[Translation] A multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of inhaled bromhexine hydrochloride solution in improving sputum symptoms in adults with lower respiratory tract infections

主要目的：评价吸入用盐酸溴己新溶液改善下呼吸道感染疾病黏痰症状的有效性；次要目的：评价吸入用盐酸溴己新溶液改善下呼吸道感染疾病黏痰症状的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of inhaled bromhexine hydrochloride solution in improving the symptoms of sticky sputum in lower respiratory tract infections; Secondary objective: To evaluate the safety of inhaled bromhexine hydrochloride solution in improving the symptoms of sticky sputum in lower respiratory tract infections.

Start Date03 Dec 2024

Sponsor / Collaborator

Jiangsu Chiatai Qingjiang Pharmaceutical Co., Ltd.

CTR20241734

/ CompletedNot Applicable

盐酸溴己新片生物等效性试验

[Translation] Bioequivalence test of bromhexine hydrochloride tablets

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服盐酸溴己新片受试制剂（规格：8mg，申办者：白云山东泰商丘药业有限公司）和参比制剂（商品名：Bisolvon®，规格：8mg，持证商：Boehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH）后的药代动力学特点和生物等效性。次要研究目的研究盐酸溴己新片受试制剂（规格：8mg）和参比制剂（商品名：Bisolvon®，规格：8mg）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of bromhexine hydrochloride tablets (specification: 8 mg, applicant: Baiyunshan Dongtai Shangqiu Pharmaceutical Co., Ltd.) and the reference formulation (trade name: Bisolvon®, specification: 8 mg, licensee: Boehringer Ingelheim Pharma GmbH & Co. KG/Sanofi-Aventis Deutschland GmbH) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects. Secondary study objectives To study the safety of the test formulation of bromhexine hydrochloride tablets (specification: 8 mg) and the reference formulation (trade name: Bisolvon®, specification: 8 mg) in healthy Chinese adult subjects.

Start Date13 Jun 2024

Sponsor / Collaborator

Baiyun Mountain Dongtai Shangqiu Pharmaceutical Co. Ltd.

CTR20241528

/ Active, not recruitingNot Applicable

盐酸溴己新片在健康研究参与者中的单剂量、随机、开放、交叉、两周期空腹和餐后人体生物等效性试验

[Translation] A single-dose, randomized, open-label, crossover, two-period fasting and fed human bioequivalence study of bromhexine hydrochloride tablets in healthy study participants

主要目的：以山西立业制药有限公司的盐酸溴己新片（规格：8mg/片）为受试制剂，以Sanofi-Aventis Deutschland GmbH（赛诺菲安万特德国有限公司）的盐酸溴己新片（规格：8mg/片）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康研究参与者中的安全性。

[Translation]

Main purpose: Using bromhexine hydrochloride tablets (specification: 8 mg/tablet) of Shanxi Liye Pharmaceutical Co., Ltd. as the test preparation and bromhexine hydrochloride tablets (specification: 8 mg/tablet) of Sanofi-Aventis Deutschland GmbH as the reference preparation, according to the relevant provisions of bioequivalence test, the bioequivalence of the two preparations in healthy humans was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy study participants.

Start Date06 May 2024

Sponsor / Collaborator

Liye Pharmaceutical Co. Ltd.

100 Clinical Results associated with Bromhexine Hydrochloride

100 Translational Medicine associated with Bromhexine Hydrochloride

100 Patents (Medical) associated with Bromhexine Hydrochloride

790

Literatures (Medical) associated with Bromhexine Hydrochloride

01 Jun 2025·JOURNAL OF FOOD COMPOSITION AND ANALYSIS

Development and validation of a UHPLC-MS/MS method for the simultaneous determination of coccidiostats, NSAIDs, sedatives, and antiparasitics in hen eggs

Author: Coscolla, Clara ; Igualada, Carmen ; Miralles, Pablo ; Moragues, Francisco

