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@#TA method for the content determination of methionine sulfoxide and methionine sulfone in compound amino acid injection (18AA-II) was established in order to investigate their level in 155 batches of this product, and to explore the reason for the generation of these two impurities.The determination was performed on an Agilent Poroshell 120 EC-C18 column with mobile phases of sodium acetate/tetrahydrofuran solution (A) and sodium acetate solution -acetonitrile-methanol (B, 200∶400∶400) (gradient elution) at the flow rate of 0.5 mL/min.The excitation wavelength and the emission wavelength of the fluorescence detector were 233 nm and 441 nm, respectively.The column temperature was 40 °C, and the injection volume was 8 μL.The contents of methionine sulfoxide and methionine sulfone from 155 batches of compound amino acid injection (18AA-II) was determined using this method, and the residual oxygen content was detected by headspace gas analyzer.The results showed that the linear range of methionine sulfoxide and methionine sulfone were 0.128 1-10.250 0 μg/mL (r = 0.999 9) and 0.261 0-10.440 0 μg/mL (r = 0.999 8), respectively.The limits of quantitation were 0.13 μg/mL and 0.26 μg/mL, respectively; the limits of detection were 0.04 μg/mL and 0.09 μg/mL, respectively.RSDs of precision, stability and repetitive test were all lower than 1.3%.The recoveries ranged 98.00%-100.79% (RSD = 1.15%, n = 9) and 98.19%-102.31% (RSD = 1.33%, n = 9).The content level of oxidized related substances from different manufacturers showed significant difference, showing relevance with the residual oxygen content to some extent, yet no significant correlation with the added amount of antioxygen (sodium pyrosulfite).The method is validated to be useful for the content control of methionine sulfoxide and methionine sulfone in compound amino acid injection (18AA-II).It is quite necessary to include the determination of oxidized related substance into the quality specification.Manufacturers should strengthen the control of remaining oxygen in their products.
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Objective To establish a method for HPLC to determine content of acetyl tyrosine in pediatric compound amino acid injection (19AA-Ⅰ).Methods The chromatographic separation was achieved on a Agilent Hypersil ODS column (250 mm ×4.0 mm,5 μm) with Agilent 1200 liquid chromatography system.The mobile phases consisted of 20 mmol/L sodium dihydrogen phosphate solution ( adjusting pH to 2.5 with phosphoric acid)-acetonitrile (90:10) at a flow rate of 1.0 mL/min, the detection wavelength was 210 nm, the column temperature was 25℃.Results Acetyl tyrosine was completely separated from other amino acids.The calibration curves for acetyl tyrosine revealed good linearity in the range of 12.062-120.62μg/mL (r=0.9999).The average recoveries (n=9) of acetyl tyrosine was 100.0%, RSD% (n=9) was 0.9.The limits of quantification (S/N=10) was 0.15μg/mL.Conclusion The methodological validation results indicate that the established method can be applied to quality control of acetyl tyrosine in pediatric compound amino acid injection (19AA-Ⅰ).
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Objective To analysis effect of compound amino acid 15 peptide 2 on levels of tumor markers in serum of postoperative patients with liver cancer.Methods 42 postoperative patients who were diagnosed with liver cancer were collected.All patients were randomly divided into experimental group and control group, 21 cases in each group.The two groups of patients were given the corresponding parenteral nutrition therapy, after treatment, the serum tumor markers, T lymphocytes, liver function and nitrogen balance related indicators in all patients were detected.Results After treatment, compared with control group, the serum alpha fetal protein(AFP),carbohydrate antigen 19-9(CA19-9) and carcino embryonie antigen(CEA) levels were lower in the experimental group (P<0.05); the serum CD3 +T cells, CD4 +T cells and CD4 +/CD8 + ratio levels were lower in the experimental group (P<0.05); the serum alanine amino transferase (ALT), aspartate aminotransferase (AST) and total bilirubin(TBIL) levels were lower in the experimental group (P<0.05); the patients in the experimental group changed to positive nitrogen balance(P<0.05).Conclusion The diluted compound amino acid 15-2 injection for intravenous injection,can significantly reduce the level of serum tumor markers in patients with liver cancer, improve the immune function of patients, correct negative nitrogen balance, protect liver function.
