Development

Development of Natto NKCP

  1. Background

    Heart disease and cerebrovascular disease (strokes) are respectively the first and the third leading causes of all deaths in developed parts of the world, with heart disease accounting for as much as 30% of all deaths and cerebrovascular disease accounting for nearly 10%. And these figures are only the tip of the iceberg in regards to the devastation of these diseases: for every one who actually dies from them, there are several others suffering from their ill effects — a stroke or a heart attack, for example, can leave a person bedridden. More mild symptoms might include neck stiffness, chronic headache, cold hands and feet, breathlessness, chest pains, poor mental function and dizziness.

    Any focus on increasing length and quality of life must look, therefore, at methods to maintain a healthy vascular system and blood flow. This is fundamental to good health and was the reason why Daiwa Pharmaceutical Co. Ltd. started research into the health properties of a traditional Japanese food called natto which was supposed to be so beneficial to health and the circulation. What they discovered was that there is a good good bacteria in this traditional fermented food, B. subtilis natto, which contains enzymes that help the body to maintain optimum blood flow and viscosity by breaking down a substance in the blood called PAI-1 that interferes with the body's natural processes. PAI-1 concentrations increase as we get older which is why our blood gets more sticky as we age and why we are increasingly at risk from vascular diseases.

    The problem with natto is is that it is a very unpleasant food to eat (it has an "acquired" taste/smell and a slimy texture); it contains high amounts of vitamin K2 which can interfere with anticoagulants such as Warfarin; the active enzyme content of natto can vary enormously from brand to brand (see below) and it is not easy to get hold of in Western countries. Daiwa Pharaceutical Co. Ltd., therefore, decided to extract the active ingredient (in the same way that good bacteria is extracted from yogart), remove the vitmain K2 in the process and to produce a standardized small tablet that would allow people to enjoy the benefits of natto without any of the drawbacks associated with it. They have called this "natto in a tablet" NKCP.

    Comparison of good bacteria activity in 89 different natto brands found in Japan showing the variation in peptidase activity. Daiwa Pharmaceutical therefore decided to produced a standardized "natto in a tablet" equivalent.


  2. Daiwa Pharmaceutical Co. Ltd.

    Daiwa Pharmaceutical Co. is a new breed of pharmaceutical company focused entirely on the development of natural food solutions. Already renowned for producing what is now the leading serious immune system supplement, BioBran MGN-3, a food extract made entirely from rice bran, Daiwa Pharmaceutical have now developed the highest quality and most active Natto extract (sometimes called nattokinase, although this is just one of its components) — NKCP. What sets Daiwa Pharmaceutical apart from many other developers of innovative foods and food supplements is its dedication to high quality research and production. Daiwa is not afraid to developing natural (and therefore not patentable) products, something which most pharmaceutical companies would be reluctant to do.


  3. Manufacturing Process

    NKCP is manufactured by culturing B. subtilis natto -- the good bacteria isolated from the natto food -- in a liquid medium under conditions suitable for the production of the active protein. The cell bodies, insoluble matter and low-molecular weight substances (which include the characterisitic odour molecules) are then removed. The peptide concentration is then standardized and the NKCP is powdered and then pressed into tablets. Below is the manufacturing flow chart for NKCP.
NKCP Manufacturing Flow Chart
     
 
Cultivation of a particular strain of Bacillus subtilis natto culture on a medium of soybean protein, glucose and soluble starch
 
   
 
Removal of insoluble fraction by continuous centrifugation and filtration by celite
 
   
 
Removal of ultra-low-molecular weight fraction by ultrafiltration
 
   
 
Removal of cells by membrane filtration
 
   
 
Addition of excipients
 
   
 
Freeze-drying
 
   
 
Powdering & Tableting
 

 

NKCP and nattoNKCP are registered trademarks of Daiwa Pharmaceutical Co. Ltd.
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