JPH07206472A - Borosilicate glass for medicine - Google Patents
Borosilicate glass for medicineInfo
- Publication number
- JPH07206472A JPH07206472A JP1482894A JP1482894A JPH07206472A JP H07206472 A JPH07206472 A JP H07206472A JP 1482894 A JP1482894 A JP 1482894A JP 1482894 A JP1482894 A JP 1482894A JP H07206472 A JPH07206472 A JP H07206472A
- Authority
- JP
- Japan
- Prior art keywords
- glass
- working point
- borosilicate glass
- thermal expansion
- medicine
- 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
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C03—GLASS; MINERAL OR SLAG WOOL
- C03C—CHEMICAL COMPOSITION OF GLASSES, GLAZES OR VITREOUS ENAMELS; SURFACE TREATMENT OF GLASS; SURFACE TREATMENT OF FIBRES OR FILAMENTS MADE FROM GLASS, MINERALS OR SLAGS; JOINING GLASS TO GLASS OR OTHER MATERIALS
- C03C3/00—Glass compositions
- C03C3/04—Glass compositions containing silica
- C03C3/076—Glass compositions containing silica with 40% to 90% silica, by weight
- C03C3/089—Glass compositions containing silica with 40% to 90% silica, by weight containing boron
- C03C3/091—Glass compositions containing silica with 40% to 90% silica, by weight containing boron containing aluminium
Abstract
Description
【0001】[0001]
【産業上の利用分野】本発明は注射用アンプル、管瓶用
ガラス等に使用される無色透明な医薬用ホウケイ酸ガラ
スに関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a colorless and transparent pharmaceutical borosilicate glass used for injection ampoules, glass for tube bottles, and the like.
【0002】[0002]
【従来の技術】注射用アンプルや管瓶用ガラスには、充
填される薬液を汚染しないように化学的耐久性が高いこ
とや、耐熱性を有するように低膨張であること等が要求
され、従来よりこのような条件を満たすものとして、S
iO2 −B2 O3 −Al2 O3−Na2 O−K2 O−B
aO系等のホウケイ酸ガラスが知られている。2. Description of the Related Art Ampoule for injection and glass for tube bottle are required to have high chemical durability so as not to contaminate the drug solution to be filled and low expansion so as to have heat resistance. Conventionally, as a condition that satisfies such a condition, S
iO 2 -B 2 O 3 -Al 2 O 3 -Na 2 O-K 2 O-B
Borosilicate glass such as aO is known.
【0003】ところで上記したようなBaOを含有する
ホウケイ酸ガラスは優れた化学的耐久性を有するもので
あるが、ガラス溶融時や成管時にBaO成分とアルミナ
系耐火物との反応によってバリウム長石結晶が析出し易
く、生産歩留りが低い。また薬品中の硫酸イオンとガラ
ス中のBaOとが反応して沈殿物が生じる恐れがある。By the way, the borosilicate glass containing BaO as described above has excellent chemical durability, but the barium feldspar crystal is formed by the reaction between the BaO component and the alumina refractory during the glass melting or forming. Is easily deposited and the production yield is low. Further, sulfate ions in the chemicals may react with BaO in the glass to form a precipitate.
【0004】このような事情から、BaOを含有しない
医薬用ホウケイ酸ガラスが各種提案されている。例えば
本発明者の発明になる特開平4−74731号にはSi
O2−B2 O3 −Al2 O3 −Na2 O−K2 O−Ca
O系のホウケイ酸ガラスが開示されている。Under these circumstances, various borosilicate glasses for medical use which do not contain BaO have been proposed. For example, in Japanese Patent Laid-Open No. 4-74731, which is the invention of the present inventor,
O 2 -B 2 O 3 -Al 2 O 3 -Na 2 O-K 2 O-Ca
O-based borosilicate glass is disclosed.
