Abstract
Objective. To optimize the preparation formula and technology of Chuilian Jianpi granules. Methods. The formulation and preparation process were optimized by single factor experiment and response surface analysis, with the molding rate, hygroscopicity, and fluidity of particles as the comprehensive evaluation indexes, and the comprehensive score as the response value according to different weights. To further evaluate the stability and feasibility of the preparation formulation and technology, the physical fingerprint of the granules was constructed by seven indicators including particle tap density, bulk density, hygroscopicity, water content, angle of repose, Hausner ratio, and relative homogeneity index. Results. The optimum formula conditions of Chuilian Jianpi granules were as follows: the dosage ratio of drug to adjuvant was 1 : 0.8, lactose:mannitol = 1.5 : 1, and the amount of wetting agent (90% ethanol) was 25% of the granules, with high-speed stirring granulation. The similarity of the physical fingerprints of the 10 batches of Chuilian Jianpi granules was high, which is above 98.5%. Conclusion. The optimized preparation technology was stable and feasible, which can provide reference for the development of Chuilian Jianpi granules and other Chinese medicine granules.
Highlights
Introduction e Chuliani Jianpi granule is a prescription developed by the Mengcheng County Hospital of Traditional Chinese Medicine of Anhui Province based on modern pharmacological studies. e Mengcheng County Hospital has exclusive ownership of the prescription. is prescription is composed of 17 traditional Chinese medicines, including Spreading Hedyotis Herba, Sedi Herba, Scutellariae Barbatae Herba, Polygoni Cuspidati Rhizoma Et Radix, Pheretima, Poria, Galli Gigerii Endothelium Corneum, Crataegi Fructus, Citri Sarcodactylis Fructus, Aurantii Fructus, Moutan Cortex, Rhei Radix Et Rhizoma, Artemisiae Scopariae Herba, Schisandrae Chinensis Fructus, Glycyrrhizae Radix Et Rhizoma, Astragali Radix, and Coptidis Rhizoma
Years of clinical verification by the Mengcheng County Hospital of Traditional Chinese Medicine proved its functions of clearing away heat and toxic materials, soothing liver, and regulating qi, as well as fortifying the spleen and disinhibiting dampness
Focusing on the quality by design (QbD), this paper adopted the molding rate, moisture absorption rate, and fluidity of granules as evaluation indexes [1,2,3,4,5,6]. e team optimized the preparation formula and production procedures of Chuilian Jianpi granules by single-factor-based Box–Behnken experiment. e physical fingerprint of the particles was established based on physical properties such as stacking, Complexity fluidity, stability, and uniformity [7,8,9,10]. e particles were fully evaluated to ensure the stable and controllable quality of the particles, providing experimental data for the preparation, production, and quality control of the prescription
Summary
To optimize the preparation formula and technology of Chuilian Jianpi granules. Methods. e formulation and preparation process were optimized by single factor experiment and response surface analysis, with the molding rate, hygroscopicity, and fluidity of particles as the comprehensive evaluation indexes, and the comprehensive score as the response value according to different weights. 1. Introduction e Chuliani Jianpi granule is a prescription developed by the Mengcheng County Hospital of Traditional Chinese Medicine of Anhui Province based on modern pharmacological studies. Years of clinical verification by the Mengcheng County Hospital of Traditional Chinese Medicine proved its functions of clearing away heat and toxic materials, soothing liver, and regulating qi, as well as fortifying the spleen and disinhibiting dampness. It is mainly used for chest pain caused by dampness and heat in the liver and gallbladder, mouth pain, nausea and vomiting, dysuria or yellowish urine, yellowing of body and eyes, chronic hepatitis, and ascites due to cirrhosis. Focusing on the quality by design (QbD), this paper adopted the molding rate, moisture absorption rate, and fluidity of granules as evaluation indexes [1,2,3,4,5,6]. e team optimized the preparation formula and production procedures of Chuilian Jianpi granules by single-factor-based Box–Behnken experiment. e physical fingerprint of the particles was established based on physical properties such as stacking, Complexity fluidity, stability, and uniformity [7,8,9,10]. e particles were fully evaluated to ensure the stable and controllable quality of the particles, providing experimental data for the preparation, production, and quality control of the prescription
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