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Chen L.,Jiangxi University of Traditional Chinese Medicine | Chen L.,CAS Shanghai Institute of Materia Medica | Wang L.-Y.,Hainan Weikang Pharmaceutical Qianshan Co. | Yin X.-Z.,CAS Shanghai Institute of Materia Medica | And 9 more authors.
Yaoxue Xuebao | Year: 2013

The crystal form of solid substance had intrinsic correlation with its three dimensional crystal morphology. Based on the characterization of the three dimensional crystal morphology of clopidogrel bisulfate, this research is to establish a model based on the three dimensional morphological parameters. The granular samples composed of polymorphs of clopidogrel bisulfate and microcrystalline cellulose (MCC) were scanned by synchrotron radiation X-ray microscopic CT technology (SR-uCT) and the three dimensional structural models for which were constructed. Seven groups of three dimensional morphological parameters were calculated. Finally, the mathematical model was established with the multi-layer perception (MLP) artificial neutral network methods to identify and predict the polymorphs of clopidogrel bisulfate. The success rate of the model prediction for the polymorphs of clopidogrel bisulfate was 92.7% and the area under the ROC curve was 96.2%. The polymorphs of drugs could be identified and predicted through the numerical description of the three dimensional morphology. The volume, number of the vertices and the surface area were the major determinants for the identification of the polymorphs of clopidogrel bisulfate.


PubMed | Jiangxi University of Traditional Chinese Medicine, CAS Shanghai Institute of Materia Medica and Hainan Weikang Pharmaceutical Qianshan Co.
Type: Journal Article | Journal: Yao xue xue bao = Acta pharmaceutica Sinica | Year: 2013

The crystal form of solid substance had intrinsic correlation with its three dimensional crystal morphology. Based on the characterization of the three dimensional crystal morphology of clopidogrel bisulfate, this research is to establish a model based on the three dimensional morphological parameters. The granular samples composed of polymorphs of clopidogrel bisulfate and microcrystalline cellulose (MCC) were scanned by synchrotron radiation X-ray microscopic CT technology (SR-microCT) and the three dimensional structural models for which were constructed. Seven groups of three dimensional morphological parameters were calculated. Finally, the mathematical model was established with the multi-layer perception (MLP) artificial neutral network methods to identify and predict the polymorphs of clopidogrel bisulfate. The success rate of the model prediction for the polymorphs of clopidogrel bisulfate was 92.7% and the area under the ROC curve was 96.2%. The polymorphs of drugs could be identified and predicted through the numerical description of the three dimensional morphology. The volume, number of the vertices and the surface area were the major determinants for the identification of the polymorphs of clopidogrel bisulfate.


PubMed | Hainan Weikang Pharmaceutical Qianshan Co., CAS Shanghai Institute of Materia Medica and Anhui University
Type: Journal Article | Journal: Acta pharmaceutica Sinica. B | Year: 2015

The secretion of melatonin (MT) is obviously different in the younger and the senior sectors of the population, and the maximum plasma concentration of seniors is only half of that in the younger population group. If exogenous MT can be supplied to senior citizens based on the secretion rate and amount of endogenous MT in the younger population by a bio-mimetic drug delivery system (DDS), an improved therapeutic effect and reduced side effects can be expected. Based upon this hypothesis, the pharmacokinetic parameters of MT, namely, the absorption rate constant (k a), the elimination rate constant (k e), and the ratio of absorption rate (F) to the apparent volume of distribution (V) were obtained by a residual method depending on the plasma concentration curve of immediate release preparations in the healthy younger population. The dose-division method was applied to calculate the cumulative release profiles of MT achieved by oral administration of a controlled release drug delivery system (DDS) to generate plasma MT profiles similar to the physiological level-time profiles. The in vivo release of MT deduced from the healthy younger population physiological MT profiles as the pharmacokinetic output of the bio-mimetic DDS showed a two-phase profile with two different zero order release rates, namely, 4.919g/h during 0-4h (r=0.9992), and 11.097g/h during 4-12h (r=0.9886), respectively. Since the osmotic pump type of DDS generally exhibits a good correlation between in vivo and in vitro release behaviors, an osmotic pump controlled delivery system was designed in combination with dry coating technology targeting on the cumulative release characteristics to mimic the physiological MT profiles in the healthy younger population. The high similarity between the experimental drug release profiles and the theoretical profiles (similarity factor f 2>50) and the high correlation between the predicted plasma concentration profiles and the theoretical plasma concentration profiles (r=0.9366, 0.9163, 0.9264) indicated that a prototype bio-mimetic drug delivery system of MT was established. The similarity factors between the experimental drug release profiles and the theoretical release profile were all larger than 50 both in periods of 0-4h and 4-12h, namely, 68.8 and 57.3 for the first batch (Batch No. 20131031), 76.7 and 50.2 for the second batch (Batch No. 20131101), and 73.7 and 51.1 for the third batch (Batch No. 20131126), respectively. The correlation coefficients between the predicted plasma concentration profiles based on the release profiles of the bio-mimetic DDS and physiological profiles were 0.9366 (Batch No. 20131031), 0.9163 (Batch No. 20131101), 0.9264 (Batch No. 20131126), respectively. Since the pharmacokinetic profile of MT in any kind of animal differs markedly from that of human beings, it is impossible to test the bio-mimetic DDS in animals directly. Therefore, the predicted pharmacokinetic profile based upon the in vitro release kinetics is an acceptable surrogate for the conventional animal test. In this research, a bio-mimetic DDS for replacement of MT was designed with in silico evaluation.


