Establishment of Dissolution Specification for Fa-Tha-Lai Capsules - การจัดทําข้อกําหนดมาตรฐานการละลายของยาแคปซูลฟ้าทะลาย

Abstract

                 Recently, wide-spread usage of Fa-Tha-Lai capsules or Fa-Tha-Lai Chon capsules dramatically in-creased as an alternative medicine in Thailand. Apart from the safety and efficacy of the product, its quality control tests were considerably concerned. A dissolution method was one of the crucial tests of quality control because it was considered as a prerequisite to detect a defective product and to maintain content uniformity in batches including reproducibility among the production batches. Consequently, the establishment of dissolution specification for Fa-Tha-Lai capsules or Andrographis paniculata capsules in this study was carried out by developing a dissolution method in order to assess the quality of the product. The objective was to evaluate the dissolution behavior of Fa-Tha-Lai extract capsules, which were labeled the content of andrographolide, distributed in Thai markets. Various dissolution media were tested to optimize the dissolution method. The data of the dissolution media were evaluated by a one-way analysis of variance (ANOVA). As a result, the proposed dissolution method used a paddle type dissolution apparatus at the rotation speed 100 rpm, dissolution medium comprising 900 mL of 0.01 M hydrochloric acid containing 0.2% w/v sodium lauryl sulfate main-tained at 37.0±0.5 o C, and 45 minutes time-point. Therefore, this proposed method could be suitably used for establishing the dissolution specification of Fa-Tha-Lai extract capsules because it could discriminate the dissolution quality among the products available in Thai markets.

Key words: dissolution, paddle, Fa-Tha-Lai extract capsules, andrographolide