JP6154566B1 - Chinese medicine to normalize hormonal abnormalities of hypothyroidism due to chronic thyroiditis - Google Patents

Abstract

The present invention provides a composition for normalizing hormonal abnormalities in hypothyroidism caused by chronic thyroiditis. [Solution] A Chinese medicine that normalizes hormonal abnormalities of hypothyroidism caused by chronic thyroiditis, which contains a combination of Houren Deto-to and Kankei-kanto. [Selection figure] None

Description

  The present invention relates to a composition for normalizing hormonal abnormalities in hypothyroidism caused by chronic thyroiditis, which contains a combination of traditional Chinese medicines.

  Chinese herbal medicine is a combination of herbal medicines that treats the disease by adjusting the condition of the patient's entire body. Herbal medicine is selected and administered based on the patient's symptoms (Sho in Oriental medicine).

  Hypothyroidism in chronic thyroiditis is a disease that accounts for the majority of primary hypothyroidism. In 1956, Roitt, Doniach et al. Of the UK discovered an anti-thyroglobulin antibody in the blood of a patient with this disease, and in the same year, Whitebsky, Rose of the United States succeeded in experimentally creating thyroiditis. Chronic inflammation in was found to be inflammation involving autoimmunity. In other words, it was shown that the hormonal abnormality of hypothyroidism caused by chronic thyroiditis is a disorder of thyroid tissue due to an autoimmune mechanism.

  Because there is negative feedback between blood thyroid hormone and pituitary TSH secretion, blood TSH increases in hypothyroidism. Therefore, for hypothyroidism in chronic thyroiditis, FT4 (free thyroxine) is normal and only TSH (thyroid stimulating hormone) rises. In addition to latent hypothyroidism and TSH (thyroid stimulating hormone) rise, FT4 (free There is overt hypothyroidism that shows a decrease in thyroxine. Usually, for overt hypothyroidism, thyroid hormone replacement therapy is started immediately. 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. In other words, regardless of the normal or low value of FT4 for hypothyroidism in chronic thyroiditis, only hormone replacement therapy exists for the treatment of hormone abnormalities that show an increase in TSH. Hormone replacement therapy is not a fundamental cure for chronic thyroiditis and does not improve the cause, so it is a disadvantage of hormone replacement therapy that it must be treated for the lifetime in most cases. To date, there are three types of thyroid gland, dry thyroid, synthetic T3 and synthetic T4 preparations, which can treat latent hypothyroidism due to chronic thyroiditis and thyroid hormone abnormalities in overt hypothyroidism. Only hormones. These thyroid hormones have a variety of drugs that require attention in combination, and there are many side effects caused by thyroid hormones, and when side effects appear, normalize hormonal abnormalities of hypothyroidism caused by chronic thyroiditis. There is no cure to make it happen.

  In addition, treatment with Kampo medicines has been empirically based on the effects on hypometabolism, decreased metabolism, cold symptoms, etc.Shinbuto, Ninjinto, Hochuekkito, Tokiyakuyakusan, Onkei-to, Gojosan, Keishika-ka-yaku-yu, Keishi-ka-ka-yaku-daiko-to, Koken-chu-yu, Saiko-Kei-sha-sui-to, and tsutsuji are sometimes used, but hypothyroidism due to chronic thyroiditis It is not a treatment that can normalize hormonal abnormalities. In addition, Hochuekkito was useful for hypothyroidism in 3 elderly patients whose cause was not specified (see Non-Patent Document 1). It has been reported that Yokukansanka-Chan-Summer and Unkei-to are effective in recovering from hypothyroidism with the thyroid hormone synthesis inhibitor Metimazole administered locally (see Non-Patent Document 2). Hypothyroidism in animal experimental models is an examination of the recovery of thyroid hormone from the thyroid hormone synthesis inhibitor Metimazole, and since its etiology is different from chronic thyroiditis, it is clinically completely Unkeito herbal medicine is not used. In other words, since there is no treatment for normalizing hormonal abnormalities in hypothyroidism due to chronic thyroiditis in Chinese medicine treatment, only hormone replacement therapy can be used to treat hormonal abnormalities in hypothyroidism due to chronic thyroiditis. I have not been told.

Ai Yamaguchi: Kanagawa Medical Association Bulletin: 44-47,1991 Hideo Sugawa, et al .: Hormone and Clinical 43 (6): 637-642,1995

  The present invention provides a composition for normalizing hormonal abnormalities in hypothyroidism caused by chronic thyroiditis, which contains a combination of Orendetoto and Ryoketsukanto as active ingredients. With the goal.

