Method for rapid detection of illegally added sibutramine in products
A technology for products and testing equipment, applied in the fields of health food or food analysis and pharmaceuticals, can solve the problems of technical difficulties of sibutramine, interference with the conductivity of the sample solution and the total dissolved solids, etc. Simple to use effects
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Embodiment 1
[0056] Example 1. General operating conditions for detecting whether sibutramine is contained in medicines / health products
[0057] 1. Sampling volume:
[0058] Sampling recommendations for different types of samples are as follows:
[0059] sample type
Sampling volume
tablet
One oral dose (need to be crushed)
Capsules
Oral dose at one time (take the contents and grind them)
[0060] big honey pill
One-time oral dose (need to be crushed)
Granules
One-time oral dose (need to be crushed)
other solid
oral dose
[0061] This shows that the amount of the product to be inspected that the inventive method uses is few, so that the interests of the innocent operators are damaged as little as possible, the dosage of the above various types of samples is about 0.5 ~ 5g at a time, such as capsules and tablets at a time of about 0.5g. 0.5g, while the dosage of granules and big honeyed pills is about 5g at a ...
Embodiment 2
[0066] Embodiment 2, the general operation condition that detects whether sibutramine is contained in medicine / health product
[0067] 1. Sampling volume:
[0068] Sampling recommendations for different types of samples are as follows:
[0069] sample type
Sampling volume
tablet
One oral dose (need to be crushed)
Capsules
Oral dose at one time (take the contents and grind them)
big honey pill
One-time oral dose (need to be crushed)
Granules
One-time oral dose (need to be crushed)
6 --> other solid
oral dose
[0070] This shows that the amount of the sample to be inspected used by the method of the present invention is small, so as to damage the interests of innocent operators as little as possible.
[0071] 2. Preparation of the test solution
[0072] Take medicine, health food or food, add 20ml of ethanol, and shake for 1 minute.
[0073] 3. Develop color and judge the result
[0074]It is determi...
Embodiment 3
[0075] Embodiment 3, test whether there is sibutramine in detection medicine, health food and food
[0076] Adopt the method of embodiment 1 to detect 20 batches of samples rapidly (all are the sampling samples of drug supervision department). In addition, in accordance with the "National Drug and Food Administration Drug Inspection Supplementary Inspection Method and Inspection Item Approval Document 2006004", the HPLC / MS / MS method was used to test the samples to verify the screening results.
[0077] The HPLC / MS / MS detection method recorded in the drug inspection supplementary inspection method and inspection item approval document 2006004 is as follows:
[0078] Chromatographic conditions: mobile phase A is 0.02mol / L ammonium acetate, mobile phase B is 0.1% acetic acid aqueous solution / acetonitrile, and the elution is carried out according to the following gradient table.
[0079] time (min)
A(%)
B(%)
0.00
70
30
12.00
70
30 ...
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