Administration, Topical ; Cinnamomum zeylanicum ; Episiotomy ; methods ; Female ; Gels ; administration & dosage ; Humans ; Phytotherapy ; methods ; Plant Preparations ; administration & dosage ; Pregnancy

FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.
Biostatistics ; Drug Approval ; Pharmaceutical Preparations ; Plant Preparations ; Research Design ; statistics & numerical data ; United States ; United States Food and Drug Administration ; statistics & numerical data

Using sustained release tablets of Ginkgo bibolia extract as model drug,discuss technical feasibility of using biotic index to evaluate sustained release tablets. Chosing two pharmacological indicatrix: antioxidant ability and inhibition of platelet aggregation, to investigate the influence factors on experimental result, optimize the method and experiment condition, and set up pharmacological indicatrix evaluation method. Using those methods to determinate biological effects of dissolved liquid. Drawing release curves and biological effects curves, discussing their correlation. A good correlation was observed, illustrating that pharmacological indicatrix could evaluate sustained release tablets.
Animals ; Antioxidants ; administration & dosage ; chemistry ; Delayed-Action Preparations ; Female ; Ginkgo biloba ; chemistry ; Male ; Plant Extracts ; administration & dosage ; chemistry ; Platelet Aggregation Inhibitors ; administration & dosage ; chemistry ; Rabbits ; Tablets

Recently, the use of herbal medicines has been increased all over the world due to their therapeutic effects and fewer adverse effects as compared to the modern medicines. However, many herbal drugs and herbal extracts despite of their impressive in-vitro findings demonstrates less or negligible in-vivo activity due to their poor lipid solubility or improper molecular size, resulting in poor absorption and hence poor bioavailability. Nowadays with the advancement in the technology, novel drug delivery systems open the door towards the development of enhancing bioavailability of herbal drug delivery systems. For last one decade many novel carriers such as liposomes, microspheres, nanoparticles, transferosomes, ethosomes, lipid based systems etc. have been reported for successful modified delivery of various herbal drugs. Many herbal compounds including quercetin, genistein, naringin, sinomenine, piperine, glycyrrhizin and nitrile glycoside have demonstrated capability to enhance the bioavailability. The objective of this review is to summarize various available novel drug delivery technologies which have been developed for delivery of drugs (herbal), and to achieve better therapeutic response. An attempt has also been made to compile a profile on bioavailability enhancers of herbal origin with the mechanism of action (wherever reported) and studies on improvement in drug bioavailability, exhibited particularly by natural compounds.
Biological Availability ; Drug Delivery Systems ; Herbal Medicine ; Humans ; Lipids ; chemistry ; Nanoparticles ; administration & dosage ; chemistry ; Nanotechnology ; Pharmaceutical Preparations ; administration & dosage ; Plant Extracts ; chemistry ; pharmacokinetics ; pharmacology ; Plants, Medicinal ; Solubility

BACKGROUND: Herbs have been used worldwide as complementary and alternative medicines. In Korea, herbs for medical purpose are strictly controlled by the Korea Food and Drug Administration (KFDA). But it does not provide standards for metal antigens. OBJECTIVE: This study conducted to identify the metal contents of Korean herbs and herbal products and to give information on counselling metal allergic patient. METHODS: The concentration of three metal allergens with high antigenicity, cobalt (Co), chromium (Cr), nickel (Ni) was quantitatively determined using inductively coupled plasma with a mass spectrometer after nitric acid (HNO₃) digestion. The herbal objects are as follows: 1) ten kinds of herb plants, 2) ten herbal products sold in Korean drugstores, and 3) ten herbal extracts prescribed by Korean herbal doctors. RESULTS: In 30 samples, Ni and Cr were detected in all items. Co was not detected in two drugstore products. CONCLUSION: Although the levels of metal detected in this study were very low relative to international guidelines and KFDA regulations, the herbal preparations contained similar or higher metal levels than known metal-rich foods. It can cause problems when it added to the daily diet and cause deterioration of skin lesions of metal sensitized person.
Allergens ; Chromium ; Cobalt ; Complementary Therapies ; Dermatitis ; Diet ; Digestion ; Herbal Medicine ; Humans ; Korea ; Metals ; Nickel ; Nitric Acid ; Plant Preparations ; Plasma ; Skin ; Social Control, Formal ; United States Food and Drug Administration

OBJECTIVETo study the clinical efficacy of Suogudan Granule (SGDG) in the treatment of rheumatoid arthritis (RA).

