JP2018177720A - Chinese medicine agent for normalizing hormone abnormality of hypothyroidism due to chronic thyroiditis - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a composition for normalizing hormone abnormality of hypothyroidism due to chronic thyroiditis.SOLUTION: A Chinese medicine agent for normalizing hormone abnormality of hypothyroidism due to chronic thyroiditis contains a mixture of oren-gedoku-to and ryokei-jutsukan-to as active ingredients.SELECTED DRAWING: None

Description

  The present invention relates to a composition for normalizing hormonal abnormalities of hypothyroidism due to chronic thyroiditis comprising a combination drug of traditional Chinese medicine.

  Traditional Chinese medicine is a combination of several herbal medicines, which treats the disease by conditioning the patient's entire body. Chinese herbal medicines are selected and administered on the basis of the patient's condition (a proof in Oriental medicine (Sho)).

  Hypothyroidism in chronic thyroiditis is a disease that accounts for the majority of primary hypothyroidism. The cause of chronic thyroiditis was discovered in 1956 by Roitt, Doniach et al. Of the United Kingdom discovered anti-thyroglobulin antibodies in the blood of patients with this disorder, and Whitebsky and Rose of the same year successfully developed thyroiditis experimentally in the same year, and the thyroid Chronic inflammation in was found to be inflammation involving autoimmunity. Thus, it has been shown that hormonal abnormalities of hypothyroidism due to chronic thyroiditis are disorders of thyroid tissue due to autoimmune mechanisms.

  Because there is negative feedback between blood thyroid hormone and pituitary TSH secretion, blood TSH increases in thyroid hypothyroidism. Therefore, for hypothyroidism in chronic thyroiditis, FT4 (free thyroxine) is normal, and only TSH (thyroid stimulating hormone) is elevated. In addition to latent hypothyroidism and TSH (thyroid stimulating hormone) elevation, FT 4 (free) There is overt hypothyroidism that shows a decrease in thyroxine). Usually, in overt hypothyroidism, thyroid hormone replacement therapy is initiated promptly. However, in the case of latent hypothyroidism, it is clinically usual to start thyroid hormone replacement therapy when TSH (thyroid stimulating hormone) rises to approximately 10 ng / dl or more. That is, regardless of normal or low FT4 hypothyroidism in chronic thyroiditis, there is only hormone replacement therapy for hormonal abnormalities that show elevated TSH. Hormone replacement therapy is not a fundamental treatment for chronic thyroiditis and is a drawback of hormone replacement therapy that treatment must be continued for a lifetime in most cases because the cause is not improved. In addition, agents capable of treating hypothyroidism due to chronic thyroiditis and thyroid hormone abnormalities in overt hypothyroidism to date, dry thyroid, three types of thyroid with synthetic T3 and synthetic T4 preparations It is only a hormone. These thyroid hormones have many drugs that require careful use in combination, and there are many side effects caused by thyroid hormone, and when side effects appear, normalize hormonal abnormalities of hypothyroidism due to chronic thyroiditis. There is no cure for it.

  In addition, the treatment using Chinese medicine is empirically based on the effects of hypothyroidism on metabolic decline, cold symptoms, etc. Shinbuto, Ninjinto, Hochueikkito, Tokiyakusan, Yon-kho, Gojo-san, Keishi-ka Yaku-to, Keishi-ka Yaku-dai-ko-to, Kokenchu-to, Saiko-Keishi-ryuka-to, Tsuji, etc. may be used, but hypothyroidism due to chronic thyroiditis It is not a therapeutic agent that can normalize hormonal abnormalities in In addition, it has been reported that Hochu-eiki-to was useful for hypothyroidism in 3 elderly people whose cause has not been identified (see Non-Patent Document 1). Yokukansanko and Henkeito were reported to be effective for recovery from hypothyroidism by the thyroid hormone synthesis inhibitor Metimazole administered orally (see Non-Patent Document 2), Hypothyroidism in an animal experimental model is a study of thyroid hormone recovery from thyroid hormone synthesis inhibitor Metimazole, and its pathogenesis is different from that of chronic thyroiditis. The herbal medicine of Yunkei-to is not used. That is, since a therapeutic agent to normalize hormonal abnormality of hypothyroidism due to chronic thyroiditis is not present in the traditional Chinese medicine treatment, the hormonal abnormality of hypothyroidism due to chronic thyroiditis is treated with only hormone replacement therapy. I have not been.

Yamaguchi Aiji: Bulletin of Kanagawa Medical Association: 44-47, 1991 Hideo Sukawa, et al .: Hormones and Clinical Practice 43 (6): 637-642, 1995

  The present invention provides a composition for normalizing hormonal abnormalities of hypothyroidism due to chronic thyroiditis, comprising a combination of Oren-gedoku-to (Ourengedokuto) and Ryokei-kanto (Ryokei-jikanto) as active ingredients. With the goal.

