Chinese Journal of Pharmaceuticals

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Perspectives & Review

Application of Morphologically-directed Raman Spectroscopy in the Bioequivalence Study of Suspension-based Nasal Spray

WANG Li, ZHOU Lili, LIU Yang, SHAO Qi

2024, 55(7): 887-899. https://doi.org/10.16522/j.cnki.cjph.2024.07.001

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Bioequivalence studies of suspension-based nasal sprays are challenging tasks for generic drug developers. Researchers should not only conduct consistency studies on the dosage and formulation characteristics of excipients in accordance with the requirements of the guidelines, but also need to use analytical tools to determine the consistency of key quality attributes such as particle size and particle size distribution of active pharmaceutical ingredients. This study explored the application of morphologically-directed Raman spectroscopy in the study of particle size distribution of nasal suspensions. The method has been approved by the U.S. FDA for the studies that substitute bioequivalence of clinical endpoints, which is critical for cost reduction and faster development for consistency evaluation of suspension-based nasal spray products.

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Perspectives & Review

Research Progress on Mesoporous Silica for Oral Delivery of Peptide and Protein Drugs

HU Qingyuan, LU Xiaohong, GAO Dongxu, HE Jun

2024, 55(7): 900-908. https://doi.org/10.16522/j.cnki.cjph.2024.07.002

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The oral delivery of peptide and protein drugs has received widespread attention in recent years, and how to overcome gastrointestinal physiological barriers and improve bioavailability is a key issue in their clinical applications. Mesoporous silica is an artificially synthesized nanoscale inorganic porous material. Due to the unique properties, such as controllable particle size, pore size, morphology, and surface chemistry, mesoporous silica has the potential to serve as an oral delivery carrier for peptide and protein drugs. This article reviews the main barriers that hinder the oral absorption of peptides and protein drugs, the characteristics, synthesis, surface modification methods, and some recent advances of mesoporous silica, hoping to provide new ideas for the application of mesoporous silica to oral delivery of peptide and protein drugs.

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Perspectives & Review

Research Progress on the Synthesis of Edoxaban

WANG Sikai, SONG Shengjie, MA Liangxiu, HE Zhiliang, LI Jianjun

2024, 55(7): 909-918. https://doi.org/10.16522/j.cnki.cjph.2024.07.003

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Edoxaban(1), an oral inhibitor of coagulation factor Ⅹ a(F Ⅹ a), is clinically used for the treatment of venous thromboembolism complicated by undergoing orthopaedic surgery of the lower limbs. According to retrosynthetic analysis, 1 is mainly composed of three key intermediates, namely tert-butyl [(1R,2S,5S)-2-amino-5-(dimethylcarbamoyl)- cyclohexyl]carbamate(2), 5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxylic acid(3), and 2-[(5-chloropyridin- 2-yl)amino]-2-oxoethyl acetate(4). Among them, the synthesis of the cis-cyclohexanediamine fragment of 2 and the thiazole ring fragment of 3 is more difficult. The paper summarizes the schemes for the synthesis of cis-cyclohexanediamine fragments by azide salts(esters), photo-extension reaction, Burgess reagent and other starting materials, and the synthesis of the thiazole ring fragment by monocyanine and sulphur, Asinger reaction, Grignard reagent and trichloroacetophenonium salts, and briefly comments on the corresponding advantages and disadvantages.

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Perspectives & Review

Application Features and Challenges of Nanofiltration Technology in Complex Solution of Traditional Chinese Medicines

ZHANG Lian, XU Yangyang, LI Cunyu, ZHI Xinglei, PENG Guoping,

2024, 55(7): 919-927. https://doi.org/10.16522/j.cnki.cjph.2024.07.004

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Nanofiltration, as a technology without thermal effect is suitable for the purification and separation of heat-sensitive components of traditional Chinese medicines(TCM). However with the transition of separation environment from water to organic solution, the physical and chemical properties of nanofiltration separation layer change, which makes it difficult for the separation model suitable for aqueous solution environment to guide the orderly separation of organic solution. Based on the charge effect, dissolution-diffusion effect and pore size screening effect, combined with the properties and production rules of TCM components, the regulation rules of complex solution environment can be explored. In this paper, the application features and challenges of nanofiltration separation technology in the field of TCM are analyzed around the complex solution environment. The nanofiltration separation mechanism in complex solution environment is reviewed, which provide a reference for improving the applicability of nanofiltration technology.