METHODSNinety patients with RA were randomly divided into the treated group and the control group. The treated group was administered orally with SGDG 6 g each time, thrice a day, while the control group with the combined therapy of Fenbid Capsules 0.3 g each time, twice a day and Tripterygium tablet 20 mg each time, thrice a day. The treatment course for both groups was 6 weeks. The changes of clinical symptoms and signs, and laboratory indices such as erythrocyte sedimentation rate (ESR), rheumatoid factor (RF), antistreptolysin O (ASO), routine examination of blood and urine, liver and kidney function, etc. before and after treatment were observed.

RESULTS(1) The total effective rate in the treated group (88.0%) was obviously higher than that in the control group (67.5%) with significant difference (P < 0.05). (2) The improvement in arthralgia, joint swelling, time of morning stiffness, 15-meter walking, analgesia initiation and persistence in the treated group was better than that in the control group (P < 0.05, P < 0.01), but there was no obvious difference in improvement of joint tenderness, range of joint motion, grip strength, and initiating detumescence time (P > 0.05). (3) The improvement in ESR and RF in the treated group was better than that in the control group with significant difference (P < 0.05). The negative-conversion rate of ASO in the treated group was also higher than that in the control group (P < 0.01). (4) No evident abnormality in blood, urine, liver or kidney function was found in either group.

CONCLUSIONSGDG is effective and safe for the treatment of RA.

Administration, Oral ; Adult ; Aged ; Antistreptolysin ; analysis ; Arthritis, Rheumatoid ; drug therapy ; Blood Sedimentation ; Drugs, Chinese Herbal ; administration & dosage ; Female ; Humans ; Male ; Middle Aged ; Phytotherapy ; Plant Preparations ; administration & dosage ; Rheumatoid Factor ; analysis ; Tripterygium

BACKGROUND/AIMS: DA-9701 is a newly developed drug made from the vegetal extracts of Pharbitidis semen and Corydalis tuber. The aim of this study was to evaluate the effect of DA-9701 on colorectal distension (CRD)-induced visceral hypersensitivity in a rat model. METHODS: Male Sprague-Dawley rats were subjected to neonatal colon irritation (CI) using CRD at 1 week after birth (CI group). At 6 weeks after birth, CRD was applied to these rats with a pressure of 20 to 90 mm Hg, and changes in the mean arterial pressure (MAP) were measured at baseline (i.e., without any drug administration) and after the administration of different doses of DA-9701. RESULTS: In the absence of DA-9701, the MAP changes after CRD were significantly higher in the CI group than in the control group at all applied pressures. In the control group, MAP changes after CRD were not significantly affected by the administration of DA-9701. In the CI group, however, the administration of DA-9701 resulted in a significant decrease in MAP changes after CRD. The administration of DA-9701 at a dose of 1.0 mg/kg produced a more significant decrease in MAP changes than the 0.3 mg/kg dose. CONCLUSIONS: The administration of DA-9701 resulted in a significant increase in pain threshold in rats with CRD-induced visceral hypersensitivity.
Analgesics/administration & dosage/*pharmacology ; Animals ; Arterial Pressure/drug effects ; Colon, Descending/physiology ; Dilatation/methods ; Gastrointestinal Agents/administration & dosage/*pharmacology ; Male ; Pain Threshold/drug effects ; Plant Preparations/administration & dosage/*pharmacology ; Rats, Sprague-Dawley ; Visceral Pain/physiopathology/*prevention & control

OBJECTIVETo evaluate the clinical effect and safety of Safflower Yellow injection (SYI) in treating coronary heart disease angina pectoris (CHD-AP) with Xin-blood stagnation syndrome (XBSS).

METHODSAdopted was the multi-centered, randomized, positive parallel controlled method, 448 patients with CHD-AP-XBSS were enrolled and divided into two groups, 336 in the tested group treated with SYI and 112 in the control group treated with Salvia injection by intravenous dripping once a day for 14 days, so as to observe the conditions of angina, electrocardiogram, and therapeutic effect on traditional Chinese medicine (TCM) symptoms as well as the safety of the treatment.

RESULTSThe significantly effective rate and total effective rate in the tested group were 60.06% (194/323) and 91.02% (294/323) respectively; Those in improvement of TCM symptoms were 40.18% (129/321) and 75.23% (243/323) respectively, which were better than those in the control group (P < 0.01).

