JP4766818B2 - Agents for improving and treating specific back pain, hip joint pain and groin pain during pregnancy - Google Patents
Agents for improving and treating specific back pain, hip joint pain and groin pain during pregnancy Download PDFInfo
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- JP4766818B2 JP4766818B2 JP2002215261A JP2002215261A JP4766818B2 JP 4766818 B2 JP4766818 B2 JP 4766818B2 JP 2002215261 A JP2002215261 A JP 2002215261A JP 2002215261 A JP2002215261 A JP 2002215261A JP 4766818 B2 JP4766818 B2 JP 4766818B2
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- pain
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Description
【０００１】
【発明の属する技術分野】
本発明は、妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善・治療剤に関する。より詳しくは、妊産婦の腰痛、股関節痛及び鼠径部痛の改善・治療剤に関する。
【０００２】
【従来の技術】
骨の形成に重要な役割を担っているカルシウムについて、妊娠期間中に母胎から胎児に移行するカルシウムの量は２７ｇ〜３０ｇ程度といわれている。通常成人が摂取するカルシウムの必要量が１日６００ｍｇであるのに対し、妊娠期間中は１日１０００ｍｇが好ましいとされている。又、骨の形成の一部を担っているコラーゲンは、骨の組織にカルシウムを定着させる働きがある。
【０００３】
このような骨代謝の変化の激しい妊娠時期における、骨密度の変化について、妊娠により骨密度の低下はないとしている報告が多くある。しかし、妊娠に伴う腰痛は、妊娠初期から末期にかけて、程度の差こそあれ、大部分の妊婦が自覚する症状である。したがって、このような妊娠に伴う腰痛は、骨密度の変化といった一元的なものと考えるより、子宮の増大に伴う体重増加を支えるための腰部、背部への負担増、妊娠特有の姿勢等の多元的な原因に基づくと考えられている。
【０００４】
これらの痛みに対する治療方法は、鎮痛剤や湿布剤、あるいはコルセット着装といったものしかなく、安全かつ有効な治療方法はなかった。このような現実に踏まえ、妊娠中に発症ないし著しく増強した、腰痛、股関節痛、鼠径部痛を有する妊婦に対し、有効な薬の出現が望まれている。
【０００５】
【発明が解決する課題】
本発明は、妊娠中に発症ないし著しく増強した、腰痛、股関節痛、鼠径部痛などのいわゆる妊娠による骨盤痛の改善・治療剤を提供することにある。
【０００６】
【課題を解決する手段】
上記課題を解決するために、妊娠に起因する腰痛、股関節痛、鼠径部痛等の骨盤痛に対して、カルシウムとコラーゲンの配合製剤、アスパラギン酸カルシウム含有製剤等の治療効果について検討し、良好な改善・治療効果が得られ、上記課題を解決した。
【０００７】
本発明の第１の特徴は、カルシウムとコラーゲンを含有することを特徴とする妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善・治療剤である。妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を訴える患者にカルシウムとコラーゲンの配合剤を毎日投与した結果、妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を改善・治療する効果が認められた。
【０００８】
本発明の第２の特徴は、カルシウム１００〜４００ｍｇとコラーゲン１０〜２００ｍｇを含有することを特徴とする請求項１記載の妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善・治療剤である。
【０００９】
本発明の第３の特徴は、アスパラギン酸カルシウムを含有することを特徴とする妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善・治療剤である。妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を訴える患者にアスパラギン酸カルシウムを含有する製剤を毎日投与した結果、妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を改善治療する効果が認められた。
【００１０】
本発明の第５の特徴は、少なくともアスパラギン酸カルシウム１００〜４００ｍｇを含有することを特徴とする請求項３に記載の妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善・治療剤である。
【００１１】
本発明の第５の特徴は、カルシウムとコラーゲン、及びアスパラギン酸カルシウムを含有することを特徴とする妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の治療剤である。妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を訴える患者にコラーゲン、カルシウム、及びアスパラギン酸カルシウムを含有する製剤を毎日投与した結果、妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を改善治療する効果が認められた。
