Quality control method of near-infrared holographic fingerprint for pills of six ingredients with rehmannia
A quality control method, the technology of Liuwei Dihuang Pills, is applied in the measurement of color/spectral properties, medical preparations containing active ingredients, pill delivery, etc., which can solve the problem of evaluating and controlling the quality of Liuwei Dihuang Pills and ensuring the stability of Liuwei Dihuang Pills. , uneven quality and other problems, to achieve the effect of improving quality control standards, easy to master, and good reproducibility
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preparation example Construction
[0023] (1) Preparation of the test product: take the commercially available Liuwei Dihuang condensed pills, pulverize them, pass through a 100-mesh sieve, weigh 10g, and set aside;
[0024] (2) Preparation of standard products: crush Rehmannia glutinosa, Chinese yam, Cornus officinalis, Cortex Moutan, Alisma and Poria respectively, and pass through a 100-mesh sieve; take 8g of rehmannia glutinosa, 4g of Chinese yam, 4g of Cornus officinalis, and 3g of peony according to the provisions of the 2005 Pharmacopoeia Mix skin, 3g Alisma and 3g Poria cocos evenly, make standard Liuwei Dihuang Wan, set aside;
[0025] (3) Spectra of the test product and standard product: Put 10g of the test product and the standard product into the quartz sample cup respectively, and use the diffuse reflectance accessory of the integrating sphere to collect the near-infrared spectrum. -1 , the light source is attenuated by an empty gate, the gain is 2 times, and the gold foil is used as a reference to ...
Embodiment 1
[0031] Take samples of Liuwei Dihuang Concentrated Pills produced by manufacturers marked 8, 9, and 10, crush them, pass through a 100-mesh sieve, weigh 10g, and set aside; measurement method: put 10g of samples directly into a quartz sample cup, and use an integrating sphere diffuse reflectance accessory Collect near-infrared spectra. Acquisition conditions: the acquisition spectrum range is 10000 ~ 4000cm -1 , the light source is attenuated by an empty gate, and the gain is 2 times; the gold foil is used as a reference to scan, the number of scans is 32 times, and the resolution is 8cm -1 ; Collect 20 spectra for each sample; Quality identification: replace the near-infrared spectrum data of manufacturer 1 in the basic model of mass analysis with the near-infrared spectrum data measured by the samples of Liuwei Dihuang Concentrated Pills produced by the three manufacturers of 8, 9, and 10 , processed with the data analysis software TQAnalyst 8.0, established the quality ana...
Embodiment 2
[0037] Take Liuwei Dihuang Concentrated Pills of three batch numbers (batch numbers 071289, 080286, 080319) produced by the manufacturer marked 1, pass through a 100-mesh sieve, weigh 10g, and set aside; measurement method: put the sample directly into the quartz sample cup , near-infrared spectra were collected using an integrating sphere diffuse reflectance accessory. Acquisition conditions: the acquisition spectrum range is 10000 ~ 4000cm -1 , the light source is attenuated by an empty gate, and the gain is 2 times; the gold foil is used as a reference to scan, the number of scans is 32 times, and the resolution is 8cm -1 , 20 spectra were collected for each sample; quality identification: the near-infrared spectrum data measured by the above three batches of Liuwei Dihuang Concentrated Pills were replaced successively by the near-infrared spectrum data of No. 1 in the basic model of quality analysis of Liuwei Dihuang Pills. The analysis software TQ Analyst 8.0 was used fo...
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