
(1)~(4) shown in the following table two of contrast and experiment.
Table two
As the high performance liquid chromatography detection result of above table two it is found that in combination with shown in Fig. 1 to Fig. 4, apply for human hair
Current atmosphere pressure desiccation and the dry tirofiban hydrochloride of boulton process two ways, the tirofiban hydrochloride being finally dried to obtain
Appearance in faint yellow.Since the preparation that tirofiban hydrochloride finally prepares formation is tirofiban hydrochloride sodium chloride injection,
It is required that being achromaticity and clarification, therefore appearance index is undesirable.
In addition, have the shortcomings that moisture content is higher with the dry tirofiban hydrochloride of this two kinds of drying means, it is particularly critical
Be tirofiban hydrochloride related substance, total impurities content increases separately from 0.05% to 0.46%, 0.38%, related substance
In significant change, quality is undesirable.Using the dry this product of freeze-drying mode, appearance meets the requirements, but moisture content compared with
Height, and total impurities content increases to 0.28% from 0.05%, is in significant change.With the dry this product of fluid-bed drying, character, water
Divide, impurity content meets the requirements.
The more than comprehensive analysis test data of four kinds of different drying modes, it is final to determine that fluid-bed drying is suitable for hydrochloric acid and replaces sieve
The drying of non-class's wet product.Under the premise of the power 2.3kw of HighefficientFluidbeddrier, optimum process condition are as follows: drying temperature
45 DEG C, drying time 15 minutes, air mass flow 50m3/h。
Meanwhile joining Fig. 1 to Fig. 4 it is found that it has been found that the appearance time for detecting tirofiban hydrochloride in Fig. 1 is
25.371min, and there are 6 detection peaks in relation to substance；The appearance time of detection tirofiban hydrochloride is in Fig. 2
25.480min, and there are 8 detection peaks in relation to substance；The appearance time of detection tirofiban hydrochloride is in Fig. 3
25.917min, and there are 6 detection peaks in relation to substance；The appearance time of detection tirofiban hydrochloride is in Fig. 4
25.608min, and the only 4 detection peaks in relation to substance.It follows that using fluid-bed drying to tirofiban hydrochloride wet product
The number (i.e. the number of impurity) for the related substance being dried in rear resulting tirofiban hydrochloride has been clearly not available reduction,
To improve final tirofiban hydrochloride purity obtained.
The series of detailed descriptions listed above only for feasible embodiment of the invention specifically
Protection scope bright, that they are not intended to limit the invention, it is all without departing from equivalent implementations made by technical spirit of the present invention
Or change should all be included in the protection scope of the present invention.
It is obvious to a person skilled in the art that invention is not limited to the details of the above exemplary embodiments, Er Qie
In the case where without departing substantially from spirit or essential attributes of the invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, the present embodiments are to be considered as illustrative and not restrictive, and the scope of the present invention is by appended power
Benefit requires rather than above description limits, it is intended that all by what is fallen within the meaning and scope of the equivalent elements of the claims
Variation is included within the present invention.Any reference signs in the claims should not be construed as limiting the involved claims.
In addition, it should be understood that although this specification is described in terms of embodiments, but not each embodiment is only wrapped
Containing an independent technical solution, this description of the specification is merely for the sake of clarity, and those skilled in the art should
It considers the specification as a whole, the technical solutions in the various embodiments may also be suitably combined, forms those skilled in the art
The other embodiments being understood that.
Claims (6)
1. a kind of drying means of tirofiban hydrochloride, which is characterized in that using HighefficientFluidbeddrier to tirofiban hydrochloride
Wet product carries out fluidized drying；
Wherein, the drying temperature in HighefficientFluidbeddrier is 40~50 DEG C, and drying time is 10~20 minutes, air mass flow 30
~70m3/h。
2. drying means according to claim 1, which is characterized in that drying temperature in HighefficientFluidbeddrier is 45 ±
4 DEG C, drying time is 12~18 minutes, 40~60m of air mass flow3/h。
3. drying means according to claim 2, which is characterized in that drying temperature in HighefficientFluidbeddrier is 45 ±
2 DEG C, drying time is 12~18 minutes, 40~60m of air mass flow3/h。
4. drying means according to claim 1, which is characterized in that drying temperature in HighefficientFluidbeddrier is 45 ±
1 DEG C, drying time is 15 minutes, 45~55m of air mass flow3/h。
5. drying means according to claim 1, which is characterized in that the drying temperature in HighefficientFluidbeddrier is 45
DEG C, drying time is 15 minutes, air mass flow 50m3/h。
6. drying means according to any one of claim 1 to 5, which is characterized in that the tirofiban hydrochloride wet product
Moisture content be 8.55%.
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| CN201810707944.0A CN109028765A (en) | 2018-07-02 | 2018-07-02 | A kind of drying means of tirofiban hydrochloride |
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| CN201810707944.0A CN109028765A (en) | 2018-07-02 | 2018-07-02 | A kind of drying means of tirofiban hydrochloride |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110988158A (en) * | 2019-11-25 | 2020-04-10 | 鲁南制药集团股份有限公司 | Method for detecting related substances of tirofiban hydrochloride injection |
| CN115598257A (en) * | 2022-11-04 | 2023-01-13 | 华夏生生药业（北京）有限公司（Cn） | Method for detecting multiple impurities in tirofiban hydrochloride injection |
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|---|---|---|---|---|
| CN110988158A (en) * | 2019-11-25 | 2020-04-10 | 鲁南制药集团股份有限公司 | Method for detecting related substances of tirofiban hydrochloride injection |
| CN115598257A (en) * | 2022-11-04 | 2023-01-13 | 华夏生生药业（北京）有限公司（Cn） | Method for detecting multiple impurities in tirofiban hydrochloride injection |
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Application publication date: 20181218 |
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| RJ01 | Rejection of invention patent application after publication |