【００１２】
【発明の実施の態様】
本発明の実施の形態を以下に例示するが、コラーゲン・カルシウム含有製剤、及びアスパラギン酸カルシウム含有製剤の薬剤の含有量、及び賦形剤、滑沢剤、結合剤の含有量はそれぞれの剤形で異なり、以下の製剤例に限定されるものではない。
【００１３】
製剤例
本発明の妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善治療剤は、それ自体単独で痛みを訴える患者に用いることも可能であるが、薬学的に許容され得る製剤用添加物を用いて有効成分を含む医薬組成物を製造して用いることが望ましい。このような医薬組成物としては、顆粒剤、細粒剤、散剤、錠剤、硬カプセル剤、シロップ剤、乳剤、懸濁剤、液剤などを挙げることができ、これらは経口投与が望ましい。固形製剤は、混合、充填、または打錠等の従来汎用の方法により製造することができる。このような固形製剤に用いられる賦形剤としては、結晶セルロース、ソルビトール、マルチトール、乳糖、蔗糖等、結合剤としてはヒドロキシプロピルセルロース、ヒドロキシメチルプロピルセルロース、でんぷん、タルク、メチルセルロース、デキストリン等が挙げられる。滑沢剤、凝集防止剤としてはステアリン酸マグネシウム、蔗糖脂肪酸エステル、含水二酸化ケイ素などが例示できる。
【００１４】
本発明で使用されるコラーゲンは、一般に市販されている動物性のコラーゲンであればいずれでも良くその量は製剤１錠中にコラーゲンとして少なくとも２５〜１００ｍｇ相当量含有することが望ましい。カルシウムは炭酸カルシウム、リン酸軽カルシウム、酢酸カルシウム等が例示できるが、カルシウムとして１錠中に少なくとも１００〜４００ｍｇ相当量含有することが望ましい。又、アスパラギン酸カルシウムは１錠中に少なくとも１００〜４００ｍｇ相当量を含有することが好ましい。その他、ビタミンビタミン等のビタミン類、マグネシウム塩、ナトリウム塩等の無機塩類を適宜配合することができる。
【００１５】
製剤例−１
アスパラギン酸カルシウム １００ｍｇ
賦形剤 適量
滑沢剤 適量
【００１６】
製造例−２
アスパラギン酸カルシウム ２００ｍｇ
賦形剤 適量
滑沢剤 適量
【００１７】
製造例−３
アスパラギン酸カルシウム ４００ｍｇ
賦形剤 適量
滑沢剤 適量
【００１８】
製剤例−４
カルシウム １００ｍｇ
コラーゲン ２５ｍｇ
マグネシウム ８ｍｇ
ビタミンＣ ２０ｍｇ
ナトリウム １ｍｇ
賦形剤 適量
滑沢剤 適量
香料 微量
【００１９】
製剤例−５
カルシウム ２００ｍｇ
コラーゲン ５０ｍｇ
マグネシウム ８ｍｇ
ビタミンＣ ２０ｍｇ
ナトリウム １ｍｇ
賦形剤 適量
滑沢剤 適量
香料 微量
【００２０】
製剤例−６
カルシウム ４００ｍｇ
コラーゲン １００ｍｇ
マグネシウム １６ｍｇ
ビタミンＣ ４０ｍｇ
ナトリウム ２ｍｇ
賦形剤 適量
滑沢剤 適量
香料 微量
【００２１】
製剤例−７
カルシウム １００ｍｇ
アスパラギン酸カルシウム １００ｍｇ
コラーゲン ５０ｍｇ
マグネシウム ８ｍｇ
ビタミンＣ ２０ｍｇ
ナトリウム １ｍｇ
賦形剤 適量
滑沢剤 適量
香料 微量
【００２２】
製剤例−８
カルシウム ５０ｍｇ
アスパラギン酸カルシウム ２００ｍｇ
コラーゲン ５０ｍｇ
マグネシウム ８ｍｇ
ビタミンＣ ２０ｍｇ
ナトリウム １ｍｇ
賦形剤 適量
滑沢剤 適量
香料 微量
投与例
【００２３】
当院で妊婦検診・出産のために通院している妊婦で、妊娠経過観察中に腰痛、股関節痛及び鼠径部痛が出現あるいは著しい増強を認めた平均年齢２８．９才、平均出産回数１回の患者２５名に対し、製剤例２に示すアスパラギン酸カルシウムを６００ｍｇ／日を経口的に服用し、２週間後の改善・治療効果を観察した。改善・治療効果の認められた患者に対しては、さらに出産まで継続して服用した。服用期間の観察中にアスパラギン酸カルシウム摂取によると思われる副作用は認められなかった。
【００２４】
改善・治療効果は以下のとおりであり、投与例中腰痛患者２０例中９例（４５％）、股関節痛７例中３例（４２．９％）に改善・治療効果が認められた。
【００２５】
当院で妊婦検診・出産のために通院している妊婦で、妊娠経過観察中に腰痛、股関節痛及び鼠径部痛が出現あるいは著しい増強を認めた平均年齢２９．２才、平均出産回数１．０５回の患者４２名に対し、製剤例５に示すコラーゲンとカルシウムの配合剤をカルシウムとして６００ｍｇ／日を経口的に服用し、２週間後の改善・治療効果を観察した。改善・治療効果の認められた患者に対しては、さらに出産まで継続して服用した。服用期間の観察中にコラーゲンとカルシウムの配合剤摂取によると思われる副作用は認められなかった。
【００２７】
改善・治療効果は以下のとおりであるが、投与例中腰痛患者３０例中２８例（９３％）、股関節痛１２例中５例（４１．７％）に改善・治療効果が認められた。
【００２８】
以上、妊娠時に特異的な腰痛、股関節痛及び鼠径部痛を訴える患者にアスパラギン酸カルシウムを含有する製剤、またはコラーゲンとカルシウムを含有する製剤を服用させた結果、アスパラギン酸カルシウムを含有する製剤を服用した患者の内、４８％の患者で有効性が認められた。これに対しコラーゲンとカルシウムを配合した製剤を服用した患者では７６．２％の患者に有効性が認められた。アスパラギン酸カルシウムを含有する製剤とコラーゲンとカルシウムを配合した製剤とを比較すると、コラーゲン・カルシウム配合剤の方がアスパラギン酸カルシウムよりも有意に高い効果が得られた。
