长沙上禾生物staherb小白菊内酯Parthenolide专业生产中英文简介

公司官网 http://www.staherb.com/ 资质:HALAL, KOSHER等认证

☎：19573130018 杨经理（微信同号）

## 中文专业生产简介｜Professional Manufacturing (CN)

产品：小白菊提取物 / 小白菊内酯 Parthenolide（C₁₅H₂₀O₃，CAS 20554-84-1，菊科小白菊 *Tanacetum parthenium* 叶花蕾愈创木烷型倍半萜内酯，α-亚甲基-γ-内酯+4,5-环氧双亲电中心，HPLC-UV 220 nm，mp 114–116℃）

生产商：长沙上禾生物科技有限公司（Changsha Staherb Natural Ingredients Co., Ltd. / Staherb®，2010 年长沙麓谷，环创 B8 202，国家高新技术企业，小白菊内酯为抗炎/肿瘤工具分子与医药中间体主力，西北引种基年处理干料百吨级）

生产基地：长沙高新麓谷环创 B8——干料粉碎机组（20–40 目）+ 60%–75% 食品级 EtOH 动态逆流罐（55–65℃ 夹套护内酯）+ 板框/离心 + 0.45 μm MF + AB-8 中极型大孔树脂柱群 + 硅胶柱预分 + 制备 HPLC（C18 乙腈-水 60:40 @220 nm）+ 重结晶釜（0–4℃）+ 喷雾干燥（进 160–180℃/出≤50℃ 秒干）+ 冻干/真空带干 + 充氮分装线 + 沃特斯 HPLC-UV@220 nm（PTL CRS 外标）+ LC-MS（ESI⁻ m/z 247.2）+ ¹H NMR 抽检 + 旋光仪；食品/医药中间体级车间，ISO 9001 / ISO 22000 / cGMP-like / HALAL / KOSHER 兼容；干料来自新疆伊犁/甘肃酒泉/陕西宝鸡高海拔引种与英国肯特/保加利亚罗多普定制，长沙麓谷 B8 非种植产地（COA 注 "Origin: China / Processed in Changsha, Hunan" 或 "EU-origin processed in Changsha"）。

产能与硬件：年处理小白菊干料百吨级、AB-8 富集 PTL 段数十吨、标提（0.2%–2% HPLC）数十吨、高纯单体 90%/95%/98%/99% HPLC 数吨级、科研级 10 mg–1 g 分装；高纯供 NF-κB/IKKβ 工具分子、DMAPT/ACT001 类起始物料、AML/CD44+ CSC 临床前底物。

体系认证：ISO 9001 / ISO 22000 / HALAL / KOSHER / cGMP-like；COA 多标记联检——Parthenolide HPLC-UV@220 nm（乙腈-水 60:40，PTL CRS 外标，Rt 附）+ 伴生樟黄苷同检 + 环氧开环有关物质（≤1%）+ 水分≤5%(单体) + 炽失≤0.5% + 重金属(Pb≤0.5/Cd≤0.3/As≤1 ppm 药用严限) + 农残(GB2763+EU396 47 项零检) + 溶剂残留（EtOH/EtOAc/MeCN/石油醚 ICH Q3C）+ 微生物 + 40℃/75%RH 6 月加速 + mp 114–116℃。

### 专业生产工艺路线（双主轨：标化粉轨 + 高纯单体轨）

小白菊内酯生产的专业性不在"提得出倍半萜"，而在"护内酯（α-亚甲基-γ-内酯+4,5-环氧，>80℃ 长时/强碱/敞口光氧致开环差向，全程≤65℃ 提、≤50℃ 减浓、≤50℃ 喷干、避光充氮）+ 切叶绿素/黄酮/单萜油/蜡质（AB-8 中极型是分水岭，70% EtOH 主洗脱窗）+ 制备 HPLC 把伴生倍半萜（樟黄苷/圣菊苷/其它内酯）分干净 + 0–4℃ 慢结晶保白晶与环氧完整 + 双轨报告（总倍半萜≠PTL%）"六道关卡——Staherb SOP 严格锁死：

**"盛花前 6–7 月采上部叶+花蕾（叶:蕾≈3:1，新疆/甘肃/陕西高海拔干料水分≤8%、PTL 0.3%–0.6% DW，花蕾富集批 0.8%–1.2%）→ 除梗 20–40 目粉碎 → 双轨分流：

A 轨｜低温醇提：60%–75% 食品级 EtOH，55–65℃ 动态逆流 2–3 次（L/S 8–12:1，严控>80℃ 防 α-亚甲基-γ-内酯开环）→ 板框/离心 → 0.45 μm MF 除不溶叶绿杂。

