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Quality
and Safety
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Chinese medicine is
a healing tradition with long history, great sophistication and dynamism.
This unique healing system is based on the long observation of births,
ageing, diseases and deaths. Chinese herbal therapy is an elaborate and
effective method to create and maintain the physical well-being of both
humans and animals. Chinese herbs are classified, combined and administered
according to 4 criteria: their nature (cold, cooling, neutral, warming
and hot), their flavour (bitter, pungent, salty, sour and sweet) involving
quite some seasonal, cosmological and five elements correspondences, their
energy (which can be ascending or descending, sinking or floating) and
their meridian tropism, which can direct a herbal combination to specific
organ, function or tissue. Thus thousands of plants and natural substances
have been combined into active formulas. In mainland China these formulas
are usually consumed as a herbal tea. As this practice is laborious and
time-consuming, Kaiser Pharmaceutical in Taiwan developed scientific processing
methods in order to concentrate these herbal formulas into granular, liquid
and tablet forms. |
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Initially a small
herb shop, Kaiser Pharmaceutical(KP) soon developed into a GMP-licensed
manufacturer of granulated extracts. GMP (Good Manufacturing Practice)
is the international standard in regulating pharmaceutical production
and distribution. These modern scientific processing methods and the rigorous
quality control set KP apart from all the other sources of Chinese herbs. |
| KP and Sinecura developed and maintain the strictest standards of quality control, resulting in a full certification of each batch of every product. Cutting edge technology and the uncompromising pursuit of quality meet world-wide appreciation. Today KP products are distributed in Australia, Canada, the EEC, Israel, Japan, Switzerland and the US. |
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| INTRODUCTION
INCLUDING SAFETY AND QUALITY CONTROL |
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Kaiser Pharmaceutical(KP) in Taiwan have developed scientific processing methods in order to concentrate whole herbs into herbal formulas in granular, liquid and tablet forms. Initially a small herb shop, KP soon developed into a GMP licensed manufacturer of granulated extracts (5:1). GMP (Good Manufacturing Practice) is the international standard in regulating pharmaceutical production and distribution. These modern scientific processing methods and the rigorous quality control set KP apart from all other sources of Chinese herbs. KP is the only producer of concentrated extracts who is able to collect the volatile oils during the extraction process. The oils are reintroduced downstream in a closed system. The extraction process is carefully monitored in order to respect the exact 'decoction time'. pH-level is monitored likewise to achieve maximal (or in some cases, minimal) extraction of active substances. The concentration and granulation process is conducted at the lowest possible temperatures, to avoid the destruction of the more delicate active constituents. KP and Sinecura developed and maintain the strictest standards of quality control, resulting in a full certification of each batch of every product. Cutting edge technology, and the uncompromising pursuit of quality meet world-wide appreciation. Today KP products are distributed in Australia, Canada, the EEC, Israel, Japan, Switzerland and the USA. 1) Quality raw materials: KP herb purchasers buy only the freshest, finest herbs available from the People's Republic of China. Herb conformity and origin is verified by experienced botanists, in Taiwan and in Europe. Herbal and animal substances are being selected according to the C.I.T.E.S regulations (protection of endangered botanical and animal species). Substances occurring on the C.I.T.E.S list are accompanied by a certificate, guaranteeing its cultivated origin. 2) Formulation: During the formulation stage herbs are carefully weighed and alternatively combined to create both traditional as well as custom formulas. All single herbs and formulas are processed according to the tenets of Chinese medicine and the traditional decoction procedures (i.e. decoction of the complete formula or pre-decoction of ingredients in vinegar, wine, ginger solutions etc., some herbs are stir fried, wine fried etc.) 3) Extraction: In a process used exclusively by KP, volatile oils are removed and later reintroduced. Single herbs and formulas are cooked in large vats of water in a closed and controlled environment (pH monitoring, decoction time monitoring). The extraction and condensation process result in an extracted liquid: the starting point for processing both the dry and liquid (4x and 4y+z) final products. 4) Evaporation: As collected volatile oils are reintroduced, the liquid extract is pumped to reservoirs on its way to the low temperature evaporator, where it will be further concentrated. Low temperature is essential to preserve unsteady active ingredients. Equable concentration of the plant's distinct components depends entirely on the slow path of low temperature evaporation. The liquid extract is filtered and vacuum packed after checking its micro biological purity. It is further stabilised and bottled in the laboratory of Sinecura. Liquid extracts are subjected to the same strict testing procedures as the dry extracts. Granulation: In a completely enclosed chamber, protected against cross-contamination, the concentrated herb extracts undergo a non-continuous granulation process known as flow coating. The concentrate is sprayed on starch particles of the same herbs(s) and is vacuum-dried at low temperature. Formulation: once the formulas or the single herbs are modified towards their dry granular form, they are siphoned into a separate clean-room to be bottled, labelled and sealed. Automated machines press them into tablets and eventually pour them into capsules. 5) After processing: each batch of every product is subjected to careful analysis to ensure a consistent and stable amount of active ingredients. Quality control is reflected in a final certificate, listing all relevant information and test results of the particular lot:
Sinecura is the only European distributor to include the latter three tests in the standard quality control, in spite of the high costs involved. Because the balance between maximum safety and maximum efficacy is our highest priority. |