Bailing Capsule combined with α-ketoacid tablets for stage 3 chronic kidney disease: Protocol of a double-blinded, randomized, controlled trial.

BACKGROUND: Chronic kidney disease (CKD) is a progressive and irreversible loss of kidney function. After stage 3, there will be increased risks of hypertension, heart failure, bone disease, anemia, gastrointestinal symptoms, and progression to end-stage kidney failure without proper intervention and treatment. Compound α-ketoacid tablets (KA) administration plays an important role in clinical CKD adjunctive therapy for patients with restricted protein intake. Bailing Capsule (BC), a commonly used Chinese patent medicine for renal diseases, could regulate human immune function, repair renal tubular epithelial cells, prevent renal tubular atrophy, and reduce kidney damage to improve renal function. In this study, we try to conduct a double-blinded, randomized, controlled trial to observe the efficacy and safety of BC combined with KA in treating patients with stage 3 CKD. METHODS: This is a double-blinded, randomized, controlled trial. Patients will be randomly divided into treatment group (BC and KT) and control group (BC-simulation and KT) in a 1:1 ratio according to random number table. The treatment course will be 8 weeks, and the changes of subjective symptoms, patient global assessment (PGA) scale, serum creatinine, cystatin C, and estimated glomerular filtration rate, all related adverse events, vital sign measurements, and physical examinations will be recorded. SPSS 21.0 will be used for data analysis. CONCLUSIONS: The results will show whether BC combined with KA could alleviate the symptoms of fatigue, anorexia, halitosis, nausea, itching, and edema, improve kidney function in patients with CKD at stage 3. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/24AJ7.

[Controlled study on therapeutic effect of vessel pricking therapy and western medication for treatment of Henoch-Schonlein purpura nephritis].

OBJECTIVE: To compare the difference of therapeutic effects between vessel pricking therapy and Prednisone for treatment of Henoch-Schonlein purpura nephritis. METHODS: Seventy cases of acute purpura nephritis syndrome were randomly divided into an observation group (40 cases) and a control group (30 cases). Patients in observation group were differentiated into sthenia and asthenia syndromes. Vessel pricking therapy was applied at Hegu (LI 4), Quchi (LI 11), Xuehai (SP 10) etc. by triangular needle for sthenia symptom; shallow needling was used at Pishu (BL 20), Shenshu (BL 23), Zusanli (ST 36) etc. by filiform needle. The control group was treated with oral admi-nidtration of Prednisone. The symptom score of TCM, 24 h urinary protein, red blood cell count of urinary sediment of both groups were observed before and after treatment and therapeutic effects were compared. RESULTS: The total effective rate of 92.5% (37/40) in observation group was superior to that of 80.0% (24/30) in control group, and there was a significant difference between two groups (P < 0.05); the symptom score of TCM, 24 h urinary protein, red blood cell count of urinary sediment were all improved in both groups after treatment (all P < 0.05), and moreover, the improvement in observation group was superior to that of control group (all P < 0.05); after treatment, the symptom score of TCM of sthenia syndrome was lower than that of asthenia syndrome in observation group (P < 0.05). CONCLUSION: Vessel pricking therapy has a significant therapeutic effect for treatment of Henoch-Schonlein purpura nephritis, superior to that of oral administration of Prednisone, and the therapeutic effect is better for treating sthenia syndrome than for asthenia syndrome.

HPLC determination and pharmacokinetics of chlorogenic acid in rabbit plasma after an oral dose of Flos Lonicerae extract.

A simple and sensitive high-performance liquid chromatography (HPLC) method has been developed for the determination of chlorogenic acid (3-O-caffeoyl-D-quinic acid) in plasma and applied to its pharmacokinetic study in rabbits after administration of Flos Lonicerae extract. Plasma samples are extracted with methanol. HPLC analysis of the extracts is performed on a C(18) reversed-phase column using acetonitrile-0.2% phosphate buffer (11:89, v/v) as the mobile phase. The UV detector is set at 327 nm. The standard curves are linear in the range 0.0500-1.00 microg/mL (r = 0.9987). The mean extraction recovery of 85.1% is obtained for chlorogenic acid. The interday precision (relative standard deviation) ranges from 5.0% to 7.5%, and the intraday precision is better than 9.0%. The limit of quantitation is 0.0500 microg/mL. The plasma concentration of chlorogenic acid shows a C(max) of 0.839 +/- 0.35 microg/mL at 34.7 +/- 1.1 min and a second one of 0.367 +/- 0.16 microg/mL at 273.4 +/- 39.6 min.

[Preparation and simultaneous determination of corynoline and acetylcorynoline in the herb of Corydalis bungeana].

OBJECTIVE: To isolate and purify corynoline and acetylcorynoline from Corydalis bungeana and develop a reversed-phase HPLC method of determining the two components in C. bungeana. METHOD: Alkaloids were isolated from the ethanolic extract with column gel chromatography, and identified on the basis of spectral analysis (UV, 1H-NMR, 13C-NMR) and physicochemical properties. For quantitative analysis of the two components, samples were separated on an ODS column with mobile phase of methanol-15 mmol.L-1 potassium dihydrogen phosphate/potassium phosphate dibasic (pH 6.70, 70:30). The flow rate was 0.8 mL.min-1, and the detection was set at 289 nm. RESULT: The purity was 99.5% and 99.1% for corynoline and acetylcorynoline respectively. The calibration curves were linear in the range of 6.9-110.4 mg.L-1 corynoline and 8.7-139.5 mg.L-1 acetylcorynoline. The RSD was 2.1% and 2.7%, and the average recovery was 97.3% and 97.2% respectively. CONCLUSION: The method of isolating and purifying corynoline and acetylcorynoline from Corydalis bungeana and the HPLC method of simultaneous determination of the two components have been developed. The HPLC method is simple, easy to perform and applicable to the content determination of corynoline and acetylcorynoline in C. bungeana of various origins.