B 轨｜AB-8 富集：滤液调 pH≈6.0 上 AB-8 中极型（2 BV/h）→ 去离子水洗 3 BV 切糖/蛋白/色素 → 70% EtOH 5 BV 洗脱 PTL 富集段（文献 AB-8 吸附率 92.5%、解吸率 89.3%） → ≤50℃ N₂ 减压回收 EtOH 减浓。

分流后处理：

　① 标化粉轨：富集液（或免树脂直接减浓）喷雾（160–180/≤50℃ 秒干，加 β-CD/麦芽糊精抗结）或冻干/真空带干 → 多批 HPLC 配锁 Parthenolide 0.2%/0.3%/0.5%/0.8%/1%/2% 标化粉。

　② 单体轨：0.8%–2% 富集膏 → 硅胶柱（石油醚-乙酸乙酯梯度）或 AB-8 粗提至 50%–65% → 制备 HPLC C18 乙腈-水 60:40 @220 nm 切 PTL 主峰 → 收集减浓 → 热乙醇/乙酸乙酯溶 → 乙酸乙酯-正己烷（1:3）或乙醇-水 0–4℃ 慢析 2–3 次（1℃/min 降温） → PTL 白晶 ≥95%/98%/99%（HPLC-UV@220 nm，伴生内酯≤0.5%，环氧开环物≤1%）→ 40–45℃ 避光真空干 → 充氮铝箔。

　③ 改型轨（选供）：DMAPT/氨基酸酯前药、β-CD 包合、纳米晶（医药研发）。

全程 304/316L 或玻璃接触、避光、N₂ 保护、禁强碱/高温敞口/硫熏前体**。

▍前处理（CCP1 基源锁）

干料入厂 HPLC-UV@220 nm 初筛 PTL≥0.3%–0.5% DW（优选≥0.5%，花蕾批≥0.8%，拒<0.2%）、伴生樟黄苷同检、水分≤8%、SO₂≤150 mg/kg、47 项农残零检、Pb≤0.5/Cd≤0.3/As≤1；杭白菊/钮扣菊/艾菊（*T. vulgare*）混入（TLC+显微鉴）、盛花后老叶（PTL<0.1%）、未除梗全草、>80℃ 直火烘、陈料（存>2 年）拒收。

▍轨 A：低温醇提（内酯红线）

• 60%–75% EtOH、55–65℃ 动态逆流 2–3×1–2 h（L/S 8–12:1）——极性有机溶剂提倍半萜内酯业界标准（专利 Justia 5384121 明载 EtOH 优于石油醚  ），Staherb 单体/标提批统一用此窗；>80℃ 长时致 α-亚甲基-γ-内酯 Michael 弹头自聚/开环，是 PTL 含量虚高（开环物共流）与晶型褐变头号原因。

▍轨 B：AB-8 中极型（核心分水岭）

AB-8 对愈创木烷内酯吸附选择性优于叶绿素/黄酮苷/单萜油，pH≈6.0（天然近中性不加酸碱）上样 2 BV/h；水洗切糖蛋白色素；70% EtOH 5 BV 是 PTL 主洗脱窗（静态吸附 45.2 mg/g、吸附率 92.5%、解吸 89.3%  ），文献 D101/HP-20 同窗可替；这一步决定"标提能不能稳 0.2%–2%、单体上制备 HPLC 前杂负荷低不堵柱"。

▍单体后处理（CCP2 环氧与晶型锁）

• 制备 HPLC C18 乙腈-水 60:40（或 55:45）@220 nm 切 PTL 主峰，伴生内酯/黄酮分峰收集；

• 0–4℃ 重结晶（乙酸乙酯热溶→滴正己烷 1:3，或乙醇-水，1℃/min 慢降，pH 5–7 醋酸缓冲防环氧开环）→ 白色针状晶，mp 114–116℃；

- HPLC-UV@220 nm ≥98%（99% 级 TDS 硬指标：伴生内酯≤0.5%、环氧开环物≤1.0%、单杂≤0.5%、总杂≤2.0%），旋光 [α]ᴅ²⁰ -81.4°（CHCl₃）校验；