Due to Regulation (EU) 2022/1644, it is required for the first time to monitor veterinary drug residues of coccidiostats and antiparasitics (groups A3d, B2), non-steroidal anti-inflammatory drugs (NSAIDs), sedatives (groups A2d, A3f), and other substances (group B1e) in eggs.This work contains the first method addressing the simultaneous determination of 22 pharmacol. active substances of those families in hen eggs, following the requirements of Regulation (EU) 2021/808, recently amended by Regulation (EU) 2024/2052.Sample preparation was based on a liquid extraction (with acetonitrile and Na₂SO₄) followed by solid phase extraction, as a cleanup step, and anal. by UHPLC-MS/MS.After method development, the anal. figures of merit were evaluated, observing satisfactory relative matrix effects (≤ 20 %), linearity (R² ≥ 0.98), accuracy (85-113 %), trueness (-15 to +13 %), repeatability (2.5-18.2 %), reproducibility (3.5-23.1 %), specificity (blank signals <30 % of limit of quantification), and ruggedness (78-130 %).The method limits of quantification values ranged from 0.5 to 30 μg kg^-1, with decision limit for confirmation (CCα) values from 0.57 to 335.26 μg kg^-1.

08 Apr 2025·ACTA CHROMATOGRAPHICA

Determination of four dry cough medications in fixed dose form by developed stability indicating liquid chromatography-photodiode array detection

Author: Chandrashekar, C. ; Jagadeesh, K. ; Suresh Varma Dendukuri, B. N. ; Guttula, Rama Swamy ; Leela Kumari, B. ; Saroja, J.

Abstract:

This study deals with the development of HPLC assay method for the determination of guaifenesin (GUF), bromhexine (BRH), chlorpheniramine (CHP), and dextromethorphan (DEE) in bulk and Leekuf tablets. Column C18 Aligent eclipse was used to analyse GUF, BRH, CHP and DEE. The H3PO4 (0.01%) and methanol combined in 70:50 (vol/vol) parts was used as mobile phase. The HPLC assay method was validated in accordance with the ICH prerequisite and was capable of providing accurate (99.90% recovery for BRH, 99.40% recovery for CHP, 100.00% recovery for GUF and 99.50% for DEE) and precise (0.160–0.805% RSD range for GUF, BRH, CHP and DEE) quantitative results under slight variations in chromatographic circumstances in the range of quantities 25–150 μg mL−1 (GUF), 2–12 μg mL−1 (BRH), 0.5–3 μg mL−1 (CHP) and 2.5–15 μg mL−1 (DEE). These results concluded that HPLC assay method developed was beneficial for the evaluation of GUF, BRH, CHP and DEE simultaneously in commercial tablet dose. The degradants eluted are well resolved from the GUF, BRH, CHP, and DEE peaks, showing that the process is stability indicating.

01 Feb 2025·SCIENCE OF THE TOTAL ENVIRONMENT

Suspect screening and quantitative analysis of 165 contaminants of emerging concern in water, sediments, and biota using LC-MS/MS: Ecotoxicological and human health risk assessment

Article

Author: Verruck, Silvani ; Lemos Dal Pizzol, Juliana ; Rocha, Gustavo ; Rocha Ribas, Mateus ; Amaral Alexandre, Luan ; Perin, Maurício ; Alves de Oliveira, Luan Valdemiro ; Kasuko Palmeiro, Jussara ; Hoff, Rodrigo ; da Silva, Alice Cristina

This study aimed to implement a targeted multiple reaction monitoring (MRM) screening strategy using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) for the initial detection of 165 compounds of emerging concern (CECs) in water, sediment, and fish samples. Following the screening, confirmatory and quantitative analyses were conducted using analytical standards for the detected compounds. Qualitative results were confirmed using high-resolution mass spectrometry (HRMS) for those CECs without available standards. Ecotoxicological and human health risk assessments were performed for the quantified CECs. The analysis identified 35 suspect CECs (12 quantified with analytical standards), including parent compounds and metabolites of anti-inflammatories, antibiotics, antidepressants, sedatives, stimulants, and illicit drugs. High concentrations of these CECs were particularly evident near a Wastewater Treatment Plant (WWTP), where notable levels of compounds such as caffeine (4.02-15.03 ng L^-1), ciprofloxacin (6.05 ng L^-1), clindamycin (6.04-7.01 ng L^-1), and diclofenac (1.36-2.20 ng L^-1) were detected. Sediment samples exhibited the highest incidence of CECs, with caffeine reaching the highest concentration (55.89 μg kg^-1). Ciprofloxacin (2.94 to 4.18 μg kg^-1) was the sole CEC detected in biota samples. The ecotoxicological risk assessment indicated that the concentrations of all detected compounds posed significant ecotoxicity risks to the aquatic environment. In particular, caffeine and diclofenac presented considerable acute and chronic toxic risks to aquatic organisms, including algae, crustaceans, and fish. The Hazard Index (HI) values (3.65^-7 to 8.06^-8) suggest that ingesting ciprofloxacin at the concentrations found in fish does not represent a significant risk to human health. However, due to the reported risks to estuarine biota, it is crucial to continuously monitor the accumulation of these compounds in food widely consumed by the local population to assess potential impacts on human health.