  Until now, there is no medicine that can treat hormonal abnormality of hypothyroidism caused by chronic thyroiditis, but the present inventor can normalize hormonal abnormality of hypothyroidism caused by chronic thyroiditis. We were able to develop a Chinese medicine that can be used. In other words, the mixed Chinese medicine of Houren Deto-to and Sakai Keitou-to can normalize 91.20% of patients with hormonal abnormalities of hypothyroidism due to chronic thyroiditis, thus completing the present invention.

That is, the present invention is as follows.
[1] A traditional Chinese medicine that normalizes hormonal abnormalities in hypothyroidism caused by chronic thyroiditis, which contains a combination of Hou Ren Deto and Tokei Katsura Ayu.

  The composition containing the combination of Huangren detoxification and keikeienkanto as an active ingredient of the present invention can normalize hormonal abnormalities of hypothyroidism caused by chronic thyroiditis.

Hereinafter, the present invention will be described in detail.
The composition of the present invention comprises Huangren Detoyu and Otsukushien, which contain, as active ingredients, Huangrendetoto (Formula antidoti coptidis) and Formula glycyrrhizae atractylodis cinnamomi hoelen. It is a mixture of Amayu.

  Orendetoto is a herbal medicine, Copridis Rhizoma, Scutellariae Radix, Phellodendri Cortex, and Gardeniae Fructus). As for the daily dose in adults, the blended weight of each dry crude drug is, for example, 1.5 g to 2.0 g of yellow chain, 3.0 g of yellow rice, 1.5 g to 3.0 g of jaundice, and 2.0 g to 3.0 g of yam.

  In the following, yellow chain, yellow rice, jaundice and yam will be described, but things other than those shown below may be indicated. Yellow ream refers to a dried rhizome except for the roots of Ranunculaceae's Crenis Coptis japonica Makino or other related plants. Yellow gourd means dried roots excluding the pericarp of Scutellaria baicalensis Georgi from Labiatae. Jaundice refers to dried bark excluding the pericarp (cork skin) of the Rutaceae yellowfin Phellodendron amurense RUPR. Or other related genera. Other plants belonging to the same genus include, for example, the cinnamon hinder Phellodendron chinense Schneider. Mountain lion refers to the dried fruits of Gardenia jasminoides ellis or other related plants of the Rubiaceae family.

  Korentoto can be produced by obtaining the above four kinds of herbal extract preparations and mixing them at the above blending weight. Alternatively, the above four kinds of dry herbal medicines can be produced in 600 ml of hot water at the above blending weight and boiled (concentrated) to 300 ml over 1 hour, and 300 ml can be produced as a daily dose. Mix 100 ml of each herbal medicine once to make 200 ml once and take 3 times a day before each meal. You can mix 150ml of each herbal medicine once to make 300ml once and take it twice a day before breakfast and dinner.

  Commercially available products can also be used. As a commercially available product, Osugi Hokuren Detox Extract T Tablet (Osugi Pharmaceutical), Kracie Hokuren Detox Extract (Krasie Yakuhin), Kotaro Hokuren Detox Extract Fine Granules (Kotaro Kampo Pharmaceutical), Sakamoto Hokuren Detox Extract Granule-S (Sakamoto Hanpo Pharmaceutical Co., Ltd.), Tsumura Korentoto extract granule (for medical use) (Tsumura), JPS Korentoto extract granule (for dispensing) (JP).

  Ryokei tsukanto can be found in Hoelen, Atractylodis Lanceae Rhizoma, Atractylodis Rhizoma, Cinnamomi Cortex and licorice ( It is a herbal medicine containing Glycyrrhizae Radix. As for the daily dose in adults, the blended weight ratio of each dry crude drug is, for example, cocoon 4 g to 6 g, cocoon or white cocoon 2 g to 3 g, cinnamon 3 g to 4 g, and licorice 1 g to 2 g.

  Hereinafter, cocoons and cinnamon will be described, but things other than those shown below may be indicated. Salmon or birch and licorice are as described above.

  Acupuncture refers to a dried potato nucleus of the Porphya cocos Wolf from the Polyporaceae family as it is or with almost no outer layer removed. Cinnamon means dried bark of Cinnamomum cassia Blume of Lauraceae or other related genera.

