Application Of Cistanche in Functional Food in China-How Much Cistanche Should You Take?

Abstract: From ancient times to the present, Cistanche has have been used as wine and stewed soup in Inner Mongolia, Xinjiang, and other regions of our country. With the deepening of modern scientific research, the research on the content of the main active ingredients and mechanism of Cistanche has become more abundant. These research foundations have also confirmed that it canrelieve physical fatigue, regulate immunity, treat osteoporosis, and improve cardiovascular diseases. It helps to improve the health function of memory, antioxidation, and other directions. Therefore, Cistanche has a good development prospect and potential application value in the field of health food. This article describes the compliance basis of the raw materials of Cistanche in China's health food, including the basis for safe use and the technical requirements and compliance recommendations involved in the health food declaration materials. Secondly, combined with the collation of the search data of the national “special food information query platform”, the application status of the approved health food containing Cistanche and its products was analyzed. And researched its safety evaluation and health function-related progress. It is expected to provide a reference for the registration and application of raw materials of Cistanche further processing technology and functional research directions. 

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Keywords: Cistanche; raw material; safety; function; functional food

Cistanche is one of the traditional precious Chinese medicinal materials in my country, with high medicinal value and enjoys the reputation of "desert ginseng". Modern research shows that Cistanche has certain health functions such as antioxidant [1], relieving physical fatigue [2], and immune regulation [3]. "The Pharmacopoeia of the People's Republic of China" records it as the dry scaly succulent stem of Cistanche deserticola Y.C.Ma or Cistanche tubulosa (Schenk) Wight. Constipation and other effects.

"Compendium of Materia Medica" records: "Cistanche deserticola, nourishing life, nourishing kidney qi, nourishing essence and blood is also a medicine. Men's Dan Yuan is deficient and Yang Dao has been sinking for a long time; The medicine is warm but not hot, tonifying but not harsh, warm but not dry, slippery but not leaking, so it has the name of calmness.”

In January 2020, the National Health Commission and the State Administration of Market Supervision, in accordance with the provisions of the "Food Safety Law", after a safety assessment and extensive public consultation, finally officially announced that nine substances such as Cistanche were carried out according to the traditional food and traditional Chinese medicine. The material of material (referred to as food and drug substance) is used for pilot production and operation, and Cistanche deserticola (desert) is among them. The release of this document is not only conducive to expanding the use of traditional Chinese medicinal materials and promoting the development of local characteristic industries but also conducive to the diversified development of health food formulations and compatibility, as well as promoting the progress of research on deep processing and refined extraction of raw materials.

Therefore, the article reviews the compliance basis of Cistanche raw materials in health food in my country, the product application status, functional components and health care functions of cistanche and its extracts that have been approved as raw materials for health food, with a view to providing information for the future use of Cistanche raw materials in health food in my country. It provides a certain reference and basis for the compliance use, research and development and application in the

1 Basis for the use of Cistanche in health food and precautions for declaration

1.1 Basis of use

The history of use of Cistanche can be traced back to "Shen Nong's Materia Medica". In the Pharmacopoeia, it is divided into two species, Cistanche Deserticola and Cistanche Tubulosa: the former mainly uses Haloxylon ammonium as the parasitic object, which is mostly produced in Inner Mongolia and other regions; while the latter is mainly hosted by red willow, which is mostly produced in Xinjiang and other regions. At present, some scholars have divided Cistanche into 4 types, namely desert Cistanche, Cistanche tuberose, Cistanche salt raw and Cistanche sand[4].

The basis for the use of Cistanche comes from Article 8 of the "Regulations on the Application and Review of Wild Animal and Plant Health Foods (Trial)" (Guo Shi Yao Jian Note [2005] No. 202) issued by the former State Food and Drug Administration in 2005: It is forbidden to use wild licorice, cistanche, snow lotus, and their products as raw materials to produce health food. If artificially cultivated licorice, cistanche, and snow lotus and their products are used as raw materials for health food, the source of raw materials, the purchase and sale contract, and the purchased license (copy) issued by the raw material supplier shall be provided. This clause emphasizes that the source of raw materials of Cistanche must meet the two conditions of legal business qualification and artificial cultivation.

1.2 Notices for declaration

Cistanche Extract can also be used as raw materials for health food. The health food raw material extract mentioned in "Shanghai Health Food Manufacturing Enterprises Health Food Raw Material Extract Management Guide" refers to the raw material extraction, The health food raw material obtained after the purification and other pretreatment steps. When the Cistanche Cistanche and Cistanche Cistanche extracts are declared as health food raw materials, the detailed extract production process and parameter description shall be provided.

