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抗高血压草药产品原料药及成品剂型中重金属和掺假对抗疗法成分的药物评价与毒理学定量分析

PHARMACEUTICAL EVALUATION AND TOXICOLOGICAL QUANTIFICATION OF HEAVY METALS AND ADULTERATED ALLOPATHIC CONTENTS IN RAW AND FINISHED DOSAGE FORM OF ANTIHYPERTENSIVE HERBAL PRODUCTS.

作者信息

Khan Muhammad Asif, Badshah Amir, Shahid Muhammad

机构信息

Department of Pharmacy, University of Peshawar, Peshawar, 25120, Pakistan.

出版信息

Afr J Tradit Complement Altern Med. 2016 Sep 29;13(6):54-60. doi: 10.21010/ajtcam.v13i6.9. eCollection 2016.

DOI:10.21010/ajtcam.v13i6.9
PMID:28480360
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5412202/
Abstract

BACKGROUND

Herbal products of questionable quality create major concern for human population since their production is often not controlled and regulated.

MATERIAL AND METHODS

Antihypertensive herbal products were subjected to pharmaceutical quality control parameters specified in Pharmacopoeias, toxic quantification of heavy metals by flame atomic absorption spectrophotometer and adulterated allopathic contents were quantified using advanced HPLC techniques.

RESULTS

A lot of variations in pharmaceutical parameters like moisture contents and LOD% values were observed. Also deviations to a greater extent in weight variation, (P1, P2, P6, P12, P16, P17, P19, and P20), and hardness of the tablets of products (P1, P3, P8 and P11) were found. Friability of tablets of the Products (P3, P9 and P11) was found failed. Heavy metals i-e Fe (1597.20ppm, 1648ppm) in P5, P9, Pb (61.32ppm, 16.59 ppm) in P5, Cr (96.91ppm,108.48 ppm) in P4, P14, Cd (39.53ppm, 32.31 ppm) in P11, P12, Cu (28.22ppm, 21.04 ppm) in P15, P17, Zn (80.31ppm,76.27 ppm) in P15, P16, Ni (45.46ppm,22.18ppm) in P9, P13 in toxic concentrations were detected. Adulterated allopathic contents of Amlpdopine in higher quantities, administered according to manufacturer dose were found in P12 (20.30 mg/day), Verapamil in P2 (93.50 mg/day), Nifedipine (38.65 mg/day) in P6. Products P4, P5 and P7 were found to have a combination of Amlodipine and Hydrochlorothiazide and higher concentrations were found in P5 (10.72 mg/day, 24.75 mg/day).

CONCLUSION

The antihypertensive herbal products contained different kind of adulterants. Our findings suggest that effective regulatory measures should be put in place to address this problem. This will help to decrease the toxic effects of these remedies and increase the commercialization, internationalization and harmonization of antihypertensive herbal products.

摘要

背景

质量存疑的草药产品引发了人们的重大担忧，因为其生产往往缺乏控制和监管。

材料与方法

对降压草药产品进行药典规定的药物质量控制参数检测，用火焰原子吸收分光光度计对重金属进行毒性定量分析，并用先进的高效液相色谱技术对掺假的对抗疗法成分进行定量分析。

结果

观察到许多药物参数存在差异，如水分含量和干燥失重百分比值。还发现产品（P1、P2、P6、P12、P16、P17、P19和P20）的重量差异以及产品（P1、P3、P8和P11）片剂的硬度有较大偏差。发现产品（P3、P9和P11）片剂的脆碎度不合格。检测到有毒浓度的重金属，如P5、P9中的铁（1597.20ppm，1648ppm），P5中的铅（61.32ppm，16.59ppm），P4、P14中的铬（96.91ppm，108.48ppm），P11、P12中的镉（39.53ppm，32.31ppm），P15、P17中的铜（28.22ppm，21.04ppm），P15、P16中的锌（80.31ppm，76.27ppm），P9、P13中的镍（45.46ppm，22.18ppm）。在P12中发现按制造商剂量服用时含有较高量掺假的氨氯地平对抗疗法成分（20.30毫克/天），P2中含有维拉帕米（93.50毫克/天），P6中含有硝苯地平（38.65毫克/天）。发现产品P4、P5和P7含有氨氯地平和氢氯噻嗪的组合，P5中含量更高（10.72毫克/天，24.75毫克/天）。

结论

降压草药产品含有不同种类的掺假物。我们的研究结果表明，应采取有效的监管措施来解决这一问题。这将有助于减少这些药物的毒性作用，并促进降压草药产品的商业化、国际化和协调统一。

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