The great majority of quality related problems are associated with unregulated herbal products.
These arise because of the nature of the herbal ingredients, which are complex mixtures of constituents, and it is well documented that levels of plant constituents can vary considerably depending on environmental and genetic factors.
Control of the starting materials is essential in order to ensure reproducible quality of herbal medicinal products.
The following aspects need to be considered in the control of starting materials.
The problems associated with unregulated herbal products, highlight the public health issues that can arise when the herbal ingredients have not been authenticated correctly.
Herbal ingredients must be accurately identified by macroscopical and microscopical comparison with authentic material or accurate descriptions of authentic herbs.
It is essential that herbal ingredients are referred to by their binomial Latin names of genus and species; only permitted synonyms should be used. Even when correctly authenticated, it is important to realize that different batches of the same herbal ingredient may differ in quality due to a number of factors.
Instances of herbal remedies adulterated with other plant material and even with conventional medicines.
Reports of herbal products devoid of known active constituents have reinforced the need for adequate quality control of herbal remedies.
Aerobic bacteria and fungi are normally present in plant material and may increase due to faulty growing, harvesting, storage or processing.
Herbal ingredients, particularly those with high starch content may be prone to increased microbial growth. It is not uncommon for herbal ingredients to have aerobic bacteria present at 102 –108 colony forming units per gram.
Pathogenic organisms including Enterobacter, Enterococcus, Clostridium, Pseudomonas, Shigella and Streptococcus have been shown to contaminate herbal ingredients.
Herbal ingredients, particularly those grown as cultivated crops, may be contaminated by DDT or other chlorinated hydrocarbons, organophosphates, carbamates or polychlorinated biphenyls. Limit tests are necessary for acceptable levels of pesticide contamination of herbal ingredients.
Ethylene oxide, methyl bromide and phosphine have been used to control pests which contaminate herbal ingredients. The use of ethylene oxide as a fumigant with herbal drugs is no longer permitted in Europe due to concerns about carcinogenic residues.
Lead, cadmium, mercury, thallium and arsenic have been shown to be contaminants of some herbal ingredients. Limit tests for such toxic metals may be needed for certain herbal ingredients.
Tests to limit other contaminants such as endotoxins, mycotoxins and radionuclides may need to be considered to ensure suitable quality for medicinal purposes. Commitments
Our commitment to quality is evidenced in every aspect of our business, from the passion sourcing and testing of herbs and the in-depth research and development of herb active constituents for therapeutic applications, to the development of manufacturing and extraction processes that have revolutionized the herbal products industry.
Trade, "Organic raw materials", or at least "Wild crafted one" To support sustainable agricultural methods.
To ensure authenticity and validity, we must, wherever possible, work directly with suppliers of quality organic herbs. Organic growers should be certified by organic certification organizations. It is also vital that only wild crafted herbs which have been harvested in an ecologically sensitive way are used.
To be a responsible biotechnology based research, manufacturing and marketing company supplying the finest raw materials to provide innovative solutions to the dietary supplement, phytopharmaceutical industries and cosmetics.
Stress on developing and bringing to market products with scientific and clinical support, our core business philosophy is in large part responsible for fueling the company’s ongoing commercial success.
working closely with customers and business partners in order to develop products that meet the changing market needs in burgeoning field human health products, to meet customer's requests for high-quality standardized extracts at competitive prices and for prompt delivery.
The most fundamental concept is that different herbs require different methods for extraction.
When doing extractions from plants, it is important to know what chemical compounds will extract into what solvents and through what method of extraction:
Our pilot plant provide a way to simulate a continuous countercurrent extraction process and pre-determine process parameters such as temperature, solvent requirement, yields, production time and costs. Knowing the product quality and evaporation behavior or temperature sensitivity of an extract is important for a successful extraction.
The facilities consist of Pilot-Extraction Plant, Pilot-Evaporation Plant and Pilot-Drying Plant.