There are few articles or reports collecting evidence about parenterally administered salvianolate from premarketing and postmarketing research or studies systematically. This article is an exact miniature of a systematical report about parenterally administered salvianolate. We analyzed information from four aspects, such as quality control reports, non-clinical premarketing safety experiments, postmarketing research (efficacy studies, hospital information system data and national spontaneous reporting system data) and literature analysis. All the four aspects build an evidence body for Kudiezi Solution in order to inform its safety use in clinical practice and further study.
Hospital Information Systems ; Humans ; Plant Extracts ; administration & dosage ; adverse effects

Based on the demand of nasal drug delivery high drug loadings, using the unique phase transfer of solute, integrating the phospholipid complex preparation and submicron emulsion molding process of Scutellariae Radix extract, the study obtained the preparation of the high drug loadings submicron emulsion of Scutellariae Radix extract. In the study of drug solution dispersion method, the uniformity of drug dispersed as the evaluation index, the traditional mixing method, grinding, homogenate and solute phase transfer technology were investigated, and the solute phase transfer technology was adopted in the last. With the adoption of new technology, the drug loading capacity reached 1.33% (phospholipid complex was 4%). The drug loading capacity was improved significantly. The transfer of solute method and timing were studied as follows,join the oil phase when the volume of phospholipid complex anhydrous ethanol solution remaining 30%, the solute phase transfer was completed with the continued recycling of anhydrous ethanol. After drug dissolved away to oil phase, the preparation technology of colostrum was determined with the evaluation index of emulsion droplet form. The particle size of submicron emulsion, PDI and stability parameters were used as evaluation index, orthogonal methodology were adopted to optimize the submicron emulsion ingredient and main influential factors of high pressure homogenization technology. The optimized preparation technology of Scutellariae Radix extract nasal submicron emulsion is practical and stable.
Administration, Intranasal ; Emulsions ; Plant Extracts ; Technology, Pharmaceutical ; methods

To prepare and evaluate dry powder inhalation (DPI) of extraction of Trollius chinensis Bunge (TCB). Orthodox design was employed to optimize the parameters of spray drying to prepare micronized TCB powder, the DPI was prepared by mixing micronized TCB powder and lactose. The results showed that the fine particle fraction (FPF) and emitted dose (ED) of micronized TCB powder was (21.07 +/- 1.74)%, (75.31 +/- 21.05)%, respectively, and for DPI was (56.4 +/- 2.2)%, (95.9 +/- 3.0)%, respectively. Therefore, the prepared DPI meeted requirements in the Chinese Pharmacopeia, indicating a good application prospect.
Administration, Inhalation ; Dry Powder Inhalers ; Excipients ; Plant Extracts ; administration & dosage ; isolation & purification ; Powders ; Ranunculaceae

The article briefly introduces the development history and status of the supervision and administration of herbal extracts, and summarizes the problems existing in the process of supervision and management. Meanwhile provides the countermeasures and suggestions of strengthening the supervision and administration of herbal extracts.
Drugs, Chinese Herbal ; administration & dosage ; Humans ; Plant Extracts ; administration & dosage ; standards

OBJECTIVETo observe the effects of Dachengqi Granule (DCG) in the recovery of gastrointestinal function and the condition of patients in the perioperative period of total laparoscopic hysterectomy.

METHODSTwo hundred and one patients received total laparoscopic hysterectomy were assigned to 2 groups, the treated group (103 cases) was orally administered DCG twice, 9 g at 4:00 pm, one day before operation and 6 g at 16 h after operation, while to the control group, enema with 400 mL of soap solution at 8:00 pm one day before operation and acupoint ST 36 injection with 1 mL neostigmine at 16 h after operation were given.

