Beconase AQ | 5534-09-8

• 物质功能分类: 原料药 - 激素及调节内分泌功能类药 - 肾上腺皮质激素类药
• 分子结构分类: 有机化合物 - 脂质和类脂质分子 - 类固醇和类固醇衍生物
• 英文名称: Beconase AQ
• 英文别名: [2-(9-chloro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl)-2-oxoethyl] propanoate
• CAS: 5534-09-8
• 化学式: C₂₈H₃₇ClO₇
• 分子量: 521.0
• InChiKey: KUVIULQEHSCUHY-UHFFFAOYSA-N

物化性质

• 熔点：
  117-120 C
• 比旋光度：
  D +98.0° (c = 1.0 in dioxane)
• 沸点：
  613.3°C (rough estimate)
• 密度：
  1.0766 (rough estimate)
• 溶解度：
  氯仿（微溶）、二恶烷（微溶、超声）、甲醇（微溶、加热）
• 最大波长(λmax)：
  238nm(EtOH)(lit.)
• 稳定性/保质期：
  常温常压下稳定，这是一种类白色或微黄色的结晶性粉末。

计算性质

• 辛醇/水分配系数(LogP)：
  3
• 重原子数：
  36
• 可旋转键数：
  8
• 环数：
  4.0
• sp3杂化的碳原子比例：
  0.71
• 拓扑面积：
  107
• 氢给体数：
  1
• 氢受体数：
  7

安全信息

• 危险品标志：
  T
• 安全说明：
  S36/37/39,S45,S53
• 危险类别码：
  R60,R61
• WGK Germany：
  3
• 海关编码：
  2937290090
• 危险品运输编号：
  NONH for all modes of transport
• RTECS号：
  TU3805000
• 储存条件：
  应存放在2-8℃的环境中，避光、阴凉且干燥的地方，并密封保存。

SDS

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Section 1. Chemical Product and Company Identification
Beclomethasone Dipropionate
Common Name/
Trade Name
Beclomethasone Dipropionate

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Section 3. Hazards Identification
Potential Acute Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
Potential Chronic Health CARCINOGENIC EFFECTS: Not available.
Effects MUTAGENIC EFFECTS: Not available.
TERATOGENIC EFFECTS: Classified POSSIBLE for human.
DEVELOPMENTAL TOXICITY: Classified Development toxin [POSSIBLE].
Repeated exposure to a highly toxic material may produce general deterioration of health by an accumulation in
one or many human organs.

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Section 4. First Aid Measures
Eye Contact Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at
least 15 minutes. Cold water may be used. WARM water MUST be used. Get medical attention if irritation
occurs.
Skin Contact Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Serious Skin Contact Not available.
Inhalation If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention immediately.
Serious Inhalation Not available.
Ingestion Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
unconscious person. Loosen tight clothing such as a collar, tie, belt or waistband. Get medical attention if
symptoms appear.
Serious Ingestion Not available.

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Section 5. Fire and Explosion Data
Flammability of the Product May be combustible at high temperature.
Auto-Ignition Temperature Not available.
Flash Points Not available.
Flammable Limits Not available.
Products of Combustion These products are carbon oxides (CO, CO2), halogenated compounds.
Fire Hazards in Presence of Slightly flammable to flammable in presence of heat.
Various Substances
Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
of Various Substances Risks of explosion of the product in presence of static discharge: Not available.
Fire Fighting Media SMALL FIRE: Use DRY chemical powder.
and Instructions LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Special Remarks on As with most organic solids, fire is possible at elevated temperatures
Fire Hazards
Special Remarks on Explosion Fine dust dispersed in air in sufficient concentrations, and in the presence of an ignition source is a potential dust
Hazards explosion hazard.
Beclomethasone Dipropionate

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Section 6. Accidental Release Measures
Small Spill Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by
spreading water on the contaminated surface and dispose of according to local and regional authority
requirements.
Large Spill Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water
on the contaminated surface and allow to evacuate through the sanitary system.

