Currently, China has officially approved 22 special medical-use carbohydrate component formulas designed for people over one year who suffer from specific diseases or need carbohydrate supplementation.
The 22 carbohydrate component formulas are all domestic products made by 20 companies, among which, DAISY FSMP and Tibet DUOXIN HEALTH had two approved products, and the other 18 companies had one product. Jiangsu Province has the highest number of approved products, totaling 7.
The first carbohydrate component formula 泉克 was registered by Tibet DUOXIN HEALTH and approved in 2020, other carbohydrate component formulas were approved mostly in 2021, 2023, and 2024.
Details of 22 carbohydrate component products
S.N. | Company | Product Name | Province | Register N. |
---|---|---|---|---|
1 | Tibet DUOXIN HEALTH | 泉克 (Quanke) | Tibet | 國食注字TY20200010 |
2 | GUANGDONG JUNJOY | 君蓓安 (Junbeian) | Guangdong | 國食注字TY20210007 |
3 | Hainan Donglian | 富安 (Fuan) | Hainan | 國食注字TY20210010 |
4 | Jiangsu Zhengda Fenghai | 素乾® (Suqian) | Jiangsu | 國食注字TY20210011 |
5 | DAISY FSMP | 冬澤速棠 (Dongze Sutang) | Jiangsu | 國食注字TY20210013 |
6 | CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD | 葆棠華 (Baotanghua) | Jiangsu | 國食注字TY20210017 |
7 | Zhejiang Yiyuansu | 益安喜® (Yianxi) | Zhejiang | 國食注字TY20210020 |
8 | Jiangsu Xihong | 西沁® (Xiqin) | Jiangsu | 國食注字TY20210024 |
9 | Hebei Aisheng | 諾葆安® (Nuobaoan) | Hebei | 國食注字TY20230001 |
10 | Shandong Ruoyao | 若和® (Ruohe) | Shandong | 國食注字TY20230004 |
11 | Chenxin Pharmaceutical | 欣飴元 (Xinyiyuan) | Shandong | 國食注字TY20230016 |
12 | DAISY FSMP | 冬澤予棠 (Dongze Yutang) | Jiangsu | 國食注字TY20230047 |
13 | AusNuotore Nutritional Products | 愛優諾賦力素(AusNuotore Fulisu) | Jiangxi | 國食注字TY20230048 |
14 | Guangdong Yue Microbiology | 采衡® (Caiheng) | Guangdong | 國食注字TY20230067 |
15 | Zhejiang Hisun Sulikang | 伊暢佳® (Yinchangjia) | Zhejiang | 國食注字TY20230068 |
16 | Wuxi Hengyi | 恒益舒棠 (Hengyi Shutang) | Jiangsu | 國食注字TY20240006 |
17 | Tibet DUOXIN HEALTH | 艾諾佳 (Ainuojia) | Tibet | 國食注字TY20240009 |
18 | Jilin Maifu Nutrition | 麥孚卡能®(Maifu Kaneng) | Jilin | 國食注字TY20240010 |
19 | Guizhou Jinjiu Biotech | 玖康益® (Jiukangyi) | Guizhou | 國食注字TY20240027 |
20 | Tecang Pharmaceutical | 速勁 (Sujing) | Shandong | 國食注字TY20240029 |
21 | Kwins Health Pharmaceutical | 拜全術韋 (Baiquan Shuwei) | Jiangsu | 國食注字TY20240043 |
22 | Tianjin Hezhi Guangping Pharmaceutical | 維特膳棠 (Weite Shantang) | Tianjin | 國食注字TY20240044 |
Formula Content
S.N. | Company | Product Name | Formula ingredients |
---|---|---|---|
1 | Tibet DUOXIN HEALTH | 泉克 (Quanke) | Water, maltodextrin, crystalline fructose |
2 | GUANGDONG JUNJOY | 君蓓安 (Junbeian) | Water, maltodextrin, crystalline fructose, citric acid monohydrate, sodium citrate, potassium citrate, sucralose |
3 | Hainan Donglian | 富安 (Fuan) | Water, maltodextrin, crystalline fructose, potassium citrate, citric acid, sodium citrate, stevioside, food flavor |
4 | Jiangsu Zhengda Fenghai | 素乾® (Suqian) | Water, maltodextrin, crystalline fructose, sodium citrate, potassium citrate, citric acid, food flavoring, sucralose |
5 | DAISY FSMP | 冬澤速棠 (Dongze Sutang) | Maltodextrin, table dextrose, crystalline fructose |