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Paper

Improvement of Resolution Process for Schizophrenia Candidate Drug Ulotaront Hydrochloride

XUE Yunlin, QIAN Kun, WANG Zhen, YAO Xingyu, CHEN Yin

2024, 55(7): 928-931. https://doi.org/10.16522/j.cnki.cjph.2024.07.005

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The resolution process for schizophrenia candidate drug ulotaront hydrochloride(SEP-363856, 1) had been optimized in this study. By screening five common resolving agents, namely L-malic acid, L-lactic acid, L-tartaric acid, L-camphorsulfonic acid, and L-camphoric acid, the best one was determined to be L-tartaric acid, and the optimal equivalent was found to be 0.3. The recrystallization solvent and its amount were also optimized, and 25 volumes of anhydrous ethanol was used to obtain (S)-(5,7-dihydro-4H-thieno[2,3-c]pyran-7-yl)-N-methylmethylamine L-tartrate(8). Compound 8 was treated with aqueous potassium hydroxide and subsequent salt formation with HCl in ethyl acetate, then 1 was obtained with ee value of 99.0％ . The optimized resolution yield increased from 27％ (original research process) to 38％ , and the total yield increased from 14％ (original research process) to 21％ .

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Synthesis of Degradation Products from the Forced Degradation Tests of Eldecalcitol

CHEN Yangsheng, MA Qingtong, QIU Chuanlong, LIU Zhenyu, WANG Qingting

2024, 55(7): 932-939. https://doi.org/10.16522/j.cnki.cjph.2024.07.006

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Forced degradation tests of eldecalcitol API were conducted under acidic, alkaline, oxidative, lightexposed, and high-temperature conditions. Five degradation products were generated, namely (1R,2R,3R,5Z,7E)-2-(3- hydroxypropoxy)-9,10-secocholesta-5,7,10(19),24(25)-tetraene-1,3-diol(AD-1), (1R,2R,3R,5E,6Z,8Z)-2-(3-hydroxypropoxy)- 9,10-secocholesta-5(10),6,8(9)-triene-1,3,25-triol(AD-2), (1R,2R,3R,5E,7E)-2-(3-hydroxypropoxy)-9,10-secocholesta- 5,7,10(19)-triene-1,3,25-triol(AD-3), (1R,2R,3R,5E,6E,8Z)-2-(3-hydroxypropoxy)-9,10-secocholesta-5(10),6,8(9)- triene-1,3,25-triol(AD-4) and (1R,2R,3R,14S,5E,6Z,8Z)-2-(3-hydroxypropoxy)-9,10-secocholesta-5(10),6,8(9)-triene- 1,3,25-triol(AD-5). Among them, AD-1 and AD-5 were not found in literatures. This study developed synthetic routes for AD-1 and AD-5, and optimized the synthesis process for AD-4. The structures of these products were confirmed by 1H NMR, 13C NMR, and MS. This paper provides the references for the quality research of eldecalcitol, as well as its production, packaging, and storage.

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Recombinant Expression, Purification and Activity of Complement C5 Inhibitor OmCI

WANG Yandan, SHANGGUAN Wenwen, LU Jianguang, HUANG Zongqing, HUA Haoju, JIANG Baoming, FENG Jun,

2024, 55(7): 940-947. https://doi.org/10.16522/j.cnki.cjph.2024.07.007

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Ornithodoros moubata complement inhibitor(OmCI, 1) is a complement C5 inhibitor for the treatment of complement-mediated diseases. In this study, a recombination, expression, isolation and purification method of 1 was established, and activity of the obtained 1 was verified. The protein was expressed in extracellular soluble form by high density fermentation technique of recombinant Escherichia coli(E. coli), and the yield of fusion protein was 317 mg/L. The fermentation supernatant was pretreated by acid-adjusted clarification, enzyme digestion to remove the tagged proteins. Then it was purified by anion-exchange chromatography and reversed-phase chromatography to get the target protein with a purity of 98.2％ , and the total yield was 62.8％ . The relative molecular weight of target protein was verified to be correct by mass spectrometry. According to the results of the in vitro complement classical pathway inhibition assay, the IC50 and the binding constant (KD) to complement C5 were 8.59 and 4.74 nmol/L, respectively. The results proved that 1 was successfully expressed in E. coli and exhibited C5 inhibitory activity. This study provides a reference for the efficient preparation of complement C5 inhibitors.

