Anhui Anke Yuliangqing Pharmaceutical Co., Ltd. specializes in the development, manufacturing, and distribution of pharmaceuticals and medical equipment. The company offers a wide range of products such as rubber paste and cream, oral solutions, granules, hard capsules, tinctures, ointments, plasters, antipyretics, and heatstroke prevention suits.The company is headquartered in Anqing, China.

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Skin and Musculoskeletal Diseases

Herbal medicine

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Drugs associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Kangfu Tincture

Target-

Mechanism-

Active Org.

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Originator Org.

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Active Indication

Eczema [+1]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

First Approval Date25 May 2020

Clinical Trials associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

CTR20230760 / Not yet recruitingNot Applicable

氟比洛芬凝胶贴膏（40mg）在中国健康受试者空腹外用条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of flurbiprofen gel patch (40 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择持证商为 Mikasa Seiyaku Co.,Ltd的氟比洛芬凝胶贴膏（商品名：泽普思，规格：40mg）为参比制剂，对安徽安科余良卿药业有限公司生产并提供的受试制剂氟比洛芬凝胶贴膏（规格：40mg）进行空腹外用条件下人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在外用条件下的生物等效性。次要研究目的： 1、观察中国健康受试者外用受试制剂氟比洛芬凝胶贴膏（规格：40mg）和参比制剂氟比洛芬凝胶贴膏（商品名：泽普思，规格：40mg）后的安全性。 2、评估健康志愿受试者在试验期间，外用受试制剂氟比洛芬凝胶贴膏（规格：40mg）和参比制剂氟比洛芬凝胶贴膏（商品名：泽普思，规格：40mg）的附着力及外用刺激性情况。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the flurbiprofen gel patch (trade name: Zepusi, specification: 40mg) with the license holder Mikasa Seiyaku Co., Ltd was selected as the reference preparation, and the test preparation flurbiprofen gel patch (specification: 40mg) produced and provided by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd. was subjected to human bioequivalence test under fasting external use conditions, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under external use conditions. Secondary research objectives: 1. Observe the safety of Chinese healthy subjects after external use of the test preparation flurbiprofen gel patch (specification: 40mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi, specification: 40mg). 2. To evaluate the adhesion and external irritation of the test preparation flurbiprofen gel patch (specification: 40 mg) and the reference preparation flurbiprofen gel patch (trade name: Zepus, specification: 40 mg) on healthy volunteers during the trial.

Start Date-

Sponsor / Collaborator

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

CTR20223178 / Not yet recruitingNot Applicable

氟比洛芬凝胶贴膏（40mg）在中国健康受试者空腹外用条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性预实验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence pilot study of flurbiprofen gel patch (40 mg) in Chinese healthy subjects under fasting conditions

主要研究目的：按有关生物等效性试验的规定，选择持证商为 Mikasa Seiyaku Co.,Ltd 的氟比洛芬凝胶贴膏（商品名：泽普思，规格：40mg）为参比制剂，对安徽安科余良卿药业有限公司生产并提供的受试制剂氟比洛芬凝胶贴膏（规格：40mg）进行外用条件下人体生物等效性预试验，评估空腹给药后受试制剂和参比制剂的药代动力学特征，为正式试验的设计提供一定的参考依据。次要研究目的： 1、观察中国健康受试者外用受试制剂氟比洛芬凝胶贴膏（规格：40mg）和参比制剂氟比洛芬凝胶贴膏（商品名：泽普思®，规格：40mg）后的安全性。 2、评估健康志愿受试者在试验期间，外用受试制剂氟比洛芬凝胶贴膏（规格：40mg）或参比制剂氟比洛芬凝胶贴膏（商品名：泽普思®，规格：40mg）附着力及外用刺激性情况。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, the flurbiprofen gel patch (trade name: Zepusi, specification: 40mg) with the license holder Mikasa Seiyaku Co., Ltd was selected as the reference preparation, and the test preparation flurbiprofen gel patch (specification: 40mg) produced and provided by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd. was used for human bioequivalence pre-test under external conditions to evaluate the pharmacokinetic characteristics of the test preparation and the reference preparation after fasting administration, so as to provide a certain reference basis for the design of formal trials. Secondary research objectives: 1. Observe the safety of Chinese healthy subjects after external use of the test preparation flurbiprofen gel patch (specification: 40mg) and the reference preparation flurbiprofen gel patch (trade name: Zepusi®, specification: 40mg). 2. To evaluate the adhesion and external irritation of the test preparation flurbiprofen gel patch (specification: 40 mg) or the reference preparation flurbiprofen gel patch (trade name: Zepus®, specification: 40 mg) in healthy volunteers during the trial.