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Section 7. Handling and Storage
Precautions Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not
breathe dust.
Storage Keep container tightly closed. Keep container in a cool, well-ventilated area. It should be stored at 25 deg. C (77
deg. F), but storage at temperatures between 15 and 30 deg. C (59 to 86 deg. F) are acceptable. The product
should not be exposed to temperatures above 120 deg. F. because container may burst.

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Section 8. Exposure Controls/Personal Protection
Engineering Controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below
recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
airborne contaminants below the exposure limit.
Personal Protection Safety glasses. Lab coat. Dust respirator. Use a dust respirator is ventilation if inadequate and handling of
product creates visible dust clouds. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used
a Large Spill to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
BEFORE handling this product.
Exposure Limits Not available.

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Section 9. Physical and Chemical Properties
Physical state and appearance Solid. (Solid powder.) Odor Odorless.
Taste Not available.
521.1 g/mole
Molecular Weight
Color White to creamy
pH (1% soln/water) Not available.
Not available.
Boiling Point
Melting Point 201°C (393.8°F) - 208 C.B^
Not available.
Critical Temperature
Specific Gravity Not available.
Vapor Pressure Not applicable.
Vapor Density Not available.
Volatility Not available.
Odor Threshold Not available.
Water/Oil Dist. Coeff. Not available.
Not available.
Ionicity (in Water)
Dispersion Properties Not available.
Very slightly soluble in cold water.
Solubility
Beclomethasone Dipropionate

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Section 10. Stability and Reactivity Data
The product is stable.
Stability
Instability Temperature Not available.
Excess heat
Conditions of Instability
Not available.
Incompatibility with various
substances
Corrosivity Not available.
Special Remarks on Not available.
Reactivity
Special Remarks on Not available.
Corrosivity
Polymerization Will not occur.

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Section 11. Toxicological Information
Routes of Entry Inhalation. Ingestion.
Toxicity to Animals WARNING: THE LC50 VALUES HEREUNDER ARE ESTIMATED ON THE BASIS OF A 4-HOUR EXPOSURE.
Acute oral toxicity (LD50): >3750 mg/kg [Rat].
Acute toxicity of the dust (LC50): 51.6 mg/m3 2 hours [Rat].
Chronic Effects on Humans Not available.
Other Toxic Effects on Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Humans
Special Remarks on
Not available.
Toxicity to Animals
Special Remarks on Not available.
Chronic Effects on Humans
Special Remarks on other Acute Potential Health Effects:
Toxic Effects on Humans Skin: May cause skin irritation.
Eyes: Dust may cause eye irritation.
Inhalation: A massive single dose is unlikely to cause adverse effects. Dust may cause respiratory tract
(nasopharyngeal) irritaiton with nasopharyngitis, nasal burning, rhinorrhea, hoarseness, bronchospasm, coughing
and possible nasal septum perforation. It may also cause headache, nausea, vomiting.
Ingestion: May cause gastrointestinal tract irritation with nausea, vomiting, hypermotility, diarrhea.
Other adverse effects of inhalation or ingestion may include: decreased or blurred vision, frequent urination,
increased thirst, increased appetite, indegestion, nervousness, convulsions, seizures, muscle contraction or
spasticity, trouble sleeping weight gain, dizziness, flushing of the face or cheeks, hiccups, and increased
sweating.
Chronic Potential Health Effects:
Inhalation or Ingestion: Prolonged or repeated inhalation or ingestion may cause possible hypersensitization; acne
or other skin problems; hip or shoulder pain; osteoporosis; gradual blurring or loss of vision (cataracts or
glaucoma); eye pain or redness; tearing and sensitivity of eyes to light; rounding out of the face; purple lines on
arms, face, legs, trunk, groin; unusual increase in hair growth; hypertension; menstrual irregularities; muscle
weakness; unusual bruising; rapid weight gain; swelling of feet or lower legs; irregular heartbeat; muscle cramps
or pain; unusual tiredness or weakness; impaired wound healing; headache; insomnia; pain in back, ribs, arms or
legs; continuing abdominal or stomach pain or burning; nausea; vomiting; bloody or black tarry stools; tendon
rupture; thin, fragile skin; blood (changes in erythrocyte and leukocyte count), thymus, and spleen
Medical Conditions Aggravated by Exposure: Hypersensitivity to material; ocular herpes simplex; AIDS or HIV
infection; heart disease; congestive heart failure; recent heart attack; intestinal anastomoses; strongyloides
infestation; diabetes mellitus; mayasthenia gravis; impaired kidney function or disease; esophagitis; gastritis or
peptic ulcer; chicken pox or measles (including recent exposure); tuberculosis; system fungal infections.
Beclomethasone Dipropionate

