OBJECTIVE: To study the effect of samples having different pH values in the bacterial endotoxins test (BET). METHODS: The BET was conducted as an assay of the concentration of endotoxins by using kinetic-turbidimetric technique. Samples having different pH values but containing same concentration reference standard endotoxin (RSE) were tested by TAL/LAL reagents. The average result on the standard curve was calculated and the mean recovery observed. RESULTS: The reagents had three highly sensitivities in pH 5.20, pH 7.83/pH 6.23 and pH 10.55. After adjustment to pH 6 to 8, the mean recovery was 76.5%～115.9% or 85.8%～99.8%. When the sample pH value was less than 3 or more than 12, the test was unsuitable for the inhibition test, and the mean recovery was less than 56.8%. CONCLUSION: It is necessary to adjust the pH of the solution to be tested in the BET, adjust the sample to pH (6.5～7.5) when using TAL reagents, and adjust to pH (6.2±0.1) or pH(6.7～7.8) when using LAL reagents.

To study a method for determination of sulfamethoxazole, sulfadiazine and trimethoprim tablets, a compound tablet of sulfamethoxazole, sulfadiazine and trimethoprim. METHOD: A capillary zone electrophoresis (CZE) method was used to assay three components of this compound preparation. RESULTS: The complete separation of components was achieved with 0.05 molL-1 pH 6.0 running phosphate buffer and a constant voltage of 20 kV (current of 95 μA～105 μA). The retention times of individual components were between three and eight minutes and a good linearity was shown between concentration and peak area in the concentration range over 70 μgml-1～750 μgml-1. When acetanilide was used as internal standard, the relative standard deviation (RSD) of each component determined in a batch was less than 1% (n=9). The recovery of each component was not less than 96.45% with RSD less than 3%. The analytical results obtained from 6 samples of clinical use were inconsistent with those by standard method, however the quantity of each sulfa drug was obtained by CZE method. CONCLUSION: The results showed this method is accurate, simple, and rapid. When this method is used, the quantity of each three components is determined, but by the standard method, only the total quantity of the two sulfa drugs is obtained.

To prepare and study the pharmacokinetics and release bioavailability in olunteers and concentrations in plasma in patients. METHODS: Ethylcellulose was used matrix in phase separation-coacervation for preparation of microencapsulation. The release experiments were performed in a rotating shaker. The isoniazid concentration in plasma was determined by spectrophotometrical method following a single oral dose of sustained-release cupsule and ordinary tablet respectively given to 10 volunteers in a open randomized cross-over test. MCP86 was used to process main pharmacokinetic parameters. RESULTS: The sustained-release of capsule and ordinary teblet in vitro, T50 was 1 h and 0.032 h respectively. The drug in sustained-release capsule was sustained release over 10 h. The main parameters in body: ordinary tablets: cmax=11.12 μgml-1, tmax=1.41 h, K=0.201 h-1; sustained release capsule: cmax=4.99 μgml-1, tmax=1.80 h, K=0.03 h-1. The concentration of blood at 36 h was (0±0)μgml-1 and 1.63 μgml-1 respectively. Except tmax, there was significant difference between the two fomulations (P＜0.01). The concentration of blood in patient at 1.5 h and 36 h. ordinary tablet and sustained-release capsule respectively were (8.24±2.60)μgml-1, (0±0)μgml-1and (3.69±0.86)μgml-1, (2.09±0.56)μgml-1. CONCLUSION: The sustained-release capsule will play an important part in prevention and treatment of tuberculosis as the result of its reasonable formulation and simple technology.

OBJECTIVE: To develop a HPLC method for assaying strychnine and brucine in traditional Chinese drug Maqianzi San. METHODS: With μBondapak C18 (10 μm) column (4 mm×300 mm), MeOH-H2O-HAc-(C2H5)3N(70∶230∶2.4∶0.3) as mobile phase, we set a detector at 254 nm. RESULTS: Linear range of strychnine and brucine was 0.367 2 μg～0.061 2 μg and 0.945 0 μg～0.157 5 μg respectively. The recovery rate of strychnine and brucine was 100.36% (RSD=1.09%) and 100.01% (RSD=1.46%) respectively. CONCLUSION: This method provides a simple and feasible way to control the quality of Maqianzi San.