【0005】[0005]
【発明が解決しようとする課題】しかしながら上記特開
平4−74731号に開示のホウケイ酸ガラスは、作業
点が高い(1165℃以上)という欠点がある。即ち、
作業点が高いと、素材管からバーナー加工してアンプル
や管瓶等のガラス容器に成形する際の成形温度を高くせ
ざるを得ず、その結果ガラスからアルカリ成分が揮発し
て成形中のアンプルや管瓶の内面に焼き付いてしまう。
この焼き付いたアルカリ分は洗浄しても完全に除去する
ことができず、これが薬液の保存中や薬液充填後のオー
トクレーブ加熱で溶け出して薬液のpHを上げたり、薬
液を変質させたりする可能性がある。また成形時にアル
カリ成分が揮発すると、これが成形治具に付着して成形
不良を起こしたり、成形治具の寿命を縮める原因とな
る。However, the borosilicate glass disclosed in Japanese Unexamined Patent Publication (Kokai) No. 4-74731 has a drawback that the working point is high (1165 ° C. or higher). That is,
If the working point is high, it is necessary to raise the molding temperature when the material tube is burner processed into glass containers such as ampoules and tube bottles, and as a result, the alkaline component volatilizes from the glass and the ampoule being molded. And the inside of the tube bottle will be burned.
This burned alkaline component cannot be completely removed even by washing, and it may melt during storage of the chemical solution or heating in an autoclave after filling the chemical solution to raise the pH of the chemical solution or change the quality of the chemical solution. There is. Further, when the alkaline component volatilizes during molding, it adheres to the molding jig and causes defective molding, or shortens the life of the molding jig.
【0006】本発明の目的は、要求される諸特性を満足
し、しかも低い作業点を有する無色透明な医薬用ホウケ
イ酸ガラスを提供することである。An object of the present invention is to provide a colorless and transparent pharmaceutical borosilicate glass which satisfies the required properties and has a low working point.
【0007】[0007]
【課題を解決するための手段】本発明者は種々の研究を
行った結果、構成成分をSiO2 、B2 O3 、Al2O3
、Na2 O、K2 O、CaO及び清澄剤のみに制限
し、且つこれらの成分の割合を厳密に限定することによ
り、上記目的が達成できることを見いだし、本発明とし
て提案するものである。As a result of various studies, the present inventor has found that the constituents are SiO 2 , B 2 O 3 , and Al 2 O 3.
It was found that the above object can be achieved by restricting only Na, Na 2 O, K 2 O, CaO and a fining agent and strictly limiting the proportions of these components, and it is proposed as the present invention.
【0008】即ち、本発明の医薬用ホウケイ酸ガラス
は、本質的にSiO2 、B2 O3 、Al2 O3 、Na2
O、K2 O、CaO及び清澄剤のみからなり、前記各成
分の割合が重量百分率でSiO2 70.0〜75.0
%、B2 O3 12.1〜15.0%、Al2O3 3.0
〜4.9%、Na2 O5.5〜7.5%、K2 O0.5
〜2.5%、CaO0.1〜1.0%、清澄剤0.01
〜0.5%であり、30〜380℃における熱膨張係数
が46〜52×10-7/℃、作業点が1140℃以下、
第12改正日本薬局方 注射剤用ガラス容器試験法 ア
ルカリ溶出試験第1法に基づくアルカリ溶出量が0.3
0ml以下であることを特徴とする。That is, the medicinal borosilicate glass of the present invention is essentially composed of SiO 2 , B 2 O 3 , Al 2 O 3 and Na 2.
O, K 2 O, CaO and a fining agent only, and the ratio of each of the above components is SiO 2 70.0 to 75.0 in weight percentage.
%, B 2 O 3 12.1-15.0%, Al 2 O 3 3.0
~4.9%, Na 2 O5.5~7.5%, K 2 O0.5
~ 2.5%, CaO 0.1-1.0%, fining agent 0.01
Is 0.5%, the thermal expansion coefficient at 30 to 380 ° C. is 46 to 52 × 10 −7 / ° C., the working point is 1140 ° C. or less,
12th revision Japanese Pharmacopoeia Glass container test method for injections Alkali elution test
It is characterized by being 0 ml or less.
