Study on quality control of Xiaozhong Ointment NO. 1 based on the relationship between quality fractions of main components in monarch and minister drugs and the clinical efficacy

doi:10.5246/jcps.2023.09.063

Journal of Chinese Pharmaceutical Sciences ›› 2023, Vol. 32 ›› Issue (9): 764-771.DOI: 10.5246/jcps.2023.09.063

• Drug administration and clinical pharmacy column • Previous Articles Next Articles

Study on quality control of Xiaozhong Ointment NO. 1 based on the relationship between quality fractions of main components in monarch and minister drugs and the clinical efficacy

Shi Jin¹^,²^,³, Chengyin Li¹^,²^,³, Xinyue Jing⁴, Yunru Peng⁵^,⁶, Shaohua Dong¹^,²^,³, Wanjin Sun¹^,²^,³^,^*()

1 Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan 430061, Hubei, China
2 Affiliated Hospital of Hubei University of Chinese Medicine, Wuhan 430061, Hubei, China
3 Hubei Province Academy of Traditional Chinese Medicine, Wuhan 430074, Hubei, China
4 Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu, China
5 Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing 210028, Jiangsu, China
6 Jiangsu Province Academy of Traditional Chinese Medicine, Nanjing 210028, Jiangsu, China

Received:2023-03-12 Revised:2023-04-23 Accepted:2023-06-21 Online:2023-09-30 Published:2023-09-30
Contact: Wanjin Sun

Abstract

Abstract:

In the present study, we aimed to determine the mass fractions of caudatin in cynanchum auriculatum, a component of monarch drug, and ferulic acid in ferulae resina, a component of minister drug, in Xiaozhong Ointment NO.1 using high-performance liquid chromatography (HPLC). The relationship between the mass fractions and clinical efficacy, which was expressed by the degree of pain relief, was explored in several batches of samples to establish the quality control ranges of active ingredients. A Waters X-Bridge column (250 mm × 4.6 mm, 5 μm) was used for separation at 30 °C. The optimized mobile phase consisted of acetonitrile and a 0.1% phosphoric acid water solution and was delivered by gradient elution at a flow rate of 1.0 mL/min. The PDA detector was set at 210 nm, and the injection volume was 10 μL. The intensity of pain was indicated using the Numeric Rating Scale (NRS) method. The percentage of pain relief was calculated using the formula (A – B)/A × 100%, where A and B are the pre- and post-medication scores, respectively. The pain relief degrees were categorized into 0–4 degrees. After the methodology study, the mass fractions of caudatin and ferulic acid were obtained from 10 batches of samples, and the percentage reductions in NRS were recorded in the patients using these samples. The results showed that the two groups with lower mass fractions also achieved lower percentage decreases in NRS than the other groups. An additional five batches of samples were tested, and the mass fractions were greater than the averages minus the standard deviation of the previous 10 batches. Therefore, the proposed quality control ranges were that the mass fractions of caudatin and ferulic acid should not be less than 0.4087 and 0.8511 mg/g, respectively. This accurate, sensitive, convenient, and reproducible HPLC method and the research on the consistent correlation between mass fraction and clinical efficacy laid a foundation for better quality control and further mechanism study of this preparation.

Key words: Xiaozhong Ointment NO. 1, Quality control, Pain intensity numerical rating scale, Caudatin, Ferulic acid

Supporting:

Shi Jin, Chengyin Li, Xinyue Jing, Yunru Peng, Shaohua Dong, Wanjin Sun. Study on quality control of Xiaozhong Ointment NO. 1 based on the relationship between quality fractions of main components in monarch and minister drugs and the clinical efficacy[J]. Journal of Chinese Pharmaceutical Sciences, 2023, 32(9): 764-771.

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References 18

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Study on quality control of Xiaozhong Ointment NO. 1 based on the relationship between quality fractions of main components in monarch and minister drugs and the clinical efficacy

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