FCG Full Composition Granules

The concept behind FCG Full Composition Granules is the production of a wide range of herbal granules whose effectiveness can be clearly demonstrated in clinical trials and experienced by practitioners and patients as being equivalent to that achieved by herbal formulas prescribed and decocted in the traditional way.

The traditional method of taking herbs involves the relatively time-consuming process of decocting a prescription of raw herbs in water twice and drinking the resulting liquid. Recently, the use of granules based on herbal extracts has increased in popularity. However, issues have arisen relating to the concentration ratio and to whether a combined granule formula taken as an infusion can be as effective as drinking a decoction.

Using traditional formula decoctions as the standard for comparison, Kang Ren Tang has developed a variety of production techniques for individual Chinese materia medica on the basis of the inherent characteristics of these substances. It is the first manufacturer to offer an effective and reliable solution to the problem of granule equivalence by determining an Equivalence Factor for each substance. This has enabled it to advance beyond the hitherto “industry standard” 5:1 ratio for concentrated powders and granules.

Implementation of the following procedures make FCG granules the optimum response to modern demands for effective and convenient herbal solutions:

  • Selection of superior-quality raw materials – Kang Ren Tang’s exhaustive ten-year research programme has enabled it to define the best source and species of each of the materia medica included in its range.
  • Determination of the cooking methods most appropriate for retention of all the ingredients of each herb – this ensures that the granule extract is equivalent in effect to that achieved when the herb is used in a combined decoction.
  • Adoption of modern production techniques enabling all the ingredients in the decoctions to be transferred to FCGs through extraction, concentration and spray-drying granulation.
  • Application of patented production technology and advanced quality control methods (including infrared fingerprint spectrum techniques) throughout the sourcing and manufacturing process.
  • Testing of each granule hundreds of times through numerous clinical trials on patients.

The development of FCG granules has been an iterative process, involving a variety of chromatography techniques and the use of infrared fingerprint spectrum testing, a method which is commonly used for determining the characteristics of Western pharmaceuticals but which to date has been more rarely applied on a comprehensive basis to herbal materials.

Just as human fingerprints are unique to each individual person, so infrared spectroscopy provides a spectral fingerprint that uniquely identifies a particular chemical compound. Since no two compounds have the same infrared spectrum, identity of the sample can therefore be confirmed by comparison of this region to a known spectrum.

Every materia medica has a different fingerprint depending on its locality and species and the methods employed in its processing — this is its specific feature. The fingerprint of a particular materia medica originating from the same locality and species and processed correctly according to the same method is consistent across different samples — its specific feature can therefore be replicated. Comparison of samples against benchmark standards ensures that raw materials come from traditionally authentic areas of cultivation and that the best-quality plant species are accurately identified and correctly processed.

IR fingerprint spectrum technology for herbal medicines is the only method that can represent a complete set of information for a particular materia medica. It enables quality to be controlled throughout the production process from raw material via intermediate product to finished product, ensuring a consistently high, stable level of product quality from batch to batch.

For more information on the application of infrared fingerprinting to FCG granules, download the article The Application of Infrared Fingerprinting Technology which appeared in the November 2015 issue of the RCHM Journal.

The main advantages of FCG Full Composition Granules:

  • Modern patented production technology for traditional herbs and formulae
  • Highest standards of quality assurance and control, including infrared fingerprinting
  • Strict hygiene and safety requirements in GMP-certified production facility
  • Total flexibility in prescription formulation
  • Automated dispensary system

For a detailed introduction to FCG Full Composition Granules (北京康仁堂全成分中药配方颗粒), a Practitioner Reference Guide (中医师手册) is now available for viewing and downloading in an English version and a Chinese version (中文版).