JP2007277128A - Method for prophylaxis, amelioration of lifestyle-related disease and prophylactic, ameliorant for the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To establish treatment method for obesity, diabetes and hyperlipidemia, and to provide pharmaceuticals effective to obesity, diabetes and hyperlipidemia. <P>SOLUTION: The invention relates to the method comprising administration of either of Bofu-tsushousan (R), Magnoliae Cortex powder and Curcuma zedoaria powder, and powders of Astragali Radix, Elsholtzia ciliata, Eleutherococcus senticosus, Cassia tora, Citrus aurantium, Antidesma pentandrum and Actinidia polygama. The amount of administration of the Bofu-tsushousan (R) per day follows the amount defined by Chinese medicine formulation per day, and other ingredients are each defined as 0.5-25 wt.% of the Bofu-tsushousan (R). The administration is carried out three times per day at before every meal or two times per day at before morning and evening meal by equally dividing the amount of administration per day into tree or two. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a method for preventing / ameliorating lifestyle-related diseases and a preventive / ameliorating agent, and more particularly, to a method for preventing and treating lifestyle-related diseases such as obesity, diabetes, hyperlipidemia and the like and a medicine used therefor.

  Obesity is considered to be a trigger for metabolic syndrome, which is the cause of lifestyle-related diseases such as diabetes and cardiovascular diseases, and has become a major problem in modern society. Various attempts such as dietary calorie restriction and exercise have been made to eliminate obesity, but none of them are long-lasting and often fail.

  By the way, Chinese herbal breezes are composed of various herbal ingredients as will be described later. In the ingredients, Bowfu, Keigai and Maou show a strong sweating action, and Keigai and Maou promote diuresis. Mentha has a mild sweating effect and also has a healthy stomach effect. Forsythia, Sanshishi, Ogon, and raw gypsum have strong anti-inflammatory and antipyretic effects. Forsythia enhances heat dissipation by mild sweating, and works for incentives and diuresis. Sanshishi works daringly, and Ogon works daringly and diuretics, strengthening the detoxification effect. Raw gypsum works to suppress increased vascular permeability. Diou removes feces in the intestinal tract together with bowshade by copying, and also assists detoxification by bile and diuretic action. Casseki has a diuretic effect. Sandalwood enhances digestion and absorption, drawing water from the digestive tract into the blood and diuresis. Toki and peanut have nourishing tonic, nourishing and nourishing the body.

  Due to the effects described above, Fengtsu Sansho is considered effective for excretion of metabolites and reduction of fat content, and has been mainly used for the treatment of obesity. However, as will be described later, the therapeutic effect by itself cannot be expected so much.

  On the other hand, the present inventor has completed and filed an application for an anti-obesity agent that uses a vehicle anterior element and Morohaya in order to improve the anti-obesity effect of Fukatsu Tsusho-san (Patent Document 1).

JP-A-11-130689

  As mentioned above, it is known that Fengtsu Sansho has an anti-obesity effect, but by itself, its effect is extremely weak, and obesity by the present inventor and associated diabetes, liver dysfunction, hypertension. According to the results of administration to patients, only about 10% was recognized as effective. Moreover, since treatment requires a long period of time, it imposes a great deal of patience and mental burden on the patient, and most patients have failed within six months and cannot be treated.

  Patients with chronic diseases that are likely to be caused by obesity, such as back pain, stiff shoulders, dizziness, knee joint pain, and high blood pressure, which are particularly common among female patients, have been treated with various drugs for a long time. It was not easy to improve.

  The present invention has been made in such a situation, and further improves the anti-obesity agent (Japanese Patent Laid-Open No. 11-130689) related to the development of the present inventor and dramatically improves the anti-obesity effect of Fukatsutsu Seisaku. In addition, the prevention / improvement method and preventive / ameliorating agent for lifestyle-related diseases that can prevent and ameliorate lifestyle-related diseases such as hyperlipidemia and diabetes that are superior in a very short period of time compared to the case of single administration. The issue is to provide.

  The method for preventing / ameliorating lifestyle-related diseases according to the present invention comprises administering Fufutsu Seisaku, Kokuboku powder and Gajutsu powder, Ogi powder, Koju powder, Gokajin powder, Ketsumeishi powder, Kijutsu powder, Hihatsu powder and Mokten Ryo powder. It is characterized by doing.

  Expanding blood vessels by combining various herbs, in particular, one of Koboku and Gakutsu, Ogi, Koji, Gokajin, Ketsumeishi, Kijitsu, Hihatsu and Mokten Ryou Or improve muscle function, adjust gastrointestinal movement, improve various physical functions such as sweating and diuretic effect, and improve lifestyle diseases without strict diet and exercise.

