JP2004051613A - Improving/treating agent of specific lumbago, coxodynia and inguinodynia in pregnancy - Google Patents
Improving/treating agent of specific lumbago, coxodynia and inguinodynia in pregnancy Download PDFInfo
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Abstract
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１０〜２００ｍｇ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好ましい。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Ｂ、ビタミンＣ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]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to an agent for ameliorating / treating specific back pain, hip joint pain and groin pain during pregnancy. More specifically, the present invention relates to an agent for improving and treating low back pain, hip joint pain and groin pain of a pregnant woman.
[0002]
[Prior art]
Regarding calcium, which plays an important role in bone formation, it is said that the amount of calcium transferred from the mother to the fetus during pregnancy is about 27 g to 30 g. Normally, the required amount of calcium to be taken by an adult is 600 mg per day, whereas 1,000 mg per day is preferable during pregnancy. Collagen, which plays a part in bone formation, has a function of fixing calcium to bone tissue.
[0003]
There are many reports that changes in bone density during pregnancy, when such changes in bone metabolism are severe, indicate that pregnancy does not reduce bone density. However, back pain associated with pregnancy is a symptom that most pregnant women are aware of, albeit with varying degrees, from early to late pregnancy. Therefore, rather than considering such low back pain due to pregnancy as a unified factor such as a change in bone density, there are multiple factors such as an increase in the burden on the lower back and back to support weight gain due to an increase in the uterus, and a pregnancy-specific posture. It is believed to be based on a common cause.
[0004]
The only treatment methods for these pains were painkillers, compresses, and wearing corsets, and there was no safe and effective treatment method. In view of such a reality, it is desired that a pregnant woman who has low back pain, hip joint pain, and groin pain that has developed or has significantly increased during pregnancy has an effective drug.
[0005]
[Problems to be solved by the invention]
An object of the present invention is to provide an agent for improving or treating so-called pelvic pain due to pregnancy, such as back pain, hip joint pain, and groin pain, which has developed or has significantly increased during pregnancy.
[0006]
[Means to solve the problem]
In order to solve the above problems, for low back pain due to pregnancy, hip joint pain, pelvic pain such as groin pain, to study the therapeutic effect of calcium and collagen combination preparations, calcium aspartate containing preparations and the like, good Improvement and therapeutic effects were obtained, and the above problems were solved.
[0007]
A first feature of the present invention is an agent for improving and treating low back pain, hip joint pain and groin pain which is specific to pregnancy, which contains calcium and collagen. Daily administration of a combination of calcium and collagen in patients complaining of specific low back pain, hip pain and groin pain during pregnancy, as a result of improving and treating specific low back pain, hip pain and groin pain during pregnancy Was done.
[0008]
The second feature of the present invention is the agent for improving and treating specific low back pain, hip joint pain and groin pain at the time of pregnancy according to claim 1, which contains 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 ameliorating and treating low back pain, hip joint pain and groin pain specific to pregnancy, which contains calcium aspartate. Daily administration of a formulation containing calcium aspartate to patients complaining of specific low back pain, hip pain and groin pain during pregnancy showed an effect of improving and treating specific low back pain, hip pain and groin pain during pregnancy Was done.
[0010]
The fifth feature of the present invention is the agent for ameliorating / treating specific low back pain, hip joint pain and groin pain during pregnancy according to claim 3, which contains at least 100 to 400 mg of calcium aspartate. .
[0011]
A fifth feature of the present invention is a therapeutic agent for back pain, hip joint pain, and groin pain that is specific during pregnancy, characterized by containing calcium, collagen, and calcium aspartate. Daily administration of a formulation containing collagen, calcium, and calcium aspartate to patients complaining of specific low back, hip and groin pain during pregnancy, resulting in improvement of specific low back, hip and groin pain during pregnancy A therapeutic effect was observed.