To prepare sustained phenylpropanolamine*HCl (PPA*HCl)-resin complexes and to study the factors influencing the in vitro dissolution of it. METHOD: The sustainedPPA*HCl-resin complexes were prepared by coating the complexes with different kinds of ethylcellulose (EC) as coating embranes. The factors influencing the release rate of PPA*HCl from the complexes, such as resin particle size, the viscosity and thickness of coating membrane, the dispersion medium of EC (water or alcohol) as well as thepH and ion strength of dissolution medium were studied in detail. RESULTS: Thefactors above all influenced the dissolution of the complexes to ifferent extent. When prepared by EC 200 Pa*s (150 g*kg-1), the dissolution of the coated complexes in 0.1 mol*L-1 HCl accorded with the requirements of sustained PPA*HCl capsulesof USP ⅩⅩⅢ. ONCLUSION: The sustained PPA*HCl can be prepared by coating the drug-resin complexes with EC.

OBJECTIVE:To determine whether bacterial endotoxins test(BET) can replace the pyrogen test for the sodium bicarbonate injection.METHODS:The comparative experiment of tachypleus amebocyte lysate(TAL) and rabbits were studied to determine the sensitivity.RESULTS:The sensitivity of TAL test was 0.125 EU.ml－1, 12 times higher than that of using rabbits.CONCLUSIONS:BET may replace pyrogen test.

OBJECTIVE:To eualuate in vitro antibacterial activities of silver nitrate and povidone-iodine for preventing ophthalmia neonatorum. METHODS:Minimal inhibitory concentration(MIC) and mininmal bactericidal concentration (MBC) were deter-mined by double broth dilution method. RESULTS:For Stapanrens Streppnenmonia and N gonorhveae,the MIC50 of silver nitrate were＜4～8μg.ml－1 and its MIC90 were 8～32μg.ml－1.The MIC50 of povidone-iodine were64～256μg.ml－1 and its MBC90were 512 μg.ml-1. CONCLUSION: Silver nitrate and povidone-iodine exhibited activities against common pathogens of ophthalmia neonatorum isolates.Silver nitrate was more active than povidone-iodine.

OBJECTIVE:To observe the effects of borneol affecting the transdermal amount of drugs.METHODS:Drugs permeation tests were performed in a two-compartment diffusion cell through cobra skin in vitro,in rabbits and on the human skin blanching assay in vivo,respetively.RESULTS:In vitro,borneol increased the percutaneous transport of metronidazole and 5-fluorouracil.The potency of 3.0% borneol was different from that of 1.0%borneol.On the human skin beanching assay in vivo it indicated that borneol enhanced the bioavailability of percutaneous penetration of triamcinolone acetonide acetate.In rabbits,borneol increased AUCo～12h of salicylic acid in plasma.CONCLUSION:It indicated borneol is a effective percutaneous penetration enhancer.

OBJECTIVES:The effect of water-soluble polymers polyvinylpyrrolidone(PVP) and polyethylene glycol(PEG)on the complexation of drugs with β-cyclodextrin were investigated.METHODS:the thermodynamic properties of drugs in aqueous β-CD solution and in aqueous solut.RESULTS:The maximum solubilization concentration of PVP or PEG appeared from 1.5g.L－1 to 3.0g.L－1.At this low concentration,PVP or PEG had insignificant effect on the viscosity of the aqueous β-CD solution.The solubilising effect ofβ-CD on chloramphenicol was improved by 15% when containing 2.5g.L－1 polyethylene glycol in the solution and on vitamininum B2by 98%when containing 2.5g.L－1 polyvinylpyrrolidone.In aqueous solutions water-soluble polymers were shown to increase the solubilising effect of β-CD on drugs.Additing of PEG or PVP to the aqueous complexation medium resulted in an increased negative enthalpy change,together with an increased negative entropy change.CONCLUSION：Water-soluble polymers were shown to increase the solubilising effect of β-CD on drugs.

OBJECTIVE：To study the effects of Gushikangfuwan on osteoporosis caused by retinoic acid in rats. METHODS:The osteoporosis was induced by retinoic acid(70mg.kg-1,ig)daily in rats for two weeks. The pharmacologic effects of Gushikangfuvan was observed. RESULTS: Compared with the retinoic acid group Gushikangfuwan (6g.kg-1)enhanced the relative bone volume,average bone trabecula and bone Lacuna length in rats.Gushikangfuwan (3g.kg-1,6g.kg-1) also enhanced the content of calcium and phosphorus of thigh bone. CONCLUSIONS：Gushikangfuwan may ameliorate the bone quality and enhance the bone density in rats.