JP2000336033A - Preparation containing precipitated calcium carbonate or calcium carbonate and hyperphosphatemia improving agent - Google Patents

Preparation containing precipitated calcium carbonate or calcium carbonate and hyperphosphatemia improving agent

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Publication number
JP2000336033A
JP2000336033A JP11188031A JP18803199A JP2000336033A JP 2000336033 A JP2000336033 A JP 2000336033A JP 11188031 A JP11188031 A JP 11188031A JP 18803199 A JP18803199 A JP 18803199A JP 2000336033 A JP2000336033 A JP 2000336033A
Authority
JP
Japan
Prior art keywords
calcium carbonate
precipitated calcium
tablet
component
hyperphosphatemia
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP11188031A
Other languages
Japanese (ja)
Inventor
Katsuhiko Asano
克彦 浅野
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MERUKU HOEI KK
Original Assignee
MERUKU HOEI KK
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by MERUKU HOEI KK filed Critical MERUKU HOEI KK
Priority to JP11188031A priority Critical patent/JP2000336033A/en
Publication of JP2000336033A publication Critical patent/JP2000336033A/en
Pending legal-status Critical Current

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Abstract

PROBLEM TO BE SOLVED: To obtain the subject improving agent established with efficacy and effectiveness by incorporating a precipitated calcium carbonate or calcium carbonate for preparing a tablet or powder agent as the preparation form which are stable as the preparation and easy for ingesting in clinical place. SOLUTION: This preparation is a tablet containing (A) a precipitated calcium carbonate or calcium carbonate and in addition preferably to the above component (B) a vehicle component (e.g. lactose, manitol, a corn starch), (C) a binder (e.g. a hydroxypropylcellulose, carboxymethylcellulose, crystalline cellulose, corn starch, povidone, methylcellulose), (D) a disintegrating agent (e.g.; a lowly substituted hydroxypropylcellulose, carmellose sodium, a corn starch), (E) a lubricant (e.g. magnesium stearate, a talc). The blending ratio is e.g. 100-1,000 mg component A, 10-110. mg component B, 2-25 mg component C, 4-70 mg component D and 0.5-6 mg component E.

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【0001】[0001]

【発明の属する技術】本発明は,沈降炭酸カルシウムを
有効成分とする慢性腎不全患者並びに腎透析患者におけ
る高リン血症改善剤として使用される内服固型剤で,製
剤的に安定で,かつ,服用し易い錠剤あるいは散剤,細
粒剤,顆粒剤に関する.
BACKGROUND OF THE INVENTION The present invention relates to an internal solid preparation containing a precipitated calcium carbonate as an active ingredient, which is used as an agent for improving hyperphosphatemia in chronic renal failure patients and renal dialysis patients. Tablets, powders, fine granules and granules that are easy to take.

【0002】[0002]

【従来の技術】従来のリン結合剤はアルミニウム製剤が
用いられていたが,長期投与による副作用として,骨
症,脳症,貧血,の発現が疑われ,その使用が制限され
るに至ったためこれに代わるものが必要となった.その
ため,リン結合を示すカルシウムとして沈降炭酸カルシ
ウムが用いられるようになったが,沈降炭酸カルシウム
は粉末であり,服用しにくく,また,高リン血症改善剤
としての効能・効果は確立されていない.
2. Description of the Related Art Conventional phosphorus binders used aluminum preparations. However, long-term administration has been suspected of causing osteopathy, encephalopathy, and anemia as side effects, and their use has been limited. An alternative was needed. For this reason, precipitated calcium carbonate has come to be used as calcium that shows phosphorus binding. However, precipitated calcium carbonate is a powder, is difficult to take, and its efficacy and effect as a hyperphosphatemia improving agent has not been established. .

【0003】また,沈降炭酸カルシウム原末は「制酸
剤」として古くから医療現場で使用されているが,リン
結合を目的とした高リン血症改善剤ではない.
[0003] Precipitated calcium carbonate bulk powder has long been used in medical practice as an "antacid", but is not a hyperphosphatemia improving agent for the purpose of phosphorus binding.

