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• 2026 Volume 57 Issue 6
  Published: 10 June 2026

    

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Perspective & Review
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  Perspective & Review

  Research Progress on Near-infrared Photothermal Therapy Combined with Microneedles for the Treatment of Skin Diseases

  REN Zhenni, ZHAO Feng, SUN Rongjun, XIANG Bai, ZHANG Guoqiang

  2026, 57(6): 625. https://doi.org/10.16522/j.cnki.cjph.2026.06.001

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  Photothermal therapy, as an emerging non-invasive treatment modality, demonstrates significant advantages in the treatment of skin diseases due to its high efficacy, selectivity, and controllability. However, the limited range of light irradiation restricts its broad clinical application. In recent years, the combination of microneedle technology with photothermal therapy has not only effectively overcome the skin drug penetration barrier but also enabled precise drug delivery and controlled-release under photothermal stimulation, significantly improving therapeutic outcomes and reducing adverse effects. This review systematically evaluates the research progress on the synergistic application of nearinfrared photothermal therapy and microneedle technology in the treatment of psoriasis, melanoma, atopic dermatitis and skin wounds. It analyzes the key challenges of this combination therapy in terms of drug loading capacity, biocompatibility of photothermal materials, and safety assessment, and looks forward to future directions for its development in precision medicine and personalized treatment.
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  Perspective & Review

  Analysis of the Difffculties in Developing Detection Methods for Nitrosamine Impurities in Complex Compounds

  YANG Xuefang, LI Yan

  2026, 57(6): 634. https://doi.org/10.16522/j.cnki.cjph.2026.06.002

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  Detection of nitrosamine impurities in complex compounds with molecular weights of 1 000 or more and multiple chiral centers has become a major bottleneck in industrial development and quality control. To address this analytical challenge, this study investigated the origins and countermeasures of key issues including matrix interference, neutral loss fragmentation, positional isomerism and stereoisomerism, structural interconversion, low mass spectral response, and abnormal ion ratio deviation, focusing on sample pretreatment and optimization of LCMS/MS conditions. By adjusting sample pretreatment methods and optimizing chromatographic-mass spectrometric conditions, matrix interference can be effectively reduced, and the sensitivity, stability and precision of analytical methods can be improved. The systematic strategy established in this study can provide a reference for the control and safety evaluation of nitrosamine impurities in complex chiral new drugs.
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  Paper

  Synthesis of Falecalcitriol

  MA Qingtong, LIU Zhenyu, LIU Zhaorong, WANG Qingting, CHEN Yangsheng

  2026, 57(6): 640. https://doi.org/10.16522/j.cnki.cjph.2026.06.003

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  A convergent synthetic route of falecalcitriol based on the coupling of CD-ring and A-ring intermediates, had been developed using vitamin D2 as the starting material. The key features of this synthetic process were as follows. ① Two trifluoromethyl groups were introduced into the CD-ring side chain using trifluoromethyltrimethylsilane(TMSCF3) in the presence of tetrabutylammonium fluoride, thereby eliminating highly toxic hexafluoroacetone gas while significantly improving the yield. ② The methoxymethyl(MOM) ether protecting group was replaced with triethylsilyl, thus avoiding the use of toxic chloromethyl methyl ether, and preventing potential damage to the target product during acidic deprotection of the MOM group. ③ A mixture of dichloromethane and n-hexane(1 ∶ 1) was adopted for recrystallization solvent, which eliminated the Class 1 solvent 1,2-dichloroethane. This optimized synthetic route afforded falecalcitriol in an HPLC purity of 99.7 ％ and an overall yield of 48.5 ％ (based on vitamin D2), demonstrating promising potential for industrial production.
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  Improved Synthesis of JAK Inhibitor Baricitinib

  WANG Shaolin, GUO Lihong, XU Jie, ZHAI Lihai,

  2026, 57(6): 648. https://doi.org/10.16522/j.cnki.cjph.2026.06.004

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  Starting from 4-chloro-7H-pyrrolo[2,3-d]pyrimidine, the JAK inhibitor baricitinib was synthesized through a six-step process including pivaloyloxymethyl protection, Kochi-Fürstner coupling reaction, Vilsmeier-Haack reaction, pyrazolyle cyclization, Michael addition and deprotection, with a total yield of 61％ . The HPLC purity of the final product was more than 99.8％ , with total impurities less than 0.5％ and any single impurity less than 0.1％ . The chemical structures of the final product and its intermediates were confirmed by 1H NMR, 13C NMR and HRMS. The raw materials used in this optimized synthetic process were inexpensive and readily available. This process avoids the use of expensive palladium catalysts, eliminating the risk of heavy metal contamination in the final product.
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  Synthesis of the Related Substances of Cariprazine Hydrochloride