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Section 12. Ecological Information
Ecotoxicity Not available.
BOD5 and COD Not available.
Products of Biodegradation Possibly hazardous short term degradation products are not likely. However, long term degradation products may
arise.
The products of degradation are as toxic as the product itself.
Toxicity of the Products
of Biodegradation
Special Remarks on the Not available.
Products of Biodegradation

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Section 13. Disposal Considerations
Waste Disposal Waste must be disposed of in accordance with federal, state and local environmental
control regulations.

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Section 14. Transport Information
DOT Classification Not a DOT controlled material (United States).
Not applicable.
Identification
Not applicable.
Special Provisions for
Transport
DOT (Pictograms)

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Section 15. Other Regulatory Information and Pictograms
No products were found.
Federal and State
Regulations
California California prop. 65: This product contains the following ingredients for which the State of California has found
to cause cancer which would require a warning under the statute: No products were found.
Proposition 65
Warnings
California prop. 65: This product contains the following ingredients for which the State of California has found
to cause birth defects which would require a warning under the statute: Beclomethasone Dipropionate
Other Regulations EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances. EINECS no.
226-886-0.
WHMIS (Canada) Not controlled under WHMIS (Canada).
Other Classifications
DSCL (EEC) This product is not classified according Not applicable.
to the EU regulations.
Health Hazard
HMIS (U.S.A.) 1 National Fire Protection
1 Flammability
1 Association (U.S.A.)
Fire Hazard
1 0 Reactivity
Health
Reactivity
0
Specific hazard
Personal Protection
E
Beclomethasone Dipropionate
WHMIS (Canada)
(Pictograms)
DSCL (Europe)
(Pictograms)
TDG (Canada)
(Pictograms)
ADR (Europe)
(Pictograms)
Protective Equipment
Gloves.
Lab coat.
Dust respirator. Be sure to use an
approved/certified respirator or
equivalent.
Beclomethasone Dipropionate
All chemicals may pose unknown hazards and should be used with caution. This Material Safety Data Sheet (MSDS) applies only to the material as packaged. If this product is
combined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this MSDS. It shall be the user's responsibility to develop proper
methods of handling and personal protection based on the actual conditions of use. While this MSDS is based on technical data judged to be reliable, Spectrum Quality Products,

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SECTION 16 - ADDITIONAL INFORMATION
N/A

制备方法与用途

丙酸倍氯米松气雾剂

丙酸倍氯米松气雾剂（二丙酸氯倍他米松气雾剂）是目前常用的治疗哮喘的激素类药物。它具有抗炎和抗过敏的作用，有助于扩张支气管、解除痉挛，缓解哮喘症状，并降低发作频率。尽管药物在体内起效需要2至3天，喷后不能迅速缓解病人的呼吸困难，因此对急性哮喘发作无效。

药理学特性

丙酸倍氯米松是人工合成的第一代糖皮质激素，是一种受体亲和力较低的前体药物。95%的丙酸倍氯米松吸入后在肺内迅速被酶水解为活性代谢物17-单丙酸倍氯米松（17-BMP），最终水解为无活性的倍氯米松。BDP水溶性较低，导致其在支气管黏膜的黏液层溶解缓慢，限制了其肺部吸收过程。BDP和BMP口服绝对生物利用度分别为13%和26%，首过消除约为70%。

