Near-infrared quality monitoring method for pharmaceutical granules

Abstract

The invention discloses a near-infrared quality monitoring method for pharmaceutical granules. The method includes the following steps that: the near-infrared spectral information of the granules which is obtained through the partial least squares method is correlated with the true values of measured index component contents, so that a correction model can be established; outlier judgment is performed through Mahalanobis distance, so that whether the particle size uniformity of the granules meets requirements can be judged; whether the index component contents of each batch of granules meet quality control standards is judged through calculation; if the index component contents of each batch of granules meet the quality control standards, the next step is executed; and RSD values are calculated, if the predicted RSD values of an N-th batch of granules and the predicted RSD values of a (N+1)-th batch of granules are smaller than or equal to 5.0%, and it is judged that the granules conform to quality uniformity. According to the method of the invention, the quality uniformity of produced pharmaceutical particles are evaluated in a particle shaping stage, so that a next uniform mixingprocess can be omitted, a production rhythm can be accelerated, production efficiency can be improved, production cost can be reduced, a storage space for intermediate transporter can be decreased, and the utilization efficiency of a production site can be improved.

Description

technical field [0001] The invention belongs to the field of quality inspection and analysis of pharmaceuticals, and in particular relates to a near-infrared quality monitoring method for pharmaceutical granules. Background technique [0002] The current pharmaceutical granules adopt a batch production mode. The 2010 version of GMP stipulates that "batch" refers to a certain amount of raw materials, packaging materials or finished products produced through one or several processing processes with expected uniform quality and characteristics. Oral or external solid and semi-solid preparations are homogeneous products produced by one-time mixing with the same mixing equipment before molding or sub-packaging. [0003] The wet preparation process of drug granules includes steps such as making soft materials, granulating, drying, and granulating. Among them, in the granulation step, generally multiple sub-batches are mixed evenly by mixing equipment, and then sub-packaged to ob...

AI Technical Summary

Problems solved by technology

[0004] The current common soft material mixing equipment is generally 2000kg per batch. According to the size of the soft material mixing equipment, the shortcoming of small batch production and direct whole grain packaging is that the batch is small and there are many batches, which requires a lot of inspection costs.

[0005] Large-scale production requires multiple sub-batches to be mixed evenly after being sized by mixing equipment, and then repacked after passing the inspection. The disadvantages are: 1. A large space is required to store the transit place for particle intermediates; 2. Increase the uniform mixing process, mixing The process also causes interruption of production, which reduces production efficiency

However, this method does not solve the problem of batch particle size uniformity and content uniformity

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