【００３０】
【発明の効果】
妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の出現あるいは著しい増強を認めた患者にアスパラギン酸カルシウムを含有する製剤、または、コラーゲンとカルシウムを含有する製剤を投与したところ、妊娠時に特異的な腰痛、股関節痛及び鼠径部痛の改善・治療効果が認められた。また、その効果はアスパラギン酸カルシウムを含む製剤よりも、コラーゲンとカルシウムを配合した製剤の方が有意に高い効果が得られた。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an agent for improving / treating specific back pain, hip joint pain and groin pain during pregnancy. More specifically, the present invention relates to an agent for improving / treating low back pain, hip joint pain and groin pain in pregnant women.
[0002]
[Prior art]
Regarding calcium, which plays an important role in bone formation, the amount of calcium transferred from the mother's fetus to the fetus during pregnancy is said to be about 27 to 30 g. While the required amount of calcium normally taken by adults is 600 mg per day, 1000 mg per day is preferred during pregnancy. Collagen, which is part of bone formation, has the function of fixing calcium in bone tissue.
[0003]
There are many reports that bone density changes during pregnancy with such a rapid change in bone metabolism do not cause a decrease in bone density due to pregnancy. However, back pain associated with pregnancy is a symptom that most pregnant women are aware of, to some extent, from the beginning to the end of pregnancy. Therefore, the back pain associated with pregnancy is considered to be a single factor, such as a change in bone density. Based on common causes.
[0004]
Treatment methods for these pains are only analgesics, poultices, or corset wearing, and there is no safe and effective treatment method. In light of this reality, the emergence of effective drugs is desired for pregnant women who have low back pain, hip joint pain, and groin pain that have developed or remarkably increased during pregnancy.
[0005]
[Problems to be solved by the invention]
An object of the present invention is to provide an agent for improving / treating so-called pregnancy-induced pelvic pain such as low back pain, hip joint pain, and groin pain that has developed or remarkably increased during pregnancy.
[0006]
[Means for solving the problems]
To solve the above problems, we examined the therapeutic effects of combined preparations of calcium and collagen, calcium aspartate-containing preparations, etc. for pelvic pain such as low back pain, hip joint pain, and groin pain caused by pregnancy. Improvement and treatment effects were obtained and the above problems were solved.