【0004】[0004]

【発明が解決しょうとする課題】本発明は,上述の課題
を解決し,製剤的に安定で,臨床現場で服用し易い剤形
である錠剤化あるいは散剤化を行い,高リン血症改善剤
の効能・効果を確立することを課題とする.
DISCLOSURE OF THE INVENTION The present invention solves the above-mentioned problems and provides tablets or powders that are stable in formulation and easy to take in clinical settings, and are used to improve hyperphosphatemia. The purpose is to establish the efficacy and effect of

【0005】[0005]

【課題を解決するための手段】本発明者らは,かかる課
題を解決するため検討した結果,沈降炭酸カルシウム
(又は炭酸カルシウム)に加えて,賦形薬として例えば
乳糖,崩壊剤として例えば低置換度ヒドロキシプロピル
セルロース,結合剤として例えばヒドロキシプロピルセ
ルロース及び滑沢剤として例えばステアリン酸マグネシ
ウムなどを処方した製剤が長期間安定で,また,崩壊及
び溶出がスムーズである錠剤化及び散剤化(細粒剤化,
顆粒剤化)に成功した. すなわち,本発明は以下のとおりである. ・沈降炭酸カルシウムを有効成分とした高リン血症改善
剤. ・有効成分として沈降炭酸カルシウムに賦形薬成分とし
て乳糖,マニトール,コンスターチの一種あるいはその
組み合わせよりなる成分,結合剤としてヒドロキシプロ
ピルセルロース,カルボキシメチルセルロース,結晶セ
ルロース,コンスターチ,ポビドン,メチルセルロース
の一種あるいは組み合わせよりなる成分,崩壊剤として
低置換度ヒドロキシプロピルセルロース,カルメロース
ナトリウム,コンスターチの一種あるいは組み合わせよ
りなる成分,更に滑沢剤としてステアリン酸マグネシウ
ム,タルクの一種あるいは組み合わせよりなる成分を含
有する錠剤である,請求項1の高リン血症改善剤. ・下記の配合成分割合からなる請求項2の錠剤. 沈降炭酸カルシウム 100〜1000mg/1錠 賦形薬 10〜110mg/1錠 結合剤 2mg〜25mg/1錠 崩壊剤 4mg〜70mg/1錠 滑沢剤 0.5〜6mg/1錠 ・沈降炭酸カルシウム10〜90%の割合に賦形薬成分
として乳糖,マニトール,結晶セルロース,ヒドロキシ
プロピルセルロース,カルボキシメチルセルロース,メ
チルセルロース,コンスターチ,ポビドンの組み合わせ
よりなる成分を配合してなる散剤,細粒剤,顆粒剤であ
る請求項1の高リン血症改善剤. ・下記の配合成分割合からなる請求項4の散剤. 沈降炭酸カルシウム 10〜90% 賦形薬 10〜90%
Means for Solving the Problems As a result of investigations for solving the problems, the present inventors have found that, in addition to precipitated calcium carbonate (or calcium carbonate), lactose as an excipient and low-substituted as a disintegrant, for example. A formulation containing hydroxypropylcellulose, a binder such as hydroxypropylcellulose, and a lubricant such as magnesium stearate is stable for a long time, and is disintegrated and disintegrated smoothly into tablets and powders (fine granules). ,
Granulation). That is, the present invention is as follows.・ A hyperphosphatemia improver containing precipitated calcium carbonate as an active ingredient. -Precipitated calcium carbonate as an active ingredient, an ingredient consisting of lactose, mannitol, one kind or combination of constarch as an excipient ingredient, and a binder consisting of one or combination of hydroxypropylcellulose, carboxymethylcellulose, crystalline cellulose, constarch, povidone, methylcellulose Tablets containing one or a combination of low-substituted hydroxypropylcellulose, carmellose sodium, and starch as disintegrants, and one or a combination of magnesium stearate and talc as lubricants. The agent for improving hyperphosphatemia according to claim 1. The tablet according to claim 2, wherein the tablet has the following compounding component ratio. Precipitated calcium carbonate 100-1000 mg / 1 tablet Excipient 10-110 mg / 1 tablet Binder 2 mg-25 mg / 1 tablet Disintegrant 4 mg-70 mg / 1 tablet Lubricant 0.5-6 mg / 1 tablet ・ Precipitated calcium carbonate 10 Powders, fine granules, and granules comprising a combination of lactose, mannitol, crystalline cellulose, hydroxypropylcellulose, carboxymethylcellulose, methylcellulose, constarch, and povidone as excipient components in a proportion of up to 90%. The agent for improving hyperphosphatemia according to claim 1. The powder according to claim 4, comprising the following compounding component ratio. Precipitated calcium carbonate 10-90% Excipient 10-90%