【0009】[0009]
【作用】本発明の医薬用ホウケイ酸ガラスは、本質的に
SiO2 、B2 O3 、Al2 O3 、Na2 O、K2 O、
CaO及び清澄剤のみからなる。なおこれら以外の成分
が含まれると所望の特性が得られなくなり好ましくな
い。例えばBaOの添加は前述のように生産歩留りの低
下等を招き、またZrO2 を添加するとガラスの粘性が
増大し、結果的にアルカリ溶出量が多くなってしまう。The medicinal borosilicate glass of the present invention is essentially composed of SiO 2 , B 2 O 3 , Al 2 O 3 , Na 2 O, K 2 O,
Consists of CaO and fining agent only. If components other than these are contained, desired characteristics cannot be obtained, which is not preferable. For example, the addition of BaO causes a decrease in production yield as described above, and the addition of ZrO 2 increases the viscosity of glass, resulting in a large amount of alkali elution.
【0010】次に各成分の組成範囲を上記のように限定
した理由を述べる。Next, the reason why the composition range of each component is limited as described above will be described.
【0011】Si02 は主要なガラス形成酸化物であ
り、その含有量は70.0〜75.0%、好ましくは7
2.5〜74.5%である。SiO2 が75.0%より
多いとガラスの溶融性及び成形性が著しく悪くなり、一
方70.0%より少なくなると熱膨張係数が大きくなり
過ぎて耐熱性が悪くなり、バーナー加工後に直ちに徐冷
しないと成形品が破損し易くなる。SiO 2 is the main glass-forming oxide, the content of which is 70.0 to 75.0%, preferably 7
It is 2.5 to 74.5%. If the SiO 2 content is more than 75.0%, the glass meltability and moldability will be significantly deteriorated, whereas if it is less than 70.0%, the thermal expansion coefficient will be too large and the heat resistance will be poor, and the glass will be annealed immediately after burner processing. Otherwise, the molded product will be easily damaged.
【0012】B2 O3 はガラスの溶融性を向上させる成
分であり、その含有量は12.1〜15.0%、好まし
くは12.2〜14.0%である。B2 O3 が15.0
%より多くなると化学的耐久性が悪くなり、一方12.
1%より少ないと上記した効果が得られない。B 2 O 3 is a component that improves the meltability of glass, and its content is 12.1 to 15.0%, preferably 12.2 to 14.0%. B 2 O 3 is 15.0
%, The chemical durability deteriorates, while 12.
If it is less than 1%, the above effect cannot be obtained.
【0013】Al2 O3 はガラスの失透を抑制し、また
化学的耐久性を向上させる成分であり、その含有量は
3.0〜4.9%、好ましくは3.8〜4.8%であ
る。Al2 O3 が4.9%より多いとガラスの高温粘性
が大きくなって作業点が高くなり、その結果、成形時に
アルカリ成分が揮発し易くなってしまう。またガラスの
溶融性が悪くなる。一方3.0%より少ないとガラスの
液相温度が高くなって溶融中に失透し易くなったり、ガ
ラスが分相し易くなる。Al 2 O 3 is a component that suppresses devitrification of glass and improves chemical durability, and the content thereof is 3.0 to 4.9%, preferably 3.8 to 4.8. %. If the Al 2 O 3 content is more than 4.9%, the high temperature viscosity of the glass becomes large and the working point becomes high, and as a result, the alkaline component tends to volatilize during molding. In addition, the meltability of the glass deteriorates. On the other hand, if it is less than 3.0%, the liquidus temperature of the glass becomes high and the glass is liable to devitrify during melting or the glass is likely to undergo phase separation.
【0014】Na2 Oはガラスの溶融性を向上させる効
果があり、その含有量は5.5%〜7.5%、好ましく
は6.0〜7.5%である。Na2 Oが7.5%より多
くなると化学的耐久性が悪くなるとともに熱膨張係数が
大きくなって耐熱性が低下する。一方5.5%より少な
くなると上記効果が得られなくなる。Na 2 O has the effect of improving the meltability of the glass, and its content is 5.5% to 7.5%, preferably 6.0 to 7.5%. If the content of Na 2 O is more than 7.5%, the chemical durability becomes poor and the coefficient of thermal expansion becomes large to lower the heat resistance. On the other hand, if it is less than 5.5%, the above effect cannot be obtained.