[0007]
The first feature of the present invention is an agent for improving and treating low back pain, hip joint pain and groin pain specific to pregnancy, characterized by containing calcium and collagen. As a result of daily administration of a combination of calcium and collagen to patients who complain of specific low back pain, hip pain and groin pain during pregnancy, the effect of improving and treating specific low back pain, hip pain and groin pain during pregnancy It was.
[0008]
The second feature of the present invention is an agent for improving and treating low back pain, hip joint pain and groin pain specific to pregnancy according to claim 1, characterized by containing 100 to 400 mg of calcium and 10 to 200 mg of collagen. is there.
[0009]
A third feature of the present invention is an agent for improving and treating low back pain, hip joint pain and groin pain specific during pregnancy, characterized by containing calcium aspartate. As a result of daily administration of a preparation containing calcium aspartate to patients who complain of specific low back pain, hip pain, and groin pain during pregnancy, the effect of improving and treating specific low back pain, hip joint pain and groin pain during pregnancy It was.
[0010]
The fifth feature of the present invention is the agent for improving and treating low back pain, hip joint pain and groin pain specific to pregnancy according to claim 3, characterized by containing at least 100 to 400 mg of calcium aspartate. .
[0011]
The fifth feature of the present invention is a therapeutic agent for lumbago, hip pain and groin pain specific to pregnancy characterized by containing calcium, collagen, and calcium aspartate. Daily administration of a formulation containing collagen, calcium and calcium aspartate to patients who complain of specific back pain, hip pain and groin pain during pregnancy improves specific back pain, hip joint pain and groin pain during pregnancy The effect of treatment was recognized.
[0012]
BEST MODE FOR CARRYING OUT THE INVENTION
Embodiments of the present invention will be exemplified below, but the contents of drugs in collagen / calcium-containing preparations and calcium aspartate-containing preparations, and the contents of excipients, lubricants and binders are the respective dosage forms. However, it is not limited to the following formulation examples.
[0013]
Formulation Example The therapeutic agent for the improvement of back pain, hip pain and groin pain specific to pregnancy according to the present invention can be used by itself for a patient complaining of pain, but pharmaceutically acceptable addition for pharmaceutical preparations It is desirable to produce and use a pharmaceutical composition containing an active ingredient using the product. Examples of such a pharmaceutical composition include granules, fine granules, powders, tablets, hard capsules, syrups, emulsions, suspensions, liquids and the like, and these are preferably administered orally. The solid preparation can be produced by a conventional method such as mixing, filling, or tableting. Excipients used in such solid preparations include crystalline cellulose, sorbitol, maltitol, lactose, sucrose, etc., and binders include hydroxypropylcellulose, hydroxymethylpropylcellulose, starch, talc, methylcellulose, dextrin, etc. It is done. Examples of the lubricant and the aggregation inhibitor include magnesium stearate, sucrose fatty acid ester, hydrous silicon dioxide and the like.
[0014]
The collagen used in the present invention may be any animal collagen that is generally commercially available, and the amount is preferably contained in an amount equivalent to at least 25 to 100 mg of collagen in one tablet. Examples of calcium include calcium carbonate, light calcium phosphate, calcium acetate and the like, and it is desirable to contain at least 100 to 400 mg equivalent amount in one tablet as calcium. Moreover, it is preferable that calcium aspartate contains at least 100 to 400 mg equivalent in one tablet. In addition, vitamins such as vitamin vitamins and inorganic salts such as magnesium salts and sodium salts can be appropriately blended.