- 40–45℃ 避光真空干，棕瓶充氮 2–8℃（单体 -20℃ DMSO 母液分装），有效期 18–24 月。

▍后处理与敏控

批混→金属探测（粉态）→1/5/25 kg 内层棕铝箔/PE-铝箔+外纸板桶充氮；科研级 10 mg–1 g 棕玻瓶 -20℃ 充氮 DMSO 母液。COA 必双轨：总倍半萜（可选 UV 算）/PTL（HPLC-UV@220 nm，乙腈-水 60:40，PTL CRS 外标）+ 环氧开环有关物质单报；总倍半萜% ≠ PTL% 是行业常见误导，用"小白菊提取物"模糊出货即违规。配方端提示客户 pH 5–7、避光、2–8℃ 密封（单体 -20℃ 充氮 DMSO）、H317 接触致敏、抗凝/妊娠/菊科过敏红线。

### 专业生产供货矩阵

• 小白菊标提：Parthenolide 0.2% / 0.3% / 0.5% / 0.8% / 1% / 2% HPLC-UV@220 nm（棕黄–类白粉）

• 高纯单体轨：90% / 95% / ≥98% / ≥99% HPLC-UV@220 nm（白晶），科研级 10 mg–1 g

- 改型选供：DMAPT / 氨基酸酯前药 / β-CD 包合 / 纳米晶（医药研发）

• 伴生背景：樟黄苷/圣菊苷同条件检，不混标

> ⚠️ Staherb 生产合规边界：长沙麓谷 B8 为盛花前叶:蕾 3:1 干料（新疆/甘肃/陕西≥800m 或欧源）≤45℃干水分≤8%→除梗20-40目→60-75%EtOH 55-65℃逆流×2-3→板框+0.45μMF→AB-8 pH6 水洗3BV+70%EtOH 5BV(吸附92.5%/解吸89.3%)→≤50℃N₂减浓→标提喷雾160-180/≤50℃或冻干 / 富集膏硅胶或AB-8粗提50-65%→制备HPLC C18 MeCN-H₂O 60:40 @220nm切主峰→乙酸乙酯-正己烷1:3或EtOH-H₂O 0-4℃(1℃/min)重结晶2-3×→PTL≥99%白晶mp114-116℃[α]D-81.4°→充氮分装中心非种植产地；COA 必注"Parthenolide HPLC-UV@220nm (MeCN-H₂O 60:40, CRS ext) + epoxide-open impurity≤1% + mp114-116℃ + heavy Pb≤0.5ppm drug-strict + 47-pesticide zero + ICH Q3C solvent + ISO/HALAL/KOSHER/cGMP-like, ≤65℃ extract ≤50℃ conc ≤50℃ dry pH5-7 N₂ dark 2-8℃/-20℃ DMSO, H317 sensitization anticoag/pregnancy/Asteraceae-allergy redline"；不跨境宣称治疗急性偏头痛/AML/类风湿。

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## English Professional Manufacturing｜EN

Product: Feverfew Extract / Parthenolide (guaiane sesquiterpene γ-lactone from Asteraceae *Tanacetum parthenium* leaf-bud, CAS 20554-84-1, C₁₅H₂₀O₃, MW 248.32, α-methylene-γ-lactone + 4,5-epoxide, HPLC-UV 220 nm, mp 114–116℃)

Manufacturer: Changsha Staherb Natural Ingredients Co., Ltd. (Staherb®, founded 2010 Changsha Lugu B8-202, national hi-tech, parthenolide as anti-inflam/oncology tool-molecule & API-intermediate line)

Production base: Changsha Lugu B8 — dry-herb mill (20–40 mesh) + 60–75% food EtOH counter-current tank (55–65℃ jacket protect lactone) + plate/centrifuge + 0.45μm MF + AB-8 mid-polar macroporous + silica pre-split + prep-HPLC (C18 MeCN-H₂O 60:40 @220nm) + recryst kettle (0–4℃) + spray (160–180/≤50℃) + FD/vac-band + N₂ pack + Waters HPLC-UV@220nm (PTL CRS ext) / LC-MS (ESI⁻ m/z 247.2) / ¹H NMR spot / polarimeter; food/API-intermediate grade, ISO9001/ISO22000/cGMP-like/HALAL/KOSHER; dry herb from Xinjiang-Yili/Gansu-Jiuquan/Shaanxi-Baoji high-altitude introduced + UK-Kent/Bulgaria-Rhodope custom, Changsha Lugu B8 not plantation (COA "Origin: China / Processed in Changsha, Hunan" or "EU-origin processed in Changsha").

Capacity & hardware: ht-scale dry-herb/yr, tens t AB-8-enriched PTL cut, std extract (0.2–2% HPLC) tens t, high-pure 90/95/98/99% HPLC several t, research 10 mg–1 g; high-pure for NF-κB/IKKβ tool, DMAPT/ACT001-starting-material, AML/CD44+ CSC preclinical substrate.