【0015】K2 Oは化学的耐久性を向上させるととも
に液相温度を下げる成分であり、その含有量は0.5〜
2.5%である。K2 Oが2.5%より多いとガラスの
粘性が高くなり過ぎる。逆に0.5%より少なくなると
上記した効果が得られなくなる。K 2 O is a component that improves the chemical durability and lowers the liquidus temperature, and the content thereof is 0.5-.
It is 2.5%. If K 2 O is more than 2.5%, the viscosity of the glass becomes too high. On the contrary, if it is less than 0.5%, the above effect cannot be obtained.
【0016】なおNa2 OとK2 Oの合量は8.5%以
下であることが好ましい。即ち、これらの成分の合量が
8.5%を超えると熱膨張係数が高くなって耐熱性が低
下するとともに、アルカリ溶出量が多くなるためであ
る。The total amount of Na 2 O and K 2 O is preferably 8.5% or less. That is, when the total amount of these components exceeds 8.5%, the coefficient of thermal expansion becomes high, the heat resistance decreases, and the amount of alkali elution increases.
【0017】CaOはガラスの溶融性を向上させる働き
があり、その含有量は0.1〜1.0%である。CaO
が1.0%より多くなると化学的耐久性が悪くなり、逆
に0.1%より少ないと上記した効果が得られなくな
る。CaO has a function of improving the melting property of glass, and its content is 0.1 to 1.0%. CaO
If it is more than 1.0%, the chemical durability is deteriorated, and if it is less than 0.1%, the above effect cannot be obtained.
【0018】清澄剤としては、As2 O3 、Sb2 O
3 、NaCl等の1種又は2種以上を0.01〜0.5
%含有する。清澄剤が0.5%より多いとAs、Sb、
Cl等の溶出量が増大したり、バーナー加工によりガラ
スが変色してしまうおそれがある。逆に0.01%より
少ないと清澄効果がない。As the fining agent, As 2 O 3 and Sb 2 O
3 , 1, 2 or more such as NaCl 0.01-0.5
%contains. If the clarifying agent is more than 0.5%, As, Sb,
There is a possibility that the amount of Cl and the like eluted may increase or that the glass may be discolored by burner processing. On the contrary, if it is less than 0.01%, there is no fining effect.
【0019】また本発明の医薬用ホウケイ酸ガラスは、
30〜380℃における熱膨張係数が46〜52×10
-7/℃、作業温度が1140℃以下であり、第12改正
日本薬局方 注射剤用ガラス容器試験法 アルカリ溶出
試験第1法に基づくアルカリ溶出量が0.30ml以下
であることを特徴とする。熱膨張係数がこの範囲より大
きくなると耐熱性が悪くなり、逆に小さくなるとワンポ
イントカットアンプルのカラーピグメントの接着性が低
下して剥離する恐れがある。作業点が1140℃より高
くなると成形時にアルカリ成分の揮発が著しくなり、ま
た成形治具が劣化し易くなる。またアルカリ溶出量が
0.30mlよりも大きくなると、上記アルカリ溶出試
験第1法の融封できる容器の規定に適合しないために注
射用アンプルや管瓶に使用できなくなる。Further, the pharmaceutical borosilicate glass of the present invention comprises:
Thermal expansion coefficient at 30 to 380 ° C. is 46 to 52 × 10
-7 / ° C, working temperature is 1140 ° C or lower, and the amount of alkaline elution is 0.30 ml or less based on the 12th revised Japanese Pharmacopoeia Test method for glass containers for injections . If the coefficient of thermal expansion is larger than this range, the heat resistance will be poor, and if it is smaller, the adhesiveness of the color pigment of the one-point cut ampoule will be reduced and peeling may occur. If the working point is higher than 1140 ° C., the volatilization of the alkaline component becomes remarkable during molding, and the molding jig is apt to deteriorate. If the amount of alkali elution is more than 0.30 ml, it cannot be used for injection ampoules and vials because it does not meet the regulation of the container capable of being fused and sealed in the above first method of alkali elution test.
