What Is Cetrimide?

Sibutramine is the first weight-loss drug approved by SDA (State Drug Administration) to be marketed in China. In the past three decades, the US FDA has only approved the marketing of Sibutramine and Orlistat. Sibutramine was approved by the FDA in November 1997 and officially launched in the United States in February 1998. Sibutramine was identified by the European CPMP (Monopoly Drug Commission) as the drug of choice for weight loss.

Qumei

Sibutramine is the first weight-loss drug approved by SDA (State Drug Administration) to be marketed in China. In the past three decades, the US FDA has only approved the marketing of Sibutramine and Orlistat. Sibutramine was approved by the FDA in November 1997 and officially launched in the United States in February 1998. Sibutramine was identified by the European CPMP (Monopoly Drug Commission) as the drug of choice for weight loss.

Chinese name

Qumei

Foreign name

Sibutramine

Types of

Weight loss drugs

Time to market

February 1998

Qumei Compression Stocking Qumei (Hong Kong) International Group Co., Ltd., headquartered in Kowloon, Hong Kong, is a company specializing in medical compression

Qumei was developed in strict accordance with the following requirements of the WTO (World Health Organization) on diet pills:

1. The principle of uniform weight loss, weight loss should be controlled within 0.5 ~ 1kg / week.

2, both weight loss and long-term maintenance of weight loss.

[Product identification] The product is a capsule, and the content is white or off-white powder.

main ingredient

1. This product cannot be used at the same time as a monoamine oxidase inhibitor (MAOI). MAOI should be discontinued for at least 2 weeks before starting treatment with this product; and the product should be discontinued for at least 2 weeks before using MAOI.

2. Since this product inhibits serotonin reuptake, it is not suitable for combination with other serotoninergic drugs.

3 Patients who are taking medicines that affect blood pressure and heart rate, including norephedrine, ephedrine, and pseudoephedrine, should use this product with caution.

4 This product has potential interactions with drugs that inhibit the metabolism of cytochrome P450 (3A4), such as ketoconazole and erythromycin, but the effect is not significant.

Weight loss through exercise: Obese people consume certain aerobic sports to make them consume excess body fat, promote metabolism, and achieve the purpose of exercise to lose weight. Generally, the greater the amount of exercise, the longer the exercise time, the more sugar and fat consumed, the more obvious the weight loss effect. The most common ways to lose weight in exercise are swimming, jogging,

Take an appropriate amount of the fine powder (about 10mg of sibutramine hydrochloride), add 5ml of water, stir to dissolve, filter, and add 5 drops of chromium ammonium thiocyanate test solution to the filtrate to produce a light red precipitate.

In the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.

Identification of chloride in aqueous solution of this product (Chinese Pharmacopoeia 2005 Edition Appendix III).

According to high performance liquid chromatography (Chinese Pharmacopoeia 2005 Edition Appendix V D) determination.

Chromatographic conditions and system suitability test using octadecylsilane bonded silica gel as filler; methanol-water-triethylamine (75: 25: 0.1); glacial acetic acid to adjust pH to 6.0 as mobile phase; detection wavelength It is 223nm. The theoretical number of plates based on sibutramine hydrochloride should not be less than 2000, and the resolution of the sibutramine hydrochloride peak and the adjacent impurity peaks should meet the requirements.

Take 20 capsules of the product by measuring method , remove the capsule shell together, accurately weigh the contents, mix well, accurately weigh an appropriate amount (equivalent to about 10 mg of sibutramine hydrochloride), place it in a 100 ml measuring bottle, and add ethanol-water (1 1 Appropriate amount of solution, shake to dissolve and dilute to the mark, shake well, filter, and accurately take 20l of the filtrate, inject it into the liquid chromatograph, and record the chromatogram; Anhydrous matter), dissolved and diluted with ethanol-water (1: 1) solution to make a solution containing 0.1mg per 1ml, measured in the same way. Calculate the peak area according to the external standard method and multiply the result by 1.057 to get it.