  苓 桂 朮 甘 湯 can be produced by obtaining the above four kinds of herbal extracts and mixing them in the above amounts. Alternatively, the above four kinds of dry crude drugs can be produced in the above blending amount in 600 ml of hot water and boiled to 300 ml over 1 hour, and 300 ml can be produced as a daily dose. Commercially available products can also be used. As a commercially available product, Kracie 苓 Katsura Ayu Extract Fine Granule (Krasie Yakuhin), Kotaro 苓 Katsura Ayu Extract Fine Granule (Kotaro Kampo Pharmaceutical), Tsumura 苓 Katsura Ayu Extract Granule (Tsumura), Osugi 苓 Katsura Ayu Extract TG (Osugi Pharmaceutical Co., Ltd.), JPS 苓 Katsura Ayu Extract Granule (for dispensing) (JP S) and the like.

  The herbal medicine extract contained in Hou Ren Detoyu or Sakai Katsura Ayuto can be used as a powder, for example, by extracting the above herbal medicine with water or hot water, ethanol, acetic acid, etc., and drying by spray drying or freeze drying. . The powder is mixed to produce Huangren Detoxification Hot Water or Sakai Keikanto, and these are mixed to produce a mixture.

  As a daily dose for adults, the combination of Huangren Detoyu and Tokei Katsuri-Ayu may be mixed with 1.3 g to 2.71 g of Huangren Detox Dry Extract Powder and 1.5 g to 7 g of Totsuo Kaito Sweet Dry Powder. In this case, mix 100 ml of each Chinese medicine once to make 200 ml once and take 3 times a day before each meal. You can mix 150ml of each herbal medicine once to make 300ml once 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 commercial yellow renzento extract and the commercially available katsura candy sweet water may be divided into three, mixed and taken three times a day before meals. In addition, the designated daily doses of the commercially available Huangren Detox extract and the commercially available katsura candy sweet water may be divided into two, mixed and taken twice a day before dinner in the morning. Add the appropriate excipients, adjuvants, etc. used in normal preparations and mix them into oral preparations such as powders, granules, tablets, capsules, liquids, syrups, etc. according to conventional methods for preparation. Inventive compositions can be obtained. Moreover, you may mix | blend binder, a disintegrating agent, surfactant, a corrigent, and a fragrance | flavor suitably. Examples of the excipient include starch, dextrin, lactose, sucrose, mannitol, crystalline cellulose, and silicic anhydride.

  The composition of the present invention varies depending on the dosage form, but usually contains about 0.1 to 100% by weight of Hou Ren Deto-to and Tokei Katsuri-anto in the entire composition. The dose of the composition of the present invention to a patient may be administered over several days to several tens of months, taking into account the age of the patient, once a day or divided into several times.

  The combination of Huangren detoxification and keikeienkanto normalizes the hormonal abnormality of hypothyroidism caused by chronic thyroiditis.

  The combination of Hou Ren Deto-to and Sakai Keito-to can be used as a treatment for hormonal abnormalities in hypothyroidism caused by chronic thyroiditis. In addition, a combination of Houren Deto-to and Sakaikeitokanto can be used as a therapeutic agent for hypothyroidism caused by chronic thyroiditis.

  For example, in the case of an adult, if the daily medical dose is 7.5 g for a commercial medical Kampo extract, 2.5 g of each Kampo medicine is orally administered three times a day before meals. Depending on the response of each patient, it is administered until the patient's symptoms and skin inflammation disappear. Moreover, what is necessary is just to administer according to the dosage according to age shown in Table 1 when a patient is a non-adult under 17 years old.

  For example, in the case of an adult, if the daily dosage is 7.5 g for a commercially available medical herbal extract preparation, a mixed mixture of 2.5 g of Hou Ren Deto-to and 2.5 g of Tokeikei-kanto is orally administered three times a day before meals. Administer for the period until symptoms disappear.

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

  Furthermore, the composition of this invention can be mixed with a foodstuff and a drink, and can be used as a food-drinks composition or a feed composition. At this time, for example, when the daily dose of a commercially available Chinese herbal medicine extract is 7.5 g in humans, the amount of 100 mg / kg What is necessary is just to mix | blend. The composition of the present invention can also be used as a food / beverage composition or feed composition such as powder, granule, liquid or paste. The foods and drinks include functional display foods, health foods and drinks, specific health foods and drinks, nutritional functional foods and drinks, health supplement foods and drinks, and the like. Here, the food for specified health refers to food that is ingested for the purpose of specific health in the diet and displays that the purpose of the health can be expected by the intake. The functional labeling food means food that displays the functionality on the product package based on the chemical basis at the responsibility of the operator.

