Ginkgo series

Ginkgo, native to China, is one of the oldest trees species in the world. It can date back to Carboniferous period (230,000 years ago). The average lifespan of ginkgo is between 2000 and 4000 years and its vitality is very tenacious.

As a traditional Chinese medical material, ginkgo has been cultivated and used for thousands of years.

  • In 2011, the first workshop of ginkgo biloba extract was put into trial production. In such a chaotic industry back then, we have always insisted on manufacturing authentic products.

  • In 2015, the former CFDA (China Food and Drug Administration, now the National Medical Products Administration) conducted an investigation on 90 Ginkgo biloba extract manufacturers across the country. Delekang is one of the few companies whose products were all certified as qualified. Our persistency in quality has been rewarded and we have gained a firm foothold in the market.

  • In 2016,Delekang’s ginkgo biloba extract was approved as API (Active Pharmaceutical Ingredient) by the former Jiangsu FDA. In the subsequent cooperation with various drug companies, we have been continuously optimizing the quality of ginkgo biloba extract to be able to consist stably in various dosage forms.

  • By 2019, we pushed the quality to a whole new level. Ginkgolic acid was controlled below 1ppm, and ginkgo toxin below 50 ppm. Pesticide residues met the EU regulation on maximum pesticide residue levels (EC No 396/2005).

  • In 2019, shikimic acid was found during the process of ginkgo biloba extraction, which could greatly reduce the cost of shikimic acid in the market.

  • Mass production of shikimic acid was achieved in 2020.

The data tell everything. With technical progress during the last ten years, we have made high-quality products more affordable for more people.

Ginkgo biloba extract

CAS number:90045-36-6

HS code:13021940.00

Summary

In the 1960s, Dr Willmar Schwabe Group developed standardized Ginkgo biloba extract EGb 761, which promotes vasodilation and improves blood flow through and is used to treat memory loss, tinnitus etc. [1]. In the assessment report of Ginkgo biloba in 2014, the European Medicines Agency recognized the therapeutic effect of Ginkgo biloba extract on the improvement of (age-associated) cognitive impairment and of quality of life in mild dementia[2]. In the United States, Ginkgo biloba extract is widely used as a dietary supplement [3]. In China, the main functions of ginkgo biloba extract preparations are:

Promoting blood circulation to remove obstruction in collaterals. It can be used for patients with chest blockage, heartache, stroke, hemiplegia, stiff tongue caused by blood stasis and obstruction of the collaterals, and stable angina pectoris and cerebral infarction with the syndromes mentioned above. [4] The Ginkgo biloba extract produced by Delekang has been approved by the Administration for Market Regulation (formerly Food and Drug Administration) and can be used as API (Active Pharmaceutical Ingredient) for the production of various drug preparations. At the same time, we have also obtained the "Food Production License", which permits us to produce Ginkgo biloba extract for dietary supplement.

Our advantages

Ginkgo biloba extract is a very common ingredient that almost every plant extract manufacturer can make. However, only few manufacturer can make ginkgo biloba extract of good quality, not to mention excellent quality. In the past decade, we have been constantly refreshing the quality level of ginkgo biloba extract:

  • Through years of cooperation with ginkgo leaf suppliers, we have been extensively collecting and analyzing the quality data of ginkgo leaves from different regions to find suitable raw materials for standardized products with stable quality.

  • Complying with Chinese Pharmacopoeia, U.S. Pharmacopoeia and European Pharmacopoeia standards

  • Complying with EU regulation on maximum pesticide residue levels (EC No 396/2005) .

  • Limiting ginkgolic acid below 1ppm

  • Limiting ginkgotoxin below 50ppm

  • The production line has been approved by China FDA

  • Compatible with most oral dosage forms

While ensuring high quality, Delekang is also striving to make products more affordable. Unlike plant extract manufacturers making everything, we have the following advantages as a specialized manufacturer:

  • Through technology development, the raw materials are fully utilized to reduce the cost of raw materials. The extracted ginkgo leaves and waste materials can be used to extract sodium copper chlorophyllin and shikimic acid, and the used leaves can be used as fuel to provide renewable energy for the production line.

  • Through scale effect, the fixed cost per unit, such as investment in R&D, equipment, and facilities, can be diluted through a larger output.

  • Unlike the universal extraction equipment, our specialized production line designed for ginkgo biloba is more effective in controlling quality and reducing cost of production.

Specifications

Items CP USP EP In-house
Flavonol glycosides ≥24.0% 22.0-27.0% 22.0-27.0% 22.0-27.0%
Terpene lactones ≥6.0% 5.4-12.0% 5.4-6.6% 5.4-12.0%
Bilobalide / 2.6-5.8% 2.6-3.2% 2.6-5.8%
Ginkgolide / 2.8-6.2% 2.8-3.4% 2.8-6.2%
Quercetin/kaempferol ratio 0.8-1.2 / / 0.8-1.2
Isorhamnetin/Quercetin ratio ≥0.15 / / ≥0.15
Ginkgolic acid ≤5mg/kg ≤5mg/kg ≤5mg/ kg ≤1mg/kg
Free quercetin ≤10mg/g ≤5mg/g / ≤10mg/g
Free kaempferol ≤10mg/g / / ≤10mg/g
Free isorhamnetin ≤4mg/g / / ≤4mg/g
Rutin / ≤4.0% / /
Pesticide residues / USP<561> EC396/2005 /
Loss on drying ≤5.0% ≤5.0% ≤5.0% ≤4.0%
Residue on ignition ≤0.8% / / ≤0.8%
Heavy metals ≤20m g/kg / / ≤15m g/kg
HPLC Fingerprint ≥0.90 / / ≥0.90

Package and storage

25 kg/drums; protected from light; stored in airtight and dry condition

Shikimic acid

CAS number: 138-59-0

HS Custom code: 2918190090

Structural formula

specification

Project specification Specific rotation 175 to -184 Content ≧98.0% Heavy metal ≦ 20 ppm Ash ≤ 0.8 % Loss on drying. ≤ 1.0% Solubility Easy to soluble in water (solubility: 18% m/v) Molecular weight 174.15 Character white or slightly yellow fine powder Plant source Ginkgo biloba

Packaging and storage

25kg/drum Prevented from light and stored in airtight and dry condition 参考文献 Reference 1. EGb 761: ginkgo biloba extract, Ginkor. Drugs R D. 2003;4(3):188-93. doi: 10.2165/00126839-200304030-00009. PMID: 12757407. 2. Committee on Herbal Medicinal Products. "Assessment report on Ginkgo biloba L., folium" (PDF). European Medicines Agency. 3. Z. Pang, F. Pan, and S. He.The Journal of Alternative and Complementary Medicine.Sep 1996.359-363. 4. 国家药典委员会.中华人民共和国药典[M].银杏叶片, 2020,(1):1614.