Start Date-

Sponsor / Collaborator

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

CTR20201539 / Not yet recruitingPhase 1

氟比洛芬凝胶贴膏在中国健康受试者外用条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of flurbiprofen gel patch in Chinese healthy volunteers

预试验：主要研究目的：选择日本三笠制药株式会社的氟比洛芬凝胶贴膏（规格：40mg）为参比制剂，对安徽安科余良卿药业有限公司生产的氟比洛芬凝胶贴膏（规格：40mg）（受试制剂）进行空腹外用人体生物等效性试验，估算空腹外用后氟比洛芬在体内的药代动力学特征，为正式试验的设计提供一定的参考依据。次要研究目的： 1、观察健康志愿受试者，外用受试制剂或参比制剂氟比洛芬凝胶贴膏后的安全性。 2、评估健康志愿受试者在试验期间，外用受试制剂或参比制剂氟比洛芬凝胶贴膏附着力及外用刺激性情况。正式试验：主要研究目的：选择日本三笠制药株式会社的氟比洛芬凝胶贴膏（规格：40mg）为参比制剂，对安徽安科余良卿药业有限公司生产的氟比洛芬凝胶贴膏（规格：40mg）（受试制剂）进行空腹外用人体生物等效性试验，比较受试制剂中药物的吸收速度、吸收程度与参比制剂的差异是否在可接受的范围内，比较两种制剂在空腹外用条件下的生物等效性。次要研究目的： 1、观察健康志愿受试者，外用受试制剂和参比制剂氟比洛芬凝胶贴膏后的安全性。 2、评估健康志愿受试者在试验期间，外用受试制剂或参比制剂氟比洛芬凝胶贴膏附着力及外用刺激性情况。

[Translation]

Preliminary study: Main research purpose: Select the flurbiprofen gel patch (specification: 40mg) of Mikasa Pharmaceutical Co., Ltd. of Japan as the reference preparation, and conduct a human bioequivalence test on the flurbiprofen gel patch (specification: 40mg) (test preparation) produced by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd. on an empty stomach, estimate the pharmacokinetic characteristics of flurbiprofen in vivo after empty stomach topical application, and provide a certain reference basis for the design of formal trials. Secondary research objectives: 1. Observe the safety of healthy volunteers after topical application of the test preparation or reference preparation flurbiprofen gel patch. 2. Evaluate the adhesion and external irritation of the test preparation or reference preparation flurbiprofen gel patch for healthy volunteers during the trial. Formal test: Main research purpose: Select the flurbiprofen gel patch (specification: 40mg) of Mikasa Pharmaceutical Co., Ltd. of Japan as the reference preparation, and conduct a human bioequivalence test on the flurbiprofen gel patch (specification: 40mg) (test preparation) produced by Anhui Anke Yu Liangqing Pharmaceutical Co., Ltd., to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and compare the bioequivalence of the two preparations under fasting topical conditions. Secondary research purpose: 1. Observe the safety of healthy volunteers after topical application of the test preparation and the reference preparation flurbiprofen gel patch. 2. Evaluate the adhesion and external irritation of the test preparation or the reference preparation flurbiprofen gel patch for healthy volunteers during the trial.

Start Date-

Sponsor / Collaborator

Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

100 Clinical Results associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

Xiandai Zhongyao Yanjiu Yu Shijian

Quality standard research of Kangfu tincture

Author: Ma, Na ; Pan, Ze-hua ; Xie, Hong-xing ; Han, Jin

The quality standard of Kangfu tincture was established.Radix Stemona, Herba Polygonum were identified by TLC and Mendholum was determined by GC.TLC spots developed were fairly clear, and the blank test was no interference.It showed that there was a good linear relationship in the concentration range of 0.1161 mg/mL-0.58056 mg/mL and of mentholum the average recovery was up to 98.18%, RSD was 1.87%.The methods can control the quality of Kangfu tincture effectively.

Anhui Yiyao

Determination of dimethyl sulphate in synthetic paeonol samples by high performance liquid chromatography coupled with pre-column derivatization

Author: Fang, Jin-hong

A high performance liquid chromatog. coupled with pre-column derivatization method was developed for determining di-Me sulfate (DMS) in synthetic paeonol samples.The synthetic paeonol samples reacted with p-nitrophenol under alk. and heating conditions and synthesized p-nitroanisole, which was determined by HPLC-UV detector, with C₁₈ (250 mm×4.6 mm, 5 μm) as column.The conversion rate of this derivatization was stable and durable.The solvent blank and paeonol samples did not interfere with the determination of DMS.The linear range appeared from 0.122 to 1.120 mg·L^-1.The detection limit was 0.82 ng.The precision measured by relative standard deviation (RSD) of peak area for the standard solution was 1.69% (n=6) for intra-day detection and 1.89% (n=12) for inter-day detection, resp.The average recovery was 98.8% (RSD=1.40%, n=9).The method is applicable, specific, and accurate for the determination of DMS in synthetic paeonol samples.

Xiandai Zhongyao Yanjiu Yu Shijian

Determination of camphor in Dongchuang ointment by GC

Author: Pan, Ze-hua ; Xie, Hong-xing

The objective of this paper is to determine the contents of the camphor in Dongchuang ointment by gas chromatog.Camphor was determined by gas chromatog.The results showed that camphor had a good linear relationship in the concentration range of 0.505 5-5.055 mg/mL^-1 and the average recovery was up to 98.72% with RSD of 0.65%.It was concluded that this method could be effective for the quality control of Dongchuang ointment.

100 Deals associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Anhui Anke Yuliangqing Pharmaceutical Co., Ltd.

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