[0015]
Formulation Example-1
Calcium aspartate 100mg
Excipient appropriate amount Lubricant appropriate amount [0016]
Production Example-2
Calcium aspartate 200mg
Excipient Appropriate amount Lubricant Suitable amount [0017]
Production Example-3
Calcium aspartate 400mg
Excipient Appropriate amount Lubricant Suitable amount [0018]
Formulation Example-4
Calcium 100mg
Collagen 25mg
Magnesium 8mg
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount of perfume Small amount [0019]
Formulation Example-5
Calcium 200mg
Collagen 50mg
Magnesium 8mg
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount of perfume Small amount [0020]
Formulation Example-6
Calcium 400mg
Collagen 100mg
Magnesium 16mg
Vitamin C 40mg
Sodium 2mg
Excipient Appropriate amount Lubricant Appropriate amount of perfume Small amount [0021]
Formulation Example-7
Calcium 100mg
Calcium aspartate 100mg
Collagen 50mg
Magnesium 8mg
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount of perfume Small amount [0022]
Formulation Example-8
Calcium 50mg
Calcium aspartate 200mg
Collagen 50mg
Magnesium 8mg
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount of perfume Micro dose example [0023]
An average age of 28.9 years and an average number of childbirths that occurred during pregnancy monitoring, with back pain, hip pain and inguinal pain appearing or significantly increased during pregnancy monitoring. The 25 mg patients were orally dosed with 600 mg / day of calcium aspartate shown in Formulation Example 2, and the improvement / treatment effects after 2 weeks were observed. For patients who showed improvement / treatment effects, they continued to take the medicine until delivery. During the observation period, no side effects were observed due to calcium aspartate intake.
[0024]
The improvement / treatment effects were as follows. Among the 20 administration cases, 9 out of 20 patients with low back pain (45%) and 3 out of 7 hip joint pain cases (42.9%) showed improvement / treatment effects.
[0025]
An average age of 29.2 years and an average number of childbirths in pregnant women who visited our hospital for pregnancy checkups and childbirth. During the course of pregnancy, low back pain, hip pain and groin pain were observed or markedly increased. Forty-five patients 42 times, 600 mg / day was orally taken as calcium as a combination agent of collagen and calcium shown in Formulation Example 5, and the improvement / treatment effect after 2 weeks was observed. For patients who showed improvement / treatment effects, they continued to take the medicine until delivery. During the observation period, no side effects were observed due to the intake of collagen and calcium.
[0027]
The improvement / treatment effect was as follows, but the improvement / treatment effect was observed in 28 cases (93%) of 30 back pain patients and 5 cases (41.7%) of 12 hip joint pains.
[0028]
As a result of taking calcium aspartate-containing preparations or collagen and calcium-containing preparations to patients who complain of specific low back pain, hip pain and groin pain during pregnancy, and taking calcium aspartate-containing preparations Of these patients, 48% were effective. In contrast, 76.2% of patients who took a preparation containing collagen and calcium were effective. When a preparation containing calcium aspartate was compared with a preparation containing collagen and calcium, the collagen / calcium combination agent showed a significantly higher effect than calcium aspartate.
[0030]
【The invention's effect】
When patients with specific low back pain, hip pain, and groin pain at the time of pregnancy were observed or markedly increased, a preparation containing calcium aspartate or a preparation containing collagen and calcium was administered. Improvement and treatment effects were observed for back pain, hip pain and groin pain. In addition, the effect of the preparation containing collagen and calcium was significantly higher than that of the preparation containing calcium aspartate.
Claims (3)
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| JP2002215261A JP4766818B2 (en) | 2002-07-24 | 2002-07-24 | Agents for improving and treating specific back pain, hip joint pain and groin pain during pregnancy |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2002215261A JP4766818B2 (en) | 2002-07-24 | 2002-07-24 | Agents for improving and treating specific back pain, hip joint pain and groin pain during pregnancy |
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| Publication Number | Publication Date |
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| JP2004051613A JP2004051613A (en) | 2004-02-19 |
| JP4766818B2 true JP4766818B2 (en) | 2011-09-07 |
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| Application Number | Title | Priority Date | Filing Date |
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| JP2002215261A Expired - Fee Related JP4766818B2 (en) | 2002-07-24 | 2002-07-24 | Agents for improving and treating specific back pain, hip joint pain and groin pain during pregnancy |
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| JP (1) | JP4766818B2 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007044945A2 (en) * | 2005-10-13 | 2007-04-19 | Gu, Jennifer, L. | Mineral collagen chelates and methods of making and using same |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0777491B1 (en) * | 1994-08-23 | 2004-11-17 | Deutsche Gelatine-Fabriken Stoess AG | Use of tasteless, hydrolysed collagen and agent containing the same |
| JP4609807B2 (en) * | 1996-03-28 | 2011-01-12 | 雪印乳業株式会社 | Bone-strengthening medicine, food and drink, and feed |
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| JP2004051613A (en) | 2004-02-19 |
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