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OBJECTIVE:To observe the effect of Sanhuang decoction combined with compound amino acid liposome healing membrane on treatment stage Ⅲ pressure ulcer. METHODS:According to the random number table,ninety cases of stage Ⅲ pres-sure ulcer were divided into control group A,control group B,and experimental group with 30 cases in each group. On the basis of the basic processing for each group,control group A was treated by dressing change with Sanhuang decoction only,control group B by dressing change with compound amino acid liposome healing membrane only,and experimental group by dressing change with Sanhuang decoction combined with compound amino acid liposome healing membrane. The results of treatment were observed and the curative effects were compared among 3 groups after 21 days or pressure ulcer healing. Three groups were com-pared with chi-square test and each two groups were compared with chi-square segmentation method. RESULTS:There was no dif-ference on total curative effect in control group A(62.1%)and control group B(66.7%)(P>0.05),however,there was statistical significance on total curative effect in experimental group(93.3%)and control group A(P<0.05),also in experimental group and control group B(P<0.05). CONCLUSIONS:The effect of Sanhuang decoction combined with compound amino acid liposome healing membrane on treatment of stage Ⅲ pressure ulcer is better than the effect of dressing change with Sanhuang decoction only or compound amino acid liposome healing membrane only,and the healing time of wound is shortened. This research is deserved further study.
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Objective To investigate the clinical status about the utility of compound amino acid (15) and dipeptides (2) in-jection, and to promote the rational drug use in our hospital .Methods Data from 127 patients who used compound amino acid (15) and dipeptides(2) injection in surgical wards were collected in July 2012.The data about the drug usage method , duration, administra-ted timing, drug combination and the differences in all departments was analyzed .Results Existing problems:62.2% patients used compound amino acid (15) and dipeptides (2) injection by peripheral intravenous infusion , 6.3% patients used more than 14 days and 7.1%patients infused singly.Conclusion Compound amino acid(15) and dipeptides(2) injection had problems of off-label drug use in surgical ward , which need to be improved .
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An efficient and sensitive analytical method for the simultaneous content determination of 18 amino acids in compound amino acid injection was developed using high performance liquid chromatography (HPLC) with pre-column derivatization. Phenyl isothiocyanate (PITC) was used as derivatization reagent. The target compounds were separated on a Unitary-C18 column (250 mm í 4.6 mm, 5 μm) in gradient elution mode using sodium acetate and the mixture of acetonitrile, methanol and water as mobile phases. The detection wavelength was 254 nm. The derivatization reagent dosage, derivatization time, salt concentration, the pH and the column temperature of mobile phase were investigated. Finally, 18 amino acids were separated within 40 minutes. The method showed that the good linearity (r2 ≥ 0.997 7) was at a range from 9 μg·mL-1 to 1 021 μg·mL-1. The recoveries ranged from 92.6% to 110.7%. And the relative standard deviations (RSD) ranged from 0.01% to 5.68%. The limits of quantification (LOQ, S/N = 10) ranged from 0.02 μg·mL-1 to 13.41 μg·mL-1. This method, which was simple, sensitive and accurate, can be applied for the content determination of amino acids in compound amino acid injections.
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Objective To study the effect of dimethylaminoethano (DMAE) and compound amino acid injection (AA) by mesotherapy on collagen Ⅰ and collagen Ⅲ mRNA expression levels of D-galactose-induced chemical skin aging rats.Methods 80 rats were randomly divided into individual experimental group.At 18 days after D-gal induction,rats of aging treatment groups were treated with intradermal microinjection of 0.2％ DMAE+AA,0.1％ DMAE+AA,0.2％ DMAE,0.1％ DMAE,AA,and saline,respectively,once a week for 4 weeks.At 42 days after treatment,the skin wounds were harvested.HE,PCNA,hydroxyproline and collagen Ⅰ and collagen Ⅲ mRNA expression levels of every group skins were detected.Results Dermal thickness,hydroxyproline content and collagen type Ⅰ and Ⅲ mRNA expression levels of 0.1％ DMAE+ AA and 0.2 ％ DMAE+ AA groups were significantly improved (P＜0.05),but PCNA expression of sham control group was significantly higher than all of aging groups (P＞0.05).Conclusions Local co-injection of DMAE and compound AA directly into targeted tissue under mesotherapy has marked anti-aging effects on D-galactose induced skin aging model of rat by increasing the dermal thickness,collagen content and acceleration of collagen synthesis.