6 | CSPC Zhongnuo Pharmaceutical (Taizhou) Co. LTD | 葆棠華 (Baotanghua) | Water, maltodextrin, dextrose, crystalline fructose, sodium citrate, potassium citrate, citric acid, DL-malic acid, sucralose, food flavors |
7 | Zhejiang Yiyuansu | 益安喜® (Yianxi) | Water, maltodextrin, crystalline fructose, anhydrous dextrose, sodium citrate, citric acid, food flavoring |
8 | Jiangsu Xihong | 西沁® (Xiqin) | Water, maltodextrin, crystalline fructose, food flavoring, sucralose, citric acid |
9 | Hebei Aisheng | 諾葆安® (Nuobaoan) | Maltodextrin, crystalline fructose |
10 | Shandong Ruoyao | 若和® (Ruohe) | Water, maltodextrin, crystalline fructose, citric acid |
11 | Chenxin Pharmaceutical | 欣飴元 (Xinyiyuan) | Water, maltodextrin, crystalline fructose |
12 | DAISY FSMP | 冬澤予棠 (Dongze Yutang) | Water, maltodextrin, table dextrose, crystalline fructose |
13 | AusNuotore Nutritional Products | 愛優諾賦力素 (AusNuotore Fulisu) | Maltodextrin, crystalline fructose |
14 | Guangdong Yue Microbiology | 采衡® (Caiheng) | Water, maltodextrin, crystalline fructose, DL-malic acid, food flavoring, citric acid, sucralose |
15 | Zhejiang Hisun Sulikang | 伊暢佳® (Yinchangjia) | Water, Maltodextrin, crystalline fructose, food flavoring |
16 | Wuxi Hengyi | 恒益舒棠 (Hengyi Shutang) | Maltodextrin, crystalline fructose, sodium citrate, citric acid, flavor for food |
17 | Tibet DUOXIN HEALTH | 艾諾佳 (Ainuojia) | Maltodextrin, crystalline fructose |
18 | Jilin Maifu Nutrition | 麥孚卡能® (Maifu Kaneng) | Water, Maltodextrin, crystalline fructose, citric acid, sodium citrate |
19 | Guizhou Jinjiu Biotech | 玖康益® (Jiukangyi) | Water, Maltodextrin, crystalline fructose, citric acid |
20 | Tecang Pharmaceutical | 速勁 (Sujin) | Maltodextrin, dextrose, crystalline fructose |
21 | Kwins Health Pharmaceutical | 拜全術韋 (Baiquan Shuwei) | Water, Maltodextrin, crystalline fructose, citric acid |
22 | Tianjin Hezhi Guangping Pharmaceutical | 維特膳棠 (Weite Shantang) | Maltodextrin, dextrose |
Nutrient content
Nutrient | Unit | Content level |
---|---|---|
Energy | kJ/100mL | 203~223 |
Protein | g/100mL | 0 |
Fat | g/100mL | 0 |
Carbohydrates | g/100mL | 12.5~13.1 |
Sodium | mg/100mL | 0~74 |
The 22 carbohydrate component products share a similar formula design – these products consist of two or more carbohydrates and aim to supply energy and carbohydrates. These products have simple formulas, no other nutrients, only carbohydrates. Companies can add as many food additives as needed during the production process, but the use method and application level must conform to the technique and necessity of application, and stay in line with the requirements of relevant national standards such as GB 29922 and GB 2760.
According to GB 29922-2013, the raw materials of the carbohydrate component products can be monosaccharides, disaccharides, oligosaccharides, polysaccharides, maltodextrins, glucose polymers, or other raw materials approved by laws and regulations. Maltodextrins, as a kind of raw material of polysaccharides, can be easily digested, has excellent solubility and stability, and is cost-effective. Thus this ingredient is widely used in various products, including beverages, candies, and milk products. However, as maltodextrin has a neutral flavor and is less sweet, it can be used in combination with crystalline fructose to enhance the taste of the product.