【0020】[0020]
【実施例】以下、実施例に基づいて本発明の医薬用ホウ
ケイ酸ガラスを説明する。EXAMPLES The pharmaceutical borosilicate glass of the present invention will be described below based on examples.
【0021】表1は本発明の実施例(試料No.1〜
4)、表2は比較例(試料No.5〜8)のガラス組
成、熱膨張係数、作業点、ガラスのアルカリ溶出量、及
びバリウム長石の析出の有無をそれぞれ示している。Table 1 shows examples of the present invention (Sample Nos. 1 to 1).
4) and Table 2 show the glass composition, the coefficient of thermal expansion, the working point, the alkali elution amount of the glass, and the presence or absence of barium feldspar precipitation in Comparative Examples (Sample Nos. 5 to 8), respectively.
【0022】[0022]
【表1】 [Table 1]
【0023】[0023]
【表2】 [Table 2]
【0024】表中の各試料は次のようにして調製した。
まず表の組成になるようにガラス原料を調合した後、白
金坩堝に入れ実験炉で1550℃−6時間の条件で溶融
した。次いで溶融ガラスを一旦板状に成形し、徐冷後、
各特性の測定に供するために必要な形状に成形した。な
おこのようにして得られた各試料は、何れも無色透明で
あった。Each sample in the table was prepared as follows.
First, glass raw materials were mixed so as to have the composition shown in the table, and then they were put into a platinum crucible and melted in an experimental furnace under the conditions of 1550 ° C. and 6 hours. Next, the molten glass is once formed into a plate shape, and after slowly cooling,
It was molded into a shape required for the measurement of each characteristic. Each of the samples thus obtained was colorless and transparent.
【0025】表から明らかなように、本発明の実施例で
ある試料No.1〜4は、30〜380℃における熱膨
張係数が48〜50×10-7/℃、作業点が1108〜
1125℃であり、ガラスのアルカリ溶出量が0.12
〜0.15mlであった。またバリウム長石の析出は認
められなかった。As is apparent from the table, the sample No. which is an example of the present invention. Nos. 1 to 4 have a thermal expansion coefficient of 48 to 50 × 10 −7 / ° C. at 30 to 380 ° C. and a working point of 1108 to
It is 1125 ° C, and the amount of alkali elution of glass is 0.12
Was ~ 0.15 ml. No precipitation of barium feldspar was observed.
【0026】これに対して比較例である試料No.5
は、熱膨張係数が47×10-7/℃、ガラスのアルカリ
溶出量が0.12mlであり、バリウム長石の析出も認
められなかったが、作業点が1180℃と高かった。試
料No.6は熱膨張係数が49×10-7/℃、作業点が
1123℃、ガラスのアルカリ溶出量が0.13mlで
あったが、バリウム長石の析出が認められた。試料N
o.7は、熱膨張係数が47×10-7/℃、ガラスのア
ルカリ溶出量が0.10mlであり、バリウム長石の析
出も認められなかったが、作業点が1145℃と高かっ
た。試料No.8は作業点が1130℃であり、バリウ
ム長石の析出も認められなかったが、熱膨張係数が38
×10-7/℃と低く、またガラスのアルカリ溶出量が
1.50mlと非常に多かった。On the other hand, sample No. which is a comparative example. 5
Had a thermal expansion coefficient of 47 × 10 −7 / ° C., an alkali elution amount of glass of 0.12 ml, and no precipitation of barium feldspar was observed, but the working point was high at 1180 ° C. Sample No. No. 6 had a coefficient of thermal expansion of 49 × 10 −7 / ° C., a working point of 1123 ° C., and an alkali elution amount of glass of 0.13 ml, but precipitation of barium feldspar was observed. Sample N
o. In No. 7, the coefficient of thermal expansion was 47 × 10 −7 / ° C., the amount of alkali elution of glass was 0.10 ml, and precipitation of barium feldspar was not observed, but the working point was high at 1145 ° C. Sample No. No. 8 had a working point of 1130 ° C. and precipitation of barium feldspar was not observed, but the thermal expansion coefficient was 38.
It was as low as × 10 -7 / ° C, and the amount of alkali elution of glass was 1.50 ml, which was very large.
