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OBJECTIVE To analyze the compatible stability of commonly used intravenous drugs in the intensive care units （ICU）， and to provide a reference for improving medication safety in clinic. METHODS The commonly used intravenous drugs in the ICU of Hebei General Hospital were investigated and confirmed in April 1-30， 2022， and used as keywords to retrieve the relevant literature about compatible stability from PubMed， CNKI， Wanfang Data and other databases， and manually filtered with Micromedex database at the same time. Then， the compatible stability results of the included literature were analyzed descriptively. RESULTS Totally 32 commonly used intravenous drugs and 39 mixed infusion combinations were collected from ICU of this hospital. A total of 40 studies were included， only 2 studies followed all quality requirements； 18 studies validated their methods to guarantee correct reproducibility； 33 studies evaluated physical stability， including precipitate formation and pH changes； 32 studies evaluated chemical compatibility， mainly content/concentration changes. A total of 666 possible two-drug combinations were obtained from the included literature， of which 254 combinations of stability data were available， including 176 were stable， 68 were unstable， and 10 were contradictory. Totally 412 combinations had no stability results. Among two-drug combinations in ICU of this hospital， 42 combinations were stable， 14 combinations were unstable， and 2 combinations were contradictory. CONCLUSIONS The pH， solvent， excipients and preparation concentration are the factors that affect the stability. There are drug combinations with unstable compatibility of commonly used intravenous drugs in ICU of this hospital. The stability study methods are limited， and the stability data cannot meet the actual clinical needs.
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Objective:To investigate the compatible stability of Xingnaojing injection in combination with 9 common medicines, and to provide a reference for clinical application of this injection. Method:According to the clinical application, Xingnaojing injection was mixed with 9 common medicines and placed in the room under dark and light conditions for 6 h. The appearance of compatible solutions was observed, and the HPLC fingerprint was analyzed by similarity evaluation and principal component analysis(PCA). Result:There were no significant changes in the appearance of compatibility of Xingnaojing injection and 9 common medicines, including piracetam and sodium chloride injection, sodium chloride injection and others. The similarities of fingerprint among compatibility of Xingnaojing injection and 9 common medicines were >0.98 at 0 h of compatibility, 6 h of placement and 6 h of illumination. The results of PCA showed that 9 groups of compatible solutions were clustered into 2 categories, the compatibility of Xingnaojing injection and 8 groups including piracetam and sodium chloride injection clustered into one category, and the relative peak areas of the characteristic components of Xingnaojing injection did not change significantly after compatibility, the compatibility of Xingnaojing injection and Danshen Chuanxiongqin injection clustered into another category, the relative peak areas of some characteristic components of Xingnaojing injection increased after compatibility of 0 h and 6 h,and it was more obvious after 6 h of illumination. Conclusion:The compatibility of Xingnaojing injection and 8 common medicines including piracetam and sodium chloride injection has good stability, while the compatibility has stability problems after Xingnaojing injection mixed with Danshen Chuanxiongqin injection. It is suggested that clinical attention should be paid to their compatibility and rational combination of medicines.
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Objective:To study the stability of safflower yellow for injection respectively mixed with fructose injection,invert sugar injection,invert sugar electrolyte injection,glucose and sodium chloride injection,5% glucose injection,10% glucose injection and 0.9% sodium chloride injection. Methods:The physical appearance,number of particles and pH value were observed at room temper-ature after mixing safflower yellow respectively with above injections for 8 hours at the same concentration as that in clinical use. The content of safflower yellow was determined by high performance liquid chromatography (HPLC). Results: There was no significant difference in appearance,pH or safflower yellow content after the mixing,and the number of insolubility particles met the requirement in Chinese Pharmacopeia (2015 edition).Conclusion:Safflower yellow for injection is stable after dissolved in the 7 varieties of infu-sions in 8h.