At present, the main source of carbohydrates in the 22 approved carbohydrate component products are maltodextrins and crystalline fructose. Glucose is also applied in some other products. The content of carbohydrates is approximately 12.5%.
There are also significant differences among the formulation characteristics. The following is a detailed comparison in terms of age, nutrient content, osmotic pressure, dosage form, net content and specifications, and shelf-life, to provide a reference basis for companies in the selection or product development.
Applicable population
Six products are suitable for people over the age of one year, 12 products are suitable for people over the age of ten years, and four products are suitable for people over the age of eighteen.
Age | Quantity | Product Name |
---|---|---|
Over 1 year | 6 | 冬澤速棠 (Dongze Sutang), 欣飴元 (Xinyiyuan), 冬澤予棠 (Dongze Yutang), 麥孚卡能® (Maifu Kaneng), 玖康益® (Jiukangyi), 拜全術韋 (Baiquan Shuwei) |
Over 10 years | 12 | 泉克 (Quanke), 葆棠華 (Baotanghua), 益安喜® (Yianxi), 西沁® (Xiqin), 諾葆安® (Nuobaoan), 愛優諾賦力素 (AusNuotore Fulisu), 采衡® (Caiheng), 伊暢佳® (Yinchangjia), 恒益舒棠 (Hengyi Shutang), 艾諾佳 (Ainuojia), 速勁 (Sujin), 維特膳棠 (Weite Shantang) |
Over eighteen | 4 | 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 若和®(Ruohe) |
Nutrient content
The basic nutrient content is 12.5% pure carbohydrates and some products contain electrolytes (sodium).
Nutrient content | Quantity | Product Name |
---|---|---|
12.5% carbohydrate | 12 | 冬澤速棠 (Dongze Sutang), 西沁®(Xiqin), 諾葆安®(Nuobaoan), 若和®(Ruohe), 欣飴元 (Xinyiyuan), 冬澤予棠 (Dongze Yutang), 愛優諾賦力素 (AusNuotore Fulisu), 采衡® (Caiheng), 伊暢佳® (Yinchangjia), 麥孚卡能® (Maifu Kaneng), 玖康益® (Jiukangyi), 拜全術韋 (Baiquan Shuwei) |
12.5% carbohydrate+sodium | 10 | 泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾®(Suqian), 葆棠華(Baotanghua), 益安喜®(Yianxi), 恒益舒棠 (Hengyi Shutang), 艾諾佳 (Ainuojia), 速勁 (Sujin), 維特膳棠 (Weite Shantang) |
Osmotic pressure
The osmotic pressure of the products' ready-to-eat state is different, and the osmotic pressure distribution range is 180 ~310 mOsmol/kg, and is mainly concentrated in 200~300 mOsmol/kg, and the low osmotic pressure is relatively well tolerated.
The Guidelines for Registration of Formulas with Carbohydrate Components for Special Medical Purposes issued on July 1, 2024, stipulate that the products contain 12.5g of carbohydrates per 100mL in the ready-to-eat state, and the osmotic pressure of the products should not be higher than 320 mOsmol/kg.
Scope of the osmotic pressure | Quantity | Product Name |
---|---|---|
100-200mOsmol/kg | 3 | 愛優諾賦力素 (AusNuotore Fulisu), 采衡® (Caiheng),玖康益® (Jiukangyi) |
200-300mOsmol/kg | 17 | 泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 葆棠華 (Baotanghua), 西沁® (Xiqin), 諾葆安® (Nuobaoan), 若和® (Ruohe), 欣飴元 (Xinyiyuan), 冬澤予棠 (Dongze Yutang), 伊暢佳® (Yinchangjia), 恒益舒棠 (Hengyi Shutang), 艾諾佳 (Ainuojia), 麥孚卡能® (Maifu Kaneng), 速勁 (Sujin), 拜全術韋 (Baiquan Shuwei), 維特膳棠 (Weite Shantang) |
300mOsmol/kg以上 | 2 | 冬澤速棠 (Dongze Sutang), 益安喜® (Yianxi) |
Dosage form
The main dosage form is liquid, including 15 liquid products and seven powdered products.
