CN111658721A - Application of 5-MTHF in preparing medicine for preventing and treating diabetic neuropathy - Google Patents

Application of 5-MTHF in preparing medicine for preventing and treating diabetic neuropathy Download PDF

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CN111658721A
CN111658721A CN202010692322.2A CN202010692322A CN111658721A CN 111658721 A CN111658721 A CN 111658721A CN 202010692322 A CN202010692322 A CN 202010692322A CN 111658721 A CN111658721 A CN 111658721A
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diabetic neuropathy
mthf
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田连忠
徐信保
葛月兰
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Wuxi Yeshan Pharmaceutical Co ltd
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61P3/00—Drugs for disorders of the metabolism
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Abstract

The invention discloses an application of 5-MTHF (methyl tetrahydrofolate) in preparation of a medicine for preventing and treating diabetic neuropathy, which belongs to the technical field of chemical pharmacy, and the technical scheme is characterized in that L-5-methyltetrahydrofolate is used as a raw material for producing the medicine for preventing and treating diabetic neuropathy, fucosan and a traditional Chinese medicine composition are added into the medicine, and the weight ratio of the L-5-methyltetrahydrofolate to the fucosan to the traditional Chinese medicine composition is 3-5:1: 1. The invention develops a new clinical indication of the known compound L-5-methyltetrahydrofolate calcium and provides a new medicine for preventing and treating diabetic neuropathy patients.