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Study on Mechanical Stress Sensitivity of Highly Water-soluble Drug Hydrogel Matrix Tablets

FENG Jiaqi, FAN Wenrong, HOU Lin, XI Quan

2024, 55(7): 948-964. https://doi.org/10.16522/j.cnki.cjph.2024.07.008

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The changes of mechanical stress in the gastrointestinal tract can cause variations in the release of highly water-soluble drug hydrogel matrix tablets, resulting in the risks of uneven drug release and even dose dumping. Therefore, reducing the sensitivity of the preparations to mechanical force changes can help stabilize the release of the drug. In this study, sodium divalproate was selected as the model drug and its matrix tablets were prepared with HPMC as the matrix carrier polymers. The key indicators determining the mechanical stress sensitivity were explored through the measurement of erosion and swelling rates, and rheological characteristics evaluation. The influences of various formulation and process factors on the mechanical stress sensitivity were explored by calculating the similarity of release curves at high and low rotation speeds(200 and 100 r/min). The results showed that the mechanical stress sensitivity depended on two key indicators: gel strength and gel swelling volume. The tablets with greater gel strength and smaller swelling volume had lower sensitivity to mechanical force. The weight-average molecular weight of the matrix material had opposite effects on the above two indicators, and its impact needed to be comprehensively judged. The release behaviors of the tablets prepared by the mixed matrix materials and single matrix material with similar viscosity were similar, but the tablets prepared by single matrix material had lower sensitivity to mechanical force due to their smaller swelling volume. When the permeation threshold was reached, the amount of matrix material in the formulation would not affect the sensitivity of the tablets to mechanical force. Hardness only affected the initial volume of the tablets and it was not an important factor affecting the mechanical stress sensitivity. The selection of key indicators of mechanical stress sensitivity and the investigation of various influencing factors can provide references for balancing the drug release rate and mechanical stress sensitivity of matrix tablets.

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Formulation Study and Process Scale-up of Solid Dispersions of Poorly Soluble Drug XNW14010 by Fluidized-bed Technology

LIU Yinghui, ZHANG Ji, LI Bao, ZHU Jinlian, WANG Wengui

2024, 55(7): 956-964. https://doi.org/10.16522/j.cnki.cjph.2024.07.009

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The solid dispersions of a KRAS G12C covalent inhibitor, XNW14010, were prepared by fluidized-bed technology with mannitol particles as the substrates. The type and amount of the carriers and the amount of mannitol particles were optimized by the single factor experiments. The optimal formulation was using poly(vinylpyrrolidone-co-vinylacetate)( PVP-VA64) as the carriers, and the mass ratio of 1-PVP-VA64-mannitol particles was 1 ∶ 1 ∶ 1.2. By exploring and optimizing the key process parameters, the process of 1 solid dispersion was scaled up in the GMP workshop. The PXRD characterization results showed that 1 existed in an amorphous state in the solid dispersions. The SEM observation revealed that the solid dispersion particles were spherical in shape and formed an even coating layer around the mannitol substrate. Moreover, the angle of repose of the solid dispersion particles was less than 40°, making it suitable for further mixing and tableting. Based on this, a scale-up production of 1 solid dispersions-based tablets was successfully developed. In the in vitro dissolution test, the dissolution rate at 10 min of 1 from the solid dispersions-based tablets was close to 100％ in pH 6.8 PBS. An in vivo experiment was carried out with Beagle dog as a model. The results showed that the drug exposure of 1 from the solid dispersions-based tablets was 8 times higher than that of 1 tablets.