Zheng C.-N.,Quanzhou Medical College | Zheng C.-N.,Iluaqiao University | Duan X.-W.,Quanzhou Normal University | Jia D.-F.,Quanzhou Medical College | And 4 more authors.
Yaoxue Xuebao | Year: 2016

This study was designed to evaluate the anti-inflammatory effect of recombinant human kallistatin (Kal) on ulcerative colitis (UC) in the mouse model. Acute colitis was induced by administration of 4% dextran sodium suffate (DSS) to KM mice for 7 days. The mice were then randomized into 5 groups: model control, Kal 0.2 mg.kg-l.d-l, 1.0 mg-kg-l'd-l and 2.0 mg.kg-l.d-l group, salazosulfapyridine (SASP) group. Ten age-matched normal KM mouse were administered with saline in the normal control. The weight, colon length, inflammation factor (MPO/SOD/MDA) and TNF-o/IL-10 levels among the five groups of mice were determined. The results showed that histological index score and MPO/MDA/TNF-A levels of high-dose Kal treatment group and SASP group were significantly lower compared with the model group (P<0.0l), but the weight, colon length, IL-10 level and SOD activity were significant higher than the model group (P<0.01), approaching the normal group. These parameters showed that Kal can significantly relieve the UC state in a dose-dependent manner. This study demonstrates that Kal significantly remits UC in mice, and participates in the regulation of inflammatory cytokines TNF-A/IL-10 levels and has some antioxidant activity.


Ahmed A.,Institute of Materials Engineering | Ahmed A.,Nanjing University | Yu H.,Institute of Materials Engineering | Han D.,Hainan WeiKang Pharmaceutical Qianshan Co. | And 3 more authors.
Macromolecular Bioscience | Year: 2014

Surface engineered nanoparticles (NPs) are fabricated from polycaprolactone-polyethylenimine-folic acid (PCL-PEI-FA) and polycaprolactone-S-S-polyethylene glycol (PCL-S-S-PEG) copolymers. FESEM reveals the core-shell structure of these NPs of about 230 nm size. It is assumed that the inner cores of these NPs are composed of PCL, while the outer shells are adorned with PEG and folic acid, introducing a stealthy nature and specific targeting capability. Moreover, the disulfide bonds in the PCL-S-S-PEG copolymers provide a reduction-induced degradation characteristic in these NPs. Cell line experiments demonstrate the enhanced endocytosis and cytotoxicity of these NPs. Thus PCL-PEI-FA/PCL-S-S-PEG NPs could be a better candidate for the tumor specific delivery of hydrophobic drugs. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.


Patent
Hainan Weikang Pharmaceutical Qianshan Co. | Date: 2012-09-28

A compound ambroxol hydrochloride composition and a preparation method therefor, which relate to the field of medicine. 0.1%-99.9% by mass of ambroxol hydrochloride and 99.9%-0.1% by mass of scopolamine serving as main ingredients and mannitol are added into water for injection; stir to dissolve, then adjusting to pH 5.0 by adding an NaOH solution; add 0.1% of activated carbon with stirring for 30 minutes; filter out the activated carbon, and then filtering the liquid with 0.45 m and 0.22 m microporous filter membranes; fill the filtered liquid into a large plate or a vial; send into a lyophilizer, cool to 40 C., and hold the temperature for 2 hours; warm to 5 C. to 0 C. slowly to lyophilize the liquid, heat to 35 C., and hold the temperature for 3 hours; take out of the lyophilizer after lyophilizing to obtain a lyophilized powder injection containing ambroxol hydrochloride and scopolamine; crush the lyophilized powder injection under a sterile conditions, and sieve with a 180-mesh sieve to obtain sterile lyophilized powder containing ambroxol hydrochloride and scopolamine; and prepare various dosage forms by using the lyophilized powder as a raw material.