[0012]
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Embodiments of the present invention will be exemplified below. The content of the drug in the preparation containing collagen and calcium, and the preparation containing calcium aspartate, and the contents of excipients, lubricants, and binders are shown in the respective dosage forms. The present invention is not limited to the following formulation examples.
[0013]
Formulation Examples The therapeutic agent for improving low back pain, hip joint pain and groin pain of the present invention which is specific for pregnancy can be used by itself for patients who complain of pain, but is a pharmaceutically acceptable additive for a pharmaceutical preparation. It is desirable to produce and use a pharmaceutical composition containing an active ingredient using a substance. Examples of such a pharmaceutical composition include granules, fine granules, powders, tablets, hard capsules, syrups, emulsions, suspensions, liquids and the like, and these are desirably administered orally. Solid preparations can be manufactured by conventional general-purpose methods such as mixing, filling, and tableting. Excipients used in such solid preparations include crystalline cellulose, sorbitol, maltitol, lactose, sucrose and the like, and binders include hydroxypropylcellulose, hydroxymethylpropylcellulose, starch, talc, methylcellulose, dextrin and the like. Can be Examples of the lubricant and the anti-agglomeration agent include magnesium stearate, sucrose fatty acid ester, and hydrous silicon dioxide.
[0014]
The collagen used in the present invention may be any commercially available animal collagen, and the amount thereof is desirably at least 10 to 200 mg equivalent as collagen in one tablet of the preparation. Examples of calcium include calcium carbonate, calcium phosphate, calcium acetate and the like, and it is preferable that calcium is contained in an amount of at least 100 to 400 mg per tablet. Further, it is preferable that one tablet contains at least 100 to 400 mg of calcium aspartate. In addition, vitamins such as vitamin B and vitamin C, and inorganic salts such as magnesium salt and sodium salt can be appropriately compounded.
[0015]
Formulation Example-1
100mg calcium aspartate
Excipient Appropriate amount Lubricant Appropriate amount
Production Example-2
200mg calcium aspartate
Excipient Appropriate amount Lubricant Appropriate amount
Production Example-3
400mg calcium aspartate
Excipient Appropriate amount Lubricant Appropriate amount [0018]
Formulation Example-4
100mg calcium
25mg collagen
8mg magnesium
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount of fragrance Trace amount [0019]
Formulation Example-5
200mg calcium
Collagen 50mg
8mg magnesium
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount of fragrance Trace amount [0020]
Formulation Example-6
400mg calcium
Collagen 100mg
16mg magnesium
Vitamin C 40mg
Sodium 2mg
Excipient Appropriate amount of lubricant Appropriate amount of fragrance A trace amount [0021]
Formulation Example-7
100mg calcium
100mg calcium aspartate
Collagen 50mg
8mg magnesium
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount of lubricant Appropriate amount of fragrance A trace amount
Formulation Example-8
50mg calcium
200mg calcium aspartate
Collagen 50mg
8mg magnesium
Vitamin C 20mg
Sodium 1mg
Excipient Appropriate amount Lubricant Appropriate amount Flavor Small amount administration example [0023]
Pregnant women attending our hospital for prenatal examination and childbirth. Low back pain, hip pain and groin pain appeared or markedly increased during pregnancy follow-up. The calcium aspartate shown in Formulation Example 2 was orally administered at a dose of 600 mg / day to 25 patients, and the improvement and therapeutic effect after 2 weeks were observed. Patients whose improvement and / or treatment effect was recognized were continued to take the drug until childbirth. During the observation of the administration period, no side effects possibly due to calcium aspartate intake were observed.
[0024]
The improvement and treatment effects were as follows. Among the administration examples, 9 cases (45%) out of 20 patients with low back pain and 3 cases (42.9%) out of 7 cases of hip joint pain showed the improvement and treatment effects.
