CN112505184B - Quality evaluation method of ceftriaxone sodium butyl rubber plug for injection - Google Patents
Quality evaluation method of ceftriaxone sodium butyl rubber plug for injection Download PDFInfo
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- CN112505184B CN112505184B CN202011383522.6A CN202011383522A CN112505184B CN 112505184 B CN112505184 B CN 112505184B CN 202011383522 A CN202011383522 A CN 202011383522A CN 112505184 B CN112505184 B CN 112505184B
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/06—Preparation
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- G—PHYSICS
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- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G01N30/8675—Evaluation, i.e. decoding of the signal into analytical information
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Abstract
The invention belongs to the field of quality evaluation of rubber plugs, and particularly relates to a quality evaluation method of a ceftriaxone sodium butyl rubber plug for injection, which comprises the following steps: the volatile components in the ceftriaxone sodium for injection are determined by headspace gas chromatography, hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl-p-methylphenol are used as objects to be detected for causing the ceftriaxone sodium to be turbid, and the quality of the butyl rubber plug is determined by detecting the concentration of the objects to be detected. The method has simple steps and convenient operation, and can realize more accurate detection in fewer steps.
Description
Technical Field
The invention belongs to the field of quality evaluation of rubber plugs, and particularly relates to a quality evaluation method of ceftriaxone sodium for injection.
Background
For injection drugs, the medicinal butyl rubber plug is one of the necessary sealing materials, and various compounding agents including a vulcanizing agent, a vulcanization accelerator, an antioxidant, a filler, an anti-scorching agent, an active agent and a lubricant are required to be added in the processing process, and a product with good physicochemical properties can be produced only through the processes of vulcanization, cleaning and the like. At higher temperatures, the compounding ingredients in the rubber plug may precipitate, and contact of the precipitate with the drug may affect the quality of the drug and present a risk of harm to human health.
The ceftriaxone sodium is a third-generation cephalosporin antibiotic, the national basic drug, the powder injection for injection is widely applied clinically, and the existing ceftriaxone sodium for injection has the outstanding quality problem that the examination item of 'clarity of solution' does not meet the specification and shows that the drug gradually becomes turbid when dissolved in the storage process. Analysis of main reasons causing the unqualified clarity reveals that the compatibility of the medicine and a rubber plug for sealing the penicillin bottle, particularly the interaction with a specific precipitate in the rubber plug is the main reason influencing the unqualified clarity of the ceftriaxone sodium solution for injection.
In order to realize the purpose of controlling the quality of a ceftriaxone sodium butyl rubber plug for injection, volatile components in the rubber plug are analyzed by adopting a gas chromatography, a turbidity value of a medicine solution is associated with the content of the volatile components, a rubber plug quality control method is established, and the method is verified by methodology.
Disclosure of Invention
Aiming at the problem that no ideal evaluation method for the quality of the rubber plug for ceftriaxone sodium exists in the prior art, the invention provides a quality evaluation method for the rubber plug for ceftriaxone sodium. The method of the invention comprises the following steps: measuring volatile components in the ceftriaxone sodium for injection by headspace gas chromatography, and taking hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl p-methylphenol as a target object to be measured for causing turbidity of the ceftriaxone sodium solution for injection; and judging whether the quality of the butyl rubber plug reaches the standard or not by detecting the concentration of the target object to be detected.
The butyl rubber plug contains various volatile substances, the research of the invention finds that the substances are main components causing the turbidity of the ceftriaxone sodium solution for injection, and the invention selects the substances as characteristic objects to judge the quality of the butyl rubber plug.
Preferably, the concentration of ceftriaxone sodium caused by hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl-p-methylphenol is the same as the turbidity of No. 1 turbidity solution as a standard value; if the concentration of the target object to be detected in the butyl rubber plug to be detected is greater than the standard value, the butyl rubber plug does not reach the standard, otherwise, the butyl rubber plug reaches the standard.