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Preparation of Injectable Sinomenine-loaded Microemulsion-based Thermosensitive Gel

NIU Yanlian, REN Shifeng, ZHANG Chengyu, LIU Shulan, ZHANG Chunyan

2024, 55(7): 965-972. https://doi.org/10.16522/j.cnki.cjph.2024.07.010

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In order to overcome the shortcomings of sinomenine(1), such as poor water-solubility, short halflife, low oral bioavailability, the oil-in-water(O/W) 1-loaded microemulsion(1-ME) was prepared successfully by aqueous titration method via drawing pseudo-ternary phase diagrams. The prepared 1-ME with excellent stability was light yellow homogeneous and transparent with obvious Tyndall phenomenon, and the particle size was 150 ～ 180 nm, which met the particle size requirements of microemulsions. Then, 1-ME was further compounded with poloxamer(P407, P188) hydrogel to obtain the injectable 1-ME-based thermosensitive hydrogels. Furthermore, the formulation of 1-ME-based thermosensitive hydrogels was optimized with the sol-gel transition temperature(Tsol-gel) as the evaluation index. The optimized formulation was as follows: the mass ratio of P407 to P188 was 17:4, and the mass ratio of Poloxamer hydrogel to 1-ME was 8:2. The Tsol-gel of 1-ME-based thermosensitive hydrogels was(35.2±1.33)℃ , which was match to the normal physiological temperature. Finally, the in vitro release performances revealed that the cumulative release rate of 1-ME-based thermosensitive hydrogels at 48 h was (66.7±6.2)％ , which showed a satisfactory long-acting and sustained-release effect in comparison with 1-ME. In conclusion, the prepared 1-ME-based thermosensitive hydrogels was expected to be used as a novel drug delivery system of intra-articular injection for the rheumatoid arthritis treatment.

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The Role of Plasma Exosomal lncRNA in Gentamicin-induced Kidney Injury in Rats

ZHENG Minhui, YANG Zixuan, GU Mengyun, SUN Zhimin, TANG Naping,

2024, 55(7): 973-986. https://doi.org/10.16522/j.cnki.cjph.2024.07.011

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Drug-induced nephrotoxicity(DIN) is a common adverse effect during drug development phase. However, conventional serum biomarkers of renal injury, such as blood urea nitrogen and serum creatinine, lack sensitivity and specificity. It is crucial to discover superior novel biomarkers of DIN. In this study, a DIN model was constructed by intramuscular injection of 80 mg/kg of gentamicin sulphate(GEN) in SD rats, and plasma exosomal lncRNA and mRNA expression profiles were evaluated by RNA sequencing. Differentially expressed(DE) lncRNAs were identified and validated through real-time reverse transcription quntitative PCR(RT-qPCR) assays. The functional roles of DE mRNAs were elucidated using Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses. Additionally, coding/non-coding co-expression and competing endogenous RNAs(ceRNAs) network to unveil potential relationships in DIN were established. The results showed that 500 differentially expressed(DE) lncRNAs and 1 027 DE mRNAs were identified, the latter primarily associated with signal transduction and the immune system. The established ceRNAs co-expression and regulation networks comprised 32 upregulated lncRNAs, 151 downregulated miRNAs, and 42 upregulated mRNAs. Through RT-qPCR, NONRATT021116.2 and NONRATT004088.2 were found notably upregulated in rat blood. Then, NONRATT021116.2/miRNA/mRNA and NONRATT004088.2/miRNA/mRNA ceRNA networks wereconstructed. Notably, let-7b-5p exhibited a high association with NONRATT021116.2, suggesting potential involvement in modulating inflammatory responses. This study reveals DE lncRNAs and mRNAs in DIN rats using sequencing techniques. Further exploration of these lncRNAs promises insights into the genetic mechanisms underlying DIN and may lead to the identification of diagnostic markers and therapeutic targets.

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Release Characteristics of Commercially Available Ambroxol Hydrochloride Sustained-release Capsules: an in vitro and in vivo Study