[0025]
Pregnant women who went to our hospital for pregnancy screening and childbirth. Back pain, hip joint pain and groin pain appeared or markedly increased during pregnancy follow-up. The average age was 29.2 years and the average number of births was 1. The combination of collagen and calcium shown in Formulation Example 5 was orally administered at a dose of 600 mg / day to 42 patients for 05 times, and the improvement and therapeutic effect after 2 weeks were observed. Patients whose improvement and / or treatment effect was recognized were continued to take the drug until childbirth. During the observation of the administration period, no side effects were considered that could be caused by taking the combination of collagen and calcium.
[0027]
The improvement / treatment effect was as follows, and the improvement / treatment effect was observed in 28 (93%) of 30 patients with low back pain and 5 (41.7%) of 12 patients with hip joint pain in the administration examples.
[0028]
As described above, as a result of taking a preparation containing calcium aspartate or a preparation containing collagen and calcium to a patient complaining of specific low back pain, hip joint pain and groin pain during pregnancy, taking a preparation containing calcium aspartate Of the patients who did, 48% of patients showed efficacy. On the other hand, 76.2% of patients who took a preparation containing collagen and calcium showed efficacy. Comparing the preparation containing calcium aspartate with the preparation containing collagen and calcium, the collagen-calcium combination showed a significantly higher effect than calcium aspartate.
[0030]
【The invention's effect】
When a patient with specific low back pain, hip joint pain and groin pain during pregnancy, or a drug containing calcium aspartate or a product containing collagen and calcium was administered to a patient with Improvement and treatment effects for lower back pain, hip joint pain and groin pain were observed. The effect of the preparation containing collagen and calcium was significantly higher than that of the preparation containing calcium aspartate.
Claims (5)
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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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| 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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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009511066A (en) * | 2005-10-13 | 2009-03-19 | グ、ジェニファー、エル． | Minerals, collagens and chelates and their production and use |
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| JPH09255588A (en) * | 1996-03-28 | 1997-09-30 | Snow Brand Milk Prod Co Ltd | Medicine, food and drink, and feed for reinforcing bone |
| JPH10504555A (en) * | 1994-08-23 | 1998-05-06 | デーゲーエフ ストーエス アクチェンゲゼルシャフト | Use of tasteless hydrolyzed collagen and drugs containing it |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH10504555A (en) * | 1994-08-23 | 1998-05-06 | デーゲーエフ ストーエス アクチェンゲゼルシャフト | Use of tasteless hydrolyzed collagen and drugs containing it |
| JPH09255588A (en) * | 1996-03-28 | 1997-09-30 | Snow Brand Milk Prod Co Ltd | Medicine, food and drink, and feed for reinforcing bone |
Non-Patent Citations (4)
| Title |
|---|
| BLACK, A.J., ET AL.: "A Detailed Assessment of Alterations in Bone Turnover Calcium Homeostasis, and Bone Density in Norma", JOURNAL OF BONE AND MINERAL RESEARCH, vol. 15, no. 3, JPN4007020908, 2000, pages 557 - 563, ISSN: 0000883439 * |
| DRINKWATER, B.L., ET AL.: "Bone density changes during pregnancy and lactation in active women: a longitudinal study", BONE AND MINERAL, vol. 14, JPN6009021914, 1991, pages 153 - 160, XP023072551, ISSN: 0001318326, DOI: 10.1016/0169-6009(91)90092-E * |
| NAYLOR, K.E., ET AL.: "The Effect fo Pregnancy on Bone Density and Bone Turnover", JOURNAL OF BONE AND MINERAL RESEARCH, vol. 15, no. 1, JPN4007020907, 2000, pages 129 - 137, ISSN: 0000883438 * |
| 本多 晃, 他.: "妊娠・産褥期の骨量変化", CLINICAL CALCIUM, vol. 9, no. 12, JPN6009021918, 25 November 1999 (1999-11-25), JP, pages 1506 - 1511, ISSN: 0001318327 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009511066A (en) * | 2005-10-13 | 2009-03-19 | グ、ジェニファー、エル． | Minerals, collagens and chelates and their production and use |
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| JP4766818B2 (en) | 2011-09-07 |
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