News (Medical) associated with Bromhexine Hydrochloride

06 Nov 2024

·pharma.economictimes.indiatimes.com

Paracetamol to PAN-D: CDSCO finds over 50 sub-standard drugs. Check full list of medicines

New Delhi: The Central Drugs Standard Control Organisation ( CDSCO ) has identified over 50 drugs which have failed in the drug test. In its latest report, the controller said 50 drugs including Paracetamol are "not of standard quality" (NSQ). The report has also flagged calcium and vitamin D3 supplements, anti-diabetes pills, and high blood pressure medicines. Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd were specifically mentioned for quality concerns. The report listed a total of 48 drugs in the NSQ category, including a Gauze Roll Non Sterile Roller Bandage. NSQ alerts come from monthly random sampling conducted by state drug officers. Some of the medicines were produced by companies like Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd, Meg Lifesciences, and Pure & Cure Healthcare. Additionally, the CDSCO shared another list that features five more drugs that failed quality tests. The pharmaceutical companies denied responsibility for these drugs. They claim they are "spurious," and one response from a company stated, "The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subjected to outcome of investigation." CDSCO NSQ Test: Full list of drugs and their manufacturers Here is the list of drugs that failed the CDSCO test along with the manufacturers: Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) - M/s. Alkem Health Science Amoxicillin & Potassium Clavulanate Tablets (Mexclav 625) - M/s. Meg Lifesciences Calcium And Vitamin D3 Tablets IP (Shelcal 500) - M/s. Pure & Cure Healthcare Pvt. Ltd. Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) - M/s. Scott-Edil Pharmacia Ltd. Vitamin B Complex with Vitamin C Softgels - M/s. Asoj Soft Caps Pvt. Ltd. Rifmin 550 (Rifaximin Tablets 550 mg) - M/s. Legen Healthcare Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan - D) - M/s. Alkem Health Science Paracetamol Tablets IP 500 mg - M/s. Karnataka Antibiotics and Pharmaceuticals Ltd. Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) - M/s. Pure & Cure Healthcare Pvt. Ltd. Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) (RL 500 ml) - M/s. Vision Parenteral Pvt. Ltd. Fexofenadine Hydrochloride Tablets IP 120 mg - M/s. Maxtar Bio-Genics Laxnorm Solution (Lactulose Solution USP) - M/s. Athens Life Sciences Heparin Sodium Injection 5000 Units (Hostranil Injection) - M/s. Health Biotech Ltd. Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) - M/s. Ornate Pharma Pvt. Ltd. Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) - M/s. Hetero Labs Limited Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) - M/s. HSN International Rolled Gauze (Non-Sterilized) - M/s. Blazon India Ciprofloxacin Tablets IP 500 mg (Ocif-500) - M/s. Ornate Labs Pvt. Ltd. Nimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim-Cold) - M/s. Unispeed Pharmaceuticals Pvt. Ltd. Adrenaline Injection IP Sterile 1 ml - M/s. Alves Healthcare Pvt. Ltd. Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) RL 500ml - M/s. Vision Parentral Pvt. Ltd. Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate, and Menthol Gel) - M/s. Universal Twin Labs Atropine Sulphate Injection IP 2 ml - M/s. Nandani Medical Laboratories Pvt. Ltd. Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G) - M/s. Daxin Pharmaceuticals Pvt. Ltd. Heparin Sodium Injection IP 25000 IU / 5ml - M/s. Scott-Edil Pharmacia Ltd. Cefepime & Tazobactam for Injection (Crupime - TZ Kid Injection) - M/s. Cosmas Research Lab. Ltd. Atropine Sulphate Injection IP (Atropine Sulphate) - M/s. Priya Pharmaceuticals Salbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup (Acozil Expectorant) - M/s. Antila Lifesciences Pvt. Ltd. Diclofenac Sodium IP - M/s. Sara Exports Ltd. Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) - M/s. Digital Vision Phenytoin Sodium Injection USP - M/s. Health Biotech Ltd. Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) - M/s. Win Cure Pharma Calcium 500 mg with Vitamin D3 250 IU Tablets IP - M/s. Life Max Cancer Laboratories Amoxycillin and Potassium Clavulanate Tablets IP 625 mg (Renamega- CV 625) - M/s. Malik Lifesciences Pvt. Ltd. Olmesartan Medoxomil Tablets IP 40 mg - M/s. Life Max Cancer Laboratories INFUSION SET-NV - M/s. Medivision Healthcare Telmisartan Tablets IP 40 mg - M/s. Life Max Cancer Laboratories Alprazolam Tablets IP 0.25 mg (Erazol-0.25 Tablets) - M/s. Elikem Pharmaceuticals Pvt. Ltd. Glimepiride Tablets IP (2 mg) - M/s. Mascot Health Series Pvt. Ltd. Calcium and Vitamin D3 Tablets IP - M/s. Unicure India Ltd. Metronidazole Tablets IP 400mg - M/s. Hindustan Antibiotics Ltd. Paziva -40 - M/s. Gnosis Pharmaceuticals Pvt. Ltd. Pantomed -40 - Digital Vision 176 Cefixime Oral Suspension IP (Dry Syrup) - Nestor Pharmaceuticals Ltd. Moxymed CV - Alexa Pharmaceuticals Frusemide Injection IP 20 mg - Nestor Pharmaceuticals Ltd. Kudajarishtam - Bala Herbals Tab Nodosis - Steadfast Medishield Pvt. Ltd. Haridrakhanda - Bhaskara Vilasam Vaidyasala Pantoprazole Inj. BP 40 mg - Kerala Medical Services Corporation Ltd. Yogaraja Guggulu - Bhaskara Vilasam Vaidyasala PANCEF-OF - Aglomed Ltd.