Description

Application of 5-MTHF in preparing medicine for preventing and treating diabetic neuropathy
Technical Field
The invention relates to the technical field of chemical pharmacy, in particular to application of 5-MTHF in preparing a medicine for preventing and treating diabetic neuropathy.
Background
The known compound L-5-methyltetrahydrofolate, also known as 5-MTHF, the 5-MTHF in this document refers to L-5-methyltetrahydrofolate of calcium, the molecular formula of which is C20H23CaN7O6Molecular weight is 497.52, CAS number is 151533-22-1, molecular structure is as follows:
Figure BDA0002589745040000011
calcium L-5-methyltetrahydrofolate is a formylated derivative of the reduced form of folic acid, is an activated form of folic acid in vivo and is mainly used as an antidote for folic acid antagonists. It is also used for megaloblastic anemia caused by pregnancy or infancy. L-5-methyltetrahydrofolic acid (L-5-MTHF) is a novel folic acid drug, which is commonly used as a food additive and a main component of a nutritional health product and is gradually known. L-5-MTHF is involved in many important biochemical reactions in vivo and has important pharmacological effects.
Diabetic neuropathy is one of the serious complications of diabetes and is mainly manifested by numbness and pain in the extremities. Symptoms begin at the distal extremity and progress progressively proximally along the extremity, presenting symptoms of numbness and pain in the fingertips, wrist, elbow and shoulders. In the early stage, sensory nerves are mainly affected, and only sensory decline is manifested, which is easily ignored by patients, and unnecessary accidental injuries such as scald and burn at the distal parts of limbs can occur. Once diabetic neuropathy occurs, it is often irreversible, and should be discovered early, treated early, and the prognosis improved.
In recent years, the research on the physiological activity of human bodies by 5-methyltetrahydrofolic acid and salts thereof is increasing. People use the folic acid as a supplement of human folic acid for preventing or treating neurological diseases, and can be applied to the treatment and adjuvant therapy of pathophysiological vascular and cardiovascular diseases, severe senile dementia and the like, thereby showing good application prospects. The L-5-methyltetrahydrofolic acid calcium can penetrate through a blood brain barrier, is used for preventing and treating neuropathy caused by diabetes, has the characteristics of obvious curative effect and less side effect, and gradually becomes a focus of common attention in the field of medical and pharmaceutical research.
Disclosure of Invention
The invention aims to provide application of 5-MTHF in preparation of a medicine for preventing and treating diabetic neuropathy, develop a new clinical indication of a known compound L-5-methyltetrahydrocalcium folate and provide a new medicine for preventing and treating diabetic neuropathy patients.
The technical purpose of the invention is realized by the following technical scheme:
an application of 5-MTHF in preparing a medicine for preventing and treating diabetic neuropathy takes L-5-methyltetrahydrofolic acid calcium as a raw material to produce the medicine for preventing and treating diabetic neuropathy, fucosan and a traditional Chinese medicine composition are added into the components, and the weight ratio of the L-5-methyltetrahydrofolic acid calcium to the fucosan to the traditional Chinese medicine composition is 3-5:1: 1.
Further, the fucosan is derived from brown algae.
Further, the traditional Chinese medicine composition comprises astragalus membranaceus, rehmannia glutinosa, radix puerariae, salvia miltiorrhiza, yams, medlar, folium mori and American ginseng, and the mass ratio of the components in the traditional Chinese medicine composition is 23:20:10:20:10:8:5: 4.
Further, according to the mass ratio of the traditional Chinese medicine composition to water being 1:10, the components in the traditional Chinese medicine composition are subjected to reflux extraction for 30min at the temperature of 95-100 ℃, and then filtered to obtain an extracting solution.
Further, the storage condition of the extract when not in use was-20 ℃.
Furthermore, the L-5-methyl tetrahydrofolate calcium is taken as a raw material to produce the health care medicine for preventing and treating diabetic psychopathy.
Furthermore, the L-5-methyl tetrahydrofolate calcium is taken as a raw material to produce health care medicines for preventing and treating diabetic psychoses, including solid preparations and oral liquid.
Furthermore, the L-5-methyl tetrahydrofolate calcium is used as a raw material to produce a therapeutic drug for preventing and treating diabetic psychoses.
Further, the therapeutic medicine comprises an oral preparation and an injection, wherein the oral preparation comprises tablets, capsules, granules and oral liquid, and the injection comprises large infusion and small volume infusion.
In conclusion, the invention has the following beneficial effects:
1. the L-5-methyl tetrahydrofolate calcium is used as a raw material for preparing a medicine for preventing and treating diabetic neuropathy, and provides a new medicine for preventing and treating diabetes patients.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It will be understood that terms such as "having," "including," and "comprising," as used herein, do not preclude the presence or addition of one or more other elements or groups thereof.
Example 1:
the medicine for preventing and treating diabetic neuropathy is prepared by taking L-5-methyltetrahydrofolic acid calcium as a raw material, and fucosan and a traditional Chinese medicine composition are added into the components. The weight ratio of the L-5-methyltetrahydrofolic acid calcium to the fucosan to the traditional Chinese medicine composition is 3:1: 1.
The fucosan is prepared by extracting brown algae with water at a ratio of 1:25 at 90 deg.C and pH of 3.5 for 4 hr. After extraction, centrifuging to obtain supernatant, adding concentrated hydrochloric acid, precipitating, centrifuging to remove algin to obtain supernatant, immediately adjusting pH to neutral with sodium hydroxide, adding edible alcohol to reach concentration of 60%, and precipitating to obtain crude fucoidan. And then purifying the crude fucosan, washing the crude fucosan with 95% ethanol and diethyl ether respectively for three times, re-dissolving the obtained polysaccharide in water, and performing ultrafiltration desalination and freeze drying to obtain the fucosan.
The traditional Chinese medicine composition comprises astragalus membranaceus, rehmannia glutinosa, radix puerariae, salvia miltiorrhiza, yam, medlar, folium mori and American ginseng, the mass ratio of the components in the traditional Chinese medicine composition is 23:20:10:20:10:8:5:4, the components in the traditional Chinese medicine composition are extracted for 30min under the condition of 100 ℃ in a refluxing mode according to the mass ratio of the traditional Chinese medicine composition to water of 1:10, and then the extracting solution is obtained through filtering. Adding the extractive solution into medicine prepared from L-5-methyltetrahydrofolic acid calcium. The storage condition of the extractive solution when not in use is-20 deg.C.
The therapeutic medicine for preventing and treating diabetic psychopathy is prepared by taking L-5-methyltetrahydrofolic acid calcium as a raw material, weighing each component according to the weight ratio of 3:1:1 of L-5-methyltetrahydrofolic acid calcium, fucosan and a traditional Chinese medicine composition, adding 500mL of water, decocting for 120 minutes with slow fire, and preparing into an oral preparation, wherein the oral preparation is oral liquid with the specification of 10 mL.
The usage and dosage are as follows: the preparation is administered twice daily, 20ml each time.
Example 2:
the medicine for preventing and treating diabetic neuropathy is prepared by taking L-5-methyltetrahydrofolic acid calcium as a raw material, and fucosan and a traditional Chinese medicine composition are added into the components. The weight ratio of the L-5-methyltetrahydrofolic acid calcium to the fucosan to the traditional Chinese medicine composition is 4:1: 1. The rest is the same as example 1.
Example 3:
the medicine for preventing and treating diabetic neuropathy is prepared by taking L-5-methyltetrahydrofolic acid calcium as a raw material, and fucosan and a traditional Chinese medicine composition are added into the components. The weight ratio of the L-5-methyltetrahydrofolic acid calcium to the fucosan to the traditional Chinese medicine composition is 5:1: 1. The rest is the same as example 1.
Example 4:
as a comparative example, the L-5-methyltetrahydrofolate calcium is directly used as a raw material to produce a therapeutic drug for preventing and treating diabetic neuropathy, the therapeutic drug is an oral preparation, and the oral preparation is oral liquid with the specification of 10 mg.
Three kinds of drugs, numbered # 1- # 3, were prepared according to the methods of examples 1 to 3, and male and female cases, 20 male and 20 female, with an average age of 49 years and an average course of diabetes of 6 years were randomly selected. The male and female cases are averagely divided into 4 groups, corresponding to 4 embodiments, including 5 male cases and 5 female cases, the prepared corresponding medicines are respectively applied to the corresponding cases for testing, the blood glucose data before and after treatment of each group of cases are respectively measured, the average value of the blood glucose data of each group of cases is taken, the result is shown in table 1, the blood glucose index is represented by FBG, 2hpG and HAb1c, and the detection instrument adopts a Roche ACCU-CHEK full-automatic blood glucose analyzer.
TABLE 1 blood glucose index before and after treatment for four groups of patients
Figure BDA0002589745040000061
As can be seen from the data in Table 1, the respective indices of blood glucose were significantly reduced in the case of the treatment drugs # 1 to # 3 as compared with the indices in the comparative example. Further shows that the fucosan and the traditional Chinese medicine composition added in the components of the traditional Chinese medicine composition act together with the traditional Chinese medicine, can effectively reduce blood sugar and blood fat in human bodies, has obvious effect on relevant diseases of diabetes, and has no obvious side effect.
The present embodiment is only for explaining the present invention, and it is not limited to the present invention, and those skilled in the art can make modifications of the present embodiment without inventive contribution as needed after reading the present specification, but all of them are protected by patent law within the scope of the claims of the present invention.

