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Objective:To investigate the effect and necessity of fine operation on the improvement of the preparation outcome of paclitaxel (albumin-binding) intravenous infusion for injection.Methods:The detailed refinement of the preparation method in the specification of paclitaxel (albumin-binding) for injection was developed. The fine operation of paclitaxel (albumin-binding) for injection mainly consists of two parts: The mixing method of solvent and drug: including syringe needle length into drug vial, solvent injection speed, state of drug waiting for dissolution, and the shaking speed of the drug vial. The method of extracting the dissolved liquid in the drug vial and injecting it into a 100 ml sterile empty 0.9% sodium chloride injection bottle: including the speed of refilling the 100 ml sterile empty 0.9% sodium chloride injection bottle, and restoring the pressure balance inside and outside the infusion bottle. The effect of fine operation on the preparation of paclitaxel (albumin-binding) for injection was evaluated by comparing the production of foam and the preparation time before and after the implementation of fine operation.Results:Before and after the implementation of fine operation, the foaming rate of the foam in the drug vial decreased from 28.57% (10/35) to 12.50% (12/96), the difference was statistically significant ( χ2 value was 4.471, P=0.029); and the foaming rate of the mixed liquid from the drug vial into the 100 ml sterile empty 0.9% sodium chloride injection bottle decreased from 46.15% (6/13) to 9.09% (3/33), the difference was statistically significant ( χ2 value was 8.140, P value was 0.004); and the preparation time of single drug was reduced by 3.37 minutes after the implementation of fine operation, the difference was statistically significant ( t value was 79.744, P<0.05). Conclusion:The preparation method of fine operation of paclitaxel (albumin-binding) for injection is operable, safe and reliable. After implementation, it can effectively reduce the production of foam in the drug vial and infusion bottle, improve the stability of drug preparation, shorten the preparation time, and ensure the safe, timely and effective medication for patients.
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Objective: To improve the quality standard of Funing granules. Methods: TLC was used for the qualitative identifica-tion of Angelicae Sinensis Radix, Chuangxiong Rhizoma, Scutellariae radix, Atractylodis macrocephalae rhizoma, Citri reticulatae peri-carpium, Cyathulae radix, Paeoniae radix alba and Glycyrrhizae radix Et rhizoma. The content of paeoniflorin was determined by HPLC. Results: The TLC spots were clear and well-separated without any interference from the negative control. The linear range of paeoniflorin was 19. 23-2525. 18 ng(r=0. 999 9), the average recovery was 101. 88% ,and the RSD was 0. 62% (n=6). Conclu-sion: The method is simple and accurate with good reproducibility, and can be used for the quality control of Funing granules.
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Objective: To establish a GC method for the determination of borneol and camphor in Xingkening capsules. Methods:A capillary column using polyethylene glycol 20000 (PEG-20M) as the stationary phase (30 m×0. 53 mm,1 μm) was employed. The flow rate of carries gas (N2) was 3. 0 ml·min-1. The inlet temperature was 200℃, the temperature of flame ionization detector was 210℃, the column temperature was 140℃, and the split ratio was 1 ∶ 1. Results: The linear range of borneol was 13. 25-1 325. 19 μg·ml-1(r=0. 999 9), and the average recovery was 100. 22% with the RSD of 0. 92% (n=6). The linear range of camphor was 1. 029-16. 464 μg·ml-1(r=0. 997 5),and the average recovery was 98. 89% with the RSD of 2. 78% (n=6). Conclusion: The method is simple, accurate and reliable, which can be used for the quality control of borneol and camphor in Xingkening capsules.
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Objective: To establish the UPLC typical chromatogram and evaluate the quality of Jinji pills. Methods: The UPLC typi-cal chromatogram was performed on an Agilent proshell 120 C18column (150 mm×4. 6 mm,2. 7 μm) with gradient elution by the mobile phase of acetonitrile-0. 1% phosphoric acid aqueous solution system at a flow rate of 0. 8 ml·min-1. The detection wavelength was 240 nm. Results: The UPLC typical chromatogram included 15 common peaks when taking berberine hydrochloride as the reference peak, and 7 of them were identified by the comparison with the reference substances. Conclusion: The established methods have high specificity and good repeatability, and can be used for the quality control of the product.