CONCLUSIONSYI Injection is effective and safe in treating CHD-AP-XBSS.

Adolescent ; Adult ; Aged ; Angina Pectoris ; drug therapy ; Cardiovascular Agents ; administration & dosage ; Chalcone ; administration & dosage ; analogs & derivatives ; Female ; Humans ; Infusions, Intravenous ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Phytotherapy ; Plant Preparations ; Salvia ; Treatment Outcome

To develop a LC-MS/MS method for the determination of protocatechuic acid, protocatechuic aldehyde, salvianolic acid A, salvianolic acid B, cryptotanshinone and tanshinone II(A) in rat plasma and brain. The plasma and brain samples were precipitated with ethyl acetate, then were separated on an Agilent eclipse plus-C18 column (2.1 mm x 50 mm, 3.5 microm) using acetonitrile (consisting of 0.1% formic acid) and water (consisting of 0.1% formic acid) as mobile phase in gradient elution mode. The mass spectrometer was operated under both positive and negative ion mode with the ESI source, and the detection was performed by MRM. The transition of 154.3/153.1 m/z for protocatechuic acid, 137.3/108 m/z for protocatechuic aldehyde, 493.0/295.2 m/z for Salvianolic acid A, 718.0/520.0 m/z for salvianolic acid B, 321.4/152.3 m/z for chloramphenicol, 297.4/254.3 m/z for cryptotanshinone, 295.5/249.3 m/z for tanshinone II(A) and 285.2/154.0 m/z for Diazepam. The calibration curves in the range of 0.625-1 000 microg x L(-1) for protocatechuic acid and protocatechuic aldehyde, 1.25-1 000 microg x L(-1) for salvianolic acid A, 2.5-1 000 microg x L(-1) for salvianolic acid B, 0.15-1 000 microg x L(-1) for cryptotanshinone, 0.625-1 000 microg x L(-1) for tanshinone II(A) are with good linearityin rat plasma and brain. The analysis method is sensitive, simple, and suitable enough to be applied in the pharmacokinetic study of the 6 main components. Animal testing gives the lgBB of the drugs and further studies of the 6 components cross the blood-brain barrier can be carried out.
Animals ; Benzaldehydes ; administration & dosage ; blood ; pharmacokinetics ; Benzofurans ; administration & dosage ; blood ; pharmacokinetics ; Blood-Brain Barrier ; metabolism ; Brain ; metabolism ; Caffeic Acids ; administration & dosage ; blood ; pharmacokinetics ; Catechols ; administration & dosage ; blood ; pharmacokinetics ; Chromatography, Liquid ; methods ; Diterpenes, Abietane ; administration & dosage ; blood ; pharmacokinetics ; Hydroxybenzoates ; administration & dosage ; blood ; pharmacokinetics ; Injections, Intravenous ; Lactates ; administration & dosage ; blood ; pharmacokinetics ; Phenanthrenes ; administration & dosage ; blood ; pharmacokinetics ; Plant Preparations ; administration & dosage ; blood ; pharmacokinetics ; Rats ; Reproducibility of Results ; Salvia miltiorrhiza ; chemistry ; Tandem Mass Spectrometry ; methods

OBJECTIVETo explore the activities of Composite Artemisia Capillaris Tablet (CACT) against hepatitis B virus replication in vitro.

METHODSBy means of radioimmunoassay (RIA), Dot blot and Southern blot, the surface and e antigen production of 2.2.15 cells, HBV DNA in 2.2.15 cell culture medium and that in 2.2.15 cells were examined respectively.

RESULTSHBsAg, HBeAg values of 2.2.15 cells treated by CACT were lower than those of the control, the HBV DNA quantities in culture medium and in 2.2.15 cells decreased as compared with those cells with no treatment by CACT given to them.

CONCLUSIONCACT could inhibit HBV DNA replication, showing its potential antiviral activity in hepatitis B treatment.

Cell Line, Tumor ; DNA, Viral ; antagonists & inhibitors ; Hepatitis B Surface Antigens ; metabolism ; Hepatitis B e Antigens ; metabolism ; Hepatitis B virus ; genetics ; immunology ; physiology ; Humans ; Medicine, Chinese Traditional ; Plant Preparations ; administration & dosage ; pharmacology ; toxicity ; Radioimmunoassay ; Tablets ; Virus Replication ; drug effects