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Quality testing method of Yinhuang Qingfei Capsules
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A quality inspection method, the technology of clearing the lungs with silver and yellow, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of lack of mature drug quality methods, etc.
Active Publication Date: 2021-01-12
湖南安邦制药股份有限公司
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[0003] However, there is no mature method for checking the quality of this medicine in the prior art
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Embodiment 1
[0060] The microscopic identification of embodiment 1 ephedra
[0061] Observe the contents of this product under a microscope. If you observe the characteristics of pores, calcium oxalate sand crystals, and square crystals ( figure 1 ), and the stomata are specific, and the side of the guard cells looks dumbbell-shaped, so it is judged that ephedra is used as raw powder for medicine.
Embodiment 2
[0062] Embodiment 2 Tinglizi TLC identification
[0063] 2.2.1 Preparation of the test solution: Take 1g of this product (Tinglizi is Tinglizi), add 20ml of absolute ethanol, ultrasonicate for 30 minutes, filter, evaporate the filtrate to dryness, add 1ml of absolute ethanol to the residue Dissolve, as the test solution ①; take 1g of this product, add methanol 20ml, ultrasonically treat for 30 minutes, filter, evaporate the filtrate to dryness, add 1ml methanol to the residue to dissolve, and use it as the test solution ②;
[0064] 2.2.2 Preparation of the reference medicinal material solution: take 1 g of Tinglizi as reference medicinal material, add 5 ml of absolute ethanol, let stand for 24 hours, filter, and use the filtrate as the reference medicinal material solution.
[0065] 2.2.3 Weigh an appropriate amount of the negative sample lacking Tinglizi according to the prescription, and make a negative control solution lacking Tinglizi in the same way.
[0066] 2.2.4 Develop...
Embodiment 3
[0068] Embodiment 3 Tinglizi TLC control medicinal material solution optimization
[0069] 3.3.1 The test solution and the negative control solution are the same as items 2.2.1 and 2.2.3 of Example 2.
[0070] 3.3.2 Reference drug solution: take 1 g of Tinglizi reference drug, add 20 ml of 70% methanol, reflux for 30 minutes, let cool, filter, evaporate the filtrate to dryness, add 4 ml of methanol to dissolve the residue, and use it as the reference drug solution.
[0071] Depend on Figure 4 It can be seen that in the chromatogram of the control medicinal material, there are orange-red spots, which are clear and concentrated; in the chromatogram of the test product, at the position corresponding to the control medicinal material, there are spots of the same color, the color of the spots is clear, the Rf value is moderate, and the separation is good , negative control without interference. And the color band of the test sample solution extracted by absolute ethanol is light...
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Abstract
The invention relates to a quality detection and control method for Yinhuang Qingfei capsules. The method comprises the following steps: (1) performing thin-layer chromatography on semen lepidii; (2)performing combined thin-layer chromatography on thunberg fritillary bulb and honey-fried ephedra; (3) performing thin-layer chromatography on semen armeniacae amarae; (4) performing thin-layer chromatography on rhizoma dioscoreae nipponicae; (5) preferably, performing thin-layer chromatography on schisandra chinensis; (6) preferably, performing thin-layer chromatography on immature bitter orange;(7) preferably, determining content of honey-fried ephedra; (8) preferably, performing microscopic identification on the honey-fried ephedra; and (9) preferably, determining content of the schisandrachinensis. According to the detection method disclosed by the invention, the drug quality of the Yinhuang Qingfei capsules can be reliably obtained and controlled.
Description
technical field [0001] The invention relates to the field of traditional Chinese medicines, in particular to a quality detection method for traditional Chinese medicines. Background technique [0002] The prescription of Yinhuang Qingfei Capsule is the ancestral prescription of Wang Hong, an old Chinese medicine doctor, and it is a good medicine for treating chronic bronchitis. In August 2002, it was awarded the certificate of Class III New Drug of Traditional Chinese Medicine issued by the State Drug Administration, and the approved production unit is Hunan Anbang Pharmaceutical Co., Ltd. In 2011, it was approved as a Class A non-prescription drug by the State Food and Drug Administration. It is made of fourteen traditional Chinese medicines such as Tinglizi, roasted ephedra, bitter almond, Fritillaria, loquat leaf, Daqingye, Shichangpu, panshania, yizhi, ginkgo leaf, schisandra, citrus aurantium, raw gypsum and licorice. . [0003] However, there is no mature method for...
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