  According to the present invention, the therapeutic effect can be drastically improved by using a combination of either Koboku or Gajutsu, Ogi, Kojyu, Gokajin, Ketsumeishi, Kizuttsu, Hibatsu, and Mokten Ryo in combination with Fufutsu Seisaku.

  Next, a description will be given of components other than the windproof sansho used in the present invention. As for Koboku, adrenaline enhancing action, ganglion blocking action, and antipilocarpine action are recognized. It has a mild laxative effect on the intestinal tract and a stimulating effect on the gastrointestinal mucosa, so that it can be used as an intestinal or digestive agent. It is also used as a diuretic.

  Gajutsu is used in place of Kokuboku when a compound containing Koboku as a medicine according to the present invention is administered to a patient and the patient complains of diarrhea.

  Since ogi contains isoflavonoids, several amino acids, folic acid, etc., it has a blood pressure lowering effect and improves blood circulation and nutritional status of the skin by vasodilation. The diuretic effect is quite pronounced. Ogi's tonicity is thought to be related to sex hormone-like effects and central nervous system excitability.

  Koju is used for sweating, diuretics, and for treating systemic edema.

  Gokadine is found to dilate blood vessels to lower blood pressure and to act on the central nerves to sedate. Increases muscle resistance and increases intramuscular ATP production by adaptogen-like action superior to ginseng. In addition, it increases blood flow in the brain and promotes the secretion of hormones in the brain.

  Jujutsu is known to have actions such as promoting bile secretion, lowering serum cholesterol, and sedation. It can also be used for the treatment of indigestion because of its ability to adjust peristaltic rhythm.

  Ketsumeishi has been reported to have antihypertensive, diuretic, antilipidemic, and gastric juice secretion promoting effects.

  Mocten Ryo has a salivary secretion promoting action, a smooth muscle inhibiting action, etc., and is used as a treatment or tonic for analgesia, rheumatism, neuralgia.

  Hihatsu is currently used in the United States by many people who suffer from obesity because it is effective for cooling by improving blood flow and has a fat burning effect.

  In the present invention, any one of Fufutsu Seisaku, Koboku or Gajutsu, Ogi, Koju, Gokajin, Ketsumeishi, Kijutsu, Hibatsu and Mokten Ryo (hereinafter, the active ingredients other than Fufutsu Seisaku are collectively abbreviated as Koboku etc.) Lifestyle-related diseases can be prevented and ameliorated by administering an anti-lifestyle-related disease drug comprising The reason why either Kokuboku or Gakutsu is used is that, when Kokuboku is used, when a patient who has been administered a drug complains of diarrhea, it is better to use Gakutsu instead of Kokuboku.

  According to a written book (e.g., supervised by the Ministry of Health and Welfare Pharmaceutical Affairs Bureau, edited by the National Pharmacopoeia Specialist Committee, published by the Pharmaceutical Industry Journal, a guide to general-purpose Kampo prescriptions), the ingredients and amounts are as follows. .2 (parts by weight, the same applies hereinafter), Peonies 1.2, Senkyu 1.2, Sunshi 1.2, Forsythia 1.2, Hakka 1.2, Showa 1.2, Keiguy 1.2, Bow Fu 1.2 , Maow 1.2, Daio 1.5, Bow Show 1.5, Sandalwood 2.0, Kyaku 2.0, Ogon 2.0, Licorice 2.0, Gypsum 2-3, Kasseki 3-5, In principle, this is concentrated in 10 times its part (thus 280-350) of hot water until it becomes 1/2 volume and the solid content is removed (hot water or extract).

  Depending on the book, the above ingredients may not contain peanuts (eg, Takatsuka Otsuka and Michiaki Yazume, published by Nippon Shokudo Co., Ltd.) Ingredients such as Yomiuri Shimbun, published by Naniwasha, and follow-up Chinese medicines, and those in which 1.2 is set to 1.5 (for example, co-authored by Kazuo Nishioka and Shintaro Takahashi, published by Naniwasha, Myoken Kampo Prescription) Some have slightly different component ratios.

  Furthermore, as a method of making an extract, 400 parts by weight of water is added to each of the above components other than bow show, decoction is made up to 200 parts, debris is added, and then bow show is added (for example, published by Michinori Kubo, Kenzo Moriyama, published by Yoikusha) Some handbooks are slightly different, as in the Japanese and Chinese medicine handbook).

  In the present invention, Fufutsu Seisaku is a book related to Chinese medicine that is currently in common use, as stipulated in the “Basic Handling Policy of Kampo Formulations” established by the Kampo Medicine Research Committee. Also included are so-called Chinese herbal formulas (herbal medicine formulations) and extracts obtained from these Chinese herbal formulas, including the described formulas, and therefore those with somewhat different ingredients and component ratios as described above. However, the extract is not appropriate in terms of storage and administration difficulties, and if it is a Kampo prescription, the patient must make such a decoction each time. Is not preferable.