【0027】なお、熱膨張係数は直径5mm、長さ50
mmの棒状に成形した試料を用い、熱膨張計によって測
定した。作業点は高温粘度計にて求めた。ガラスのアル
カリ溶出量は、第12改正日本薬局方 注射剤用ガラス
容器試験法 アルカリ溶出試験第1法に基づいて測定し
た。バリウム長石の析出の有無については、アルミナ系
耐火物ボートに塊状のガラス試料を入れ、箱形電気炉中
で1250℃で6時間加熱し、続いて1100〜900
℃の温度傾斜炉で7日間加熱した後、各温度域の部分を
薄片にし、偏光顕微鏡にて観察して評価した。The coefficient of thermal expansion is 5 mm in diameter and 50 in length.
Using a sample molded into a rod shape of mm, the measurement was performed by a thermal expansion meter. The working point was determined by a high temperature viscometer. The amount of alkali elution of glass was measured based on the 12th revision Japanese Pharmacopoeia, Glass container test method for injections, Alkali elution test method 1. Regarding the presence or absence of precipitation of barium feldspar, a lump glass sample was put into an alumina refractory boat and heated in a box electric furnace at 1250 ° C. for 6 hours, and then 1100 to 900.
After heating in a temperature gradient furnace at ℃ for 7 days, each temperature region was sliced and observed with a polarizing microscope for evaluation.
【0028】[0028]
【発明の効果】以上説明したように、本発明の医薬用ホ
ウケイ酸ガラスは、化学的耐久性等の医薬用ガラスとし
て求められる諸特性を満足し、しかも作業温度が低いた
めにバーナー加工時のアルカリ成分の揮発がなく、注射
用アンプルや管瓶用ガラスとして好適である。As described above, the pharmaceutical borosilicate glass of the present invention satisfies various characteristics required as a pharmaceutical glass such as chemical durability and has a low working temperature. It is suitable for injection ampoules and glass for tube bottles because it does not volatilize alkaline components.
Claims (1)
3 、Na2 O、K2O、CaO及び清澄剤のみからな
り、前記各成分の割合が重量百分率でSiO270.0
〜75.0%、B2 O3 12.1〜15.0%、Al2
O3 3.0〜4.9%、Na2 O5.5〜7.5%、K
2 O0.5〜2.5%、CaO0.1〜1.0%、清澄
剤0.01〜0.5%であり、30〜380℃における
熱膨張係数が46〜52×10-7/℃、作業点が114
0℃以下、第12改正日本薬局方注射剤用ガラス容器試
験法 アルカリ溶出試験第1法に基づくアルカリ溶出量
が0.30ml以下であることを特徴とする医薬用ホウ
ケイ酸ガラス。1. Essentially SiO 2 , B 2 O 3 , Al 2 O
3 , Na 2 O, K 2 O, CaO and a refining agent only, and the ratio of each component is SiO 2 70.0 in weight percentage.
~75.0%, B 2 O 3 12.1~15.0 %, Al 2
O 3 3.0 to 4.9%, Na 2 O 5.5 to 7.5%, K
2 O 0.5 to 2.5%, CaO 0.1 to 1.0%, a fining agent 0.01 to 0.5%, and a thermal expansion coefficient at 30 to 380 ° C. of 46 to 52 × 10 −7 / ° C. , The working point is 114
0 ° C or less, 12th revision Japanese Pharmacopoeia Glass container test method for injection Alkali elution test The alkali elution amount based on the first method is 0.30 ml or less, and a pharmaceutical borosilicate glass.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP1482894A JPH07206472A (en) | 1994-01-12 | 1994-01-12 | Borosilicate glass for medicine |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP1482894A JPH07206472A (en) | 1994-01-12 | 1994-01-12 | Borosilicate glass for medicine |
Publications (1)
Publication Number | Publication Date |
---|---|
JPH07206472A true JPH07206472A (en) | 1995-08-08 |
Family
ID=11871908
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP1482894A Pending JPH07206472A (en) | 1994-01-12 | 1994-01-12 | Borosilicate glass for medicine |
Country Status (1)
Country | Link |
---|---|
JP (1) | JPH07206472A (en) |
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