Recently, the Drug Administration – the Ministry of Health has announced the medicinal material for the production of “Royal Virgin” products (its scientific name is Crinum latifolium L. Amaryllidaceae). This announcement by Thien Duoc Co., Ltd is committed to ensure the quality and announces that the agriculture, collection and formulation of medicinal material will be under WHO-GACP criterion and comply with the provision outlined in Circular 14/2009/TT- BYT dated 3/9/2009 of the Ministry of Health on guidelines for applying the principles and standards of “Good Agriculture and Collection Practices” as recommended by World Health Organization. To explore this issue, SGGP visited Crinum latifolium L. plantation and medicine manufacture factory of Thien Duoc Co., Ltd.
Sai Gon Giai Phong Newspaper
23/03/2012
People usually call Royal Virgin “Toi loi”. In Vietnam, there are many Crinum plants looking alike Crinum latifolium L. Crinum latifolium L. belonging to Crinum genus has bulb-like body, many thin strip-shaped leaves. Two leaf’s margins are wavy with parallel veins. The leaf’s upper surface is concave into groove. The leaf’s lower face has a very clear mid rib. The leaf’s sheaths near the ground are red-violet. The leaves are 40-60 cm long, and 3-9 cm wide.
The peduncle is 20-50-cm long, carrying over 6-8 flowers arranging in an umbel. The petal and calyx are alike-white and pinkish in the middle, forming a 7-10 cm long tube. The sepal is 5-7cm long. The anther is string-shaped, 20-25 cm long, and adheres to back. Ovary is spool-shaped. The filament is thin beyond the anther. Currently, the production of herbal medicines is mainly controlled in its output. To ensure product quality, the important thing is input material. However, in fact, input material’s quality is not controlled.
Therefore, the quality of herbal medicinal products is not high. Some medicinal material having their resemble plants can be named such as Crinum latifolium L. in Vietnam. There are many Crinum plants having the same botanical morphology as Crinum latifolium L. but different in gene. Hence, choosing the right Crinum latifolium L. having content of bioactive substances for medicine production is a big problem. Currently, on the market, many patients and manufacturers confuse this plant with Crinum asiaticum L., which leads to the production of wrong medicine affecting consumers. Besides, patients often confuse “Diep ha chau” plant so-called “Cho de rang cua” (Phyllanthus urinaria L.) which treats liver disease with “Cho de” plant. So, products made from “Diep ha chau” should also be controlled as strictly as Crinum latifolium L. should be, if not they will affect patient health. A mass of supplements produced from Crinum latifolium L. and other plants needs to be strictly controlled to ensure safety for patients. In addition, the medicine production process that is not standardized and controlled at each stage of production leads to unstable quality. Production equipment condition in many establishments, particularly in private ones, is still handmade and prone to infection. In many places, human resources are insufficient and have not been trained to master herbal agriculture techniques. Some production establishments do not check input material so products have low quality. Traditional remedies turning into modern dosage form do not reach the content of bioactive substances, which will affect their efficacy. Aware of the importance of input materials to ensure the safety, quality, and efficacy of the capsule, we think enterprises need to perform medicine manufacture quality management under GACP-WHO – Good Agriculture and Collection Practices – World Health Organization. It is an indispensable requirement that not only decides the existence and development of enterprises but also implements medical ethics of the apothecary and serves community health well.
To create safety, quality, and efficacy of the medicine, Thien Duoc Company has started developing a plantation with an area of 15 hectares since 1999 in Long Thanh - Dong Nai. Since then, the company has carried out strict management for stages in the process of planting, tending and collecting Crinum latifolium L. under GACP-WHO criterion to ensure that materials for Crila has high bioactivity, stability, and safety.
Pharmacist - Dr. Nguyen Thi Ngoc Tram the author of research work group on Crinum latifolium L. said ‘We chose seedlings from wild plants based on genetic characteristics (ADN) of Crinum latifolium L. (which belongs to Amaryllidaceae family) which has been studied and identified botanically by the leading botanists of Vietnam. We have selected healthy seedlings whose leaves have fully bioactive substances used as raw materials to produce Crila for benign prostatic hyperplasia and uterine fibroids. Crinum latifolium L. plantation of Thien Duoc Co., Ltd in Long Thanh - Dong Nai requires GACP-WHO criterion. This plantation has a favorable location which is 1 km away from main roads, unpolluted by crowded residential areas, not near factories, enterprises, hospitals, cemeteries, with suitable climate for the plant. The plantation uses the water meeting national technical standards - running-water quality according to the provision QCVN 01: 2009/BYT issued by the Ministry of Health. In cultivating process, no chemical fertilizers, growth stimulants and pesticides are accepted but use hands or pheromones – a synthetic substance with the same chemical structure as extract from female worm – to catch caterpillars by luring male. This helps to prevent female from fertilizing and laying eggs.
To perform effectively Good Agriculture and Collection Practices under GACP-WHO criterion, it’s important to control all stages of cultivation, collection and storage. To do that, we must have two conditions including infrastructure and labor force. Technicians and technical workers in agriculture and collection need to master technical process in agriculture and collection. Infrastructure must require the standards of GACP-WHO criterion. If there are good facilities but technical staffs are not good, GACP-WHO criterion cannot be implemented. Determining the importance of these two factors, our company has trained technicians and agricultural technical workers to master techniques for medicinal material cultivation under WHO’s criteria for years.
Crila is manufactured from material of Crinum latifolium L. plantation under GACP-WHO criterion. Besides, its company’s factories are granted a certificate for meeting GMP-WHO (Good Manufacture Practices), GLP (Good Laboratory Practices), and GSP (Good Storage Practices) criteria. When confiding about patients, Pharmacist - Dr. Nguyen Thi Ngoc Tram added, “Patients should use right products, a very important thing they should do is broadening their knowledge to avoid confusing medicine with supplement because only medicine has therapeutic ability, and supplement just supports treatment. Along with helping patients to know clearly differences between medicine and supplement, managing closely doctors’ prescriptions to know whether they perform correctly the regulation of the Ministry of Health that is supplement is not prescribed. If doctors prescribe supplements, it must be managed because nowadays there are many good medicinal products with suitable price and high efficacy. One of them is Crila, which has been allowed for nationwide circulation since 2005 but patients do not know. Since Crila was born, it has had high efficacy and safety with patients so we hope that patients will use Crila for the treatment of BPH and uterine fibroids”.
At the end of the conversation, Dr. Nguyen Thi Ngoc Tram said, “Our Company carrying out agriculture, collection, and storage under standard “Good Agriculture and Collection Practices” for medicinal plants as recommended by World Health Organization is necessary to ensure the quality of herbal medicinal products. Moreover, to export the products to other countries, inputs must be controlled and planted under GACP-WHO criterion in order to be clean medicinal material with required bioactive substance concentration. Currently, our company also faces with some difficulties in the land where Crinum latifolium L. will be planted, we need to develop Crinum latifolium L. plantation with hundreds and thousands of hectares to make material for Crila production, and then export Crila to other countries. We also appreciate the support and investment from the Government to help the company create and develop Vietnam-branded herbal medicinal products which is the pride of Vietnam's pharmaceutical industry and creating jobs for workers, making the environment greener and cleaner, helping to make Vietnam a more prosperous country.