Herbal formulation contain more than 15-20 different herbs wholly or parts thereof. Herbal formulations like Asava’s, ‘Arishta’s, and Kadha’s have occupied an important place in the Indian System of Traditional Medicine (ISTM). Over the hundreds of years, these formulations are used as prophylactic as well as for the treatment of various diseases and disorders of mankind. According to ISTM, these formulations are prepared by cold or hot extraction process by subjecting to long slow fermentation. Alcohol generated (ethanol, 5-10%v/v) helps in extracting active principles from herbal crude drugs especially the water insoluble compounds1. The alcohol produced in the formulation also acts as good appetizer for health2. Owing to presence of alcohol producing yeast Herbal formulation contain more than 15-20 different herbs wholly or parts thereof. Herbal formulations like Asava’s, ‘Arishta’s, and Kadha’s have occupied an important place in the Indian System of Traditional Medicine (ISTM). Over the hundreds of years, these formulations are used as prophylactic as well as for the treatment of various diseases and disorders of mankind. According to ISTM, these formulations are prepared by cold or hot extraction process by subjecting to long slow fermentation. Alcohol generated (ethanol, 5-10%v/v) helps in extracting active principles from herbal crude drugs especially the water insoluble compounds1. The alcohol produced in the formulation also acts as good appetizer for health2. Owing to presence of alcohol producing yeast
Saccharomyces cerevisiae, grapes (Vitis vinefera) or flowers of Woodfordia fruticosa are added as inoculums to induce fermentation process3,4. Presence of other microorganism in the inoculums causes the production of number of nonethanol volatile (NEV) compounds5. These compounds are produced by various fermentation pathways6. Ethyl acetate, methanol, 1-propanol, isobutanol and isoamyl alcohol are some important NEV compounds produced in formulations are ranges from 10 to 600 mg/L. The toxicity of these compounds is well known, and practically it is impossible to remove them from the product. International Conference on Harmonization (ICH) has used the term ‘Residual solvents’ for all volatile solvents present in formulations. According to ICH, Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. These solvents are not completely removed by practical manufacturing techniques, but we can ensure the safety of products by checking their levels in final products. ICH has recommended the permissible amount of such compounds in pharmaceutical formulations for the safety of the human being or patient. Based on the possible risk to the human health, ICH has classified these compounds (solvents) into three main classes like Class 1 (solvents to be avoided), Class 2 (solvents to be limited) and Class 3 (solvent with low toxicity)7. Gas chromatography is a rapid method for the determination of volatile compounds in herbal formulations. Recently, one gas chromatography method is reported for the analysis of two NEV compounds in herbal formulation using nitrogen as a carrier gas8. In this paper, we have reported a new gas chromatographic method for the determination 18 NEV compounds in herbal formulations. In our method, hydrogen was used as carrier gas which gives good resolution and provides more rapid separation than nitrogen gas. It is less expensive than nitrogen and also acts as fuel for flame ionization detector. 1-Pentanol was used as internal standard because it does not produce in herbal formulations. Internal standard was used to improve the precision of analysis.
กำหนดสมุนไพรประกอบด้วยสมุนไพรต่าง ๆ มากกว่า 15-20 ทั้งหมด หรือส่วนใด สมุนไพรสูตรชอบ Asava ของ, ' ของ Arishta และ Kadha ของมีการครอบครองสถานสำคัญในอินเดียระบบของโบราณยา (ISTM) กว่าร้อยปี สูตรเหล่านี้ถูกใช้เป็น prophylactic เช่นส่วนการบำบัดรักษาโรคต่าง ๆ และโรคของมนุษย์ ตาม ISTM สูตรเหล่านี้จะจัดเตรียมกระบวนการสกัดเย็น หรือร้อน ด้วยแล้วก็กดชัตเตอร์ไปหมักนานช้า แอลกอฮอล์สร้าง (เอทานอล 5-10%v/v) ช่วยในการแยกใช้งานหลักจากน้ำมันยาสมุนไพรโดยเฉพาะอย่างยิ่งน้ำละลาย compounds1 แอลกอฮอล์ที่ผลิตในแบ่งยังทำหน้าที่เป็นจานดีสำหรับ health2 เพราะของแอลกอฮอล์ผลิตยีสต์กำหนดสมุนไพรประกอบด้วยมากกว่าสมุนไพรแตกต่างกัน 15-20 ทั้งหมดหรือบางส่วนดังกล่าว สมุนไพรสูตรชอบ Asava ของ, ' ของ Arishta และ Kadha ของมีการครอบครองสถานสำคัญในอินเดียระบบของโบราณยา (ISTM) กว่าร้อยปี สูตรเหล่านี้ถูกใช้เป็น prophylactic เช่นส่วนการบำบัดรักษาโรคต่าง ๆ และโรคของมนุษย์ ตาม ISTM สูตรเหล่านี้จะจัดเตรียมกระบวนการสกัดเย็น หรือร้อน ด้วยแล้วก็กดชัตเตอร์ไปหมักนานช้า แอลกอฮอล์สร้าง (เอทานอล 5-10%v/v) ช่วยในการแยกใช้งานหลักจากน้ำมันยาสมุนไพรโดยเฉพาะอย่างยิ่งน้ำละลาย compounds1 แอลกอฮอล์ที่ผลิตในแบ่งยังทำหน้าที่เป็นจานดีสำหรับ health2 เพราะของยีสต์ผลิตแอลกอฮอล์ Saccharomyces cerevisiae, grapes (Vitis vinefera) or flowers of Woodfordia fruticosa are added as inoculums to induce fermentation process3,4. Presence of other microorganism in the inoculums causes the production of number of nonethanol volatile (NEV) compounds5. These compounds are produced by various fermentation pathways6. Ethyl acetate, methanol, 1-propanol, isobutanol and isoamyl alcohol are some important NEV compounds produced in formulations are ranges from 10 to 600 mg/L. The toxicity of these compounds is well known, and practically it is impossible to remove them from the product. International Conference on Harmonization (ICH) has used the term ‘Residual solvents’ for all volatile solvents present in formulations. According to ICH, Residual solvents in pharmaceuticals are defined as organic volatile chemicals that are used or produced in the manufacture of drug substances or excipients, or in the preparation of drug products. These solvents are not completely removed by practical manufacturing techniques, but we can ensure the safety of products by checking their levels in final products. ICH has recommended the permissible amount of such compounds in pharmaceutical formulations for the safety of the human being or patient. Based on the possible risk to the human health, ICH has classified these compounds (solvents) into three main classes like Class 1 (solvents to be avoided), Class 2 (solvents to be limited) and Class 3 (solvent with low toxicity)7. Gas chromatography is a rapid method for the determination of volatile compounds in herbal formulations. Recently, one gas chromatography method is reported for the analysis of two NEV compounds in herbal formulation using nitrogen as a carrier gas8. In this paper, we have reported a new gas chromatographic method for the determination 18 NEV compounds in herbal formulations. In our method, hydrogen was used as carrier gas which gives good resolution and provides more rapid separation than nitrogen gas. It is less expensive than nitrogen and also acts as fuel for flame ionization detector. 1-Pentanol was used as internal standard because it does not produce in herbal formulations. Internal standard was used to improve the precision of analysis.
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