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OBJECTIVE:To investigate the compatible stability of Calcium folinate for injection mixed with Glucose injection and Sodium chloride injection. METHODS:Referring to clinical common concentration,each 3 Calcium folinate for injection (each injection was equal to calcium folinate 100 mg)were respectively mixed with Glucose injection 250 mL or Sodium chloride injection 250 mL. At room temperature,under light or dark condition,the appearance of mixtures,pH value and the number of in-soluble particles were investigated 0,1,2,3,4,6,8,12,24,36,48 h. The contents of calcium folinate in mixtures were deter-mined by HPLC. RESULTS:Under above condition,the color of the mixtures had no change,and no gas,precipitation and turbid-ity was found;there was no evident change in pH values(RSD<2%,n=11). 0 h after mixing,there was large number of parti-cles≥10 μm in mixtures,but the number of particle was decreased as time;within 48 h,the number of particles ≥10 μm and ≥25 μm in mixtures were all in line with the standard of Chinese Pharmacopeia(2015 edition). Under the protection from light con-dition,relative contents of calcium folinate in mixtures had no significant change(RSD<2%,n=11). Under light condition,rela-tive contents of calcium folinate in mixtures decreased significantly,decreasing to 94.5%(mixed with Glucose injection) and 88.4%(mixed with Sodium chloride injection). CONCLUSIONS:Calcium folinate for injection is more stable in Glucose injec-tion,and the stability of compatibility can be affected by light conditions. After mixed with Glucose injection and Sodium chloride injection,Calcium folinate for injection should be kept away from light and used as soon as possible
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OBJECTIVE:To investigate the compatible stability of Xiao'aiping injection combined with 3 kinds of common in-jections. METHODS:Referring to package inserts,Xiao'aiping injection 40 mL was compatible with 5% Glucose injection,10%Glucose injection or 0.9% Sodium chloride injection 160 mL,respectively. At room temperature(about 25 ℃)and high tempera-ture(40 ℃),the appearance of mixtures were observed at 0,1,2,4,8,12,24,48 h;pH value and the number of insoluble particles were detected. The contents of tenacissoside A and tenacissoside Ⅰ in mixtures were determined by HPLC. RESULTS:Un-der above condition,the mixtures were brownish yellow liquid within 48 h after Xiao'aiping injection was compatible with 5%Glucose injection or 10% Glucose injection;24 h after mixed with 0.9% Sodium chloride injection,the mixture changed from brownish yellow to reddish brown,but no precipitation was found. The pH value of mixtures had no significant change(RSD<1%,n=8). The number of particles ≥25 μm was in line with the requirements of Chinese Pharmacopeia(2015 edition). For-ty-eight hours after mixing,the number of particles ≥10 μm in the mixtures exceeded the pharmacopoeia limits. Within 48 h after mixing,the relative contents of tenacissoside A and tenacissoside I in mixtures had no significant change(RSD<2%,n=8). CON-CLUSIONS:The mixture should be used up within 24 h after Xiao'aiping injection combined with 5% Glucose injection,10%Glucose injection or 0.9% Sodium chloride injection.
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Objective:To investigate the stability of Guhong injection in infusions commonly used in clinics. Methods:The chan-ges in pH value, appearance and insoluble particles were observed, and the contents of aceglutamide, uridine, adenosine, guanosine, lilac glycosides, hydroxyl safflower yellow prime A and anhydrosafflor yellow B in Guhong injection were determined by HPLC-DAD in 8 h after the compatibility respectively at 5, 25 and 35℃ under the condition of avoiding light, indoor illumination and ultraviolet irra-diation, respectively. The contents of the related substances of acetyl glutamine were detected by HPLC. Results:In 8 h, the appear-ance, pH and insoluble particles of all compatibility solution had no significant changes. The content of aceglutamide in compatibility solution was decreased under the condition of ultraviolet irradiation (35 ℃), and the content of compositions in the other compatibility solution showed no significant changes. Under the condition of avoiding light and indoor illumination, the content of relative substances showed no significant changes before and after the compatibility, and met the relevant provisions. But under ultraviolet light, with tem-perature increasing and time prolonging, the content of the related substances was increased significantly. Conclusion: Guhong injec-tion is stable in 5 % glucose injection, 10 % glucose injection and sodium chloride injection in 4 hours, while the mixtures should a-void sunlight during the use.