药理作用及作用机制

丙酸倍氯米松是一种强效糖皮质激素类药物，其抗炎作用较地塞米松、曲安奈德、氟轻松、曲安西龙更强。它还具有抗过敏、止痒和抗细胞有丝分裂的作用。脂溶性较强，对皮肤的渗透作用较好，涂于患处30分钟后即生效，并维持时间较长。外用主要通过毛囊皮脂腺和表皮吸收，可收缩局部微血管并发挥强效的抗炎作用，不会引起因肾上腺皮质功能紊乱而产生的副作用。

药代动力学 气雾剂

丙酸倍氯米松气雾剂亲脂性较强，易渗透，约吸入量的25%到达肺部。

乳膏

本品可经皮肤吸收，尤其在皮肤破损处吸收更快。大面积使用于皮肤破损或长期用封包性敷料时可能因吸收引起全身反应。本品亲脂性强，易渗透，涂于患处30分钟后即生效。软膏剂的T1/2约为3小时，钠潴留及糖原沉着作用很弱，无雄性、雌性或蛋白同化激素样的作用，对体温和尿液也无明显影响。

适应症 丙酸倍氯米松

用于治疗湿疹、过敏性皮炎、神经性皮炎、扁平苔藓、盘状红斑狼疮、掌跖脓疱病、接触性皮炎、局限性银屑病和皮肤瘙痒症等。丙酸倍氯米松气雾剂适用于慢性或过敏性哮喘及过敏性鼻炎。

用途

系强效外用糖皮质激素类药，具有抗炎、抗过敏和止痒等作用，能抑制支气管渗出物、消除支气管粘膜肿胀并解除支气管痉挛。可用于治疗各种炎症皮肤病。

类别与毒性

类别: 有毒物品
毒性分级: 中毒
急性毒性: 口服-大鼠 LD50: >3750 毫克/公斤; 口服-小鼠 LD50: >5000 毫克/公斤

危险特性 可燃性危险特性

易燃；燃烧产生有毒氯化物烟雾。

储运特性

库房应通风、低温干燥，与食品原料分开存放。

灭火剂

干粉、泡沫、砂土、二氧化碳及雾状水。

文献信息

• Process for preparing a dry powder formulation comprising an anticholinergic, a corticosteroid and a beta-adrenergic
  申请人：CHIESI FARMACEUTICI S.P.A.

  公开号：US10086004B2

  公开（公告）日：2018-10-02

  Dry powder formulations for inhalation containing a combination of an anticholinergic, a long-acting beta2-adrenoceptor agonist, and a corticosteroid are useful for the prevention and/or treatment of an inflammatory and/or obstructive airways disease.

  含有抗胆碱能药物、长效β2-肾上腺素受体激动剂和皮质类固醇的吸入用干粉制剂可用于预防和/或治疗炎症性和/或阻塞性气道疾病。
• Nasal spray device
  申请人：IVAX PHARMACEUTICALS IRELAND

  公开号：US10188811B2

  公开（公告）日：2019-01-29

  A nasal spray device for the delivery of a pharmaceutical formulation to the nasal cavity in metered doses. The device includes: a pressurised aerosol canister including a vial containing a pharmaceutical formulation including an active ingredient, a propellant and, optionally, a co-solvent, the aerosol canister further including a metering valve having a valve stem; and an actuator for the aerosol canister, the actuator including a stem block having a receptacle into which the valve stem of metering valve of the aerosol canister is received and axially located and being displaceable relative to the vial of the aerosol canister to actuate the metering valve of the aerosol canister, a sump extending below the receptacle, the stem block further defining a discharge orifice for the pharmaceutical formulation and a transfer channel through which a dispensed dose of the pharmaceutical formulation is able to pass from the sump to the discharge orifice.