Dosage | Quantity | Product Name |
---|---|---|
Liquid | 15 | 泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 葆棠華 (Baotanghua), 益安喜® (Yianxi), 西沁® (Xiqin), 若和® (Ruohe), 欣飴元 (Xinyiyuan), 冬澤予棠 (Dongze Yutang), 采衡® (Caiheng), 伊暢佳® (Yinchangjia), 麥孚卡能 (Maifu Kaneng)®, 玖康益® (Jiukangyi), 拜全術韋 (Baiquan Shuwei) |
powder | 7 | 冬澤速棠 (Dongze Sutang), 諾葆安® (Nuobaoan), 愛優諾賦力素 (AusNuotore Fulisu), 恒益舒棠 (Hengyi Shutang), 艾諾佳 (Ainuojia), 速勁 (Sujin), 維特膳棠 (Weite Shantang) |
Net content and specifications
Currently 200mL/ bottle is the mainstream specification.
Net content and specifications | Quantity | Product Name |
---|---|---|
200mL | 13 | 泉克 (Quanke), 君蓓安 (Junbeian), 富安 (Fuan), 素乾® (Suqian), 西沁® (Xiqin), 若和® (Ruohe), 欣飴元 (Xinyiyuan), 冬澤予棠 (Dongze Yutang), 采衡® (Caiheng), 伊暢佳® (Yinchangjia), 麥孚卡能® (Maifu Kaneng), 玖康益 (Jiukangyi)®, 拜全術韋 (Baiquan Shuwei) |
400mL | 1 | 葆棠華 (Baotanghua) |
260mL | 1 | 益安喜® (Yianxi) |
Other (Powder) | 7 | 冬澤速棠 (Dongze Sutang), 諾葆安® (Nuobaoan), 愛優諾賦力素 (AusNuotore Fulisu), 恒益舒棠 (Hengyi Shutang), 艾諾佳 (Ainuojia), 速勁 (Sujin), 維特膳棠 (Weite Shantang) |
Shelf-life
The shelf-life is between 12 to 24 months.
Shelf-life | Quantity | Product Name |
---|---|---|
12M | 5 | 君蓓安 (Junbeian), 冬澤速棠 (Dongze Sutang), 益安喜® (Yianxi), 速勁 (Sujin), 拜全術韋 (Baiquan Shuwei) |
18M | 5 | 素乾® (Suqian), 葆棠華 (Baotanghua), 西沁® (Xiqin), 愛優諾賦力素 (AusNuotore Fulisu), 麥孚卡能® (Maifu Kaneng) |
24M | 12 | 泉克 (Quanke), 富安 (Fuan), 諾葆安® (Nuobaoan), 若和® (Ruohe), 欣飴元 (Xinyiyuan), 冬澤予棠 (Dongze Yutang), 采衡® (Caiheng), 伊暢佳® (Yinchangjia), 恒益舒棠 (Hengyi Shutang), 艾諾佳 (Ainuojia), 玖康益® (Jiukangyi), 維特膳棠 (Weite Shantang) |
The newly released “Guidelines for Registration of Carbohydrate Component Formulas for Special Medical Purposes” points out that for products that meet the requirements in the guidelines, the submission of application materials can be optimized. Related applicants should pay attention to the following points:
1. The source of carbohydrates must meet the requirements of GB 29922 and the registration guidelines, and the use of food additives needs to have the necessity of process or use conform to the provisions of GB 29922, GB 2760;
2. The carbohydrate content in the ready-to-eat product should be 12.5g/100mL, the osmotic pressure shall not be higher than 320 mOsmol/kg, and the formulas that do not meet the requirements still need to submit the basis of product formula design;
3. If the same applicant registers products in the same category, then the products must have differences in the characteristics of product formulations, clinical use scenarios or product formulations. Corresponding materials must be provided;
4. Applicants may not submit the stability study report when applying for registration, but are still required to organize and carry out the stability study according to the requirements of “Requirements for Stability Study of Food Formulas for Special Medical Purposes (Trial) (Revised Edition 2017)”, and keep the records so they can be checked if required.
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