DONG Jun, ZHANG Yue, DING Yifei, CHAI Xuyu, WANG Jian

2024, 55(7): 987-993. https://doi.org/10.16522/j.cnki.cjph.2024.07.012

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The differences in formulations and manufacturing processes will lead to the distinct in vitro and in vivo release properties of sustained-release preparations. According to the standards of imported registered drugs, Chinese Pharmacopoeia and relevant guidelines, the in vitro release curves and ethanol-induced dose-dumping behaviors of ambroxol hydrochloride sustained-release capsules from four different domestic and foreign manufacturers were systematically evaluated. Because of the different drug release mechanisms, the 24 h cumulative release amount of the drug from wax-matrix sustained-release capsules(Mucosolvan® Retard) was only 25.6％ , while the 4 - 6 h cumulative release amounts of the other three film-controlled sustained-release capsules were more than 85％ . The differences of drug release were also found in other pH media and ethanol-induced dose-dumping studies. Therefore, Mucosolvan® Retard and one commercially available film-controlled sustained-release capsule were selected for further release studies in simulated gastrointestinal fluids and pharmacokinetics studies in beagle dogs. In the fasted state simulated gastric fluid(FaSSGF) medium, the release of Mucosolvan® Retard and the film-controlled sustained-release capsules at 2 h were 16.0 ％ and 67.2 ％ , respectively. The pharmacokinetic results showed that the cmax of film-controlled sustained-release capsules was 1.41 times higher than that of Mucosolvan® Retard. The reason for the different in vivo release results was speculated to be related to faster release of film-controlled sustained-release capsules in the acidic medium of upper digestive tract. Finally, based on the BCS classification of ambroxol hydrochloride, the results of this study and the reported human pharmacokinetics results, the key factors for the consistent development of this generic products were discussed.

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Study on the Changes of Chemical Composition and Antioxidant Activity in Different Parts of Ginseng during Steaming and Drying

JIANG Xin, LI Mingxi, WANG Yan, GUO Ruoxi, LI Xue

2024, 55(7): 994-1002. https://doi.org/10.16522/j.cnki.cjph.2024.07.013

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In order to investigate the effects of the processing method on the chemical composition and antioxidant activity of different parts of Ginseng, the contents of 10 kinds of ginsenosides and 5-hydroxymethylfurfural (5-HMF) of different parts of Ginseng during the processing were determined by ultra-high performance liquid chromatography, and their antioxidant activities were determined. Principal component analysis(PCA), cluster analysis(HCA) and orthogonal partial least squares discriminant analysis(OPLS-DA) were combined to evaluate the quality. The results showed that the contents of ginsenosides Rg1, Re, Rb1, Rd, Rc and Rb2 increased first and then decreased, while the contents of ginsenosides Rg3, Rk1, Rg5 and Rh1 increased gradually. The content of 5-HMF increased first and then decreased. Two principal components were extracted by PCA, the fibrous root parts were distinguished from other parts by HCA, and ginsenosides Rg5, Rk1, Rg1+Re, Rg3 and Rh1 were identified by OPLS-DA as the main difference components. The antioxidant activity of Ginseng varied with different steaming times. Among them, Ginseng fibrous root samples steamed and sun-cured for the second time had the strongest scavenging ability of hydroxyl free radicals. This study revealed the relationship between chemical components and antioxidant activities in different parts of Ginseng root through the processing method named “nine steaming and nine drying” and the stoichiometric pattern recognition, that is, rare ginsenosides showed a negative correlation with antioxidant activity, which provided a scientific basis for further development and utilization of Ginseng.

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Determination of Glycolic Acid and Lactic Acid in Leuprorelin Acetate Sustained-release Microspheres by HPLC

SONG Shengfa , XIA Yunqing , LIU Wanhui , , XU Lixiao, MA Yongchao

2024, 55(7): 1003-1007. https://doi.org/10.16522/j.cnki.cjph.2024.07.014

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An HPLC method was established to simultaneously determine the contents of glycolic acid and lactic acid in leuprorelin acetate sustained-release microspheres. The Waters XSelect HSS T3 column(4.6 mm×100 mm, 3.5 μm) was used, and the analysis was carried out in the gradient elution mode with the mixed solution of phosphoric acid and water as mobile phase A, and acetonitrile as mobile phase B. The detection wavelength was 210 nm, the ffow rate was 1.0 mL/min, the column temperature was 40 ℃ , and the injection amount was 5 μL. The results showed that the method had good speciffcity, and it was linear for glycolic acid and lactic acid in the ranges of 0.015 - 0.06 mg/mL. The detection limits for both glycolic acid and lactic acid were 0.008 mg/mL, and the quantiffcation limits were 0.03 mg/mL. The average recovery rates of glycolic acid and lactic acid were 99.2 ％ and 101.6 ％ , respectively, with the RSDs were 1.54 ％ and 1.37 ％ , respectively. The results indicated that this method could be used for the determination of glycolic acid and lactic acid content in leuprorelin acetate sustained-release microspheres and their degradation process.