System certs: ISO 9001 / ISO 22000 / HALAL / KOSHER / cGMP-like; COA multi-marker — Parthenolide HPLC-UV@220nm (MeCN-H₂O 60:40, PTL CRS ext, Rt attached) + companion tanetin same-check + epoxide-open related≤1% + moisture≤5%(monomer) + LOD≤0.5% + heavy(drug Pb≤0.5/Cd≤0.3/As≤1 ppm) + pesticide(GB2763+EU396 47-item zero) + solvent(EtOH/EtOAc/MeCN/pet-ether ICH Q3C) + microbe + 40℃/75%RH 6mo accel + mp 114–116℃.

### Professional process route (dual-track: standardized powder + high-pure monomer)

Parthenolide manufacturing specialty is not "get sesquiterpene out" but "protect lactone (α-methylene-γ-lactone + 4,5-epoxide: >80℃ long/strong-base/open-light ring-open/epimerize, whole line ≤65℃ extract, ≤50℃ conc, ≤50℃ spray, dark N₂) + cut chlorophyll/flavonoid/monoterpene-wax (AB-8 mid-polar is watershed, 70% EtOH main elution) + prep-HPLC separate companion lactones/flavonoids clean + 0–4℃ slow-crystallize keep white crystal & epoxide intact + dual-report (total sesquiterpene ≠ PTL%)" six gates — Staherb SOP locks:

**"pre-full-bloom Jun–Jul upper leaf+bud (leaf:bud≈3:1, Xinjiang/Gansu/Shaanxi ≥800m dry moisture≤8%, PTL 0.3–0.6% DW, bud-batch 0.8–1.2%) → de-stem 20–40 mesh → dual split:

A-track｜low-temp extract: 60–75% food EtOH, 55–65℃ dynamic counter-current 2–3× (L/S 8–12:1, forbid >80℃ α-methylene-γ-lactone open) → plate/centrifuge → 0.45μm MF.

B-track｜AB-8 enrich: filtrate pH≈6.0 on AB-8 mid-polar (2 BV/h) → DI-water 3 BV wash cut sugar/protein/pigment → 70% EtOH 5 BV elute PTL-rich cut (lit AB-8 capacity 45.2mg/g, adsorb 92.5%, desorb 89.3%) → ≤50℃ N₂ vac-recover EtOH.

Post-split:

　① std-powder track: enrich (or non-resin conc) spray (160–180/≤50℃ flash, β-CD/maltodextrin anti-cake) or FD/vac-band → multi-batch HPLC blend-lock Parthenolide 0.2/0.3/0.5/0.8/1/2%.

　② monomer track: 0.8–2% enrich paste → silica (pet-ether/EtOAc grad) or AB-8 rough to 50–65% → prep-HPLC C18 MeCN-H₂O 60:40 @220nm cut PTL main-peak → collect conc → hot EtOH/EtOAc dissolve → EtOAc-n-hexane (1:3) or EtOH-H₂O 0–4℃ slow-crystallize 2–3× (1℃/min) → PTL white crystal ≥95/98/99% (HPLC-UV@220nm, companion lactone≤0.5%, epoxide-open≤1%) → 40–45℃ dark vac-dry → N₂ foil.

　③ modified track (opt): DMAPT / amino-ester prodrug / β-CD inclusion / nanocrystal (pharma R&D).

Whole line 304/316L or glass, dark, N₂ blanket, no strong-base/open-high-temp/SO₂-bleached feed**.

▍Pre-treatment (CCP1 botanical lock)

Dry-herb inbound HPLC-UV@220nm PTL≥0.3–0.5% DW (pref≥0.5%, bud-batch≥0.8%, reject<0.2%), companion tanetin same-check, moisture≤8%, SO₂≤150mg/kg, 47-pesticide zero, Pb≤0.5/Cd≤0.3/As≤1; *Chrysanthemum morifolium* / button-chrysanthemum / *T. vulgare* tansy admix (micro+TLC), post-full-bloom old leaf (PTL<0.1%), undegstemmed whole-herb, >80℃ open-fire, aged>2yr reject.

▍Track A: low-temp EtOH (lactone redline)

• 60–75% EtOH, 55–65℃ dynamic counter-current 2–3×1–2h (L/S 8–12:1) — polar organic solvent extraction standard (Justia 5384121: EtOH outperforms pet-spirit for PTL, least toxic residue), Staherb unified window for both std/monomer; >80℃ long drives α-methylene-γ-lactone Michael-warhead self-polymerize/ring-open, #1 cause of fake-high PTL (co-eluting open-ring) and brown crystal.

