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Establishment method and application of prediction model of scutellaria baicalensis extract production process

A technology of Scutellaria baicalensis extract and production process, which is applied in the field of prediction model establishment, can solve problems such as the inability to guarantee the consistency of product quality between batches, and achieve the effect of ensuring consistency between batches

Pending Publication Date: 2019-12-17
北京华润高科天然药物有限公司 +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the research object of the above-mentioned patent literature is a pharmaceutical preparation prepared from a variety of raw materials, which is very different from the extract of Scutellaria baicalensis. It is a passive inspection after the event, and there is no research on how to ensure the consistency of product quality between batches, and the consistency of product quality between batches cannot be guaranteed.

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  • Establishment method and application of prediction model of scutellaria baicalensis extract production process
  • Establishment method and application of prediction model of scutellaria baicalensis extract production process
  • Establishment method and application of prediction model of scutellaria baicalensis extract production process

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Embodiment 1

[0048] Example 1 Screening of production process parameters of Scutellaria baicalensis Georgi extract

[0049] (1) Preparation and content determination method of Scutellaria baicalensis Georgi extract

[0050] The preparation process of Scutellaria baicalensis Georgi extract is carried out according to the preparation method of Scutellaria baicalensis Georgi extract described in the 2015 edition of "Chinese Pharmacopoeia": Take Scutellaria baicalensis Georgi, add water to decoct, combine the decoction, concentrate to an appropriate amount, adjust the pH value to 1.0-2.0 with hydrochloric acid, Incubate at 80℃, let stand, filter, add appropriate amount of water to the precipitate and stir evenly, adjust the pH to 7.0 with 40% sodium hydroxide solution, add the same amount of ethanol, stir to dissolve, filter, and adjust the pH to the filtrate with hydrochloric acid Incubate at 1.0-2.0 at 60°C, stand still, filter, and wash the precipitate with proper amount of water and ethanol of ...

Embodiment 2

[0080] This embodiment provides a method for establishing a prediction model for the production process of Scutellaria baicalensis Georgi extract, which includes the following steps:

[0081] (1) Select the selected raw material attribute parameters of Scutellaria baicalensis Georgi, the selected production process parameters of Scutellaria baicalensis Georgi extract and the quality attribute parameters of the selected Scutellaria baicalensis Georgi extract;

[0082] Screened raw material attribute parameters of Scutellaria baicalensis Georgi

[0083] The key material properties of the selection of Scutellaria baicalensis decoction pieces include the content of baicalin, wogonin, baicalein, wogonin and melaleuca in the decoction pieces of Scutellaria baicalensis. In order to simulate the changes in the key material attribute parameters of raw materials of Scutellaria baicalensis Georgi, 10 batches of decoction pieces of Scutellaria baicalensis Georgi were purchased, which were identi...

Embodiment 3

[0115] This embodiment provides a method for predictively controlling the mixed batch ratio of raw materials by using the prediction model of the production process of the Scutellaria baicalensis extract described in Embodiment 2, which includes the following steps:

[0116] First, given a batch of raw materials of Scutellaria baicalensis pieces (No. GS1), it is assumed that the production method of fixed process parameters is used to prepare Scutellaria baicalensis extracts. The fixed key process parameters are that the density of the concentrated solution is equivalent to 0.6g slices / mL, and the amount of precipitate added to water is 1.2 It is twice the quality of decoction pieces and the holding time at 60℃ is 90min.

[0117] (1) The control target of each quality attribute parameter of the selected Scutellaria baicalensis extract is set to be no less than 10% of the cream extraction rate, no less than 85.0% of the baicalin purity, and no less than 75% of the transfer rate. Acc...

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Abstract

The invention belongs to the field of traditional Chinese medicinal material extract quality control, and provides an establishment method and application of a prediction model of a scutellaria baicalensis extract production process, and the establishment method comprises the following steps: S1, screening scutellaria baicalensis raw material attribute parameters, scutellaria baicalensis extract production process parameters and scutellaria baicalensis extract quality attribute parameters; s2, establishing a quantitative prediction model according to the screened scutellaria baicalensis raw material attribute parameters, the scutellaria baicalensis extract production process parameters and the scutellaria baicalensis extract quality attribute parameters; the establishment method uses a system modeling method to combine key material attributes, key process parameters, product key quality attributes and other information in the scutellaria baicalensis extract preparation process; the method is used for predicting and judging the product quality, extracting main control points according to the causal relationship of the quantitative prediction model, and establishing a production process prediction control scheme, so that the scutellaria baicalensis extract quality control mode is changed from post-event passive inspection control to pre-event active prevention control, and the inter-batch consistency of the product quality can be ensured.

Description

Technical field [0001] The invention belongs to the field of quality control of Chinese medicinal material extracts, and specifically relates to a method for establishing a prediction model for the production process of a skullcap extract and its use. Background technique [0002] The extract of Scutellaria baicalensis Georgi is an extract made from the dried roots of Scutellaria baicalensis Georgi, a plant in the Lamiaceae family. The preparation process is included in the 2015 edition of the Chinese Pharmacopoeia. It consists of extraction, concentration, acid adjustment, filtration, The process consists of alkali adjustment, alcohol precipitation, filtration, secondary acid adjustment, filtration, washing and drying, etc. It has the characteristics of multiple links and long processes. The fluctuation of the raw material quality of Scutellaria baicalensis Georgi and the disturbance of each process in the production process will affect the consistency of the key quality attribu...

Claims

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Application Information

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IPC IPC(8): G06Q10/04G06F17/50G06Q10/06
CPCG06Q10/04G06Q10/06395
Inventor 朱博云王秋平徐冰乔延江
Owner 北京华润高科天然药物有限公司
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