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Quality inspection method of Bupleurum and Asarum in Chaixin Injection
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A technology of injection and bupleurum, applied in instruments, measuring devices, scientific instruments, etc., can solve problems such as tailing, overlapping peak areas, poor resolution, etc., to solve serious peak tailing, accurate and reliable results, and improve The effect of detection efficiency
Active Publication Date: 2022-05-17
CHINA INST OF VETERINARY DRUG CONTROL
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according to Figure 1A and Figure 1B It can be seen that no matter in the reference substance solution chromatogram ( Figure 1A ), or sample solution chromatogram ( Figure 1B ), the peaks of methyl eugenol (retention times are 2.577min and 2.578min) are all tailing seriously, the peak shape is not sharp, the left and right are asymmetrical, that is, the peak shape is poor, and the peak of methyl eugenol is consistent with the internal standard The distance between the peak of n-eicosane and other adjacent impurity peaks is close, the peak areas overlap, and the resolution is poor
The above chromatograms show that the determination method in the existing standard is poorly operable to evaluate the product quality of Chaixin Injection, and due to the low accuracy of the determination method, it is difficult to use it to control product quality, which may easily lead to poor product quality. Stablize
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[0053] Gas chromatograph: Agilent 7890A, equipped with FID detector.
[0054] Capillary chromatographic column: the column length is 30 m, the inner diameter is 0.530 mm, the film thickness is 1.00 μm, and polyethylene glycol (FFAP) modified by nitrohydroquinone is used as the stationary phase, purchased from Agilent Company.
[0055] Column temperature: program temperature rise, the initial temperature is 50-90°C, keep for 1 minute, raise the temperature to 170°C at a rate of 5-25°C per minute, keep for 10 minutes, then raise the temperature to 240°C at a rate of 5°C per minute, keep 10 minutes; detect with a hydrogenflameionizationdetector, the detector temperature is 230-270°C; the injection port temperature is 190-230°C; nitrogen is used as the carrier gas, and the flow rate is 5ml per minute.
[0056] (2), detection of n-hexanal content:
[0057] Take 5ml of the sample of Chaixin injection to be tested and...
Embodiment 2
[0061] Embodiment 2, the establishment of detection n-hexanal content method
[0063] Adopt DB-FFAP, DB-624 and HP-5 chromatographic column respectively, operate according to the description in embodiment 1 part (2), the reference substance solution that n-hexanal concentration is 6 μ g / ml is detected, compares different chromatographic columns Conditions, the difference of n-hexanal peak area, the results are shown in Table 3.
[0064] Table 3 The peak area of n-hexanal under different chromatographic column conditions
[0065] Column type DB-FFAP DB-624 HP-5 Hexanalpeak area 88 86 87
[0066] According to the results in Table 3, under the three chromatographic column conditions, the peak area values of n-hexanal are basically the same, and are greater than 50, indicating that the response value of n-hexanal is hardly affected by the polarity of the chromatographic column, and the response value is appropriate, which can be used for the detection of The c...
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Abstract
The invention discloses a quality inspection method for Bupleurum and Asarum in Bupleurum injection, using n-hexanal as the marker of Bupleurum and methyl eugenol as the marker of Asarum, and adopting a gas chromatograph under the same chromatographic condition The markers of Bupleurum Radix and Asarum are detected respectively; specifically, the extraction of n-hexanal, the extraction of methyl eugenol and the detection of n-hexanal and the detection of methyl eugenol are carried out. In the method of the invention, n-hexanal is used as the marking component of Bupleuri, and methyl eugenol is used as the marking component of Asarum, which solves the problems of low response value and poor sensitivity of n-caproic acid. Simultaneously, the invention solves the problems of severe tailing of the methyl eugenol peak, poor separation degree and the like. The method of the invention is used to detect the contents of Bupleurum and Asarum in the chaixin injection, the result is accurate and reliable, the operation is convenient, and the contents of these two main components can be detected simultaneously, thereby improving the detection efficiency.
Description
technical field [0001] The invention relates to the field of drug detection, in particular to a method for detecting the contents of Bupleuri and Asarum in Bupleurum injection. Background technique [0002] Chaixin Injection is an injection made from Bupleurum and Asarum as the main components through water extraction and other steps; its function is to relieve fever, dispel wind and cold, and is mainly used to treat horses, cattle, sheep, pigs, etc. There are many manufacturers and clinical applications for colds and fevers in cats, dogs, cats, etc. In the process of product quality supervision, it is necessary to regularly conduct quality inspections (referred to as quality inspections) on the contents of Bupleurum and Asarum in different batches of injection products to determine whether the products meet the standards. [0003] At present, in the "Quality Standards for Bupleurum Injection" (recorded in the Ministry of Agriculture and Rural Affairs of the People's Republ...
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