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国家药品监督管理局进口药品注册标准   National Medical Products Administration (NMPA) Registration Standards for Imported Drugs

标准号：JS20190041  Standard number: JS20190041

屋尘螨变应原制剂  House dust mite allergen preparation

WuChenManBianYingYuanZhiJiMites allergens ALK（503）D．p

本品系以灭活的屋尘螨纯化培养物碎片（螨虫虫体、虫体碎片、螨虫排泄物、幼虫、虫卵等）为起始原材料，经纯化、分离、提取、过滤等工艺制备得到螨变应原活性物质，然后将其吸附至氢氧化铝而成的屋尘螨变应原制剂。本品含防腐剂苯酚，不含抗生素。
This strain is based on inactivated house dust mite purification culture fragments (mite body, insect body fragments, mite excrement, larvae, eggs, etc.) as the starting raw material, through purification, separation, extraction, filtration and other processes to prepare mite allergen active substances, and then adsorb them to aluminum hydroxide to make house dust mite allergen preparation. This product contains the preservative phenol and does not contain antibiotics.
本注册标准包括原液检定和制剂检定两部分。  This registration standard includes two parts: drug substance verification and preparation verification.

一、原液检定  1. Verification of stock solution

1．鉴别实验  1. Identification experiments
采用交叉免疫电泳法（附件 1 ），免疫电泳图谱与内参一致。
The cross-immunoelectrophoresis method (Annex 1) was used, and the immunoelectrophoresis profile was consistent with the internal control.
2．蛋白成分测定   2. Determination of protein components
采用 SDS－PAGE 法，条带与内参图谱一致。
Using the SDS-PAGE method, the bands were consistent with the internal control map.

3．变应原 Der p1、Der p2 含量
3. Allergen Der p1 and Der p2 content

采用免疫扩散法（附件 2 ），含量应在 75 ∼ 133 % 75 ∼ 133 % 75∼133%75 \sim 133 \% 范围。
Immunodiffusion method (Annex 2) is used, and the content should be 75 ∼ 133 % 75 ∼ 133 % 75∼133%75 \sim 133 \% in the range.

4．变应原活性  4. Allergen activity

采用 TACA 抑制试验（附件 3），活性范围应为 50～200\％。
With the TACA inhibition test (Annex 3), the activity range should be 50~200\%.

5．蛋白含量  5. Protein content

采用 BCA 法测定，蛋白含量应为 35 ∼ 70 % 35 ∼ 70 % 35∼70%35 \sim 70 \% 。
Determined by the BCA method, the protein content should be 35 ∼ 70 % 35 ∼ 70 % 35∼70%35 \sim 70 \% .
6．水分含量   6. Moisture content
按《中国药典》2015年版（三部）通则 0832 水分测定法检测，其水分应不大于 5 % 5 % 5%5 \% 。
According to the "Chinese Pharmacopoeia" 2015 edition (three) general rule 0832 moisture determination test, its moisture should not be greater than 5 % 5 % 5%5 \% .
7．微生物限度  7. Microbial limits
按《中国药典》2015年版（四部）通则 1105、1106、1107 方法测定微生物限度检查法检查，不大于 10 2 cfu / 10 2 cfu / 10^(2)cfu//10^{2} \mathrm{cfu} / 克。
According to the 2015 edition of the Chinese Pharmacopoeia (Part IV) General Principles 1105, 1106, 1107 method for the determination of microbial limit inspection method, not more than 10 2 cfu / 10 2 cfu / 10^(2)cfu//10^{2} \mathrm{cfu} / grams.