Drug Approval

12 Aug 2024

·www.echemi.com

The Race for China's Next Top Diabetes Drug: Winsunny Pharmaceutical and Yiheng Pharma Vie for Pioglitazone and Metformin Combination

On August 8, the official website of China Medical Science and Technology Achievements Transformation Center (CDE) released a news that Beijing Winsunny Pharmaceutical and Nanjing EASEHEAL Pharmaceutical two companies of pioglitazone metformin tablet generic drug listing application has been officially accepted. The news quickly garnered widespread attention as it heralded the arrival of a new player in a high-profile drug market competition. Pioglitazone metformin tablets are a drug widely used to improve blood sugar control in people with type 2 diabetes. In 2023, the drug's sales in the national hospital market have exceeded 1 billion yuan, a year-on-year increase of 14.09%, ranking 12th in the diabetes treatment drug market, according to data from Yaofongyun. At present, only two companies in the market, Jiangsu Deyuan Pharma and Hangzhou Huadong Medicine, have been approved for production and passed the consistency evaluation. Pioglitazone metformin tablets are a diabetes treatment made from a combination of two active ingredients: metformin and pioglitazone. It is primarily used to treat type 2 diabetes. Its dual action mechanism is embodied in the following two aspects: First, pioglitazone effectively promotes the conversion and utilization of glucose in muscle and adipose tissue by improving the body's sensitivity to insulin, thereby improving the body's ability to regulate blood sugar. Secondly, metformin further reduces blood sugar levels by inhibiting the production of glucose in the liver, thus achieving effective control of blood sugar. The drug is effective, can effectively control fasting blood glucose and postprandial blood glucose, improve the metabolic disorders of diabetes. It can also delay the development of type 2 diabetes and prevent and reduce the occurrence of complications. Pioglitazone metformin tablets have a good safety profile, do not cause common insulin treatment side effects such as hypoglycemia, and can reduce the risk of cardiovascular disease, cardiometabolic protection. In addition, the drug only needs to be taken once a day and is convenient to administer, helping to improve patient compliance. The application of Beijing Winsunny Pharmaceutical and Nanjing EASEHEAL Pharmaceutical was accepted, indicating that China will have a third pharmaceutical company qualified to produce this diabetes treatment drug. This will undoubtedly provide more options for patients and could increase competition among Chinese pharmaceutical companies. In recent years, Beijing Winsunny Pharmaceutical has been active in the application of new drugs, including 18 varieties including bromohexine hydrochloride oral solution, Lansoprazole enteric capsules, etc., are being declared. Nanjing EASEHEAL Pharmaceutical also recently has a number of generic drugs in the review stage, such as voriconazole dry suspension, Indapamide sustained-release tablets. With the addition of more players, the pioglitazone metformin tablet market is expected to become more diversified, offering more quality treatment options for patients with diabetes. This will undoubtedly drive continued innovation in the field and let us look forward to the future.