  Although there are no traditional Chinese medicine treatments that can treat hormonal abnormalities of hypothyroidism due to chronic thyroiditis, the present inventor can normalize hormonal abnormalities of hypothyroidism due to chronic thyroiditis We were able to develop traditional Chinese medicine. That is, a combination of Oren-to-doki-to and Shukei-ka-kan-to combined herbal medicines can normalize 91.20% of patients showing hormonal abnormality of hypothyroidism due to chronic thyroiditis, and completed the present invention.

That is, the present invention is as follows.
[1] A traditional Chinese medicine that normalizes hormonal abnormalities of hypothyroidism due to chronic thyroiditis, which contains a combination of Oren-gedoku-to and Ryokei-ka-kan-to as active ingredients.

  The composition containing the combination of Oren-to-doki-to and Sakai-kei-to-to according to the present invention as active ingredients can normalize hormonal abnormalities of hypothyroidism due to chronic thyroiditis.

Hereinafter, the present invention will be described in detail.
A composition according to the present invention comprises as an active ingredient, Oren-gedo-to (Formula antidoti coptidis) and Formula glycyrrhizae atractylodis cinnamomi hoelen as an active ingredient. It is a combination drug of sweet water.

  Oren-doku-to (Ourengedokuto) is a herbal medicine that is a herbal medicine (Copridis Rhizoma), Augon (Scutellariae Radix), Jaundice (Phellodendri Cortex), and Ponia japonicus (Sanshoshi) (Gardeniaeae) It is a Chinese medicine formulated with Fructus. The daily weight in adults is, for example, 1.5 g to 2.0 g of yellow ginseng, 3.0 g of yellow gourd, 1.5 g to 3.0 g of jaundice, and 2.0 g to 3.0 g of yam dumpling.

  Hereinafter, while Huang Ren, Huang Gong, Huang Jing and Yamako are described, they may refer to things other than those shown below. Huang Ren refers to a dried rhizome from which the roots of the Oppositeidae (Ranunculaceae) Opuntium Coptis japonica Makino or other congeners have been substantially removed. Huanggan refers to a dried root removed from the skin of Scutellaria baicalensis Georgi of Labiatae. Jaundice refers to the dried bark of the Citrusaceae (Rutaceae) phellodendron amurense RUPR. Other congeners are, for example, the Chinese cabbage phellodendron chinense Schneider. "Yamako" refers to dried fruits of Gardenia jasminoides ellis or other congeners of the Rubiaceae family (Rubiaceae).

  Orengedokuto can be produced by obtaining the above four herbal extracts and mixing them at the above-mentioned weight. Alternatively, the above four types of dry herbal medicines can be added to 600 ml of hot water in the above-mentioned blended weight and boiled down (concentrated) to 300 ml over 1 hour to produce 300 ml of the daily dose. Mix 100 ml of each herbal medicine once to make 200 ml and take three times daily before meals. It is also possible to mix 150 ml of each herbal medicine once to make 300 ml and take it twice a day before breakfast and dinner.

  Moreover, a commercially available thing can also be used. As commercially available products, aubergis japonic acid extract extract T tablet (Osugi Pharmaceutical), Kracie Chinese pigmented olyxtomic acid extract tablet (krassy drug), Kotaro Kiyogen-doki-to extract fine particles (Kotaro Kampo pharmaceutical product), Sakamoto kodoku-yokudoki-to extract Granule-S (Sakamoto Hankyaku Pharmaceutical Co., Ltd.), Tsumura-Oren-Toto-to extract extract granules (for medical use) (Tsumura), JPS-O-oren-tototo extract extract granules (for preparation) (JAPS), etc.

  Red wines (Rho kei chi kantou) are 茯苓 (Hoelen), 蒼朮 (Ho tract A (Atractylodis Lanceae Rhizoma) or birch (Atractylodis Rhizoma), cinnabar (Kinhi) (Cinnamomi Cortex) and licorice ( It is a herbal medicine mixed with (Glycyrrhizae Radix). The daily weight ratio in adults is, for example, 4 to 6 g of mulberry, 2 to 3 g of mulberry or birch, 3 to 4 g of cinnamon and 1 to 2 g of licorice, for example.

  The following description will be made with regard to rattan and cinnamon, but may refer to those other than those shown below. Persimmon or white birch and licorice are as described above.

  The term “rice cake” refers to those which have been dried with the sclerotia of the pinewood Poria cocos Wolf of the family Polyporaceae, as it is, or with the outer layer almost removed. Cinnamon refers to dried bark of Cinnamomum cassia Blume of Lauraceae (Lauraceae) or other congeners.

