12-05-2022 дата публикации
Номер: US20220143125A1
The present invention discloses Fuke Qianjin Capsules and a quality control method therefor. The capsules are made of Radix Et Caulis Flemingiae, Caulis Mahoniae, Herba Andrographis, Zanthoxylum dissitum Hemsl., Caulis Spatholobi, Radix Angelicae Sinensis, Radix Codonopsis, and Radix Rosa Laevigata as raw materials. Each of the Fuke Qianjin Capsules contains not less than 2.0 mg of Z-ligustilide, and a total amount of andrographolide and dehydroandrographolide is not less than 1.9 mg. A new standard for controlling quality of the Fuke Qianjin Capsules has been established through an analysis of chemical ingredients in the Fuke Qianjin Capsules. This standard adds a variety of core ingredient content to the existing pharmacopoeia standards. According to the Fuke Qianjin Capsules made in this range, the consistency of effects between different batches is more stable. Moreover, the more the types of core ingredients are limited, the more stable the consistency of the drug effect. 1. A quality control method for Fuke Qianjin Capsules , wherein the quality control method comprises the following steps:using Radix Et Caulis Flemingiae, Radix Rosa Laevigata, Herba Andrographis, Radix Angelicae Sinensis, Caulis Mahoniae, Zanthoxylum dissitum Hemsl., Caulis Spatholobi and Radix Codonopsis as raw materials;S1, first extracting the Radix Angelicae Sinensis by ethanol percolating to prepare a cream;S2, extracting the Herba Andrographis by ethanol refluxing to prepare a cream;S3, boiling and extracting the Caulis Mahoniae and the Zanthoxylum dissitum Hemsl. with water twice, after filtering, combining two filtrates to prepare a cream;S4, boiling and extracting the Radix Et Caulis Flemingiae, the Radix Rosa Laevigata, the Caulis Spatholobi, and the Radix Codonopsis with water once and then filtering, boiling with water a filtered residue with a Radix Angelicae Sinensis residue produced in the step S1, an Herba Andrographis residue produced in the step S2 and a Caulis Mahoniae and ...
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