[Study on quality standard of Sophora flavescens root extract].

As a part of the project for the Chinese Pharmacopoeia (2015 edition), the quality standard of Sophora flavescens root extract was investigated and established. According to the methods described in the Appendix of Chinese Pharmacopoeia (2010 edition), the water and ash inspections were carried out. The marker components trifolirhizin, sophoraflavanone G, oxymatrine and oxysophocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine, matrine, oxysophocarpine and sophocarpine was conducted by HPLC and the total flavonoids were measured by ultraviolet spectrophotometry, using sophoraflavanone G as reference substance. The results indicated the spots on the plate were clear with good resolution and the contents of oxymatrine, matrine, oxysophocarpine and sophocarpine in the 13 batches of the samples were 3.87% - 11.1%, 0.970% - 4.33%, 1.30% - 2.59% and 0.260% - 1.14%, respectively. The total flavoids in the 13 batches of the samples were 3.88% - 7.93%. In the study, the validated methods were reproducible and the established quality standard was feasible, which could be used for the quality control of S. flavescens root extract and related preparations.

[HPLC Fingerprint of Anisodus tanguticus Root].

OBJECTIVE: To establish an HPLC fingerprint of Anisodus tanguticus root for its quality control. METHODS: The analysis was carried out on a Ultimate AQ C18 (250 mm x 4.6 mm, 5 µm) column with the gradient elution of acetonitrile and KH2PO4 buffer soution, whose pH was adjusted to 3.0 with phosphoric acid. The flow rate, column temperature, detection wavelength and injection volume was 1.0 mL/min, 30 degrees C, 210 nm and 10 µL separately. The similarity evaluation and principal component analysis were used to analyze HPLC fingerprint of Anisodus tanguticus root. RESULTS: HPLC fingerprint of Anisodus tanguticus root was established with 15 common peaks by determining 18 batches of Anisodus tanguticus root samples. Four characteristic peaks, anisodine, scopolamine, anisodamine and anisodamine, were confirmed by comparing their retention time and UV spectrum with standard reference substances. The simiarities of 18 batches of Anisodus tanguticus root were between -0.891 and 0.987. Comprehensive evaluation scores of 18 batches of Anisodus tanguticus root were between -0.85 and 0.89 by principal component analysis. CONCLUSION: The established HPLC fingerprint has good precision, repeatability and stability, which can provide more comprehensive information for identification and quality control of Anisodus tanguticus root.

Study on quality standard of Sophora flavescens root extract / 中国中药杂志

As a part of the project for the Chinese Pharmacopoeia (2015 edition), the quality standard of Sophora flavescens root extract was investigated and established. According to the methods described in the Appendix of Chinese Pharmacopoeia (2010 edition), the water and ash inspections were carried out. The marker components trifolirhizin, sophoraflavanone G, oxymatrine and oxysophocarpine in the samples were identified by qualitative TLC. The determination of oxymatrine, matrine, oxysophocarpine and sophocarpine was conducted by HPLC and the total flavonoids were measured by ultraviolet spectrophotometry, using sophoraflavanone G as reference substance. The results indicated the spots on the plate were clear with good resolution and the contents of oxymatrine, matrine, oxysophocarpine and sophocarpine in the 13 batches of the samples were 3.87% - 11.1%, 0.970% - 4.33%, 1.30% - 2.59% and 0.260% - 1.14%, respectively. The total flavoids in the 13 batches of the samples were 3.88% - 7.93%. In the study, the validated methods were reproducible and the established quality standard was feasible, which could be used for the quality control of S. flavescens root extract and related preparations.

Transcultural psychopharmacology: present and future.

Transcultural psychopharmacology is a field that seeks to determine whether differences exist in the pharmacokinetic and pharmacodynamic handling of psychotherapeutic drugs among various ethnic groups and, where present, to determine the reasons for such variation. During the past two decades a number of studies have reported differences in the pharmacokinetics and pharmacodynamics of psychotropic medications among various ethnic groups. These variations appear to be mainly determined by genetic predisposition but can be influenced by other factors such as environment, psychosocial supports, and physicians' prescribing habits. Due to study design limitations, many questions regarding the transcultural aspects of psychotropic medications still remain unanswered. This critical review discusses the transcultural psychopharmacology of Asian versus non-Asian populations. It will also include data on tardive dyskinesia, discuss new developments, touch on the problems associated with present research in the area, and provide recommendations for designing future research studies.