RESULTSTotal laparoscopic hysterectomy was accomplished successfully in all patients, no need to receive open abdominal operation, and with no post-operational complications. In the treated group, the operation time was (116.8 +/- 29.7) min, the operative blood loss was (141.6 +/- 25.1) mL, the post-operative temperature was (37.38 +/- 1.39) degrees C, while those in the control group were (119.6 +/- 28.4) min, (150.6 +/- 22.1) mL, and (37.55 +/- 0.43) degrees C, correspondingly, showing insignificant difference between the two groups (P > 0.05). The white blood cell count on the 1st day after operation was (11.18 +/- 2.93) x 10(9)/L in the treated group, and (12.57 +/- 3.55) x 10(9)/L in the control group (P < 0.01); time for post-operative aerofluxus in them was (35.66 +/- 5.72) h, and (41.77 +/- 6.06) h; time for post-operative defecation (48.47 +/- 18.97) h, and (54.81 +/- 21.30) h, respectively, all showed statistical difference between the two groups (P < 0.01 or P < 0.05).

CONCLUSIONAdministering DCG before and early after operation can effect better than pre-operational enema in ensuring the gynecological operation progression smoothly, and it could also promote the recovery of post-operational gastrointestinal function and improve patients' condition in the perioperative period.

Drugs, Chinese Herbal ; administration & dosage ; Enema ; Female ; Humans ; Hysterectomy ; Laparoscopy ; Neostigmine ; administration & dosage ; Perioperative Period ; Plant Extracts ; administration & dosage

OBJECTIVEDevelop an LC-MS method to determine evodiamine and rutaecarpine in rats plasma simultaneously. The method was employed to investigate pharmacokinetics of evodiamine and rutaecarpine.

METHODBlood samples were collected in different time after oral administrated with the extracts of Euodiae Fructus, the plasma concentration of evodiamine and rutaecarpine was determined by LC-MS, pharmacokinetic parameters were calculated by WinNonlin 5.1 software.

RESULTThe linear ranges of evodiamine and rutaecarpine were 0.5-100 microg x L(-1) (r = 0.995 9), 1-200 microg x L(-1) (r = 0.999 3) respectively. The average recovery were exceeded 76% (n = 5), the precision of inner-day and inter-day were less than 15%. The pharmacokinetics parameters AUC, t1/2, CL _F of evodiamine were: (2 215.24 +/- 414.49), (4 230.62 +/- 753.77), (13 219.21 +/- 3 740.95) min x ng(-1) x mL(-1); (146.57 +/- 38.38), (114.38 +/- 14.65), (163.37 +/- 8.83) min; (184 607.29 +/- 32 502.21), (192 878.22 +/- 31 897.37), (19 3224.63 +/- 62 278.74) mL x min(-1). The pharmacokinetics parameters AUC, t1/2, CL_F of rutaecarpine were (2 283.53 +/- 298.51), (4 424.84 +/- 276.95), (14 239.93 +/- 3648.27) min x ng(-1) x mL(-1); (167.10 +/- 15.82), (131.58 +/- 20.07), (144.41 +/- 13.65) min; (1 177 340.54 +/- 2 4942.21), (181 262.92 +/- 11 162.22), (177 508.10 +/- 52 611.80) mL x min(-1).

CONCLUSIONThe method described in this report has high sensitivity and selectivity, and was suitable for pharmacokinetic studies of evodiamine and rutaecarpine. The kinetic process of evodiamine and rutaecarpine in rats in vivo were all yielded to be one-compartment model.

Administration, Oral ; Animals ; Evodia ; Indole Alkaloids ; pharmacokinetics ; Male ; Plant Extracts ; pharmacokinetics ; Quinazolines ; pharmacokinetics ; Rats ; Rats, Wistar

This project is to study the metabolites of Laportea bulbifera extract in rat feces. After the SD rats were gavaged with the extract(136 g·kg~(-1), according to the crude drug dose), the metabolites in their feces were detected by UHPLC-Q-TOF-MS~E technique, and the obtained mass spectrometry data was combined with UNIFI software for prediction. The prototype components and metabolites in rat feces were identified with reference materials and related literature. A total of 43 metabolites were identified(including 8 prototype components and 35 metabolites). The metabolic pathways mainly include monocaffeoylquinic acid(hydrogenation reduction, ring-opening cracking, sulfation, hydroxylation, glucuronidation), quercetin(O-C2 bond ring-opening cleavage, C2-C3 double bond reduction, rutin carbonylation) and so on. The metabolites and metabolic process of L. bulbifera extract in rat feces were clarified, which provided a basis for the study of the active substances and its mechanism of action.
Administration, Oral ; Animals ; Chromatography, High Pressure Liquid ; Feces ; Plant Extracts ; Rats ; Rats, Sprague-Dawley ; Urticaceae