【0006】更に,腎透析患者を含めて血清リン値改善
効果を指標に臨床を実施し,有効性,安全性を確認し
た.また,服用のし易さでは,担当医及び患者の判定も
よく,初期の目的である服用のし易いさを改善した高リ
ン血症改善作用を有する製剤を確立した.
[0006] In addition, a clinical study was performed using the serum phosphorus level improvement effect as an index, including in patients with renal dialysis, to confirm the efficacy and safety. In addition, with regard to ease of taking, the physician and the patient were able to judge well, and a preparation with a hyperphosphatemia-improving action, which improved the initial purpose of easy taking, was established.

【0007】[0007]

【発明の実施の形態】以下に本発明の実施例を示す.Embodiments of the present invention will be described below.

【0008】[0008]

【試験結果】新剤型である錠剤の物性試験及び定量例に
よって具体的に示す. 1.試料 本発明品:実施例1〜4の錠剤 2.試験 実施例1〜4について,外観,物性(重量,直径,厚
み,硬度,摩損率)及び定量を測定した. 3.試験結果 試験結果を表1に示す.
[Test results] The results are shown specifically by physical property tests and quantitative examples of the new tablets. 1. 1. Sample Sample product of the present invention: tablets of Examples 1 to 4. Tests For Examples 1 to 4, the appearance, physical properties (weight, diameter, thickness, hardness, wear rate) and quantification were measured. 3. Test results Table 1 shows the test results.

【0009】実施例1 沈降炭酸カルシウム250g,結晶セルロース25g,
低置換度ヒドロキシプロピルセルロース17.5g,ヒ
ドロキシプロピルセルロース6gととり,適量の水を用
いて練合し,乾燥した後,整粒する.これにステアリン
酸マグネシウム1.5gを加え,10分間混合し,打錠
用顆粒とする.これを直径8mmの杵を用いて打錠す
る.
Example 1 250 g of precipitated calcium carbonate, 25 g of crystalline cellulose,
Take 17.5 g of low-substituted hydroxypropylcellulose and 6 g of hydroxypropylcellulose, knead with an appropriate amount of water, dry, and size. 1.5 g of magnesium stearate is added thereto and mixed for 10 minutes to obtain granules for tableting. This is tableted using an 8 mm diameter punch.

【0010】実施例2 沈降炭酸カルシウム500g,乳糖41.8g,カルボ
キシメチルセルロース30.0g,メチルセルロース2
4gととり,適量の水を用いて練合し,乾燥した後,整
粒する.これにステアリン酸マグネシウム4.2gを加
え,10分間混合し,打錠用顆粒とする.これを直径1
0mmの杵を用いて打錠する.
Example 2 500 g of precipitated calcium carbonate, 41.8 g of lactose, 30.0 g of carboxymethyl cellulose, 2 of methyl cellulose
Take 4 g, knead with an appropriate amount of water, dry and size. To this, 4.2 g of magnesium stearate is added and mixed for 10 minutes to obtain granules for tableting. This is diameter 1
Tablet using a 0 mm punch.