Preferably, the sum of the concentrations of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane, the concentration of 2, 6-di-tert-butyl p-methylphenol and the total concentration of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl p-methylphenol are used as indexes to be measured. Researches find that the relation between the concentration of single siloxane and the turbidity of the ceftriaxone sodium solution for injection is not obvious, and the reason for influencing the turbidity is the result of the combined action of a plurality of volatile components, so that the result can be more accurate by jointly controlling the volatile components influencing the turbidity. Further, the influence of the volatile components in the butyl rubber plug on the turbidity of the ceftriaxone sodium solution for injection can be accurately evaluated by selecting the indexes to be tested as the indexes to be tested and by linearly relating the total concentration of the hexamethylcyclotrisiloxane, the octamethylcyclotetrasiloxane and the decamethylcyclopentasiloxane to the turbidity of the ceftriaxone sodium solution for injection, and linearly relating the concentration of the 2, 6-di-tert-butyl p-methylphenol to the turbidity of the ceftriaxone sodium solution for injection, and by linearly relating the total concentration of the hexamethylcyclotrisiloxane, the octamethylcyclotetrasiloxane and the decamethylcyclopentasiloxane to the turbidity of the ceftriaxone sodium solution for injection.
Preferably, whether the concentration reaches the standard is judged by judging whether the total peak areas of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane, the peak area of 2, 6-di-tert-butyl-p-methylphenol and the total peak areas of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane reach the standard or not. Because the production technology of the butyl rubber plug of each enterprise is different, the size, the weight and the contained components of the rubber plug are different, and the concentration of volatile components is difficult to quantify, so the comparison is carried out by peak areas.
Preferably, a certain concentration of octamethylcyclotetrasiloxane is selected as the standard;
and detecting the standard substance and the sample to be detected in the same instrument in sequence, and judging whether the product is qualified or not by judging the total peak areas of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane, the peak area of 2, 6-di-tert-butyl p-methylphenol and the multiple relation between the total peak area of the methylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl p-methylphenol and the peak area of the standard substance in the sample to be detected. The peak area is changed greatly in the process of directly detecting by the peak area due to the change of an instrument and detection conditions, the standard substance is determined according to the sample with specific concentration, and the sample is injected with the sample to be detected under the same instrument and the same conditions, so that a reference standard is provided for area detection, and accurate detection is facilitated.
Preferably, the octamethylcyclotetrasiloxane concentration is selected as the standard of 0.0518 mg/ml;
and (3) introducing the standard substance with the concentration and a sample to be detected, and if the total peak area of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane in the sample to be detected is more than 3.5 times of the area of the standard substance, the peak area of 2, 6-di-tert-butyl-p-methylphenol is more than 3 times of the peak area of the standard substance, and the total peak area of methylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and butylhydroxytoluene is more than 4 times of the peak area of the standard substance, determining that the product is unqualified.
In the process of judging the concentration by the peak area, due to the particularity of gas chromatography detection, if the peak area is too small, the detection concentration of the material cannot be effectively judged, and if the peak area is too large, the problem of overload of an instrument and inaccurate peak area exists. As the turbidity is in linear relation with the peak area, the total siloxane chromatographic peak area, the 2, 6-di-tert-butyl-p-methylphenol (BHT) chromatographic peak area and the peak area sum range of the total siloxane and BHT corresponding to No. 1 turbidity solution are calculated by a linear equation and are shown in Table 1.
TABLE 11 ranges of chromatographic peak areas for siloxane, 2, 6-di-tert-butyl-p-methylphenol and their sum
According to the area value, in order to facilitate subsequent calculation, octamethylcyclotetrasiloxane (corresponding concentration is 0.0518mg/ml) with the area of 10 is taken as a standard, and whether the sample to be detected reaches the standard or not can be conveniently and accurately judged by judging the multiple relation between other components and the octamethylcyclotetrasiloxane. Because the chromatographic peak areas measured by different gas chromatographs are different, when the chromatographic peak areas are measured on other instruments, the peak area corresponding to the octamethylcyclotetrasiloxane with the concentration is selected as a standard, and the multiple relation between the volatile component and the peak area is compared. And the judging method is not limited by instrument change.