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Research and Solution of Tablet Fragmentation in the Feeding Process of the Hole Feeding Device

TANG Shun, XU Honghui, WANG Yunwei, YUAN Xiaofan, XU Xiuhui

2024, 55(7): 1008-1015. https://doi.org/10.16522/j.cnki.cjph.2024.07.015

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In this paper, the stress of tablets in the hole feeding device of aluminum plastic packaging machine(hereinafter referred to as the feeding device) was analyzed, and solutions to the problem of tablet fragmentation in the feeding process were proposed through calculation and experimentation. The fragmentation rate and cavitation rate of the tablets during the feeding process were taken as the evaluation indexes. Based on the single factor test, Minitab 15.0 software was used to optimize the setting parameters of falling height, vibration frequency and guide groove radian of the vibrating disk in the feeding device, and the fitting models were analyzed. The mechanical analysis results showed that the tablets were obviously stressed in the vibrating plate, guide groove and blanking track of the feeding device. In this study, the optimal conditions were as follows: selecting the tablets with an average hardness of 45 N as the models, the gas pressure of the vibrating plate was 0.16 MPa, the accumulation thickness of the tablets on the vibrating plate was 2.5 cm, the vibration frequency was 37.00 Hz, the falling height of the vibrating plate was 3.00 mm, and the radian of the guide groove of the vibrating plate was 95.00°. A continuous production was conducted under above conditions and at the speed of 200 plates per 1 min for 6 h, the fragmentation rate in the feeding process could be reduced to 0, and the cavitation rate was only 1.44％ . In addition, increasing the hardness of the tablet can improve its own mechanical strength, thereby improving the problem of tablet fragmentation.

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Comparison between a New Type of Cell Intelligent Manufacturing Line and Manual Preparation

ZHONG Guiqiang, ZHANG Fen, WANG Qingfang, LIANG Xiao, LIU Muyun

2024, 55(7): 1016-1031. https://doi.org/10.16522/j.cnki.cjph.2024.07.016

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To address the shortcomings of low efficiency, high cost and large batch-to-batch variation of manually prepared cells, this study developed a novel smart production line for human umbilical cord mesenchymal stem cells(hUCMSCs), and compared the basic cell characteristics, safety and efficacy of the obtained cells with those of traditional manually prepared cells. The results showed that the hUC-MSCs prepared by the smart production line were fibrous , and the cell surface markers met the requirements of MSCs defined by the International Society for Cell & Gene Therapy. The results of cell sterility and mycoplasma were negative, and the content of endotoxin was lower than 0.5 EU/mL. The results of oncogenes, oncogenes suppressor and karyotyping analyses were normal. The expression of telomerase was in low activity. The results of abnormal toxicity were normal. The cell viability was higher than 90％ . And the strong capabilities of osteogenesis, adipogenesis and chondrogenesis were observed under the microscope. And the cells could inhibit the proliferation of Th1, Th2 and Th17 cells and promote the proliferation of Treg cells. The hUC-MSCs prepared by this production line met the quality standards and showed no significant difference compared with those prepared manually. In conclusion, the cell intelligent production line developed in this study is more advantageous in terms of cell homogeneity, capacity enhancement, cost optimization and superiority of deployment, which provides a new idea to realize the scale-up and industrialization of cell preparation.

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Pharmaceutical Management & Information

Regulatory Policies, Challenges and Development Trends of Excipients in Pediatric Formulations

WANG Qiwei, CHEN Guiliang

2024, 55(7): 1024-1031. https://doi.org/10.16522/j.cnki.cjph.2024.07.017

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Pharmaceutical Management & Information

Analysis on National Negotiated Drug Landing Policy Based on Content Analysis Methodology

QIANG Yan, ZHANG Haochen, MOU Yan, SONG Yan, ZHANG Qianjin

2024, 55(7): 1032-1036. https://doi.org/10.16522/j.cnki.cjph.2024.07.018

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Pharmaceutical Management & Information

Practice and Reflection on Drug Regulatory Data Governance Based on Two-level Data

TANG Wanchen, SUN Hao, YOU Yuwei, GU Miao

2024, 55(7): 1037-1043. https://doi.org/10.16522/j.cnki.cjph.2024.07.019

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