【0011】実施例3 沈降炭酸カルシウム500g,乳糖51.8g,低置換
度ヒドロキシプロピルセルロース35.0g,ヒドロキ
シプロピルセルロース9gととり,適量の水を用いて練
合し,乾燥した後,整粒する.これにステアリン酸マグ
ネシウム4.2gを加え,10分間混合し,打錠用顆粒
とする.これを直径10mmの杵を用いて打錠する.
Example 3 500 g of precipitated calcium carbonate, 51.8 g of lactose, 35.0 g of low-substituted hydroxypropylcellulose and 9 g of hydroxypropylcellulose were kneaded with an appropriate amount of water, dried, and sized. . To this, 4.2 g of magnesium stearate is added and mixed for 10 minutes to obtain granules for tableting. This is tableted using a 10 mm diameter punch.

【0012】実施例4 沈降炭酸カルシウム500g,乳糖44.8g,低置換
度ヒドロキシプロピルセルロース36.0g,ヒドロキ
シプロピルセルロース15gをとり,適量の水を用いて
練合し,乾燥した後,整粒する.これにステアリン酸マ
グネシウム4.2gを加え,10分間混合し,打錠用顆
粒とする.これを直径10mmの杵を用いて打錠する.
Example 4 500 g of precipitated calcium carbonate, 44.8 g of lactose, 36.0 g of low-substituted hydroxypropylcellulose and 15 g of hydroxypropylcellulose are kneaded with an appropriate amount of water, dried, and sized. . To this, 4.2 g of magnesium stearate is added and mixed for 10 minutes to obtain granules for tableting. This is tableted using a 10 mm diameter punch.

【0013】[0013]

【試験結果】新剤型である散剤の物性試験及び定量例に
よって具体的に示す. 1.試料 本発明品:実施例5〜6の散剤 2.試験 実施例5〜6について,外観,物性(粒度分布),含量
を測定した. 3.試験結果 試験結果を表2に示したように,外観,粒度分布及び含
量とも問題を認めなかった.
[Test results] This is shown in detail by physical property tests and quantitative examples of the new formulation powder. 1. Sample Product of the present invention: powder of Examples 5 to 6 Test The appearance, physical properties (particle size distribution), and content of Examples 5 to 6 were measured. 3. Test results As shown in Table 2, no problems were observed in appearance, particle size distribution and content.

【0014】実施例5 沈降炭酸カルシウム250g,乳糖20g,カルボキシ
メチルセルロース15g,メチルセルロース15gをと
り,適量の水を用いて練合し,乾燥した後,整粒・篩過
し,散剤とする.
Example 5 250 g of precipitated calcium carbonate, 20 g of lactose, 15 g of carboxymethylcellulose and 15 g of methylcellulose are kneaded with an appropriate amount of water, dried, sized and sieved to obtain a powder.

【0015】実施例6 沈降炭酸カルシウム500g,乳糖40g,カルボキシ
メチルセルロース30g,メチルセルロース30gをと
り,適量の水を用いて練合し,乾燥した後,整粒・篩過
し,散剤とする.
Example 6 500 g of precipitated calcium carbonate, 40 g of lactose, 30 g of carboxymethylcellulose and 30 g of methylcellulose are kneaded with an appropriate amount of water, dried, sized and sieved to obtain a powder.

【0016】[0016]

【発明の効果】本発明の製剤は患者にとって服用し易い
ものである.一方,沈降炭酸カルシウムは既に制酸剤と
して広く臨床使用され,その安全性は周知されている
が,透析患者の高リン血症改善の有用性は証明されてい
ない.そこで,1錠中沈降炭酸カルシウム500mgを
含有する錠剤(実施例3の錠剤)を用いて薬理試験及び
臨床試験を実施した結果を以下に示す.
The preparation of the present invention is easy for patients to take. On the other hand, precipitated calcium carbonate has already been widely used as an antacid in clinical practice, and its safety is well known, but its usefulness in improving hyperphosphatemia in dialysis patients has not been proven. The results of pharmacological and clinical tests using tablets containing 500 mg of precipitated calcium carbonate per tablet (tablets of Example 3) are shown below.