  Therefore, in the present invention, Fukatsu Sansho-san as a so-called extract preparation in which the extract is formulated by a conventional method is used for convenience. In addition, as a manufacturing method of the extract formulation, for example, about 7 times the amount of water is added to the mixture of the above components, and the mixture is stirred and extracted at about 80 ° C. to 90 ° C. for about 3 hours, and then centrifuged at warm temperature. Obtain an extract and concentrate it under reduced pressure to obtain a dry extract by spray drying, or add a suitable adsorbent (eg silicic anhydride, starch, etc.) to a soft extract with increased extract concentration There is a method to make the end. In addition, it goes without saying that Kampo extract preparations are included regardless of whether they are for general use or for medical use.

  In the present invention, the daily dose of Fufutsu Seisaku may be the amount of extract or extract preparation obtained when the weight part of the prescription described in the book is in g units and the volume part is in milliliter units. . Therefore, the daily dose of a commercially available extract preparation can be used as it is as the daily dose in the present invention.

  In the present invention, a processed product of the plant may be used as the processed product, such as dried, pulverized, extracted, formulated, or some combination of these operations. The form suitable for oral administration is mentioned.

  In the present invention, the quantitative relationship between Fukatsutsu Seisaku and Koboku is about 0.5% to 25% by weight for each of Kokutoku etc. For 0 grams, Koboku and Ogi should have a ratio of 0.3 grams of powder, and Koju, Gokadine, Kijutsu, Ketsumeishi, and Hibatsu should have a ratio of 0.5 grams of powder and 1.0 grams of Mokten Ryo powder. .

  In administration, these powders may be administered individually, but it is preferable that they are combined into one form such as tablets and pills by a conventional method. For this purpose, Morohaya powder and mannitol solution are used as excipients and spreading agents. Morohaya is considered to be a substance that helps faecal passage through the intestinal tract by the action of fat mucus in food due to the action of the mucus polysaccharide. Morohaya is also nutritionally superior because it contains various vitamins.

  In the present invention, the drug is preferably administered orally in two or three divided doses per day, and the dose time is not particularly limited, but is preferably fasting before meals.

  Hereinafter, the present invention will be described in detail based on examples.

  Fufutsu Seisaku Extract (Honsa Pharmaceutical KK sale, the same applies below) 5.0g, Koboku powder, Ogi powder (KK Tenkaidou sale, same applies below) 0.5g each, Koju powder, gokajin powder, kijutsu powder , Ketsumeishi powder, Hibatsu powder 0.5g each, Mokten Ryo powder 1.0g, Morohaya powder (KK K. Kanghan Pharmaceutical Research Laboratories) 0.5g, add 2.5ml of 20W / v% mannitol and knead 12 tablets were obtained.

  The preparation of the present invention is preferably administered orally in two to three times a day, and the time of taking is not particularly limited, but is preferably before meals.

  21-year-old woman (height 159.0 cm, weight 84.1 kg, body fat percentage 48.0%, obesity 51.2%, right leg fat percentage 46.9%, left leg fat percentage 47.3%, right arm body Fat percentage 43.9%, left arm fat percentage 45.6%, trunk body fat percentage 49.2%), and Fengshu Sansho extract granule 7.5g for one day, divided into three times before meal And continued for 28 days. During this period, the meal was not particularly limited. As a result, there was no change in body weight, body fat percentage, and obesity before the start of the experiment.

  Next, after completing the above experiment, the same tablet as that of Example 1 was given to the same person for one day, and this was divided into three times and administered before meals, and continued for 11 months. 0cm, body weight 56.1kg, body fat percentage 29.7%, obesity level 0.9%, right foot fat percentage 32.2%, left leg fat percentage 32.9%, right arm fat percentage 23.9%, left arm The body fat percentage was 25.3% and the trunk body fat percentage was 28.7%). In addition, about the meal, there was no restriction | limiting similarly to the case of only Fengtsu Seikisan extract granule.

  52-year-old woman (height 148.0cm, weight 75.6kg, body fat percentage 50.1%, obesity 56.9%, right foot fat percentage 47.1%, left leg fat percentage 47.8%, right arm body (Fat rate 47.9%, left arm body fat rate 50.2%, trunk body fat rate 51.9%) Fengtsu Sansho extract granule 7.5g twice a day for 21 days, morning and evening, before meals However, there was no change in body weight, body fat percentage, or obesity level.