At the same time, in order to ensure the safety and quality of the extract raw materials used in health food, it is necessary to formulate scientific and reasonable technical requirements, and comply with the corresponding and latest food safety standards, especially mycotoxins, pesticide residues and pollutants, etc. requirements.

If there is no corresponding national standard, you can refer to industry standards, local standards and enterprise standards. According to the "Production Product Evaluation Center" issued by the Food Evaluation Center of the State Administration for Market Regulation in April 2020

According to the requirements of item 8 of "Common Problems and Precautions of Product Technical Requirements", there is no corresponding national standard for Cistanche deserticola extract. application service Service Guide

1.2.1 Formulate corresponding quality requirements for raw and auxiliary materials

The main contents include raw material name and source (including Latin name), preparation method (solvent used for extraction and amount of use, temperature, time, frequency, etc.), extraction rate (range), sensory requirements, general quality control indicators, pollutant indicators (lead , total arsenic, total mercury), pesticide residues (666, DDT), landmark component indicators, microbial indicators (such as total number of colonies, coliforms, mold and yeast, Staphylococcus aureus, Salmonella), etc. The setting and detection methods of each index in its quality standard can refer to the research of scholars such as Gao Jiamin [5].

In addition, it should also be noted that when Cistanche Deserticola, Cistanche tubulosa, and their extracts are used as raw materials for health food, it is necessary to provide an identification report, source of raw materials, purchase and sales contract, and purchase license issued by the raw material supplier (provincial economic and trade department). A copy of the issued acquisition license) (in order to prevent grassland degradation, the collection of licorice, cistanche and snow lotus must be approved by the relevant government departments, and the use is restricted) and the toxicity test report of the raw materials of cistanche.

2 Application status of Cistanche deserticola in health food

As of July 15, 2021, the data retrieved from the current national "Special Food Information Query Platform" shows that Cistanche Deserticola, Cistanche tubulosa, and their extracts have been approved as health food raw materials.

There are 47 products in total, including 40 using Cistanche deserticola, 4 using Cistanche Tubulosa extract, and 3 using Cistanche Salsa extract.

2.1 Feature Claims

From the point of view of function claims, most of the products claim to relieve physical fatigue, regulate immunity, and the two together, followed by anti-oxidant function claim products, in addition to a small amount of auxiliary blood lipid-lowering, increasing bone density, laxative, auxiliary improvement Memory function claims products, the specific statistics are shown in Table 1. Among them, the number of products that single claim to relieve physical fatigue, regulate immunity, antioxidants, laxative and help improve memory accounted for 36.17% (17 in total), 23.40% (11 in total), and 4.26% (in total). 2), 2.13% (1 in total), the number of products claiming to regulate immunity and relieve physical fatigue at the same time accounted for 14.89% (7 in total), and the number of other products accounted for 17.02% (8 in total).

Combined with the research progress of the health care function of Cistanche deserticola, its main health care function is to relieve physical fatigue and regulate immunity, so these two functions have the largest number of approvals.

2.3 The characteristics of the logo components

The main chemical components in Cistanche are phenylethanol glycosides, iridoids, lignans and their glycosides, sugars, etc., as well as a small amount of benzyl alcohol glycosides, monoterpenes, alkaloids, volatile oils, amino acids, Inorganic trace elements and other components [6-8]. Therefore, in the selection of iconic ingredients, echinacoside and verbasin are mainly selected, and some are saponins and polysaccharides.

2.4 Dosage of Cistanche

The recommended daily dosage of Cistanche in the Chinese Pharmacopoeia is 6-10g. In April 2018, the former Health and Health Commission issued the "Letter on Requesting Opinions on the Administration of Treating 9 Substances such as Codonopsis pilosula as Traditional Chinese Medicine Substances" (Guoweiban Food Letter [2018] No. 278), and it is planned to use Cistanche deserticola. (Desert) is added to the list of "substances that are both food and Chinese medicinal materials", and the daily consumption is limited to ≤3 g/d, and detailed regulations are given for its Latin name, family name, part of use, and unsuitable people . In January 2020, the Department of Food Safety Standards and Monitoring and Evaluation issued the "Notice on the Pilot Work on the Management of 9 Substances such as Codonopsis pilosula that are both food and Chinese medicinal materials according to tradition" “Substances of Foodstuffs” pilot list, indicating that it may be added to the list of food and drug substances in the future.

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