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OBJECTIVE:To investigate the effects of blood concentration monitoring of cylosporin A(CsA) in patients with nephrotic syndrome(NS)on efficacy and safety. METHODS:The medical records of 154 NS patients receiving CsA and blood concentration monitoring in nephrology department of China-Japan Friendship Hospital during Jan. 2014-Aug. 2017 were analyzed retrospectively. The results of blood concentration monitoring in 63 adult inpatients with refractory NS receiving CsA for the first time within 6 months of initial treatment were analyzed statistically. The relationship of blood concentration monitoring with efficacy and safety was analyzed. RESULTS:The blood concentration of CsA in 154 patients were monitored for 512 times with an average of 3.32 times/person,and average blood concentration was(125.98±105.13)ng/mL. The patients with blood concentration of CsA＜100 ng/mL accounted for 44.14%. There was no statistical significance in average monitoring times or average blood concentration between male and female,average blood concentration of CsA among different age groups (P＞0.05). The blood concentration was monitored for 237 times in 63 adult inpatients with refractory NS receiving CsA for the first time within 6 months of initial treatment(induction period). Average blood concentration of effective group were significantly higher than ineffective group;the proportion of effective group with blood concentration＜100 ng/mL was significantly lower than that of ineffective group,with statistical significance (P＜0.05). Among 63 patients,17 patients suffered from ADR (the incidence of ADR was 26.98%). The average blood concentrations of ADR patients were significantly higher than those without ADR;the monitoring times of ADR patients with blood concentration＞150 ng/mL was significantly higher than those without ADR,with statistical significance(P＜0.05). There was no statistical significance in the incidence of ADR between effective group and ineffective group (P＞0.05). Among effective group,there was no statistically significance in average blood concentration between ADR patients and patients without ADR(P＞0.05);the monitoring times of ADR patients with blood concentration＞150 ng/mL was significantly higher than patients without ADR,with statistical significance(P＜0.05). With the increase of monitoring times,the incidence of ADR decreased gradually. There was no statistical significance in the incidence of ADR among patients who were monitored for different times (P＞0.05). CONCLUSIONS:The pharmacokinetics of CsA varies in different patients and many factors affect its blood concentration. The changes of blood concentration affect the efficacy and safety of CsA. It is difficult to determine the dosage of CsA based on experience in the treatment of NS with CsA. Great importance should be attached to blood concentration monitoring of CsA and the implementation of individualized dosage regimen based monitoring results so as to improve therapeutic efficacy and reduce the occurrence of ADR.
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Objective:To identify toddalolactone and establish the analysis method for Jinji tablets.Methods: An Hypersil DBS C18column(250 mm×4.6 mm,5 μm) was used. The mobile phase consisted of acetonitrile-0.1% phosphoric acid solution. The flow rate was 0.8 ml·min-1and the detection wavelength was at 330 nm. Toddalolactone was identified by an LC-MS method and the re-sult was compared with that of the reference regent.TLC and HPLC analytical methods were used for analysis of toddalolactone.Re-sults:Totally 58 batches of Jinji tablets were tested,and the suspected samples were confirmed by HPLC-MS/MS.Toddalolactone was detected out from 20 batches of samples. Conclusion:The method is simple,rapid and accurate, which is able to detect toddalolac-tone quickly and effectively.