Take the appropriate amount of the fine powder under the content determination item (equivalent to 25mg of sibutramine hydrochloride), put it in a 50ml measuring bottle, add the ethanol-water (1: 1) solution to shake and dissolve, and dilute to the mark, and shake well. After filtration, take the filtrate as the test solution; precisely measure 1ml of the filtrate and place it in a 100ml measuring flask, add ethanol-water (1: 1) solution to dilute to the mark, shake well, and use it as a control solution. Perform the test according to the chromatographic conditions under the content determination item. Measure 20 l of the control solution and inject it into the liquid chromatograph. Adjust the detection sensitivity so that the peak height of the main component is about 20% of the full range. Then measure the test solution and the control accurately. Each 20 l of the solution was injected into the liquid chromatograph, and the chromatogram of the test solution solution was recorded to twice the retention time of the main peak. The sum of the area of each impurity peak (except for the solvent peak) in the chromatogram of the test solution must not be greater than 2.0 times (2.0%) the area of the main peak of the control solution.

Content uniformity Take 1 capsule of this product, pour the contents into a 50ml (5mg specification) or 100ml measuring bottle (10mg specification), the capsule shell is washed with an ethanol-water (1: 1) solution, and the washing solution is incorporated into the measuring bottle In the medium, add an appropriate amount of ethanol-water (1: 1) solution, shake to dissolve, dilute to the mark with the above solution, shake well, filter, and take the filtrate as the test solution, and measure it according to the method under content determination. Should comply with the regulations (Appendix X E of the second part of the Chinese Pharmacopoeia 2005 Edition).

Take the product for dissolution, according to the dissolution method (Chinese Pharmacopoeia 2005 Edition, Appendix X C, the first method), take 500ml 0.1mol / L hydrochloric acid solution as the solvent, rotate at 100 revolutions per minute, operate according to law, after 30 minutes At the time, take 10ml of the solution, filter, and take the filtrate as the test solution; take another 25mg of sibutramine hydrochloride reference (calculated as anhydrous), put it in a 50ml measuring bottle, add ethanol-water (1: 1 ) Dissolve an appropriate amount of solution and dilute to the mark. Shake well, take 2ml precisely, place in a 100 order volumetric flask (5mg specification), or 50ml (10mg specification), add 0.1mol / L hydrochloric acid solution to dilute to the scale, shake well. As a reference solution, measure it according to the method under content determination, and calculate the dissolution amount of each grain. The limit is 75% of the labeled amount, which should meet the requirements.

Others should comply with the relevant provisions under the capsules (Chinese Pharmacopoeia 2005 Edition Appendix IIE).

Contained in Qumei diet pills

Market Research : "Qumei" Out of Stock Customers Suspicious

"Qumei" is a slimming medicine launched by Taiji Group in August 2000. Its main ingredient is sibutramine hydrochloride. Because there are star endorsements such as Gong Li and Fan Bingbing, they are star products in the diet market.

Citizen Ms. Li said that she has been taking "Qumei" for some time. When she went to the Golden Elephant Pharmacy to buy medicine the afternoon before, she found that "Qumei" was taken off the shelves. "I came back to search online and I couldn't buy this product. The salesperson at the pharmacy said, 'Qumei' will be taken off the shelf on the 25th of this month and will not be sold again in the future. I don't know what's wrong with this medicine."

Ms. Li said that when she took "Qumei", she always had side effects such as dry mouth and occasional constipation. This time the drug was quietly taken off the shelf. She was worried that there was a problem with the drug and she hoped that the manufacturer would give a reasonable explanation.

The staff of the sales department of Golden Elephant Pharmacy confirmed the day before that "Qumei" has been taken off the shelf on the 25th of this month due to the recall of the manufacturer. "This medicine will not be sold in the future. We have not been notified."

The reporter then logged in to the brand-new pharmacy, Dulwich Pharmacy, Jiashitang pharmacy and other websites to find that there were no "Qumei" sales.

Mr. Wu, who is responsible for drug sales in Beijing, Taiji Group said that the group has issued recall instructions. Except for some remote retail outlets, most outlets in Beijing have stopped selling "Qumei".

Other manufacturers: similar products are still sold

The reporter learned that in the domestic market, there are dozens of weight-loss products containing sibutramine. Besides "qumei", there are also "Aoquqing", "Xinfenmeilin", "Kexiu", etc. Many brands. After Qumei was removed from the market,

Qumei (generic name: Sibutramine) weight-loss pills are off the shelf! As a major weight loss product of the Taiji Group, it has been advertised on major media such as major TV stations. It is still well known in the public. As such a well-known weight-loss medicine, who should be responsible for this? Is it ok to stop selling it? Who should consumers look for?