二、制剂检定  2. Preparation verification

1．鉴别试验  1. Identification test
用 Western－Blot 方法进行检测，应可见两种主要变应原条带（Der p1 25kDa； Der p2 14 kDa ）。
Detection by Western-blot should show two major allergen bands (Der p1 25 kDa; Der p2 14 kDa ）。
2．外观  2. Appearance
无色、白色至淡棕色或淡绿色水溶性混悬液。   Colorless, white to light brown or light green water-soluble suspension.
3． pH
按 2015 年版（三部）通则 0631 pH 值测定法测定， pH 值应为 8.1 ∼ 8.7 8.1 ∼ 8.7 8.1∼8.78.1 \sim 8.7 。
According to the 2015 edition (Part III) General Chapter 0631 pH determination method, the pH value should be 8.1 ∼ 8.7 8.1 ∼ 8.7 8.1∼8.78.1 \sim 8.7 .
4．苯酚含量   4. Phenol content
用高效液相色谱方法进行检测，苯酚含量应为 4.75 ∼ 5.25 mg / ml 4.75 ∼ 5.25 mg / ml 4.75∼5.25mg//ml4.75 \sim 5.25 \mathrm{mg} / \mathrm{ml} 。
Detected by high-performance liquid chromatography (HPLC) with phenol content of 4.75 ∼ 5.25 mg / ml 4.75 ∼ 5.25 mg / ml 4.75∼5.25mg//ml4.75 \sim 5.25 \mathrm{mg} / \mathrm{ml} .
5．铝含量   5. Aluminum content
按 JY／T015－1996 电感耦合等离子体原子发射光谱方法通则，或现行版《中国药典》规定的适宜方法测定，铝含量应为 0.90 ∼ 1.36 、 9.0 ∼ 13.6 、 90 ∼ 136 0.90 ∼ 1.36 、 9.0 ∼ 13.6 、 90 ∼ 136 0.90∼1.36、9.0∼13.6、90∼1360.90 \sim 1.36 、 9.0 \sim 13.6 、 90 \sim 136、、 、 1020 ∼ 1250 μ g / ml 1020 ∼ 1250 μ g / ml 1020∼1250 mug//ml1020 \sim 1250 \mu \mathrm{~g} / \mathrm{ml} 。
According to JY/T015-1996 General Principles of Inductively Coupled Plasma Atomic Emission Spectroscopy Method, or the appropriate method specified in the current edition of the Chinese Pharmacopoeia, the aluminum content shall be , 0.90 ∼ 1.36 、 9.0 ∼ 13.6 、 90 ∼ 136 0.90 ∼ 1.36 、 9.0 ∼ 13.6 、 90 ∼ 136 0.90∼1.36、9.0∼13.6、90∼1360.90 \sim 1.36 、 9.0 \sim 13.6 、 90 \sim 136、、 1020 ∼ 1250 μ g / ml 1020 ∼ 1250 μ g / ml 1020∼1250 mug//ml1020 \sim 1250 \mu \mathrm{~g} / \mathrm{ml} .
6．活性  6. Activity
用 UniCAP（附录 4）方法进行检测， 100000 SQ－U 制品对检定血清中屋尘螨特异性 IgE 的抑制率应不低于 50 % 50 % 50%50 \% 。
The inhibition rate of house dust mite-specific IgE in the tested serum of 100,000 SQ-U should not be less than that of the UniCAP (Appendix 4 50 % 50 % 50%50 \% ) method.
7．游离变应原活性  7. Free allergen activity
用 UniCAP（附录 5）方法进行检测， 100000 SQ－U 制品中游离变应原对屋尘螨特异性 IgE 的抑制率应不高于 20 % 20 % 20%20 \% 。
The inhibition rate of free allergens against house dust mite-specific IgE in 100,000 SQ-U products should not be higher than that of the UniCAP (Appendix 5 20 % 20 % 20%20 \% ) method.
8．无菌实验  8. Sterility experiment
按《中国药典》2015年版（三部）通则 1101 无菌检查法检测，应无菌生长。
According to the "Chinese Pharmacopoeia" 2015 edition (Part III) General Rules 1101 sterility test test, sterile growth should be done.

【规格】  【Specifications】

100、1000、10000、100000SQ－U／ml

【包装】  【Packing】

直接接触药品的药包材：无色、水解的 I 型玻璃瓶，由氯丁基胶塞和带撕开式中心孔的铝盖密封。
Pharmaceutical packaging material in direct contact with pharmaceutical products: Colorless, hydrolyzed type I glass vials, sealed by a chlorobutyl stopper and an aluminum cap with a tear-off center hole.

【保存、运输及有效期】  [Storage, transportation and expiration date]

于 2 ∼ 8 ∘ C 2 ∼ 8 ∘ C 2∼8^(@)C2 \sim 8^{\circ} \mathrm{C} 条件下保存，不得冷冻至结冰。有效期 24 个月。启封后保存于 2 ∼ 2 ∼ 2∼2 \sim 8 ∘ C 8 ∘ C 8^(@)C8^{\circ} \mathrm{C} ，保存期不超过 6 个月。
Store 2 ∼ 8 ∘ C 2 ∼ 8 ∘ C 2∼8^(@)C2 \sim 8^{\circ} \mathrm{C} under condition and do not freeze until freezing. Valid for 24 months. After opening 8 ∘ C 8 ∘ C 8^(@)C8^{\circ} \mathrm{C} , it will be stored in 2 ∼ 2 ∼ 2∼2 \sim for a period of no more than 6 months.

【持证商】  【Licensee】

持证商名称：丹麦爱尔开－阿贝优公司  Name of licensee: Danish Erkai-Abeyou Company
注册地址：Bøge Allé 6－8，DK－2970 Hørsholm，Denmark

【生产企业名称及地址】  【Name and address of the manufacturer】

原液  Dope

生产厂名称和地址：ALK Abelló A／S，Bøge Allé 6－8，DK－2970 Hørsholm， Denmark
成品  finished product
配置、灌装场地名称和地址：ALK Abelló 6－8，DK－2970 Hørsholm，Denmark包装场地名称和地址：ALK－Abelló，S．A．，Miguel Fleta 19，E－28037 Madrid， Spain
Name and address of the configuration, filling site: ALK Abelló 6-8, DK-2970 Hørsholm, Denmark Name and address of the packing site: ALK-Abelló, S. A．，Miguel Fleta 19，E－28037 Madrid， Spain

附录  appendix

附件1交叉免疫电泳法  Annex 1 Cross-immunoelectrophoresis
附件2免疫扩散法   Annex 2: Immuno-proliferation methods
附件 3 屋尘螨变应原制剂原液变应原活性（TACA 法）
Annex 3 House Dust Mite Allergen Preparations Stock Solution Allergen Activity (TACA Method)
附件4屋尘螨变应原制剂活性测定（荧光免疫抑制法）
Annex 4: Activity Determination of House Dust Mite Allergen Preparation (Fluorescent Immunosuppressive Method)
附件 5 屋尘螨变应原制剂游离变应原活性测定（荧光免疫抑制法）
Annex 5 House Dust Mite Allergen Preparation Free Allergen Activity Determination (Fluorescent Immunosuppressive Method)