Sodium bicarbonate has been used clinically for over 200 years. Sodium carbonate was originally used as an antacid to neutralize excessive gastric acid. Sodium bicarbonate was included in the Chinese Pharmacopoeia back in 1953, as well as all subsequent editions. In addition, sodium bicarbonate is also recorded in the International Pharmacopoeia (Fourth Edition), United States Pharmacopoeia (USP 43), Japanese Pharmacopoeia (JP17), European Pharmacopoeia (EP10), British Pharmacopoeia (BP2021), Indian Pharmacopoeia (IP2018), etc.
As to medicinal value, sodium bicarbonate has been proved to be useful for treatment of status asthmaticus, asthmatic pneumonia (bronchiolitis), acute myocardial infarction, cardiopulmonary resuscitation, cerebral thrombosis, thromboangiitis obliterans, vascular headache, vertigo, 8th cranial nerve damage caused by aminoglycoside antibiotics, epidemic hemorrhagic fever shock, lumbar disc herniation, organophosphorus pesticide poisoning, antipyretic, chronic nephritis, mycotic enteritis, influenza and many other diseases. It can also be used to wash tuberculous abscess, or as cardiac acoustic contrast agent. The intravenous administration of it can be used for toxic shock due to infection.
What is worth mentioning is that sodium bicarbonate is one of the earliest varieties included in the essential drug list in China. Among the Catalogue of Drugs for Basic National Medical Insurance of China, there are four antacids and Class A gastric mucosa protection drugs, including sodium bicarbonate and rhubarb sodium bicarbonate, all of which are oral regular release dosage forms. These two drugs are mainly used to treat hyperacidity, alkalized urine, indigestion, metabolic acidemia and fungal vaginitis, as well as shocks with acidosis symptoms caused by hyperkalemia and others.
There are many kinds of sodium bicarbonate preparations on the market at present, including tablet, capsule, granules, pulvis, compound preparation, injection, etc. The kinds with more production approval numbers include sodium bicarbonate tablets, sodium bicarbonate injections, rhubarb and sodium bicarbonate tablets, gentian and sodium bicarbonate tablets, compound gentian and sodium bicarbonate tablets, etc.
II. Supply and demand status of sodium bicarbonate
China started the industrial production of sodium bicarbonate in Liaoning, Sichuan and other places as early as the 1930s. The output of sodium bicarbonate in China continued to rise after the Reform and Opening Up, and with the situation of production and sales getting better, the production capacity and output surge to new highs again and again. The production capacity of sodium bicarbonate in China in 2008 ranked the first in the world, reaching over 18 million tons.
According to data, with the high-speed economic development, the consumption of sodium bicarbonate in China, Southeast Asia, India and other regions keeps rising, and these regions has become the main consumer market in the world.
As for the pharmaceutical market, there are many kinds of sodium bicarbonate dosage forms commercially available in China, including tablet, capsule, granule, pulvis, compound preparation, injection, etc. As for tablets, there are rhubarb and sodium bicarbonate tablets, compound sodium bicarbonate tablets, gentian and sodium bicarbonate tablets, bismuth, magnesium and sodium bicarbonate tablets, compound gentian and sodium bicarbonate tablets, pediatric rhei and sodium bicarbonate tablets, etc.
When it comes to the demand, let's take uremia as an example. There are more than 520,000 hemodialysis patients in China in 2017 and 620,000 in 2018. It is estimated that the current number of uremia patients in China will be more than 740,000. According to data, the total consumption of sodium bicarbonate products for injection and hemodialysis in recent years in China is about 80,000 tons, while its own output is around 60,000 tons. It is expected that by 2025, the demand for medicinal sodium bicarbonate in China will reach 100,000 tons.
Therefore, the medical demand for sodium bicarbonate in China is huge. However, the imbalance between supply and demand of sodium bicarbonate in China is also a primary existing problem.
It mainly reflects in the following aspects.
1. Relatively low Chinese pharmaceutical production capacity: Sodium bicarbonate can be used in industry, food and pharmaceuticals by function, while, most of the sodium bicarbonate produced in China is for industrial and food use. As a result of the limit of drug quality standards, drug production license (GMP standard) and drug sales license, only a few enterprises in China produce medicinal sodium bicarbonate raw medicines.
2. Scarcity of high-quality sodium bicarbonate: Higher requirements are put forward for the preparation and purification technology because the raw medicines need high-purity sodium bicarbonate, and China is in short of high-quality sodium bicarbonate. At present, China relies more on imports to obtain high-quality sodium bicarbonate. For example, although China ranks the top with the largest output of sodium bicarbonate, the amount of imported sodium bicarbonate in 2011 was as high as 5.07 million US dollars, which is partly related to the lack of high-quality sodium bicarbonate.
Sodium bicarbonate, as a first-line clinical essential drug with long application history, definite curative efficacy, slight side effects, low price and clinical necessity, its market demand will continue to grow in the future. China, as a major country in the production and export of sodium bicarbonate, still has room for improvement in the production of high-quality sodium bicarbonate. Recently, the Solvay drug-grade Bicar® Pharma sodium bicarbonate, which was successfully registered and activated in the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) recently, can be used in pharmaceutical fields, such as hemodialysis, injection and drug production of antacid active ingredients. All parameters of raw medicines, dialysis and auxiliary material grades meet the requirements of Chinese Pharmacopoeia, which provides an effective guarantee for the demand of high-quality sodium bicarbonate raw medicines of pharmaceutical companies in China.
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