Let us first look at the current development of a Qumei diet pill incident:

2010-10-30 Some citizens reported to the Jinghua Times that the long-term "Qumei" slimming capsules (sibutramine hydrochloride capsules) that they took for a long time were unavailable. I don't know why.

The reporter wrote about Ms. Zhang of the News Center of Taiji Group. She said that the company has set up return points in major retail pharmacies across the country. As long as the packaging is not damaged, an invoice can be returned.

The question of whether or not the acetic acid diet pills will be involved in subsequent compensation is still unanswered.

Let's take a look at the back data of Qumei slimming pills being removed:

Sibutramine is a central nervous system inhibitor with excitatory and antieating effects.

In 1997, sibutramine was approved by the US FDA for marketing. In that year, Abbott's weight loss product "Nometin" with sibutramine as its main ingredient was first listed in Mexico. For more than 10 years, similar products have been popular all over the world.

In 2005, the EU included "Normetine" as a "warning drug", saying it could trigger various risks such as stroke. In 2007, the Japanese Ministry of Health and Welfare reminded the public to be careful with weight-loss products containing sibutramine hydrochloride.

In January this year, the European Union's Committee on Medicinal Products for Human Use (CHMP) stated that sibutramine may increase the risk of heart disease and stroke among users, and suspended all sibutramine-containing diet pills for sale in the EU. The US FDA and the Australian Medical Product Agency (TGA) subsequently required manufacturers to modify product specifications to warn of the risks of medication.

On October 8, the FDA issued a document ordering "Nometin" to withdraw from the US market. Health Canada later said that Abbott was recalling "Nometin" in the country.

Reactions from domestic authorities

On February 26 this year, the State Food and Drug Administration issued a message through its official website, saying that it closely follows the safety information of sibutramine. According to the news, the State Drug Administration has asked the National Center for Adverse Drug Reactions to immediately analyze the adverse reaction reports and monitoring of sibutramine-containing weight-loss drugs in China, and to conduct safety studies on the use of such drugs in China. Analysis and evaluation.

At the same time, the State Administration of Drug Administration requires pharmaceutical manufacturers to immediately take appropriate measures to inform doctors and patients of the known drug risks serious effects of sibutramine in patients with high cardiovascular risk; immediate attention to known and potential risks Revised and improved the instructions, prompting safe and reasonable medication.

The State Food and Drug Administration said that it is closely monitoring the final results of the sibutramine cardiovascular endpoint trial (SCOUT) study and will use the results to refer to the regulatory measures of other national drug regulatory authorities and take appropriate supervision in the light of China's situation. Measures.

The State Food and Drug Administration also reminded medical institutions and the public that all weight-loss drugs containing sibutramine are prescription drugs, and they must be used in strict accordance with the indications and dosages, and the response after the drug must be closely monitored to ensure the safety of drug use.

Statistics released by the State Administration of Drug Administration on the same day showed that from January 1, 2004 to January 15, 2010, the National Center for Adverse Drug Reaction Monitoring received a total of 298 reports of sibutramine-related adverse reactions. The main adverse reactions were: Heart palpitations, constipation, dry mouth, dizziness, insomnia, etc. are mostly adverse reactions that have been described in the instructions, and there are currently no deaths.

Now looking at the entire Qumei diet pills delisting event , we can see that the Taiji Group is more attentive to consumers. The products that have been questioned will be taken offline for the first time to protect the rights and interests of consumers to the greatest extent.

Let's look at the situation of other products on the market after the Qumei incident:

The reporter learned that in the domestic market, there are dozens of weight-loss products containing sibutramine. Besides "qumei", there are also "Aoquqing", "Xinfenmeilin", "Kexiu", etc. Many brands. After "Qumei" was removed from the market, "Aoquqing" produced by Nanjing Chang'ao Pharmaceutical Co., Ltd. and "Xinfenmeilin" produced by Siping Emmer Pharmaceutical Co., Ltd. are still on sale.

Ms. Sun, head of sales of "Xin Fen Mei Lin" North China, said yesterday that the company has not issued a suspension order, but since June this year, the company has stopped producing this product. Ms. Sun said that she was aware of the ban on weight-loss products containing sibutramine in Europe and the United States, and the company is awaiting further measures by the State Drug Administration to decide whether to stop selling the product.