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Method for detecting deviation of loading capacity of capsule preparation

A detection method and capsule technology, applied in capsule delivery, pharmaceutical formulations, complex mathematical operations, etc., can solve problems such as traceability

Active Publication Date: 2019-10-22
JIANGSU KANION PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The Chinese Pharmacopoeia capsule filling difference inspection is to randomly select a certain number of samples from the whole, and compare the degree of dispersion between the filling volume of each capsule and the sample mean. However, even if the method finds a problem, it is difficult to trace the cause from the production process
In the actual production process of capsule preparations, affected by fluctuations in the quality of decoction pieces, the physical properties of different batches of extract powder intermediates are also different, resulting in certain quality risks in the amount of capsules. Information, a method of predicting the deviation of capsule filling before the capsule filling process, which facilitates prior intervention and improves the precision of the capsule filling process

Method used

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  • Method for detecting deviation of loading capacity of capsule preparation
  • Method for detecting deviation of loading capacity of capsule preparation
  • Method for detecting deviation of loading capacity of capsule preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment -1

[0059] Example-1: Quantitative prediction of loading deviation of capsule preparations based on intermediate physical properties

[0060] In this implementation case, the physical properties of 25 batches of Guizhi Fuling capsule intermediates were used, and the partial least squares model was used to quantitatively predict the deviation of the filling capacity of the capsule preparation. The intermediates are soft material fine powder, wet granules, dry granules, sized granules and blended granules. The preparation process of the capsule preparation is shown in Example 3.

[0061] 1. Sample collection

[0062] Collect Guizhi Fuling capsule production process intermediates (preparation batch numbers: 180610, 180611, 180612, 180613, 180614, 180701, 180702, 180703, 180702, 180801, 180802, 180803, 180804, 180805, 180806, 180808, 1808081 , 180811, 180812, 180813, 180814, 180815, 180816) produced by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0063] 2. Determination of Physical ...

Embodiment -2

[0108] Example-2: Prediction of the deviation of capsule preparation loading based on multiple linear regression model

[0109] Two key material attributes of 25 batches of Guizhi Fuling capsules were selected, and multiple linear regression model was used to predict the filling deviation of Guizhi Fuling capsules. The key material attribute described is the median particle size value (D 50 ) and the percentage of whole particles smaller than 50 μm. The study found that the above two physical quality attributes have a significantly higher impact on the capsule preparation granulation filling process than other physical quality attributes, and can effectively reduce noise and obtain more accurate prediction results.

[0110] 1. Sample collection

[0111] Collect Guizhi Fuling capsule production process intermediates (preparation batch numbers: 180610, 180611, 180612, 180613, 180614, 180701, 180702, 180703, 180702, 180801, 180802, 180803, 180804, 180805, 180806, 180808, 180808...

Embodiment -3

[0133] Embodiment-3: A kind of preparation method of capsule preparation with stable loading difference

[0134] Taking Guizhi Fuling Capsules as an example, the preparation method of the capsule preparation of the present invention is as follows:

[0135] Take Poria cocos and crush it into fine powder; Moutan cortex is steam distilled, collect the distillate, separate the volatile components, and set aside; use 90% ethanol to extract the dregs, cassia twig, white peony root, peach kernel and the remaining poria cocos twice with 90% ethanol and combine The extract is recovered from ethanol until there is no yeast smell, concentrated under reduced pressure to an appropriate amount; the dregs of the medicine are decocted twice with water, filtered, and the filtrate is combined, concentrated under reduced pressure to an appropriate amount, and the above two concentrated solutions are mixed with Poria cocos fine powder, After drying and mixing, it becomes soft material fine powder...

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Abstract

The invention provides a method for detecting the deviation of loading capacity of a capsule preparation and is characterized in that the method comprises: determining physical quality attributes of intermediates in production process of different batches of capsule preparations; constructing a physical mass attribute data set of the intermediates, and performing data preprocessing; determining the deviation of loading capacity of various batches of the capsule preparations; taking the deviation of loading capacity of the capsule preparations as ''output'', taking the pre-processed intermediate physical mass attribute data set as ''input'', and establishing a correlation model of ''input'' and ''output''; and collecting the intermediate physical mass attribute of a sample of the capsule preparation to be tested, and calculating the deviation of loading capacity of the sample of the capsule preparation to be tested according to the established correlation model of ''input'' and ''output''. The relationship between the intermediate physical properties of the capsule preparation and the deviation of the loading capacity of a capsule preparation is quantitatively established, which canaccurately predict the deviation of loading capacity of the capsule preparation and facilitates the pre-intervention of high risk factors of the capsule loading capacity and continuous improvement ofquality control of the production process.

Description

technical field [0001] The invention relates to the field of intelligent testing, in particular to a method for detecting the deviation of the filling amount of capsule preparations. Background technique [0002] The capsule preparation process generally includes mixing, wet granulation, drying, granulation, total blending and capsule filling. The difference in capsule loading reflects the accuracy of dosage in the capsule filling process and is a key indicator for capsule quality control. The amount and precision of the capsule filling are related to the quality of the capsule product, which in turn affects the effectiveness and safety of the product. [0003] The Chinese Pharmacopoeia capsule filling difference inspection is to randomly select a certain number of samples from the whole, and compare the degree of dispersion between the filling volume of each capsule and the sample mean value. However, even if the method finds a problem, it is difficult to trace the cause ...

Claims

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Application Information

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IPC IPC(8): A61J3/07G06F17/16G06F17/18
CPCA61J3/074G06F17/16G06F17/18
Inventor 肖伟王晴徐冰王芬徐芳芳张欣陈永杰包乐伟张江艳左景省王振中乔延江罗赣
Owner JIANGSU KANION PHARMA CO LTD
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