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OBJECTIVE:To investigate the utilization of the most used splitting drugs in the inpatients of our hospital,and to promote rational use of splitting drugs. METHODS:The medical orders of oral tablets in the inpatients of our hospital in Jan. 2016 were analyzed statistically in respects of consumption quantity,classification dosage,department dosage and the proportion of scored tablets. RESULTS & CONCLUSIONS:There were 217389 medical orders of tablets in the inpatients of our hospital in Jan. 2016. There were 12792 medical orders of splitting drugs,with utilization rate of 5.88%. The most used splitting tablet were car-diovascular drugs and drug for nervous system,accounting for 53.31% and 20.72% of total. The splitting tablets were mostly used in respiratory and critical care medicine department. Top 10 departments in the list of the number of splitting drug medical orders prescribed 8993 splitting drug medical orders,accounted for 70.30% of total. Top 20 drugs in the list of the number of splitting drugs were involved in 8971 medical orders,accounting for 70.13%of total;there were 14 kinds of scored drugs and 7506 medi-cal orders of splitting scored drugs,accounting for 83.67% of top 20 medical orders of splitting drugs. Among splitting drugs,49 types had scored-line,which were prescribed in 9265 medical orders of splitting drug,accounting for 72.43% of all medical or-ders of splitting drug. Lacking of information in most package inserts about the tablet can or can not split,it is suggested to note this information in package inserts by pharmaceutical enterprises. For commonly used splitting drugs without scored-line,it is pro-posed to produce small-size drugs or add scored-line.
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Objective:To improve the quality standard for Shengji ointment. Methods:A TLC method was used to identify Resina draconis and Olibanum. An HPLC method was used to determine the content of silver sulfadiazine. The detection wavelength was set at 254 nm. The determination was performed on a Wondasil C18 column(250 mm × 4. 6 mm, 5 μm) with the mobile phase consisting of acetonitrile-0. 1% phosphoric acid(8: 92). The injection volume was 5 μl. Results:The TLC spots were clear, specific and repro-ducible. A good linear relationship was obtained between the peak areas and the concentrations of sulfadiazine within the range of 40. 97-1024. 18 μg·ml-1(r=0. 9999). The average recovery was 100. 17% (RSD=0. 64%,n=6). Conclusion: The methods are easy-operated, specific, reproducible and accurate, which can be used for the quality control of the preparation.
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Objective:To establish an HPLC method for the determination of ginsenoside Rg1 ,ginsenoside Re and ginsenoside Rb1 in Xueluotong capsules. Methods:A column of Waters Symmetry C18 ( 250 mm × 4. 6 mm,5 μm) at the temperature of 35 ℃ was used to separate the target components, the mobile phase consisted of acetonitrile-water with gradient elution, the flow rate was 1. 0 ml ·min-1 , the detection wavelength was 203 nm and the injection volume was 10 μl. Results:The linear range of ginsenoside Rg1 was 0. 055-2. 732 μg(r=0. 9998), and the average recovery was 107. 23% with RSD of 1. 17%(n=6). The linear range of ginsenoside Re was 0. 341-8. 542 μg(r=0. 9999), and the average recovery was 101. 63% with RSD of 3. 52%(n=6). The linear range of gin-senoside Rb1 was 0. 717-14. 336 μg(r=0. 9997), and the average recovery was 100. 63% with the RSD of 3. 79%(n=6). Conclu-sion:The method is simple, accurate and reliable, which can be used for the quality control of Xueluotong capsules.
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Objective:To study the effect and underlying mechanism of BCG polysaccharide and nucleic acid ( BCG-PSN) in hy-persusceptibility in guinea pigs to explore the improvement method for the quality control model of BCG-PSN. Methods:The ovalbumin induced hypersusceptibility animal model was established, the effect of BCG-PSN on hypersusceptibility in guinea pigs was observed. According to the guideline for immunity toxicity study on Chinese traditional medicine and natural medicine, the hypersusceptibility tests were carried out. Serum IgE and histamine were determined by ELISA. Results:The guinea pigs in the model group and the low dosage BCG-PSN group showed strong anaphylactic symptoms, while the middle and high dosage BCG-PNS groups showed fewer symp-toms. The level of IgE in the model group was (1. 673 0 ± 0. 158 6) μg·ml-1 and (1. 683 1 ± 0. 228 1)μg·ml-1 before and after the attacking, respectively, which was higher than that in the control group(P<0. 01). The levels of IgE in the middle and high dos-age BCG-PNS groups were decreased compared with those in the model group before and after the attacking(P<0. 01). The same re-sults were observed in the levels of histamine. Before and after the attacking, the levels of histamine in the model group was (1. 499 7 ± 0. 133 1) ng·ml-1 and (1. 512 1 ± 0. 050 6) ng·ml-1 , respectively, while the levels of histamine in low, middle and high dos-age BCG-PNS groups were decreased compared with those in the model group before and after the attacking(P<0. 01). Conclusion:BCG-PSN can dose-dependently inhibit the anaphylactic reaction induced by ovalbumin.