Patent
Hainan Weikang Pharmaceutical Qianshan Co. | Date: 2011-09-06

A puncture free bottle cork has a body and a cap for covering a bottle opening. The body has at least one channel defined therein for receiving a syringe or an infusion bottle connector. The body is composed of an exterior body and a flange integrally formed with and extending downward from the exterior body for direct insertion of the bottle opening. The number of the at least one channel corresponds to number of the syringe or the infusion bottle connector such that when the number of the at least one channel is one, injection and drawing of medication to/from the bottle is using the single one channel and when the number of the at least one channel is plural, injection and drawing of medication to/from the bottle is using different channels.


Patent
Hainan Wei Kang Pharmaceutical Qianshan Company Ltd | Date: 2014-08-27

The invention relates to a pharmaceutical composition of glutathione and acetaminophen and preparation method thereof. The active ingredients of the composition include glutathione with composition ration of 0.1% 99.9% and acetaminophen with composition ratio of 99.9% 0.1%. The further purpose of the invention is to prepare glutathione and acetaminophen composition (raw materials) into various pharmaceutically acceptable dosage forms, such as tablets, sustained/controlled release preparations, capsules, pills, syrups, films, granules, oral solutions, oral suspensions, oral emulsions and oral powders. The beneficial effects of the invention is reflected in that glutathione and acetaminophen combination can effectively prevent the liver cell damage and necrosis caused by acetaminophen overdose and is strongly in favor of cancer pain relieving and chemotherapy.


Patent
Hainan Wei Kang Pharmaceutical Qianshan Company Ltd | Date: 2015-04-08

Disclosed are a compound ambroxol hydrochloride composition and a preparation method therefor, which relate to the field of medicine. 0.1%-99.9% by mass of ambroxol hydrochloride and 99.9%-0.1% by mass of scopolamine serving as main ingredients and mannitol are added into water for injection; stir to dissolve, then adjusting to pH 5.0 by adding an NaOH solution; add 0.1% of activated carbon with stirring for 30 minutes; filter out the activated carbon, and then filtering the liquid with 0.45 m and 0.22 m microporous filter membranes; fill the filtered liquid into a large plate or a vial; send into a lyophilizer, cool to -40C, and hold the temperature for 2 hours; warm to -5C to 0C slowly to lyophilize the liquid, heat to 35C, and hold the temperature for 3 hours; take out of the lyophilizer after lyophilizing to obtain a lyophilized powder injection containing ambroxol hydrochloride and scopolamine; crush the lyophilized powder injection under a sterile conditions, and sieve with a 180-mesh sieve to obtain sterile lyophilized powder containing ambroxol hydrochloride and scopolamine; and prepare various dosage forms by using the lyophilized powder as a raw material. The preparation method provided by the present invention is scientific and reasonable, and is convenient for preparing various dosage forms.


Patent
HAINAN WEI KANG PHARMACEUTICAL QIANSHAN COMPANY Ltd | Date: 2014-06-11

The invention provides pantoprazole sodium composition lyophilized powder for injection, and relates to the technical field of medicines and manufacturing of the medicines. The pantoprazole sodium composition lyophilized powder for injection comprises the following raw material ingredients in parts by weight: 7.24-9.08 parts of pantoprazole sodium, 4.34-5.45 parts of chitosan nanoparticles and 85.25-89.11 parts of water for injection. The invention has the following advantages: 1) a composition comprising pantoprazole sodium and chitosan nanoparticles according to a ratio of 1:0.6 has a stronger effect of inhibiting an H+-K+ATPase; 2) the using amount of pantoprazole sodium can be clinically reduced, the adverse reactions of pantoprazole sodium are reduced, and 20 mg of pantoprazole sodium containing the chitosan nanoparticles has the same effect of inhibiting secretion of gastric acid as 30 mg of pantoprazole sodium without the chitosan nanoparticles; 3) the water solubility of the medicament is improved, and the good stability of the medicament is simultaneously ensured; 4) the medicament-carrying nanoparticles can change a membrane operation mechanism, increase the permeability of the medicament across a biological membrane and be conductive to realize an efficacy of the medicament in cells; and 5) the chitosan nanoparticles can replace mannitol to serve as a lyophilized skeleton agent of the lyophilized powder, thereby eliminating an active effect of mannitol on a human body.

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