部份中文赫尼可处方资料（仅供参考）
商品名：Hernicore for Intradiscal inj.
英文名：Condoliase
中文名：赫尼可注射液
生产商：Seikagaku Corporation
药品简介
2018年8月，日本上市了一款针对因椎间盘突出压迫神经，导致背痛或脚麻的新疗法—Hernicore(Condoliase，ヘルニコア椎間板注用1.25単位  “赫尼可”针剂)，本品是全球首款直接注射腰椎的椎间盘突出治疗药。
药效分类名称
腰椎间盘突出症治疗剂
批准日期：2018年5月
商標名
HERNICORE 1.25units for Intradiscal inj.
一般名
コンドリアーゼ, Condoliase（JAN）
構造式
所述缀合酶是由997个氨基酸残基组成的蛋白质，所述997个氨基酸残基是从革兰氏阴性杆菌的一种Proteus vulgaris中分离纯化的具有如下结构的单体。
Ala-Thr-Ser-Asn-Pro-Ala-Phe-Asp-Pro-Lys-［Amino acid］n-Pro
分子式
C5039H7770N1360O1525S22
分子量
約11万
使用注意事项
由于需要遮光保存，本品应放入个装箱（外箱）中保存。
批准条件
制定医药品风险管理计划并妥善实施。
药效药理
作用机理
1.药理作用
（1）在椎间盘内给药正常的家兔，发现椎间盘内水分含量降低及椎间盘高度变窄。
（2）在椎间盘内给药正常的绵羊，发现椎间盘内压最低值降低及椎间盘高度变窄。
（3）对患有椎间盘突出症的狗在椎间盘内注射了整合酶后，发现临床症状（姿势反应、脊髓反射及患部疼痛）得到了改善。
2.作用机制
一般认为，软脂酶显示硫酸软骨素、软骨素和透明质酸的分解作用，分解椎间盘髓核中的糖胺聚糖，降低髓核的保水能力，降低椎间盘内压，从而改善疝的临床症状。
适应症
保守疗法不能得到充分的改善后纵韧带下脱出型腰椎椎间盘突出症
用法与用量
通常，成人将1.25单位作为咨询酶单次给药于症状原因的高位椎间盘内。
应用注意事项
1.调制时
（1）在将本品放入单个装箱的状态下（遮光），恢复到室温。
（2）将日药典“生理盐水”1.2mL缓慢注入小瓶内。溶解时，避免起泡和剧烈搅拌。
（3）用带锁定的可置换注射器抽出小瓶的溶解液。
（4）溶解后应迅速使用。
（5）观察到小瓶有破损或龟裂等不良情况或小瓶内未保持负压时，请勿使用。
（6）由于有可能在玻璃上吸附有效成分，所以不使用玻璃制的注射器，而是使用带锁紧的可置换注射器。
2.给药方法
使用X射线透视仪，在严重无菌操作下罹患腰椎间盘突出症的椎间盘内中心缓慢给予本制剂1.0mL。
3.给药时
（1）原则上不从正中通过经硬膜穿刺给药，而是通过后外侧路径给药正中穿刺可能导致神经损伤和硬膜损伤。]
（2）不要在腰椎椎间盘内同时使用造影剂等其他药剂椎间盘内混合时无稳定性、安全性及有效性数据。另外，由于使用造影剂等，担心神经症状（横断性脊髓炎、对麻痹、脑出血）等并发症
（3）本制剂给药时感到阻力时，应停止给药。
4.给药后
不要使用残液，要废弃。
其他注意事项
1.在以0.25～10单位/disc（临床给药量的12～494倍）单次椎间盘内给药食器的情况下，在给药后26周观察到软骨终板及生长板的骨化及软骨终板的菲薄化，均未确认恢复性。
2.给兔子（软骨终板比人或食蟹猴薄）以4单位/disc（临床给药量的1056倍）单次椎间盘内注射了软骨酶时，给药后2年夹着软骨终板与髓核相接的椎体出现骨细胞坏死，未确认恢复性。
包装
椎间盘注用
1.25单位：1小瓶
贮法
遮光，保存2～8℃
使用期限
外箱及小瓶上记载
制造业销售
生化工业株式会社
销售
科研制药株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/3999447D1020_1_01/
-----------------------------------------------
HERNICORE® 1.25Units for Intradiscal Injection in Japan, Indicated
Seikagaku Corporation(Tokyo, Japan; 'Seikagaku')and Kaken Pharmaceutical Co. Ltd.(Tokyo, Japan; 'Kaken') announced today that HERNICORE® 1.25 units for intradiscal injection(generic name: condoliase)has been listed in the National Health Insurance drug price list. The planned launch date is August 2018.