  Satsuma-kai-kanto can be produced by obtaining the above four herbal extracts and mixing them in the above amounts. Alternatively, the above four types of dry herbal medicine can be put in 600 ml of hot water in the above amount and boiled up to 300 ml over 1 hour, and the 300 ml can be manufactured as a daily dose. Moreover, a commercially available thing can also be used. As commercially available products, Kracie 苓 朮 朮 (Fine 薬 品 エ), Kotaro 苓 朮 細 細 (Kotaro Kampo Pharmaceutical), 苓 苓 顆粒 顆粒 extract granules (ム ラ ム ラ), 、 ス TG TG TG (Osugi Pharmaceutical Co., Ltd.), JPS Kakei-kei-kan-to extract granules (for preparation) (JP-S), etc.

  The extract of the herbal medicine contained in Oren-doki-to or Shukei-ka-kan can, for example, extract the above-mentioned herbal medicine with water or hot water, ethanol, acetic acid, etc., and dry it by spray drying or lyophilization and use it as a powder . The powders are mixed to produce Orengedoku-to or Toukai-kanto, and these are mixed to produce a combination.

  The combined preparation of Oren-to-doki-to and Sho-kei-kan-to may be mixed with 1.3-2.71 g of Oren-lyto-Toro dried extract powder and 1.5g-7 g of Persimmon-Kain-to dried extract powder as an adult daily dose. In this case, 100 ml of each herbal medicine is mixed to make 200 ml once and taken three times a day before every meal. It is also possible to mix 150 ml of each herbal medicine once to make 300 ml and take it twice a day before breakfast and dinner. When using a commercially available Chinese herbal medicine extract, the designated daily doses of the commercially available Oren-ji-doki-to extract and the commercially-available 苓-苓 can be divided into three portions, mixed, and taken three times daily before meals. In addition, the designated daily amounts of the commercially available Oren-ji-doki-to extract and the commercially-available 苓 苓 may be divided in two, mixed, and taken twice daily a morning before dinner. The mixture is added to a suitable excipient used in a conventional preparation, an adjuvant and the like to form an oral preparation such as powder, granules, tablets, capsules, solutions, syrups and the like according to a conventional method of preparation. The composition of the invention can be obtained. In addition, a binder, a disintegrant, a surfactant, a flavoring agent and a flavor may be appropriately blended. As the excipient, for example, starch, dextrin, lactose, sucrose, mannitol, crystalline cellulose, anhydrous silicic acid and the like can be mentioned.

  Although the composition of the present invention varies depending on its formulation, it usually contains about 0.1 to 100% by weight of Orengedototo and Shokei-kanto in the whole composition. The dose of the composition of the present invention to a patient may be administered once or several times daily for several days to several tens of months, taking into consideration the age of the patient.

  The combination of Oren-gedoku-to and Sakai-kei-kan-to according to the present invention normalizes hormonal abnormalities in hypothyroidism due to chronic thyroiditis.

  A combination of Oren-to-doki-to and Sho-kei-kan-to can be used as a treatment for hormonal abnormalities in hypothyroidism due to chronic thyroiditis. In addition, a combination of Oren-to-doki-to and Sho-kei-kan-to can be used as a therapeutic agent for hypothyroidism due to chronic thyroiditis.

  For example, in the case of an adult, when the daily dose of the commercial medicinal Kampo extract preparation is 7.5 g, the combined preparation of 2.5 g of each Kampo medicine is orally administered three times a day before meals. Depending on each patient's response, they are administered until the patient's symptoms and skin inflammation disappear. In addition, when the patient is a non-adult person under 17 years old, it may be administered according to the age-specific dosage shown in Table 1.

  For example, in the case of an adult, if the daily dose is 7.5 g in the commercially available Kampo medicine extract preparation, a combined combination of 2.5 g of Orengeditoto and 2.5 g of Shoukei-kanto is orally administered three times a day before meals. Administer for a period of time until symptoms disappear.

  The compositions of the present invention can be directed to mammals, including humans. Examples of mammals other than humans include primates such as monkeys, rodents such as rats and mice, sheep, pigs, cows, cats, dogs and the like.

  Furthermore, the composition of the present invention can be mixed with food, beverage and used as a food and drink composition or feed composition. Under the present circumstances, when the daily amount of commercial Chinese herbal medicine extract is 7.5 g in a person, the amount of 100 mg / kg can be added to a single intake of food or drink or feed, for example. It should just mix so that it may become. The composition of the present invention can also be used as a food / drink composition or feed composition such as powder, granules, liquid, paste and the like. The food and drink include functional indication food, health food and drink, food and drink for specified health, nutritional function food and drink, health support food and drink and the like. Here, the food for specific health refers to a food which is ingested for the purpose of a specific health in the diet and which indicates that the purpose of the health can be expected by the intake. In addition, a functional indication food is a business owner's responsibility and means a food that displays functionality on a product package based on a chemical basis.

