[Translation] A randomized, blinded, active drug/placebo parallel-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Baofukang suppository in the treatment of bacterial vaginosis

评价保妇康栓治疗细菌性阴道病（BV）的有效性和安全性

[Translation]

To evaluate the effectiveness and safety of Baofukang suppository in the treatment of bacterial vaginosis (BV)

Start Date10 Apr 2024

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

CTR20210287 / RecruitingPhase 2

保妇康栓治疗宫颈高危型人乳头瘤病毒 16/18（HR-HPV16/18）感染合并低级别鳞状上皮内病变（CINI/P16 阴性的 CINII）有效性和安全性的随机、双盲、安慰剂平行对照、多中心 II 期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial to evaluate the efficacy and safety of Baofukang suppositories in the treatment of cervical high-risk human papillomavirus 16/18 (HR-HPV16/18) infection combined with low-grade squamous intraepithelial lesions (CINI/P16 negative CINII)

（1）探索保妇康栓治疗宫颈 HR-HPV16/18 感染合并 LSIL（CINI/P16 阴性的 CINII）的最佳给药方案。（2）初步评价保妇康栓治疗 HR-HPV16/18 感染合并 LSIL（CINI/P16 阴性的 CINII）的有效性和安全性。（3）初步评价保妇康栓治疗宫颈 HR-HPV16/18 感染的有效性和安全性。

[Translation]

(1) To explore the optimal dosing regimen of Baofukang suppository for the treatment of cervical HR-HPV16/18 infection combined with LSIL (CINI/P16 negative CINII). (2) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of HR-HPV16/18 infection combined with LSIL (CINI/P16 negative CINII). (3) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of cervical HR-HPV16/18 infection.

Start Date12 Mar 2021

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

CTR20210286 / RecruitingPhase 2

保妇康栓治疗宫颈高级别鳞状上皮内病变（P16阳性的CINII）有效性和安全性的随机、双盲、安慰剂平行对照、多中心II期临床试验

[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial on the efficacy and safety of Baofukang suppositories in the treatment of high-grade cervical squamous intraepithelial lesions (P16-positive CINII)

（1）探索保妇康栓治疗HSIL（P16阳性的CINII）的最佳给药方案。（2）初步评价保妇康栓治疗HSIL（P16阳性的CINII）的有效性和安全性。（3）初步评价保妇康栓治疗宫颈HR-HPV感染的有效性和安全性。

[Translation]

(1) To explore the optimal dosing regimen of Baofukang suppository for the treatment of HSIL (P16-positive CINII). (2) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of HSIL (P16-positive CINII). (3) To preliminarily evaluate the efficacy and safety of Baofukang suppository for the treatment of cervical HR-HPV infection.

Start Date09 Mar 2021

Sponsor / Collaborator

Hainan Bikai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Hainan Bikai Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Hainan Bikai Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Hainan Bikai Pharmaceutical Co. Ltd.

18 Oct 2019·Natural Product ResearchQ3 · CHEMISTRY

Three new labdane-type diterpenoids from Callicarpa macrophylla Vahl.

Q3 · CHEMISTRY

Article

Author: Yang, Lan-Ping ; Zhang, Qing-Ling ; Meng, Yue-Li ; Zhang, Yan-Ru ; Zhai, Yang-Yang ; Huang, Mei ; Xu, Huan-Jun ; Zhang, Wen-Kui ; Niu, Chao ; Wang, Zhen-Hui ; Li, Qiang ; Chen, Xing-Ying

Three new labdane-type diterpenoids, callicapene M3-M5 (1-3) were isolated from the Callicarpa macrophylla Vahl. Their structures were identified by spectroscopic method. The isolated compounds were evaluated for inhibitory activity on NO production in LPS-activated RAW 264.7 macrophage cells by using MTT assays. Compounds 1-3 showed potent inhibitory activity, with IC₅₀ value of 48.15, 46.31 and 38.72 μM respectively.

Zhongnan Yaoxue

Tissue distribution and excretion of docetaxel submicron emulsion

Author: Shi, Chaohui ; Tan, Yinfeng ; Liu, Qiang ; Kuang, Shaoyi ; Fu, Naiguang ; Tang, Jing ; Zhang, Li

The tissue distribution and excretion of docetaxel submicron emulsion in rats were investigated.A high-performance liquid chromatog. (HPLC) with UV detection was developed to study the concentration of docetaxel in the biol. samples.Taking paclitaxel as an internal standard, 48 SD rats were randomly divided into 2 groups: test preparation and reference preparation, and each group was i.v. administered 75 mg·m^-2 DTX.The rats were executed at 5, 30, 60 and 300 min, and tissues were taken in the same location to determine the content.The docetaxel submicron emulsion was widely distributed in the tissues of the body.The docetaxel concentration of the test group in the heart and lung was lower than that of the reference group, but higher than the reference group in the spleen.In the kidney, the docetaxel concentration of the test group increased quickly before 30 min and was higher than the reference group, and after that the concentration decreased even lower than the reference injection.The docetaxel concentrations of the 2 groups in other tissues and organs had no significant difference.The excretion of the parent drug in the urine and excrement amounted to 2% and 6% of the dose, resp.Submicron emulsion had no significant effect on docetaxel distribution, and the preparation was delivered effectively.In safety and pharmacodynamic evaluation, more attention should be paid to the alteration of toxicity and therapeutic effect after changing dosage forms.

Zhongguo Yiyao Daobao

Research on technological innovation mechanism of Chinese pharmaceutical enterprises based on Malerba innovation theory

Author: Xu Yang ; Xu Lang

This paper starts from the characteristics of innovation mechanism and innovation method, combines the current situation of China's pharmaceutical industry, takes the Malerba industrial innovation system theory as the theor. support, and constructs the technol. innovation mechanism suitable for the current situation of China's pharmaceutical industry, analyzes the innovation restriction mechanism structure of pharmaceutical enterprises from the aspects of the market structure and enterprise scale of the pharmaceutical industry, technol. capital investment capacity, and innovative human capital investment capacity.From the strategic layout of pharmaceutical enterprises, the distribution of independent research and development forces, the operating mechanism that affects industry policies, the choice of pharmaceutical enterprises' technol. innovation mode, the patent system and the innovation and decision-making capabilities of pharmaceutical enterprises, the innovation operation mechanism structure of pharmaceutical enterprises are analyzed.Therefore, this article proposes measures to build a composite technol. innovation entity, broaden the ideas for improving technol. innovation capabilities, strengthen basic innovation research, highlight the ability of intellectual property to escort technol. innovation, and accelerate the incubation of technol. innovation achievements through multiple investment channels which are the key to the innovation mechanism of Chinese pharmaceutical enterprises.

100 Deals associated with Hainan Bikai Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Hainan Bikai Pharmaceutical Co. Ltd.

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