Claims (9)

1. The application of 5-MTHF in preparing medicine for preventing and treating diabetic neuropathy is characterized in that: the medicine for preventing and treating diabetic neuropathy is produced by taking L-5-methyltetrahydrofolic acid calcium as a raw material, and fucosan and a traditional Chinese medicine composition are added into the medicine, wherein the weight ratio of the L-5-methyltetrahydrofolic acid calcium to the fucosan to the traditional Chinese medicine composition is 3-5:1: 1.
2. Use of 5-MTHF for the preparation of a medicament for the prevention and treatment of diabetic neuropathy according to claim 1, wherein: the fucosan is derived from brown algae.
3. Use of 5-MTHF for the preparation of a medicament for the prevention and treatment of diabetic neuropathy according to claim 1, wherein: the traditional Chinese medicine composition comprises astragalus membranaceus, rehmannia glutinosa, radix puerariae, the root of red-rooted salvia, yam, medlar, folium mori and American ginseng, and the mass ratio of the components in the traditional Chinese medicine composition is 23:20:10:20:10:8:5: 4.
4. Use of 5-MTHF according to claim 3 for the preparation of a medicament for the prevention and treatment of diabetic neuropathy, characterized in that: according to the mass ratio of the traditional Chinese medicine composition to water being 1:10, the components in the traditional Chinese medicine composition are extracted under reflux for 30min at the temperature of 95-100 ℃, and then filtered to obtain an extracting solution.
5. Use of 5-MTHF according to claim 4 for the preparation of a medicament for the prevention and treatment of diabetic neuropathy, characterized in that: the storage condition of the extractive solution when not in use is-20 deg.C.
6. Use of 5-MTHF for the preparation of a medicament for the prevention and treatment of diabetic neuropathy according to claim 1, wherein: the L-5-methyl tetrahydrofolic acid calcium is used as a raw material to produce the health care medicine for preventing and treating diabetic psychopathy.
7. Use of 5-MTHF for the preparation of a medicament for the prevention and treatment of diabetic neuropathy according to claim 1, wherein: the health care medicine for preventing and treating diabetic mental lesion, which comprises a solid preparation and an oral liquid, is produced by taking L-5-methyltetrahydrofolic acid calcium as a raw material.
8. Use of 5-MTHF for the preparation of a medicament for the prevention and treatment of diabetic neuropathy according to claim 1, wherein: the L-5-methyl tetrahydrofolic acid calcium is used as a raw material to produce a therapeutic medicine for preventing and treating diabetic psychoses.
9. Use of 5-MTHF for the preparation of a medicament for the prevention and treatment of diabetic neuropathy according to claim 7, wherein: the therapeutic medicine comprises an oral preparation and an injection, wherein the oral preparation comprises tablets, capsules, granules and oral liquid, and the injection comprises large infusion and small volume infusion.
CN202010692322.2A 2020-07-17 2020-07-17 Application of 5-MTHF in preparing medicine for preventing and treating diabetic neuropathy Pending CN111658721A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010135858A1 (en) * 2009-05-25 2010-12-02 成都中汇制药有限公司 Pharmaceutical composition and use for preparing medicament thereof
CN103263419A (en) * 2013-05-27 2013-08-28 深圳奥萨医药有限公司 New application of pharmaceutical composition of metformin and 5-methyltetrahydrofolate

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010135858A1 (en) * 2009-05-25 2010-12-02 成都中汇制药有限公司 Pharmaceutical composition and use for preparing medicament thereof
CN103263419A (en) * 2013-05-27 2013-08-28 深圳奥萨医药有限公司 New application of pharmaceutical composition of metformin and 5-methyltetrahydrofolate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
黄激扬 等: "同型半胱氨酸、叶酸、维生素B6及维生素B12与糖尿病并发症的相关性研究", 《四川医学》 *

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