Preferably, the conditions for measuring by headspace gas chromatography are as follows:
a chromatographic column: 5% phenyl-95% methylsiloxane;
carrier gas: nitrogen gas; the flow rate is 1.0 ml/min;
temperature programming of a chromatographic column: maintaining at 50 deg.C for 10min, heating to 170 deg.C at 10 deg.C/min, and maintaining for 20 min;
headspace conditions: maintaining at 121 deg.C for 30 min; determination of the dead time (t) of a chromatography system using methane0). The method can be used for accurately collecting and detecting the volatile substances in the rubber plug to be detected.
Preferably, the processing method of the rubber plug to be tested comprises the following steps: cutting the rubber plug into pieces, putting into a headspace bottle, and sealing with a blank rubber plug.
Preferably, the peak-off time of the components to be detected in the detection process by the above method is as follows in table 2:
TABLE 2 gas chromatography qualitative parameters of 4 volatile components in the rubber plug
As a preferred mode of operation, the method of the invention comprises the steps of:
1) measuring volatile matters, namely hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl-p-methylphenol in the butyl rubber plug to be measured by headspace gas chromatography;
the detection conditions are as follows: a chromatographic column: 5% phenyl-95% methylsiloxane;
carrier gas: nitrogen gas; the flow rate is 1.0 ml/min;
temperature programming of a chromatographic column: maintaining at 50 deg.C for 10min, heating to 170 deg.C at 10 deg.C/min, and maintaining for 20 min;
and (3) headspace conditions: maintaining at 121 deg.C for 30 min; determination of the dead time (t) of a chromatography system using methane0)；
2) Selecting octamethylcyclotetrasiloxane to determine the peak area of 0.0518mg/ml octamethylcyclotetrasiloxane, and taking the peak area as a detection standard;
and (3) introducing the standard substance with the concentration and a sample to be detected, wherein if the total peak area of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane in the sample to be detected is more than 3.5 times of the area of the standard substance, the peak area of dibutylhydroxytoluene is more than 3 times of the peak area of the standard substance, and the total peak area of methylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl-p-methylphenol is more than 4 times of the peak area of the standard substance, the product is unqualified.
The invention has the following beneficial effects:
1) the method has simple steps and convenient operation, and can realize more accurate detection in fewer steps;
2) the method of the invention has high accuracy and good reproducibility.
Detailed Description
The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.
Example 1
The embodiment relates to a quality evaluation method of a ceftriaxone sodium butyl rubber plug for injection, which comprises the following steps:
1) measuring volatile matters, namely hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl-p-methylphenol in a butyl rubber plug in a sample to be measured by headspace gas chromatography;
the detection conditions are as follows: a chromatographic column: 5% phenyl-95% methylsiloxane;
carrier gas: nitrogen gas; the flow rate is 1.0 ml/min;
temperature programming of a chromatographic column: maintaining at 50 deg.C for 10min, heating to 170 deg.C at 10 deg.C/min, and maintaining for 20 min;
headspace conditions: maintaining at 121 deg.C for 30 min; determination of the dead time (t) of a chromatography system using methane0)；
2) The octamethylcyclotetrasiloxane concentration of 0.0518mg/ml is selected as a detection standard;
4 batches of butyl rubber plugs produced by the same manufacturer are analyzed according to the conditions (two rubber plugs are selected for measuring 1 batch of samples), the total siloxane peak area and the 2, 6-ditert-butyl-p-methylphenol peak area are shown in the following table, the gas chromatographic peak areas of octamethylcyclotetrasiloxane with different concentrations are measured at the same time, a linear equation is established, y is 856.91x +0.0542, the chromatographic peak area corresponding to octamethylcyclotetrasiloxane with the concentration of 0.0518mg/ml is calculated to be 44.44, and the multiples of the chromatographic peak areas of all volatile components in the rubber plugs relative to the reference peak area are calculated and listed in table 1. As can be seen from the data in the table, the volatile components in the 4 batches of rubber plugs were all in compliance with the regulations.