HERNICORE® 1.25 units for intradiscal injection('the Agent')is a new treatment option for lumbar disc herniation whose active pharmaceutical ingredient is condoliase.This is the first therapeutic Agent in Japan with intradiscal administration. It does not require a general anesthesia and is less invasive to the patient than surgical treatment. Seikagaku obtained New Drug Application('NDA')approval for the Agent in Japan on March 23, 2018, and Kaken will distribute it in Japan. As improvement effects to the symptoms of lumbar disc herniation by prolapse of the posterior longitudinal ligament* are expected by a single administration of the Agent, Seikagaku and Kaken believe that this new treatment option is able to contribute to quality of life of patients.
The Agent is a pharmaceutical with a novel mechanism of action, and from the standpoint of safety assurance, the special Warnings and Precautions for Use in the package insert reads, 'This Agent should be administered under the supervision of a physician with sufficient knowledge and experience in the diagnosis and treatment of lumbar disc herniation. It should be administered by a physician with proficiency in performing lumbar puncture.'
Accordingly, at this time specific physician requirements and facilities requirements are being considered. Kaken will commence sales of the Agent after these requirements have been determined and strive for a phased rollout while promoting appropriate use.
*Herniation by prolapse of the posterior longitudinal ligament:atype of herniation and its structure is that it is covered by the posterior longitudinal ligament, although the hernia extends beyond the outermost layer of the annulus fibrosus
Product name: HERNICORE® 1.25 Units for Intradiscal Injection
Generic name: condoliase
Efficacy and effects: Lumbar disc herniation by prolapse of the posterior longitudinal ligament
for which sufficient improvement cannot be obtained through conservative treatment Usage and dosage: For adults, 1.25 units of condoliase are administered by a single injection in the intervertebral disc that is the source of the symptoms.
NHI drug: 1 bottle containing 1.25units
New Drug Application approval date: March 23, 2018
Date of listing in the National Health Insurance drug price list: May 22, 2018
Launch date: August 2018 (planned)
Marketing authorization holder: Seikagaku Corporation
Distributor: Kaken Pharmaceutical Co. Ltd.
Mechanism of action: It is expected that condoliase degrades chondroitin sulfate, chondroitin, and hyaluronic acid and also improves the clinical manifestations of herniation by lowering the internal pressure of the intervertebral disc due to dissolving the glycosaminoglycans* within the nucleus pulposus of the intervertebral disc, and lowering the water-holding capacity of the nucleus pulposus.
* Glycosaminoglycans(GAG): A major component of complex carbohydrates.Chondroitin sulfate and hyaluronic acid etc.
Lumbar disc herniation is the partial protrusion of the nucleus pulposus at the core ofeach intervertebral disc or the annulus fibrosus, the disc's outer layer.The resulting pressure on the spinal nerve root causes pain and numbness.
Current treatments are generally categorized into conservative treatments for temporalpain relief (rest and pharmaceutical methods such as NSAIDs)and surgical treatments.
As this Agent specifically degrades GAGs in the nucleus pulposus, resulting in decrease in the pressure on the nerve root, it is positioned as an innovative treatment of lumbar disc herniation.