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To study the bacteriostat, anti-inflammatory and relieving itching effects of Yinyanjing gel. Methods: A double dilution method was used to detect the in vitro bacteriostat effect of Yinyanjing gel. The therapeutic effects of Yinyanjing gel on bacterial vaginitis were observed in rats. The antipruritic effect of Yinyanjing gel was observed in guinea pigs. Results:MIC for Staphy-lococcus aureus was 47. 39 mg·ml-1 , and that for Escherichia coli was 189. 59 mg·ml-1 . The therapeutic effects of Yinyanjing gel on bacterial vaginitis were significant. Yinyanjing gel showed notable antipruritic effect on the itching induced by histamine phosphate in guinea pigs. Conclusion:Yinyanjing gel exhibits significant effects of bactriostasis,anti-inflammation and relieving itching.
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Objective:To compare the formula of codeine phosphate tablets produced by two enterprises. Methods: IC50 of the tablets and raw material of codeine phosphate, and the excipients from two enterprises was detected respectively. Results:IC50 of the tablets from A enterprise was 0. 169 mg·ml-1 , that from B enterprise was 0. 140 mg·ml-1 , and the difference was statistically sig-nificant(P0. 05). Conclusion: The difference in cytotoxicity of codeine phosphate tablets is manly induced by the excipients, and the products from A enterprise are better than those from B enterprise.
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<p><b>OBJECTIVE</b>To investigate the effects of topical treatment with adenovirus-mediated promyelocytic leukemia gene (PML) gene in a psoriasis-like mouse model.</p><p><b>METHODS</b>The effect of adenovirus-mediated PML gene on the granular layer of mouse tail scale epidermis and epithelial mitosis were observed on longitudinal histological sections prepared from the tail skin and vaginal epithelium of the mice.</p><p><b>RESULTS</b>Adenovirus-mediated PML gene significantly inhibited mitosis of mouse vaginal epithelial cells and promoted the formation of granular layer in mouse tail scale epidermis.</p><p><b>CONCLUSION</b>The therapeutic effect of PML gene in the psoriasis-like mouse model may be associated with increased granular cells and suppressed epidemic cell proliferation.</p>
Subject(s)
Animals , Female , Male , Mice , Adenoviridae , Genetics , Administration, Topical , Cell Proliferation , Disease Models, Animal , Epithelial Cells , Cell Biology , Genetic Vectors , Mice, Inbred Strains , Mitosis , Nuclear Proteins , Genetics , Promyelocytic Leukemia Protein , Psoriasis , Therapeutics , Skin , Cell Biology , Transcription Factors , Genetics , Tumor Suppressor Proteins , Genetics , Vagina , Cell BiologyABSTRACT
<p><b>OBJECTIVE</b>To investigate the expression of promyelocytic leukaemia (PML) protein of PML protein in Bowen's disease (BD), skin squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) and explore the role of PML in the pathogenesis of these diseases.</p><p><b>METHODS</b>PML protein in normal skin tissues and lesions of Bowen's disease, SCC and BCC were detected with immunohistochemistry.</p><p><b>RESULTS</b>Normal skin tissues did not express PML protein. In BCC, PML showed rather low expressions in the skin lesions (8.69% in cell nuclei and 4.35% in cytoplasm). The lesions in BD and SCC (grade I and II) showed obvious overexpression of PML protein in the cell nuclei and cytoplasm, and its expression in the cell nuclei of these lesions was significantly higher than that in grade III-IV SCC.</p><p><b>CONCLUSION</b>PML protein may play an important role in the early stage of SCC, and its overexpression may contribute to the carcinogenesis and metastasis of SCC.</p>