TABLE 1
Example 2
The embodiment relates to a quality evaluation method of a ceftriaxone sodium butyl rubber plug for injection, which comprises the following steps:
1) volatile matters including hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and BHT in a butyl rubber plug in a sample to be detected are measured through headspace gas chromatography;
the detection conditions are as follows: a chromatographic column: 5% phenyl-95% methylsiloxane;
carrier gas: nitrogen gas; the flow rate is 1.0 ml/min;
temperature programming of a chromatographic column: maintaining at 50 deg.C for 10min, heating to 170 deg.C at 10 deg.C/min, and maintaining for 20 min;
headspace conditions: maintaining at 121 deg.C for 30 min; determination of the dead time (t) of a chromatography system using methane0)；
2) The octamethylcyclotetrasiloxane concentration of 0.0518mg/ml is selected as a detection standard;
the butyl rubber plugs of 3 batches produced by the same manufacturer are analyzed according to the conditions (two rubber plugs are selected for measuring samples of 1 batch), the peak areas of the obtained total siloxane and the 2, 6-ditert-butyl-p-methylphenol are shown in the table below, the peak areas of the gas chromatography of octamethylcyclotetrasiloxane with different concentrations are measured at the same time, a linear equation is established, y is 492.96x-3.0192, the chromatographic peak area corresponding to the octamethylcyclotetrasiloxane with the concentration of 0.0518mg/ml is calculated to be 22.52, and the multiples of the chromatographic peak areas of all volatile components in the rubber plugs relative to the reference peak area are calculated and listed in table 2. As can be seen from the data in the table, the volatile components in the 3 batches of rubber plugs were all in compliance with the regulations.
TABLE 2
Examples of the experiments
The rubber plugs of the example 1 and the example 2 are used for producing ceftriaxone sodium for injection, the preparation is inverted for 6 months under the conditions of 40 ℃ of temperature and 90% of relative humidity, the clarity of the solution is measured, and compared with the turbidity of the No. 1 turbidity solution, the turbidity of the solution is found to be less than that of the No. 1 turbidity solution, thereby proving that the rubber plugs of the example 1 and the example 2 meet the quality requirements.
Although the invention has been described in detail hereinabove by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that many modifications and improvements can be made thereto based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.
Claims (4)
1. A quality evaluation method of ceftriaxone sodium butyl rubber plugs for injection is characterized in that volatile components in the ceftriaxone sodium butyl rubber plugs for injection are measured through headspace gas chromatography, and hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl p-methylphenol are used as objects to be detected which cause turbidity of ceftriaxone sodium solutions for injection;
octamethylcyclotetrasiloxane with a concentration of 0.0518mg/ml was selected as a standard;
respectively detecting the standard substance and the sample to be detected in the same instrument, and judging whether the product is qualified or not by judging the total peak areas of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane, the peak area of 2, 6-di-tert-butyl p-methylphenol and the multiple relation of the total peak area of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and 2, 6-di-tert-butyl p-methylphenol and the peak area of the standard substance in the sample to be detected;
and if the total peak area of hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane and decamethylcyclopentasiloxane in the sample to be detected is larger than 3.5 times of the area of the standard substance, the peak area of 2, 6-di-tert-butyl-p-methylphenol is larger than 3 times of the area of the peak of the standard substance, and the total peak area of methylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane and butylhydroxytoluene is larger than 4 times of the area of the peak of the standard substance, the product is unqualified.
2. The quality evaluation method according to claim 1, wherein the standard value is a concentration at which the turbidity of ceftriaxone sodium caused by hexamethylcyclotrisiloxane, octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, and 2, 6-di-tert-butyl-p-methylphenol is the same as the turbidity of the turbidity-free solution No. 1; if the concentration of the target object to be detected in the butyl rubber plug to be detected is greater than the standard value, the butyl rubber plug does not reach the standard, otherwise, the butyl rubber plug reaches the standard.
3. The quality evaluation method according to claim 1, wherein the conditions for the headspace gas chromatography measurement are:
a chromatographic column: 5% phenyl-95% methylsiloxane;
carrier gas: nitrogen gas; the flow rate is 1.0 ml/min;
temperature programming of a chromatographic column: maintaining at 50 deg.C for 10min, increasing the temperature to 170 deg.C/min at 10 deg.C/min, and maintaining for 20 min;
headspace conditions: maintaining at 121 deg.C for 30 min; determination of dead time t of a chromatography system using methane0。
4. The quality evaluation method according to claim 1 or 3, wherein the processing method of the rubber plug to be tested is as follows: cutting the rubber plug into pieces, putting into a headspace bottle, and sealing with a blank rubber plug.
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