Previous studies on the genus Clusia have shown anti-inflammatory and antiproliferative effects of the leaf extracts, but its antinociceptive activity has never been characterized. In the present study, the antinociceptive activity of the hexane extract of the leaves of Clusia nemorosa G. Mey, called HECn, was examined. Antinociceptive activity was evaluated using acetic acid-induced writhing, formalin, and hot-plate tests. All experiments were carried out on male Swiss mice. The extract (1-400 mg·kg(-1)), given by intraperitoneal route (i.p.) 1 h prior to testing, produced a dose-dependent inhibition on the number of abdominal writhings, with an ID50 of 62 mg·kg(-1). In addition, HECn was able to prevent the visceral pain induced by acetic acid in mice for at least 2 h. In the formalin test, HECn had no effect in the first phase, but produced an analgesic effect on the second phase with the inhibition of licking time. The HECn did not show a significant analgesic effect in the hot plate test. Pretreatment with yohimbine attenuated the antinociceptive effect induced by HECn in the writhing test. However, naloxone, atropine, or haloperidol did not affect antinociception induced by HECn in the writhing test. Together, these results indicate that the extract from the leaves of Clusia nemorosa produces antinociception in models of chemical pain through mechanisms that suggest participation of the adrenergic systems pathway.
Adrenergic Agents ; administration & dosage ; Analgesics ; administration & dosage ; Animals ; Clusia ; chemistry ; Humans ; Male ; Mice ; Nociception ; drug effects ; Pain ; drug therapy ; psychology ; Phytotherapy ; Plant Extracts ; administration & dosage ; Plant Leaves ; chemistry

OBJECTIVETo study the compatibility of dosage change of Zhishi, Houpo and Mangxiao affecting the yields of Anthraquinone components in Dachengqi decoction.

METHODResponse surface methodology (RSM) with Doehlert design was adopted to evaluate the yields of Anthraquinone components in Dachengqi decoction by dosage change of Zhishi, Houpo and Mangxiao and the analysis time was shorten through a desirability function.

RESULTResults show that Anthraquinone components were got a high yields when the dosage ratio of Dachengqi decoction were compatible as follows: Dahuang-Zhishi-Houpo-Mangxiao (1:4:2. 31:2).

CONCLUSIONThe Doehlert design with a desirability function, which allow a sequential response methodology, is a good methods, and, of cause, the mathematical model can be further extended and applied to the compatibility research of Chinese material medicine.

Anthraquinones ; analysis ; Dosage Forms ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Models, Chemical ; Plant Extracts ; administration & dosage ; chemistry

Reperfusion is the most effective treatment for acute myocardial infarction, markedly reducing mortality and morbidity. Reperfusion however induces necrotic and apoptotic damages to cardiomyocytes, that were viable prior to reperfusion, a process called myocardial ischemia/reperfusion injury(MI/RI). Over the past 30 years, hundreds of experimental interventions (both pharmacologic and nonpharmacologic) have been reported to protect the ischemic myocardium in experimental animals; however, with the exception of early reperfusion, none has been translated into clinical practice. The population-based survey assessed men have about twice the total incidence of morbidity and mortality of women, and the sex gap in morbidity tends to diminish after age 45 years. So hormone replacement therapy (HRT) is given to treat the MI/RI, and lots of studies shows that the side effect is greater for estrogen, compared with phyestrogen. In this article, we review the important pathogenesis of myocardial ischemia reperfusion injury, the prevention and limitations of HRT. And we highlight the mechanism of phyestrogens treatment the MI/RI in experiment. The aim is to provide the theoretically new way of develop the safe and effective products for the researchers.
Animals ; Humans ; Myocardial Ischemia ; drug therapy ; Myocardial Reperfusion Injury ; drug therapy ; Phytoestrogens ; administration & dosage ; Plant Extracts ; administration & dosage