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OBJECTIVE:To investigate the stability of Vidarabine monophosphate for injection combined with Aciclovir injec-tion. METHODS:HPLC method was adopted. The content variations of two drugs in mixture were determined within 8 h at 5 ℃, 25℃,35℃under dark and light. The changes in appearance,property,pH value and insoluble particles(within 24 h)were inves-tigated before and after compatibility. RESULTS:There were no significant changes in appearance and pH value at 5 ℃,25 ℃, 35 ℃ under dark,and insoluble particles were in line with Chinese Pharmacopoeia(2010 edition),and the relative content of vida-rabine monophosphate and aciclovir were above 99%(compared with 0 h)within 8 h. Under the light conditions,as the tempera-ture raised and the extension of storage time,the content of vidarabine monophosphate did not significantly decrease,but that of aciclovir had declined significantly(4 h and after 4 h),while pH value also had a certain degree of rise;the insoluble particles had no obvious change. CONCLUSIONS:The mixture of vidarabine monophosphate and aciclovir in 0.9% Sodium chloride injections is stable under dark conditions within 8 h;it is suggested that the mixture should be used up within 4 h after mixing and protect from light to guarantee the safety of drug use in the clinic.
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Objective To study compatibility stability of Danshen injection combined with dopamine injection in 5% glucose injection. Methods The relative contents of tanshinol sodium, protocatechuic aldehyde, rosmarinic acid,salvianolic acid B in Danshen injection and Dopamine hydrochloride in dopamine injection were determined by HPLC in 6h after the compatibility in the above infusion at 5 ℃,25℃,35 ℃ under dark and light,and the changes in pH value,appearance and insoluble particles were also observed.ResuIts There were no significant changes in appearance and pH value at 5℃,25℃,35 ℃ under dark,insoluble particles were in line with Chinese Pharmacopoeia,and the relative content of tanshinol sodium, protocatechuic aldehyde, rosmarinic acid,salvianolic acid B and Dopamine hydrochloride were above 99%(compared with 0h) in 6h.In the light conditions,as the temperature raised,the extension of storage time,the relative content of Dopamine hydrochloride was not significantly decreased,but the content of tanshinol sodium, protocatechuic aldehyde, rosmarinic acid and salvianolic acid B had declined,while pH value also had a certain degree of reduction,the insoluble particles had no obvious change.ConcIusion The mixture of Danshen injection and dopamine injection in 5%glucose injection is stable under dark conditions in 6h, illumination and temperature maybe the main factor affecting the stability of Danshen injection combined with dopamine injection.
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OBJECTIVE: Compatible stability of Shuxuening injection with 5 different infusions and glucose injection with insulin. METHODS: Taking Shuxuening injection with 5 different injections and glucose injection with insulin at room temperature, according to the clinical application of dose, study the compatible stability of solution with color, pH, particulates, contents of flavonoid compounds, total lactones, ginkgolides A, B and C. RESULTS: Compatibility of the solution within 12 h, the solution pH and color, compared with begin, showed no change; number of insoluble particles, ≥ 10 and 25 μm size were acceptable; flavonoid fingerprint did not change significantly; ginkgolide A, B, C and total lactone content did not change. CONCLUSION: Shuxuening injection was stable for up to 12 h in vitro in 5 different solutions and glucose injection with insulin at room temperature. Therefore, Shuxuening injection can be constituted, mixed with experiment infusion fluids. Copyright 2012 by the Chinese Pharmaceutical Association.
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OBJECTIVE: To study the compatibility stability of aztreonam after mixing with fructose injection, calorose injection and xylital injection. METHODS: The content of solution, quantity of particles, pH value and physical changes were observed after aztreonam mixing with 3 kinds of injections for 6 hours at room temperature. RESULTS: The content of solution, quantity of particles, pH value and physical changes were up to the standard. CONCLUSION: Aztreonam mixed with fructose injection, calorose injection or xylital injection is keeping stable.