Ethnicity and antidepressant response.

Modern psychopharmacology provides us with several effective antidepressants. We are increasingly recognizing the importance of interindividual differences in plasma concentration with these drugs. Such differences are caused by genetics, and the more extreme variations result from the population classified as slow hydroxylators. We now recognize that there are also substantial racial differences in the frequency distribution of slow metabolizers. The importance of studies in this area has been underscored by anecdotal reports as well as cross-cultural surveys of prescribing patterns which indicate that antidepressant dosage requirements may differ among racial groups. This review will focus on the relatively young field of cross-cultural psychopharmacology and the efforts being made to determine the importance of society, culture, environment, genetics, and biophysiology in the prescribing and metabolism of and response to antidepressant drugs.

Asian/non-Asian transcultural tricyclic antidepressant psychopharmacology: a review.

1. Transcultural psychopharmacology is a discipline that seeks to determine the relative importance of society, culture, environment, genetics, and biophysiology on the prescribing and metabolism of, and response to psychotherapeutic medications. 2. Studies and surveys comparing psychotropic medication use in Asian and non-Asian populations suggest that differences may exist in drug dosage requirements, plasma drug concentrations corresponding to therapeutic and toxic effects, and the incidence and severity of adverse drug reactions. 3. This paper reviews and critiques the published controlled studies on Asian/non-Asian transcultural tricyclic antidepressant psychopharmacology, provides guidelines for the use of psychotropic medications in Asian populations, and offers suggestions for future transcultural studies. 4. Anecdotal reports suggest that differences exist between Asian and non-Asian populations in the pharmacokinetics of tricyclic antidepressants. Controlled studies have not consistently supported this view. 5. Studies with larger sample sizes and more rigorous controls are needed to determine if such differences do, in fact, exist.

Prevalence of tardive dyskinesia among three ethnic groups of chronic psychiatric patients.

The relationship between prevalence of tardive dyskinesia and ethnicity (black, white, or Hispanic) was examined in a group of 491 chronic psychiatric patients at a large state psychiatric hospital in California. Overall, the prevalence of tardive dyskinesia was 17.7 percent. No significant differences in the prevalence of tardive dyskinesia or in neuroleptic dosage levels were found among the three groups. A relationship was found between lower prevalence of tardive dyskinesia and higher current neuroleptic dosage, suggesting that higher dosage masks symptoms of tardive dyskinesia.

Saliva and plasma desipramine levels in Asian and Caucasian volunteers.

Thirty-seven healthy volunteers (18 Asian, 19 Caucasian) ingested a single desipramine (DMI) dose of 1.0 mg/kg of body weight. Saliva and plasma samples were obtained at 1, 3, 5, 7, 12, 24, 48, 72, and 96 hrs after dosing. A nested repeated-measures analysis of variance (ANOVA) design was used to determine if the plasma/saliva DMI ratio varied between Asians and Caucasians over time. Regression analysis was used to assess the ability of saliva DMI to predict plasma DMI at any time point. The ANOVA results indicated no significant differences in DMI plasma/saliva ratios between Asians and Caucasians. There was a major effect of sampling time on the DMI plasma/saliva ratio (p = 0.0001), with the ratio falling from 1.78 at 1 hr to 0.15 at 96 hrs. At any given time at least 24 hrs after the dose, there was a significant relationship between saliva and plasma levels across individuals. However, across subjects, the 95 percent confidence limits for predicting plasma DMI from saliva DMI levels were relatively large. The potential roles and limitations of saliva DMI in pharmacokinetic studies and clinical drug monitoring are discussed.

Subjective neuroleptic response and treatment outcome under open and double-blind conditions--a preliminary report.

1. A patient's early subjective response to a neuroleptic was recorded in 17 schizophrenic patients following a fixed dose of neuroleptic under both open and double-blind placebo-controlled conditions. 2. High correlations were found between a patient's subjective response at 2.5, 24 and 48 hours after the initial dose, suggesting that the timing of the initial subjective response rating is not critical. 3. The relationship between the psychiatric improvement and subjective response was not significant under double-blind conditions (r = 0.004), while the relationship under the open condition showed a trend towards significance comparable to earlier reports (r = 0.32). 4. The findings question the usefulness of applying early subjective response to a neuroleptic to predict clinical improvement.