  ZHOU Guo, WAN Xin, HUANG Shiguang, ZHANG Zixue, WANG Guan,

  2026, 57(6): 656. https://doi.org/10.16522/j.cnki.cjph.2026.06.005

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  To better control the quality of cariprazine hydrochloride, three related substances were synthesized, namely (1R,4R)-4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexanamine(related substance A), 4-(2,3-dichlorophenyl)-N-[(1R,4R)-4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]piperazine-1- carboxamide(related substance B), and 1-[(1R,4R)-4-[2-[4-(2,3-dichlorophenyl)piperazin-1-yl]ethyl]cyclohexyl]-3- methylurea(related substance C). All the above compounds were structurally confirmed by ¹H NMR, ¹³C NMR, and HRMS. Among them, the synthesis of related substance B was reported for the first time.
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  Development and Validation of Rheological Methods for Quality Evaluation of Gel Patches

  LI Mengyao , ZHU Huiyong, ZHANG Yin, LUO Huafei, WU Yun

  2026, 57(6): 660. https://doi.org/10.16522/j.cnki.cjph.2026.06.006

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  This study took flurbiprofen gel patches as the research object and established rheological testing methods in three modes, namely oscillation amplitude sweep, oscillation frequency sweep, and step creep. The key testing parameters were optimized using a single-factor approach, followed by systematic method validation. The results showed that the oscillation amplitude mode reliably characterized the linear viscoelastic region; the oscillation frequency mode yielded parameters including storage modulus(G'), loss modulus(G''), complex viscosity(η*), and loss factor(tanδ); and the step creep mode characterized the long-term viscoelastic behavior and creep resistance of the material. The RSDs of the main indicators for each mode were all below 15％ , indicating good repeatability, precision, and overall robustness of the methods. The specificity results suggested that this method was more suitable for compatibility evaluation when minor changes occurred in raw material sources. In summary, the established rheological methods can be used for formulation development, quality control, and stability evaluation of gel patches.
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  Synthesis and Characterization of Cyclodextrin-based Dual-ligand MOF and Its Allicin-loading Property and Biological Activity

  WANG Yu, YUAN Wei, OUYANG Fengqi, YU Hao, YAN Tingxuan

  2026, 57(6): 668. https://doi.org/10.16522/j.cnki.cjph.2026.06.007

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  In this study, a dual-ligand metal-organic framework(CB-MOF) material was prepared via a solvent evaporation method using potassium ions as the inorganic metal center and cyclodextrin together with benzenetricarboxylate as the composite organic ligands. The obtained CB-MOF was then used to encapsulate allicin(1), yielding the drug-loaded MOF(1@CBM). Subsequently, the microstructure and physicochemical properties of both CB-MOF and 1@CBM were comprehensively characterized by means of SEM, UV, TGA, FT-IR, and specific surface area and porosity analysis. Meanwhile, the drug loading capacity and cumulative in vitro drug release were quantitatively determined, and the antioxidant capacity and antimicrobial activity were evaluated through in vitro tests. The results showed that CB-MOF exhibited excellent loading capacity for 1, with a drug loading of 13.66％ , and demonstrated favorable sustained-release characteristics in vitro. Furthermore, 1@CBM not only possessed signiffcant antioxidant activity but also showed broad-spectrum antimicrobial effects against both bacteria and fungi, with signiffcantly lower MIC values against Escherichia coli, Staphylococcus aureus, and Candida albicans compared with those of free 1. Combined with good biocompatibility, these properties provide a foundation for its application in the biomedical ffeld.
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  Preparation of Resveratrol Inhalable Liposomal Powder by Spray Freeze Drying

  FENG Ningning, CHENG Xi, YAN Shen, ZHANG Shengyu, WU Duo

  2026, 57(6): 678. https://doi.org/10.16522/j.cnki.cjph.2026.06.008

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  This study systematically investigated the effects of formulation properties(the mass ratio of trehalose to L-leucine) in the precursor liquid, the atomizer types(ultrasonic atomizer and two-fluid atomizer), freezing temperatures( ﹣ 40 and ﹣ 60 ℃ ), and freezing methods(self-developed spray freezing tower and liquid nitrogen freezing) on the in vitro delivery performance of resveratrol inhalable liposomal powder. The hydrodynamic size, ζ potential, and percent drug retention of resveratrol liposomes were thoroughly investigated after mixing, atomization, freezing and rehydration after drying. Furthermore, the morphology and geometric diameter of the particles were thoroughly evaluated. The results revealed that atomization of resveratrol suspension formulated with trehalose and L-leucine at a mass ratio of 7 ∶ 3 using a twin-fluid atomizer followed by spray freezing at ﹣ 40 ℃ yielded inhalable liposomal powder with good in vitro delivery and minimized drug leakage upon spray freeze-drying.
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  Preparation and Pharmacodynamic Evaluation of Upadacitinib Cream for Atopic Dermatitis