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

Example 1 Preparation of a combination of Hou Ren Deto-to and Sakai Katsura Ayu In the examples, a commercially available Chinese herbal medicine extract was used, and the specified daily doses of 3 Divide, mix and take 3 times a day before meals. The designated daily doses of commercially available Huangren detox extract and commercially available katsura candy sweet water can be divided into two, mixed and taken twice a day before dinner in the morning.

Example 2 Normalization of Hormone Abnormalities of Hypothyroidism due to Chronic Thyroiditis Subject is a case of primary hypothyroidism based on the Japanese Thyroid Society Hypothyroidism Guideline 2010 and the Japanese Thyroid Society Chronic Thyroiditis Guideline 2010 57 patients with latent hypothyroidism due to chronic thyroiditis diagnosed clinically and overt hypothyroidism (male: female = 9:48, mean age 42.8 ± 13.8 years (mean ± SD) (29 Years old to 98 years old)). In the targeted cases, there were 41 patients with latent hypothyroidism and 16 patients with overt hypothyroidism due to chronic thyroiditis. The observation period was about nine years from December 2007 to January 2017. There were 34 mixed Chinese herbal medicine treatment groups of Hou Ren Deto and Tokei Katsuri Ayu, and 23 in the Control group. In the Control group, 16 of 23 cases had latent hypothyroidism and 7 cases had overt hypothyroidism. Of 34 patients treated with Huangren detoxin and keikei kankanto, 22 patients had latent hypothyroidism due to chronic thyroiditis, and 12 patients had overt hypothyroidism due to chronic thyroiditis. . Fifteen of 16 cases of overt hypothyroidism due to chronic thyroiditis received various doses of levothyroxine sodium hydrate (T4-Na). Normal values of TSH (thyroid stimulating hormone << thyrotropin >>) were 0.35 to 3.73 μIU / mL by RIA solid phase method, and 0.9 to 1.8 ng / dl of ECLIA was used for FT4 (free thyroxine). Statistical processing used Student's T test and Chi square test.

result:
In the 13.0% (3/23) group in the control group, TSH, which is one of the indicators of hormone abnormalities in hypothyroidism due to chronic thyroiditis, became normal. In the group treated with the mixed Chinese herbal medicine of Hou Ren Deto and Tokei Katsuri Ato, the TSH level was normal in 91.2% (31/34) of the cases. In the chi-square test, the mixed Chinese medicine of Houren Deto-to and Sakaikeikanto was able to significantly normalize TSH of hypothyroidism due to chronic thyroiditis (p <0.001). In the control group, TSH3.37 ± 1.48 (mean ± SD) (n = 23) at the start of observation, 5.26 ± 2.26 (mean ± SD) (n = 23) at the end of observation, and significant (P <0.001) hormone Abnormalities worsened, but in the Chinese herbal medicine administration group of Huangren Detox and Tokeikei-kanto, TSH7.62 ± 2.60 (mean ± SD) (n = 34) before administration, 2.97 ± 0.26 (mean ± SD) after administration ) (N = 34), TSH decreased significantly and normalized (p <0.05). There was no significant change in FT4 in both groups before and after, but in the mixed Chinese herbal medicine treatment group of Hokuren detoxin and 苓 Katsurakanto, 3 out of 3 cases with FT4 declined before administration, FT4 also normalized. In other words, the mixed Chinese herbal medicine of Houren Deto-to and Sakaikeikanto is a novel Chinese medicine that can significantly normalize the hormonal abnormality of hypothyroidism caused by chronic thyroiditis.

Conclusion:
Other than hormone replacement therapy, we were able to develop a mixed Chinese medicine of Houren Deto-to and Sugakei-anto which is the only drug that can be administered to humans to treat hormonal abnormalities of hypothyroidism caused by chronic thyroiditis.

  The composition containing the combination of Huangren detoxification and keikeienkanto as an active ingredient of the present invention can be used to normalize hormonal abnormalities of hypothyroidism caused by chronic thyroiditis.

Claims (1)

A herbal medicine that normalizes hormonal abnormalities in hypothyroidism caused by chronic thyroiditis, which contains a combination of Huangren detoxin and keikeienkanto.