Acute laryngeal dystonic reactions to neuroleptics.

Two cases of acute laryngeal dystonia (laryngospasm), a rarely reported extrapyramidal reaction to neuroleptics, occurred in a public psychiatric hospital. A review of the literature revealed only seven well-documented case reports. This article discusses the clinical significance of this rare, alarming, and probably underreported phenomenon. Factors related to recognition, prediction, and management are also discussed. The review strongly advocates immediate intravenous administration of anticholinergic drugs to relieve dystonia.

Pharmacokinetics of desipramine in Asian and Caucasian volunteers.

The pharmacokinetic differences of tricyclic antidepressants (TCAs) in Asians and Caucasians remain controversial. Thirty-seven age-matched healthy volunteers (18 Asians and 19 Caucasians) ingested a single desipramine (DMI) dose of 1.0 mg/kg of body weight. Blood was obtained at 1, 3, 5, 7, 12, 24, 48, 72, and 96 hours after dosing. Serial 24-hour urine samples were collected for 5 days. There were no statistically significant differences in plasma levels between the two groups. DMI concentrations peaked a median of 5 hours after ingestion in Asians vs. 3 hours in Caucasians. Total clearances of DMI (CL DMI) and hydroxylated DMI (OH-DMI) were greater in Caucasians. These differences were no longer significant when corrected for body weight. Clearances appeared to follow tri-modal distributions. The proportions of Asians and Caucasians falling into the slow, intermediate, and rapid clearance groups were not significantly different, but there was a tendency for more Caucasians to be in the rapid clearance group.

Plasma levels and therapeutic response with trimipramine treatment of endogenous depression.

In a 6-week, double-blind study involving 34 endogenously depressed patients, plasma trimipramine levels of two dosage groups, 75-mg/day and 150-mg/day, were compared with regard to clinical efficacy as determined by scores on the Hamilton Rating Scale for Depression, the Clinical Global Impressions scale, and the Zung Self-Rating Depression Scale. Both dosage levels of trimipramine produced prompt, consistent, and progressive antidepressant effects. No correlation between plasma levels and clinical efficacy was found.

Pharmacokinetics of desipramine in Caucasian and Asian volunteers.

The plasma levels of 20 healthy Asian subjects who received a single dose of desipramine were compared with those of 20 healthy Caucasian subjects who received such a dose. The groups differed significantly only in that Asian subjects had an earlier time of peak serum concentration.

An update on tardive dyskinesia.

The authors review recent research on definition, diagnosis, neuropathophysiology, treatment, management, and factors that increase risk of tardive dyskinesia, a severe and often unremitting movement disorder associated with neuroleptic treatment. Supersensitivity of dopamine receptors is believed to be the cause of tardive dyskinesia, and treatment strategies have consisted of pharmacologic blockade of dopamine receptors, depletion of dopamine, and restoration of the balance between the dopaminergic system and the neurotransmitter systems that regulate it. Several experimental neuroleptics that do not appear to cause tardive dyskinesia may be approved for use in the United States, but for now preventive measures, such as wise prescription and gradual tapering of neuroleptics, as well as careful monitoring for symptoms of tardive dyskinesia are the clinician's best defense.

Plasma drug levels and clinical response to antidepressants.

Antidepressants are a key treatment in depression. The wide interindividual differences in plasma levels of these agents were initially seen as an explanation for nonresponse and a potential major advance in treating depressive disorders. However, efforts to relate plasma levels to therapeutic outcome have, in general, been disappointing. In the few instances where such relationships have been claimed, they have been weak and useful only for specific and problematic clinical conditions.

Effect of lithium on leukocytes: a two-year follow-up.

Leukocytosis is a common finding in patients given lithium salts, but few studies have addressed the possibility of persistent leukocyte elevation during long-term lithium therapy. We followed leukocyte counts in 32 manic-depressive patients over a 1-year period and in 25 over a 2-year period of lithium therapy, after establishing prelithium leukocyte baselines. During the first few weeks, most patients showed significant increases, which persisted throughout the course of treatment. These findings indicate that lithium might play a role in the treatment of certain leukopenic conditions.