Introduction

Health care and nutrition has currently become a major interest to public. They believe that their health could be improved and sustained by consuming health supplement or traditional or combination of both products.

This interest leads to a great number of traditional and health supplement products are widely available in Malaysia. The claims and medical uses of these products are usually based on information and common use of older generations.

Red Yeast Rice (RYR) is one of the choices among these products. It is commonly used in China and other Asian countries for lowering blood cholesterol level. It claims to be useful in improving blood circulation, alleviating indigestion and diarrhoea. It can also be used as colouring agent, food additives and preservatives.

Though RYR is a natural products, precautions are still necessary when consuming this products since experts have not studied it extensively. The long term safety and ideal dosing of these products are also unclear.

Active Content Of Red Yeast Rice

The extracts of RYR is obtained from a rice fermentation process owhich uses a type of yeast called Monascus purpureus. The extracts contain monacolins, sterols, isoflavones, and monounsaturated fatty acids or ‘healthy fats’.

A study has shown that monacolin K structure is similar to statin or lovastatin, a pharmaceutical drug, that can lower the blood cholesterol level.

(a) Struktur bahan farmaseutikal lovastatin

(b) Struktur Monacolin K dari RYR

Regulatory Control Of Red Yeast Rice

Products contain RYR is a requisite to be registered in Malaysia as traditional medicine. One of the registration requirements for RYR manufacturers is to state the content and recommended dose of monacolin K or lovastatin on the product label. Drug Control Authority (DCA) of Malaysia has specified the amount of monacolin K or lovastatinin the product containing RYR should be less than the therapeutic dose of lovastatin i.e. 20-40 mg per day. The manufacturer should also comply with the following requirements before registered and marketed the product in Malaysia:-

• the dosage of Red Yeast Rice (Monascus purpureaus) shall not be more than 10mg per day.
• the lovastatin amount in the finished product shall not be more than 1% w/w

Due to the fact that the amount of monacolin K or lovastatin may vary among different brands (due to variation in fermentation process and type of yeast been used) therefore the manufacturer is responsible to ensure the consistency of lovastatin content in the finished product. . The manufacturers can determine the content of lovastatin in their product by using liquid chromatographic method.

Side Effect

RYR may have side effects such as bloating, gas, headache and heartburn. The common side effects of lovastatin may also anticipate when taking a product containing RYR such as increasing in liver and muscle enzyme which may lead to liver related problems or disease.

Drug-Drug Interaction Or Drug Disease Interaction

The following cautions must be considered when taking product containing RYR:

1. Do not take this product if you have/are:
   • kidney disease
   • liver related disease
   • pregnant
   • lactating
2. Avoid taking this product if you are taking:
   • medicinal product containing statin to control cholesterol level
   • other product to control or lower cholesterol level
   • medicinal product to lower body immune system
   • antifungal
   • antibiotics e.g. erythromycin
   • antidepressant
3. Do not take this product of you have allergic problems to fungi and yeast.

Conclusion

Some of RYR products marketed in Malaysia do not conform to the labelling and DCA requirements. Therefore, consumers with underlying disease are encouraged to seek professional advice before taking this product. Consumers should also undergo a medical check up if suffer from allergic reaction or side effects after taking this product.