【0017】[0017]

【薬理作用】本剤の薬理作用は,腎不全に伴うリン***
能低下時に,食物中のリンを腸管内で不溶性・非吸収性
のリン酸カルシウムにすることにより,リン吸収を抑制
し,高リン血症を改善することである.このリン結合反
応の場が消化管内に限定されており,生体系の種々の調
節因子の影響を受けることが少ないところから,in
vitroの試験成績に基づき薬効を類推することが可
能であると判断し,試験を行った.その結果,胃内の想
定される1〜5の範囲のpHで暴露するとき,いずれの
条件下においてもほぼ一定のリン結合力がみられ,形成
される塩は不溶性の第二及び第三リン酸カルシウムであ
った.
[Pharmacological action] The pharmacological action of this drug is to suppress phosphorus absorption by converting phosphorus in food into insoluble and non-absorbable calcium phosphate in the intestinal tract when phosphorus excretion is reduced due to renal insufficiency. It is to improve the disease. The site of this phosphorus binding reaction is limited to the gastrointestinal tract, and is less affected by various regulatory factors of the biological system.
We determined that it was possible to infer the efficacy of the drug based on in vitro test results, and conducted the test. As a result, when the stomach is exposed to the expected pH in the range of 1 to 5, almost constant phosphorus binding force is observed under any conditions, and the salts formed are insoluble second and third calcium phosphates. Met.

【0018】[0018]

【臨床試験】更に腎透析施設で実施した臨床結果を以下
に示す.
[Clinical test] The clinical results of the renal dialysis facility are shown below.

【0019】[0019]

【有効性】1)臨床試験 I 高リン血症を呈する透析患者を対象に,実施例3の錠剤
とプラセボ投与により,本剤の有効性と安全性及び至適
用量の検討を目的とした用量検索試験を二重盲検比較法
により実施した.その結果,表3に示すように,血清リ
ン値改善効果(著効率)はプラセボ投与群20.0%に
対し,本剤1.5g/日投与群46.4%,3.0g/
日投与群82.1%と高く,三群間に用量相関性が確認
された.なお,有効率は,プラセボ投与群が36.0
%,本剤1.5g/日投与群は57.1%,3.0g/
日投与群は82.1%であった.また,概括安全度にお
ける「安全である」の率はプラセボ投与群93.3%に
対し,1.5g/日投与群,3.0g/日投与群とも9
6.7%であり,差はなかった.
[Efficacy] 1) Clinical trial I In dialysis patients presenting with hyperphosphatemia, administration of the tablet and placebo of Example 3 was conducted to investigate the efficacy, safety and optimal dosage of this drug. The search test was performed by a double-blind comparison method. As a result, as shown in Table 3, the serum phosphorous level improving effect (remarkable efficiency) was 20.0% in the placebo group, 46.4% in the group treated with 1.5 g / day, 3.0 g / day.
The daily administration group was as high as 82.1%, and a dose correlation was confirmed among the three groups. The effective rate was 36.0 in the placebo group.
%, 57.1%, 3.0 g / day
The daily administration group was 82.1%. The rate of “safe” in the overall safety was 93.3% in the placebo group and 9% in both the 1.5 g / day group and the 3.0 g / day group.
6.7%, no difference.

