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.