  LI Changjun, HUANG Lele, LI Wenhua

  2026, 57(6): 685. https://doi.org/10.16522/j.cnki.cjph.2026.06.009

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  The formulation of upadacitinib(1) cream was investigated by a single-factor experiment, and its skin retention and permeation of 1 from the optimal cream were evaluated using Bama miniature pig skin as a model. Furthermore, its pharmacodynamic effects on mice with atopic dermatitis were also examined. The composition of the final optimized formulation was as follows: 2.0 ％ of 1, 10.0 ％ of white petrolatum, 10.0 ％ of phosphate ester selfemulsifying wax, 5.0％ of isopropyl palmitate, 20.0％ of diethylene glycol monoethyl ether, 4.0％ of 1,2-propylene glycol, 0.2％ of methylparaben, 0.05％ of propylparaben, and 0.05％ of EDTA-2Na. Stability study results showed that the cream formulations with drug loadings of 0.6％ and 2.0％ met the requirements for content, related substances, and physical form after 6 months of accelerated testing, demonstrating good stability. In vivo pharmacodynamic results demonstrated that the cream was superior to betamethasone cream in reducing ear swelling and alleviating skin lesions in mice. The formulation and manufacturing process were stable and controllable, and the product had a favorable efficacy, providing a basis for the development and application of 1 as a topical formulation.
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  Simultaneous Determination of Seven Impurities in Suvorexant Bulk Drug by HPLC

  QI Jingjing, CHEN Fengqin, SUN Chunyan, LYU Huimin, WANG Ruwei

  2026, 57(6): 692. https://doi.org/10.16522/j.cnki.cjph.2026.06.010

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  An HPLC method for analyzing impurities in suvorexant bulk drug was established. Chromatographic separation was carried out on a Waters XBridge C18 column(4.6 mm×250 mm, 3.5 μm) with a mobile phase consisting of 0.1％ trifluoroacetic acid solution and acetonitrile for gradient elution. The flow rate was set at 1.0 mL/min, the column temperature was maintained at 50 ℃ , the detection wavelength was 254 nm, and the injection volume was 15 μL. The chromatographic peaks of 1 and its seven known process impurities(SM3, M1, B, C, D, E, and F) exhibited good resolution. Baseline separation was achieved between 1 and its adjacent impurities, as well as among all impurity peaks. Good linear relationships were observed between the peak areas and the mass concentrations of the seven impurities, with linear correlation coefficients all above 0.9990. The average recoveries were 97.5％ - 100.8％ with the RSDs of 0.6％ - 2.2％ . This method is sensitive, simple and accurate for the simultaneous determination of seven impurities in 1 bulk drug.
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  Determination of 7 Elemental Impurities in Glipizide by Microwave Digestioninductively Coupled Plasma Mass Spectrometry

  XU Jie, LIN Qunfeng, LI Ning, ZHANG E, ZHANG Huijing

  2026, 57(6): 698. https://doi.org/10.16522/j.cnki.cjph.2026.06.011

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  An ICP-MS method was established for the simultaneous determination of 7 elemental impurities, namely lead, cadmium, arsenic, mercury, cobalt, vanadium and nickel in glipizide bulk drug. Samples were digested by microwave digestion, then the 7 elemental impurities were simultaneously determined by ICP-MS with internal standard method. The results showed that each elemental impurity had a good linear relationship between the mass concentration and the response value within the respective range(r>0.999), with LODs of 0.001 5 - 0.126 6 ng/mL, and LOQs of 0.005 0 - 0.422 0 ng/mL. The recovery rates were 90.46％ - 103.25％, with RSDs(n=9) of 2.10％ - 4.47％. The method is simple, sensitive, and accurate, which can provide a reference for the control of elemental impurities in chemical drugs.
Pharmaceutical Management & Information
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  Pharmaceutical Management & Information

  Requirements of Visual Inspection and Analysis of Common Deficiencies for Injections

  ZHANG Yang, ZHENG Qiwen, ZHUANSUN Yan

  2026, 57(6): 702. https://doi.org/10.16522/j.cnki.cjph.2026.06.012

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  Pharmaceutical Management & Information

  Root Cause Analysis and Countermeasures for Positive Results of Biological Indicators in Sterilization Validation

  MA Hengyuan, HUANG Liling

  2026, 57(6): 710. https://doi.org/10.16522/j.cnki.cjph.2026.06.013

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  Pharmaceutical Management & Information

  Brief Analysis of FDA Pre-approval Inspection Processes and Common Deficiencies for Generic Drugs

  DENG Wanding, WANG Baofeng, GE Yuanyuan

  2026, 57(6): 718. https://doi.org/10.16522/j.cnki.cjph.2026.06.014

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  Pharmaceutical Management & Information

  Analysis and Discussion of Key Consideration for Segmented Manufacturing of Biological Products from the Perspective of Registration Inspection

  SHI Haitao, SHEN Bo, CHENG Bin, YANG Jingpeng, HE Benxia, CAO Xiaorui, LI Chao

  2026, 57(6): 724. https://doi.org/10.16522/j.cnki.cjph.2026.06.015

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  Pharmaceutical Management & Information

  Key Points and Existing Problems of Reliability Checks for Biological Product Data from the Perspective of the Entire Life Cycle of Drug Data

  YANG Jingpeng

  2026, 57(6): 730. https://doi.org/10.16522/j.cnki.cjph.2026.06.016

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  Pharmaceutical Management & Information

  Resilience of Beijing’s Biomedical Industry Innovation Ecosystem: a Regional Comparative Study

  ZHANG Yu, NIE Jia, DANG Ziyue, GUO Dongmei

  2026, 57(6): 735. https://doi.org/10.16522/j.cnki.cjph.2026.06.017

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