▍Track B: AB-8 mid-polar (core watershed)

AB-8 selectively adsorbs guaiane lactone better than chlorophyll/flavonoid-glycoside/monoterpene-oil, pH≈6.0 (near-natural no alkali) load 2 BV/h; water wash cut sugar/protein/pigment; 70% EtOH 5 BV is PTL main elution window (static 45.2 mg/g, adsorb 92.5%, desorb 89.3%), D101/HP-20 same window substitutable; decides "std steady 0.2–2%, monomer prep-HPLC inlet low-load no clog".

▍Monomer post (CCP2 epoxide & crystal lock)

• Prep-HPLC C18 MeCN-H₂O 60:40 (or 55:45) @220nm cut PTL main-peak, companion lactone/flavonoid separated;

- 0–4℃ recryst (EtOAc hot-dissolve → drop n-hexane 1:3, or EtOH-H₂O, 1℃/min slow, pH 5–7 acetate buffer anti-epoxide-open) → white needle, mp 114–116℃;

- HPLC-UV@220nm ≥98% (99%-grade TDS hard: companion lactone≤0.5%, epoxide-open≤1.0%, single-imp≤0.5%, total-imp≤2.0%), polarimetry [α]ᴅ²⁰ -81.4° (CHCl₃) verify;

- 40–45℃ dark vac-dry, amber N₂ 2–8℃ (monomer -20℃ DMSO stock aliquot), shelf 18–24mo.

▍Post & sensitive control

Batch-blend → metal-detect (powder) → 1/5/25kg inner amber-foil/PE-foil + outer fiber-drum N₂; research 10mg–1g amber -20℃ N₂ DMSO. COA mandatory dual-track: total sesquiterpene (opt UV) / PTL (HPLC-UV@220nm, MeCN-H₂O 60:40, PTL CRS ext) + epoxide-open related single-report; total sesquiterpene% ≠ PTL% common mislabel, vague "feverfew extract" without PTL% rejected. Formula-end advises pH 5–7, dark, 2–8℃ sealed (monomer -20℃ N₂ DMSO), H317 contact-sensitize, anticoag/pregnancy/Asteraceae-allergy redline.

### Professional supply matrix

• Feverfew std: Parthenolide 0.2% / 0.3% / 0.5% / 0.8% / 1% / 2% HPLC-UV@220nm (tan-to-pale powder)

- High-pure monomer: 90% / 95% / ≥98% / ≥99% HPLC-UV@220nm (white crystal), research 10 mg–1 g

• Modified opt: DMAPT / amino-ester prodrug / β-CD-inclusion / nanocrystal (pharma R&D)

- Companion markers: tanetin/santonin same-cond reported (no merge-label)

Supplier note: Staherb Changsha Lugu B8 = pre-full-bloom leaf:bud 3:1 dry (Xinjiang/Gansu/Shaanxi≥800m or EU) ≤45℃ dry moisture≤8% → de-stem 20-40mesh → 60-75%EtOH 55-65℃ counter-current×2-3 → plate+0.45μMF → AB-8 pH6 water 3BV+70%EtOH 5BV(adsorb92.5%/desorb89.3%) → ≤50℃N₂ conc → std spray 160-180/≤50℃ or FD / enrich paste silica or AB-8 rough 50-65% → prep-HPLC C18 MeCN-H₂O 60:40 @220nm cut main-peak → EtOAc-n-hexane 1:3 or EtOH-H₂O 0-4℃(1℃/min) recryst 2-3× → PTL≥99% white crystal mp114-116℃ [α]D -81.4° → N₂ repack center NOT plantation; COA must state "Parthenolide HPLC-UV@220nm (MeCN-H₂O 60:40, CRS ext) + epoxide-open≤1% + mp114-116℃ + heavy Pb≤0.5ppm drug-strict + 47-pesticide zero + ICH Q3C solvent + ISO/HALAL/KOSHER/cGMP-like, ≤65℃ extract ≤50℃ conc ≤50℃ dry pH5-7 N₂ dark 2-8℃/-20℃ DMSO, H317 sensitization anticoag/pregnancy/Asteraceae-allergy redline"; no cross-border treat-acute-migraine/AML/RA claim.

公司官网 http://www.staherb.com/ 资质:HALAL, KOSHER等认证

☎：19573130018 杨经理（微信同号）