Drug Approval

06 Dec 2021

·www.pharmaindustrial-india.com

IPC adds 9 new IP impurities standards

The Indian Pharmacopoeia Commission (IPC) has added 9 new IP impurities standards which includes Bromhexine Hydrochloride Impurity C, Cabergoline Impurity A, Cilostazol Impurity B, Citalopram Impurity B, Fosinopril Impurity A, o-toluene sulfonamide, p-toluene sulfonamide, Tributyl o-acetyl citrate/Acetyl Tributyl citrate, Vildagliptin Impurity D. Impurity standards are used to perform the system suitability, qualitative and quantitative parameters for compliance to Indian Pharmacopoeia monograph. The commission stated that certain monographs require the use of a chemical reference substance or a biological reference preparation or a reference spectrum. IPC in collaboration with USP also conducted a webinar on “Fundamentals of Dissolution” as a part of Capability Building initiative. The webinar was conducted “exclusively” for MSME (Micro, small and medium enterprises). The session conducted by Dr. Rajeev Singh Raghuvanshi - Secretary-cum-Scientific Director, IPC and Josan Thomas, Scientific Liaison, USP India, covered the science behind dissolution, fundamentals of dissolution testing, and specifics related to the qualification of USP apparatus 1 and apparatus 2. The session saw great response with 339 participants from 149 unique companies. The panelists for webinar includes Dr. Rajeev Singh Raghuvanshi - Secretary-cum-Scientific Director, IPC, Dr. Robin Kumar - Principal Scientific Officer, Dr. Gaurav Pratap Singh Jadaun - Senior Scientific Officer, IPC, Josan Thomas, Scientific Liaison, USP India, Mr. Girish Kapur- Vice President, USP India, Joseph Eaton - Senior Manager, USP Rockville. The vision of IPC is to promote the highest standards of drugs for use in human and animals within practical limits of the technologies available for manufacture and analysis. IPC is an autonomous institution of the ministry of health and family welfare, Government of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for treatment of diseases prevailing in this region. The mandate of the commission is to perform, inter-alia, functions such as revision and publication of the Indian Pharmacopoeia and National Formulary of India on a regular basis besides providing IP reference substances and training to the stakeholders on pharmacopoeial issues

100 Deals associated with Bromhexine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01778	Bromhexine Hydrochloride	R05CB02	DB09019

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Bronchitis	Japan	Sanofi KK	29 Mar 1991
Bronchitis, Chronic	Japan	Sanofi KK	29 Mar 1991
Respiratory Tract Infections	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	01 Jan 1982
Sputum excretion difficulty	Japan	Sanofi KK	01 Nov 1980
Pneumoconiosis	Japan	Sanofi KK	01 Nov 1976
Pulmonary Tuberculosis	Japan	Sanofi KK	01 Nov 1976
Xerophthalmia	-	-	01 Jan 1963

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acute sinusitis	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	06 Jul 2021
Chronic bronchial disease	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	06 Jul 2021
Chronic sinusitis	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	06 Jul 2021
Lower Respiratory Tract Infections	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	06 Jul 2021
Tracheobronchitis	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	06 Jul 2021
Bronchiectasis	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	07 Apr 2021
Bronchopneumonia	Phase 3	China	Shanghai Harvest Pharmaceutical Co., Ltd	07 Apr 2021
Obesity	Preclinical	Iran	Shahid Beheshti University	26 May 2025
Obesity	Preclinical	Sweden	University of Gothenburg	26 May 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04405999 (CTgov)	Phase 4	COVID-19	50	Bromhexine hydrochloride (Control Group)	esdwdjuqor = xmsofcqiov otcvxuqzuf (aqfsstnfxd, yttueksqrh - hyjfukyigx) View more	-	13 Apr 2022
				Bromhexine Hydrochloride (Bromhexine Hydrochloride Group)	tegpannxnw(caxxetjiut) = nptmrjrchv pgzdlbaflm (egvulltuuo, vzctvcpowj - zvwzhtiqzc) View more

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