Research on the identification and standard improvement of talc medicinal materials

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Author: JIN Wanjun ^1, ^2, ³  ZHANG Mingtong ^1, ^2, ³ NI Lin ^1, ^2, ³

Affiliation: 1. Gansu Institute for Drug Control, Lanzhou 730030, China 2. State Key Laboratory of Quality Control of Chinese Medicinal Materials and Decoction Pieces, Lanzhou 730030, China 3. Gansu Engineering Laboratory of Chinese and Tibetan Medicine Inspection and Testing Technology, Lanzhou 730030, China

Keywords: Talc Asbestos Chinese Pharmacopoeia Identification X-ray diffraction Method validation Standard improvement Quality control

DOI: 10.12173/j.issn.2097-4922.202510036

Reference: JIN Wanjun, ZHANG Mingtong, NI Lin. Research on the identification and standard improvement of talc medicinal materials[J]. Yaoxue QianYan Zazhi, 2026, 30(2): 233-239. DOI: 10.12173/j.issn.2097-4922.202510036.[Article in Chinese]  Copied

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Abstract

Objective To address the shortcomings in the current pharmacopoeial standards for talc, including incomplete quality control indicators, insufficient specificity, and gaps in certain specifications, an X-ray diffraction (XRD) method for talc identification has been established. This approach compensates for deficiencies in existing standards and provides a scientific basis for enhancing the quality benchmarks of talc as a medicinal material.

Methods A systematic review and comparison of testing methods and technical specifications for talc medicinal materials across various national pharmacopoeias were conducted. The collected samples were first identified according to the Chinese Pharmacopoeia (2025 edition). Subsequently, an XRD method was developed for sample analysis using a Cu target with Kα radiation (tube voltage 40 kV and tube current 40 mA). Continuous scanning was performed from 3° to 80° at a scanning rate of 0.02°/min.

Method validation was subsequently performed.

Results The XRD method revealed characteristic diffraction peaks for talc at 2θ angles of 9.6°±0.1°, 19.1°±0.1°, and 28.7°±0.1°. The methodological validation, including precision, stability, and repeatability, demonstrated that the method meets regulatory requirements.

Conclusion The established XRD method is rapid, simple, and features stable patterns and high specificity. It serves as a reliable analytical technique for the revision and elevation of quality standards for talc.

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References

1. 中国药典2025年版. 一部[S]. 2025: 374-375.

2. 朱晓俊, 牛东升,王鸿飞, 等. 1990年至2017年中国人群煤工尘肺的疾病负担分析[J]. 中国工业医学杂志, 2019, 32(5): 356-361. [Zhu XJ, Niu DS, Wang HF, et al. Analysis on disease burden of coal workers pneumoconiosis in Chinese population from 1990 to 2017[J]. Chinese Journal of Industrial Medicine, 2019, 32(5): 356-361.] DOI: 10.13631/j.cnki.zggyyx.2019.05.004.

3. 朱禹, 岳仁宋. 滑石的历史沿革、化学成分及其致癌性的研究进展[J]. 中药材, 2021, 44(5): 1278-1283. [Zhu Y, Yue RS. Research progress on the historical evolution, chemical composition, and Carcinogenicity of Talc[J]. Journal of Chinese Medicinal Materials, 2021, 44(5): 1278-1283.] DOI: 10.13863/j.issn1001-4454.2021.05.045.

4. 中国药典2025年版. 四部[S]. 2025: 1083-1085.

5. USP47-NF42[S]. 2024: 5892-5894.

6. EP 12.3[S]. 2026: Monograph 0438.

7. JP. 18th ed[S]. 2021, 0913.

8. 揭定华, 黄以财, 赵贵琴,等. 红外光谱法结合化学计量学快速鉴别滑石和软滑石[J]. 中国药业, 2024, 33(21): 62-66. [Jie DH, Huang YC, Zhao GQ, et al. Rapid identification of talcum and soft talcum based on infrared spectroscopy with chemometrics[J]. China Pharmaceuticals, 2024, 33(21): 62-66.] DOI: 10.3969/j.issn.1006-4931.2024.21.015.

9. 吴怡青, 刘静, 刘新, 等. 矿物类中药滑石粉的XRD Fourier图谱研究[J]. 中药材, 2019, 42(12): 2856-2860. [Wu YQ, Liu J, Liu X, et al. XRD fourier spectrum study of talc in mineral Chinese medicine[J]. Journal of Chinese Medicinal Materials, 2019, 42(12): 2856-2860.] DOI: 10.13863/j.issn1001-4454.2019.12.023.

10. 钱喜龙, 章芊芊, 朱星宇, 等. X射线技术在矿物药研究中的应用[J]. 中国现代中药, 2025, 27(4): 779-784. [Qian XL, Zhang QQ, Zhu XY, et al. Application of X-ray technology in mineral Chinese medicine research[J]. Modern Chinese Medicine, 2025, 27(4): 779-784.] DOI: 10.13313/j.issn.1673-4890.20240730006.

11. 王友邵, 孙媛, 王云云, 等. 阳起石的本草考证、品质评价及物相分析[J]. 中国实验方剂学杂志, 2024, 30(21): 194-202. [Wang YS, Sun Y, Wang YY, et al. Herbal textual research, quality evaluation and phase analysis of Tremolitum[J]. Chinese Journal of Experimental Traditional Medical Formulae, 2024, 30(21): 194-202.] DOI: 10.13422/j.cnki.syfjx.20240261.

12. 国家市场监督管理总局, 国家标准化管理委员会. 中华人民共和国国家标准. GB/T 15341-2023[S]. 2023.

13. British Pharmacopoeia. 2026 edition[S]. 2026: 2582-2584.