【0020】2)臨床試験 II 高リン血症に対して治療中又は治療予定の保存期及び透
析中の慢性腎不全患者を対象に,本剤の有効性と安全性
を検討した.その結果,血清リン値改善効果判定時の本
剤の投与量は1.0gから4.5gに分布していたが,
1.5g/日投与例44例(41.9%),3.0g/
日投与例36例(34.3%)が多かった.なお,血清
リン値の推移は良好にコントロールされ,高リン血症の
指標である7.0mg/dLを超えることはなかった.
表4に示すように,血清リン値改善効果(「有効」以
上)は82.5%,全般改善度(「有効」以上)は8
1.0%,概括安全度における「安全である」の率は9
5.4%,有用度(「有用」以上)は87.3%であっ
た.また,患者の印象では「錠剤が飲みやすい」の率は
78.5%であった.以上より,本製剤は慢性腎不全及
び透析患者における高リン血症改善剤として優れた効果
を示し,また,安全性の高い,且つ,服用し易い製剤で
あることが証明された.
2) Clinical trial II The efficacy and safety of this drug were studied in patients with chronic renal failure who are undergoing treatment or scheduled for treatment for hyperphosphatemia and undergoing dialysis. As a result, the dose of this drug at the time of determining the serum phosphorus level improving effect was distributed from 1.0 g to 4.5 g.
44 cases (41.9%), 1.5 g / day, 3.0 g / day
There were 36 daily administration cases (34.3%). The changes in serum phosphorus levels were well controlled and did not exceed 7.0 mg / dL, an index of hyperphosphatemia.
As shown in Table 4, the serum phosphorus level improving effect ("effective" or more) was 82.5%, and the overall improvement ("effective" or more) was 8%.
1.0%, “safe” rate in overall safety level is 9
The usefulness ("useful" or more) was 5.4% and 87.3%. According to the impression of the patient, the ratio of "easy to take tablets" was 78.5%. From the above results, it was proved that this product showed an excellent effect as an agent for ameliorating hyperphosphatemia in patients with chronic renal failure and dialysis, and was highly safe and easy to take.

【0021】3)臨床試験 III 高リン血症に対して治療中又は治療予定の保存期及び透
析中の慢性腎不全患者を対象に,本剤が長期投与時の血
清リン値の管理効果及び有用性を検討した.その結果,
6箇月の観察期間中血清リン値の改善は持続的で安定し
ており,表5に示すように,血清リン値改善効果は7
8.6%,全般改善度は78.6%,概括安全度は9
3.3%,有用度は78.6%であった.また,患者の
印象では「錠剤が飲みやすい」の率は88.9%であっ
た.以上より,本製剤は慢性腎不全及び透析患者におけ
る高リン血症改善剤として優れた効果を示し,また,安
全性の高い,且つ,服用し易い製剤であることが証明さ
れた.
3) Clinical trial III The efficacy and usefulness of long-term administration of this drug in patients with chronic renal insufficiency during treatment or scheduled dialysis treatment for hyperphosphatemia Was examined. as a result,
The improvement of serum phosphorus level was continuous and stable during the 6-month observation period.
8.6%, overall improvement 78.6%, overall safety 9
3.3%, the usefulness was 78.6%. According to the impression of the patient, the rate of "easy to take tablets" was 88.9%. From the above results, it was proved that this product showed an excellent effect as an agent for ameliorating hyperphosphatemia in patients with chronic renal failure and dialysis, and was highly safe and easy to take.

Claims (5)

