US 12,144,841 B2
Fuke Qianjin Capsule and quality control method therefor
Shun Jian, Hunan (CN); Yun Gong, Hunan (CN); Peng Zhang, Hunan (CN); Fujun Li, Hunan (CN); Yonggen Ling, Hunan (CN); Juanjuan He, Hunan (CN); Kanghua Wang, Hunan (CN); and Xiuwei Yang, Hunan (CN)
Assigned to QIANJIN PHARMACEUTICAL CO., LTD., Hunan (CN)
Appl. No. 17/293,920
Filed by QIANJIN PHARMACEUTICAL CO., LTD., Hunan (CN)
PCT Filed Jan. 14, 2020, PCT No. PCT/CN2020/072103
§ 371(c)(1), (2) Date Jan. 10, 2022,
PCT Pub. No. WO2020/098831, PCT Pub. Date May 22, 2020.
Claims priority of application No. 201811356104.0 (CN), filed on Nov. 14, 2018; and application No. 201811356105.5 (CN), filed on Nov. 14, 2018.
Prior Publication US 2022/0143125 A1, May 12, 2022
Int. Cl. A61K 36/758 (2006.01); A61K 9/16 (2006.01); A61K 36/19 (2006.01); A61K 36/232 (2006.01); A61K 36/29 (2006.01); A61K 36/48 (2006.01); A61K 36/738 (2006.01)
CPC A61K 36/758 (2013.01) [A61K 9/1694 (2013.01); A61K 36/19 (2013.01); A61K 36/232 (2013.01); A61K 36/29 (2013.01); A61K 36/48 (2013.01); A61K 36/738 (2013.01); A61K 2236/331 (2013.01); A61K 2236/333 (2013.01); A61K 2236/37 (2013.01); A61K 2236/39 (2013.01); A61K 2236/51 (2013.01)] 5 Claims
 
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 obtaining a Radix angelicae sinensis residue and a liquid medicine by ethanol percolating the Radix angelicae sinensis and extracting the liquid medicine to prepare a cream;
S2, obtaining a Herba andrographis residue and a liquid medicine by ethanol refluxing the Herba andrographis and extracting the liquid medicine to prepare a cream;
S3, boiling and extracting the Caulis mahoniae and the Zanthoxylum dissitum Hemsl. with water twice, after filtering, obtaining a Caulis mahoniae and Zanthoxylum dissitum Hemsl. residue and two filtrates, and combining the 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 to obtain a residue, boiling with water the filtered residue with the Radix angelicae Sinensis residue produced in the step S1, the Herba andrographis residue produced in the step S2 and the Caulis mahoniae and Zanthoxylum dissitum Hemsl. residue produced in the step S3 together, filtering, combining filtrates to prepare a cream; and
S5, combining the four creams of the steps S1, S2, S3, S4, mixing to obtain a mixed cream, detecting contents of the Z-ligustilide, the Z-3-butylidenephthalide, the genistin, the jatrorrhizine, the palmatine, the berberine, and a total amount of the andrographolide and the dehydroandrographolide in the mixed cream by a HPLC, controlling the content of Z-ligustilide, the content of genistin, the content of palmatine, the content of berberine, and the total amount of andrographolide and dehydroandrographolide in the mixed cream to reach a predetermined content, spray drying, and then pelletizing, encapsulating to obtain the Fuke Qianjin Capsules,
Wherein a content of each Fuke Qianjin Capsule is 0.4 g, and the predetermined content is controlled according to following range: each of the Fuke Qianjin Capsules contains 0.04 mg to 0.06 mg of the genistin, 0.090 mg to 0.130 mg of the palmatine, 0.13 mg to 0.18 mg of the berberine, 3.0 mg to 3.65 mg of the Z-ligustilide, and the total amount of the andrographolide and the dehydroandrographolide is not less than 3.5 mg.