  The present invention is specifically described by the following examples, but the present invention is not limited by these examples.

Example 1 Preparation of a combination of Oren-to-doki-to and Ryo-kei-kan-to In the examples, using a commercial Chinese herbal medicine extract, the designated daily amounts of the commercial-oren-en-lyto-to extract and commercial Ryo-kan It was divided, mixed and taken three times daily before meals. It is also possible to divide the designated daily amount of the commercially available Oren-zhi-doki-to extract and the commercially-available 苓-朮, and mix them, and take it twice a day before breakfast and dinner.

Example 2 Normalization of hormonal abnormality of hypothyroidism due to chronic thyroiditis The subject is a case of primary hypothyroidism based on the Japan Thyroid Association Hypothyroidism guideline 2010 and the Japanese Thyroid Association chronic thyroiditis guideline 2010 Hypothyroidism due to chronic thyroiditis clinically diagnosed and 57 patients with overt hypothyroidism (male: female = 9: 48, mean age 42.8 ± 13.8 years (mean ± SD) (29 Years old to 98 years old)). In the cases targeted, there were 41 cases of latent hypothyroidism and 16 cases of overt hypothyroidism due to chronic thyroiditis. The observation period was about nine years from December 2007 to January 2017. Thirty-four patients were treated with Oren-gedoku-to and Kakei-kan-to, and 23 with Control. In the Control group, 16 of the 23 cases had latent hypothyroidism and 7 cases had overt hypothyroidism. Of the 34 patients in the mixed Kampo medicine group treated with Oren-gedokuto and Shukei-ka-kan-to, 22 were patients with latent hypothyroidism due to chronic thyroiditis and 12 cases were overt hypothyroidism due to chronic thyroiditis . Fifteen of 16 cases of overt hypothyroidism due to chronic thyroiditis had received administration of levothyroxine sodium hydrate (T4-Na), which is a variable amount of thyroid hormone. As for normal values, TSH (thyroid stimulating hormone thy thyrotropin》) was used at 0.35 to 3.73 μIU / mL in the RIA solid phase method, and FT4 (free thyroxine) was used at 0.9 to 1.8 ng / dl in ECLIA. For statistical processing, Student's T test and Chi square test were used.

result:
During observation in 13.0% (3/23) of the Control group, TSH, which is one of the indicators of hormonal abnormalities in hypothyroidism due to chronic thyroiditis, became normal. In the group treated with the Chinese herbal medicine combination group of Oren-to-doki-to and Yuka-kei-kan-to, TSH was normalized in 91.2% (31/34) of cases. In the chi-square test, it was possible to significantly (p <0.001) mix traditional Chinese medicine of Oren-gedoto-to and Shukei-ka-kan-to to normalize TSH in hypothyroidism due to chronic thyroiditis. In addition, in the control group, the observation start time TSH 3.37 ± 1.48 (mean ± SD) (n = 23) and the observation end time 5.26 ± 2.26 (mean ± SD) (n = 23), which is significant (P <0.001) hormone Although the abnormality worsened, TSH 7.62 ± 2.60 (mean ± SD) (n = 34) before administration and 2.97 ± 0.26 (mean ± SD) after administration in the mixed Kampo medicine-administered group TSH decreased and normalized significantly (p <0.05) at (n = 34). There was no significant change in FT4 before and after in both groups, but 3 of 3 cases of FT4 reduction also normalized FT4 before administration in the mixed Kampo medicine treatment group of Oren-Goto-To and Shokei-ka-kan-to. In other words, a combination of Oren-gedoku-to and Shukei-ka-kan-to is a novel herbal medicine that can significantly normalize hormonal abnormalities in hypothyroidism due to chronic thyroiditis.

Conclusion:
Aside from hormone replacement therapy, we have been able to develop a mixed traditional Chinese medicine that is the only drug that can be administered to humans to treat hormonal abnormalities of hypothyroidism due to chronic thyroiditis.

  The composition containing the combination of Oren-to-doki-to and Sakai-kei-to-to according to the present invention as active ingredients can be used to normalize hormonal abnormalities of hypothyroidism due to chronic thyroiditis.

Claims (1)

A traditional Chinese medicine that normalizes hormonal abnormalities in hypothyroidism due to chronic thyroiditis, which contains a combination of Oren-to-doki-to and Sho-kei-kan-to as an active ingredient.