【特許請求の範囲】[Claims] 【請求項1】 沈降炭酸カルシウム又は炭酸カルシウム
を有効成分とした高リン血症改善剤.
1. A hyperphosphatemia improving agent comprising precipitated calcium carbonate or calcium carbonate as an active ingredient.
【請求項2】 有効成分として沈降炭酸カルシウムに賦
形薬成分として乳糖,マニトール,コンスターチの一種
あるいはその組み合わせよりなる成分,結合剤としてヒ
ドロキシプロピルセルロース,カルボキシメチルセルロ
ース,結晶セルロース,コンスターチ,ポビドン,メチ
ルセルロースの一種あるいは組み合わせよりなる成分,
崩壊剤として低置換度ヒドロキシプロピルセルロース,
カルメロースナトリウム,コンスターチの一種あるいは
組み合わせよりなる成分,更に滑沢剤としてステアリン
酸マグネシウム,タルクの一種あるいは組み合わせより
なる成分を含有する錠剤である,請求項1の高リン血症
改善剤.
2. Precipitated calcium carbonate as an active ingredient, lactose, mannitol, a component consisting of one or a combination of constarch as an excipient component, and hydroxypropylcellulose, carboxymethylcellulose, crystalline cellulose, constarch, povidone, methylcellulose as a binder. Component consisting of one or a combination,
Low-substituted hydroxypropylcellulose as disintegrant,
2. The hyperphosphatemia-improving agent according to claim 1, which is a tablet containing carmellose sodium, a component composed of one or a combination of constarches, and a lubricant composed of one or a combination of magnesium stearate and talc.
【請求項3】 下記の配合成分割合からなる請求項2の
錠剤. 沈降炭酸カルシウム 100〜1000mg/1錠 賦形薬 10〜110mg/1錠 結合剤 2〜25mg/1錠 崩壊剤 4〜70mg/1錠 滑沢剤 0.5〜6mg/1錠
3. The tablet according to claim 2, comprising the following compounding ingredients. Precipitated calcium carbonate 100-1000 mg / 1 tablet Excipient 10-110 mg / 1 tablet Binder 2-25 mg / 1 tablet Disintegrant 4-70 mg / 1 tablet Lubricant 0.5-6 mg / 1 tablet
【請求項4】 沈降炭酸カルシウム10〜90%の割
合に賦形薬成分として乳糖,マニトール,結晶セルロー
ス,ヒドロキシプロピルセルロース,カルボキシメチル
セルロース,メチルセルロース,コンスターチ,ポビド
ンの組み合わせよりなる成分を配合してなる散剤(30
号:5%以下)あるいは細粒剤(200号:10%以
下),顆粒剤(12号:5%以下,42号15%以下)
である請求項1の高リン血症改善剤.
4. A powder comprising a mixture of lactose, mannitol, crystalline cellulose, hydroxypropylcellulose, carboxymethylcellulose, methylcellulose, constarch and povidone as excipient components in a proportion of 10 to 90% of precipitated calcium carbonate. (30
No .: 5% or less) or fine granules (No. 200: 10% or less), granules (No. 12: 5% or less, No. 42 15% or less)
The hyperphosphatemia improving agent according to claim 1, which is
【請求項5】 下記の配合割合からなる請求項4の散
剤. 沈降炭酸カルシウム 10〜90% 賦形薬 10〜90%
5. The powder according to claim 4, which has the following compounding ratio. Precipitated calcium carbonate 10-90% Excipient 10-90%
JP11188031A 1999-05-27 1999-05-27 Preparation containing precipitated calcium carbonate or calcium carbonate and hyperphosphatemia improving agent Pending JP2000336033A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP11188031A JP2000336033A (en) 1999-05-27 1999-05-27 Preparation containing precipitated calcium carbonate or calcium carbonate and hyperphosphatemia improving agent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP11188031A JP2000336033A (en) 1999-05-27 1999-05-27 Preparation containing precipitated calcium carbonate or calcium carbonate and hyperphosphatemia improving agent

Publications (1)

Publication Number Publication Date
JP2000336033A true JP2000336033A (en) 2000-12-05

Family

ID=16216464

Family Applications (1)

Application Number Title Priority Date Filing Date
JP11188031A Pending JP2000336033A (en) 1999-05-27 1999-05-27 Preparation containing precipitated calcium carbonate or calcium carbonate and hyperphosphatemia improving agent

Country Status (1)

Country Link
JP (1) JP2000336033A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4562797B1 (en) * 2009-05-29 2010-10-13 マイラン製薬株式会社 Orally disintegrating tablets containing precipitated calcium carbonate as an active ingredient

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4562797B1 (en) * 2009-05-29 2010-10-13 マイラン製薬株式会社 Orally disintegrating tablets containing precipitated calcium carbonate as an active ingredient
WO2010137716A1 (en) * 2009-05-29 2010-12-02 マイラン製薬株式会社 Orally disintegrating tablet which contains precipitated calcium carbonate as active ingredient
JP2011006377A (en) * 2009-05-29 2011-01-13 Mylan Seiyaku Ltd Orally disintegrable tablet which contains precipitated calcium carbonate as active ingredient

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