  一种鼻腔喷雾装置，用于将药物制剂按计量剂量输送到鼻腔。该装置包括一个加压气雾罐，包括一个装有药物制剂的小瓶，药物制剂包括活性成分、推进剂和可选的助溶剂，气雾罐还包括一个计量阀，计量阀有一个阀杆；气雾罐的执行机构，执行机构包括一个阀杆块，阀杆块有一个容纳器，气雾罐计量阀的阀杆被容纳在容纳器中，阀杆块的轴向位置可相对于气雾罐的药瓶移动，以驱动气雾罐的计量阀；一个底盘，底盘延伸至容纳器下方；阀杆块进一步限定了一个药物制剂排放孔和一个传送通道，药物制剂的分配剂量可通过传送通道从底盘传送到排放孔。
• Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation
  申请人：CHIESI FARMACEUTICI S.p.A.

  公开号：US10946029B2

  公开（公告）日：2021-03-16

  Compositions comprising a corticosteroid and a beta-adrenergic are useful for treating inflammatory or obstructive airways diseases.

  由皮质类固醇和β-肾上腺素能药物组成的复合物可用于治疗炎症性或阻塞性气道疾病。
• Aerosol device
  申请人：NORTON (WATERFORD) LIMITED

  公开号：US10960154B2

  公开（公告）日：2021-03-30

  The present invention provides an aerosol device for delivering a pharmaceutical formulation by inhalation via the mouth to the lungs or to the nostril in metered doses comprising: a pressurised aerosol canister including a vial containing a pharmaceutical formulation comprising an active ingredient, a propellant and, optionally, a co-solvent, the aerosol canister further comprising a metering valve having a valve stem; and an actuator for the aerosol canister, the actuator including a delivery outlet and a stem block, the stem block having a receptacle into which the valve stem of the metering valve of the aerosol canister is received and axially located and being displaceable relative to the vial of the aerosol canister to actuate the metering valve of the aerosol canister, a sump extending below the receptacle, the stem block further defining a discharge orifice arranged to direct the pharmaceutical formulation through the delivery outlet, a transfer tunnel having an input opening and an output opening through which a dispensed dose of the pharmaceutical formulation is able to pass from the sump to the discharge orifice, and a land length defining the distance from between the input opening and output opening, wherein the input opening and the output opening have cross-sectional areas of from 0.002 to 0.8 mm2 and the cross-sectional area of the input opening is smaller than the cross-sectional area of the output opening, and wherein the land length is from 0.5 mm to 10 mm.

  本发明提供了一种气溶胶装置，用于通过口腔吸入将药物制剂以计量剂量输送到肺部或鼻孔，该装置包括一个加压气雾罐，包括一个装有药物制剂的小瓶，药物制剂包括活性成分、推进剂和可选的助溶剂，气雾罐还包括一个具有阀杆的计量阀；气雾罐的执行机构，执行机构包括一个输送口和一个阀杆块，阀杆块有一个容 置器，气雾罐计量阀的阀杆被容置在容置器中，并在轴向定位，可相对于气雾罐的药 瓶移动，以驱动气雾罐的计量阀，容置器下方有一个延伸的底盘、该阀杆块进一步限定了一个排出孔，该排出孔布置成引导药物制剂通过输送出口，一个传输通道，该传输通道具有一个输入口和一个输出口，药物制剂的分配剂量能够通过该输入口和输出口从底盘传输到排出孔，以及一个限定输入口和输出口之间距离的陆地长度，其中输入口和输出口的横截面积为 0.002 至 0.8 mm2，输入口的横截面积小于输出口的横截面积，其中陆地长度为 0.5 mm 至 10 mm。
• Pharmaceutical aerosol formulations of formoterol and beclometasone dipropionate
  申请人：Chiesi Farmaceutici S.p.A.

  公开号：EP2482799B1

  公开（公告）日：2014-06-18