Then, after the end of this experiment, the same person made a tablet obtained in the same manner as in Example 1 for 1 day, divided into 2 portions, and took it in the morning and evening before meals. In this experiment, no dietary restriction was performed.
57 days passed, height 148.0 cm, weight 65.6 kg, body fat percentage 44.7%, obesity 35.9%, right foot fat percentage 43.6%, left leg fat percentage 43.7%, right arm The body fat percentage was 41.2%, the left arm fat percentage was 43.5%, and the trunk fat percentage was 45.6%.
In addition, Honso Pharmaceutical K.K. K. Kanebo Pharmaceutical K. instead of Kyutsutsu Seisaku Extract Granules K. A tablet obtained in the same manner as in Example 1 was administered to a female patient exhibiting the same symptoms as the above-mentioned woman, and the same therapeutic effect was obtained.

48-year-old woman (height 160.0 cm, weight 72.1 kg, body fat percentage 41.5%, obesity 28.0%, right foot fat percentage 41.1%, left leg fat percentage 42.0%, right arm body (37.8% fat, 39.2% left arm fat percentage, 42.0% trunk fat percentage), and the tablets obtained in the same manner as in Example 1 were divided into two portions. I took them before meals in the morning and evening. In this experiment, no dietary restriction was performed.
After 12 months, the height was 160.0 cm, the body weight was 61.9 kg, the body fat percentage was 35.1%, the obesity level was 9.9%, the right foot fat percentage was 36.0%, the left leg fat percentage was 36.9%, the right arm The body fat percentage was 31.5%, the left arm fat percentage was 31.4%, and the trunk fat percentage was 34.8%.

A male patient was given a tablet obtained in the same manner as in Example 1 for one day, divided into three doses, taken before each meal, and a blood biochemical test was performed. Values before the experiment are ALP187 (100 to 350) (the values in parentheses are reference values, the same applies hereinafter), GOT36 (8 to 40), GPT70 (5 to 40), choline-E430 (190 to 430), γ GTP35 (0-70), total cholesterol 240 (130-220), HDL-CHO32 (35-75), triglyceride 553 (50-150), blood glucose 116 (60-109).
50 days after the experiment, ALP157, GOT20, GPT21, choline-E369, γ-GTP17, total cholesterol 142, HDL-CHO45, triglyceride 146, and blood glucose 81 were improved.

The female patient was given a tablet obtained in the same manner as in Example 1, and this was divided into three times and taken before each meal. Blood biochemical test values before the experiment were GOT60 (8-40), GPT109 (5-40), choline-E522 (190-430), γ-GTP137 (0-70), total cholesterol 264 (130-220). HDL-CHO39 (35-75), triglyceride 482 (50-150), blood glucose 121 (60-109).
Three months after the start of the experiment, GOT17, GPT18, choline-E286, γ-GTP21, total cholesterol 246, HDL-CHO49, triglyceride 78, and blood glucose 100 were improved.

  As is clear from the above experimental examples, according to the present invention, an excellent anti-obesity effect can be achieved. In particular, in the present invention, an effect was observed in improving body fat rather than simply losing weight. In addition, serum lipids were improved and liver function was thought to be improved.

This prescription has been administered for about 2 years, and the total number of patients to date has reached a considerable number. Among the subjects of administration, obesity with hyperlipidemia was the most common, and obesity patients accompanied by diabetes, liver dysfunction, and hypertension were the most common.

Claims (6)

  A method for the prevention and improvement of lifestyle-related diseases characterized by administration of either Fufutsu Seisaku, Koboku powder or Gajutsu powder, Ogi powder, Koju powder, Gokajin powder, Ketsumeishi powder, Kijutsu powder, Hibatsu powder and Mokten Ryo powder .   The method for preventing / ameliorating a lifestyle-related disease according to claim 1, wherein the lifestyle-related disease is obesity, diabetes, or hypertension.   Dosage is per day, Fengtsu Sansho is the amount of one day stipulated by Kampo prescription, and each of the other ingredients is 0.5% to 25% by weight with respect to Fukatsu Sanseiku The method for preventing or improving lifestyle-related diseases according to claim 1.   4. The method for preventing and improving lifestyle-related diseases according to claim 3, wherein the daily dose is divided into two or three equal parts and administered before meals in the morning or evening.   A prophylactic / improving agent for lifestyle-related diseases characterized by containing one of Fufutsu Seisaku, Koboku powder and Gajutsu powder, Ogi powder, Koju powder, Gokajin powder, Ketsumeishi powder, Kijutsu powder, Hibatsu powder and Mokten Ryo powder. . The content of either Koboku powder or Gadju powder, Ogi powder, Koju powder, Gokajin powder, Ketsumeishi powder, Kijutsu powder, Hihatsu powder and Mokten Ryo powder is 0.5% to 25% by weight, respectively. The preventive / ameliorating agent for lifestyle-related diseases according to claim 5, which is%.