长沙上禾生物staherb龙胆苦甙Gentiopicroside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：龙胆苦甙 / Gentiopicroside（别名龙胆苦苷，C₁₆H₂₀O₉，MW 356.32，CAS 20831-76-9，龙胆科龙胆属 *Gentiana scabra*/*manshurica*/*triflora*/*rigescens* 及秦艽 *G. macrophyla* 干燥根及根茎裂环烯醚萜苷，(5R-trans)-构型，UV λmax 270 nm，mp 191–193℃，[α]ᴅ²⁰ -196°～-210°）

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，龙胆苦甙为肝胆/消化线医药级单体主力，年综合植提产能 ~2000 t 级）

生产基地：长沙高新麓谷环创 B8——干根粉碎机组（10–20 目）+ 60%–80% EtOH 回流/冷浸罐（≤60℃ 夹套护苷键）+ 板框/离心 + 0.45 μm MF + AB-8/D101/HPD-100/HPD-826 大孔树脂柱群 + 制备 HPLC（C18 水-甲醇或乙腈-0.1% 甲酸）+ 重结晶釜（0–4℃）+ 喷雾干燥（标化粉）+ 冻干 + 充氮分装线 + 沃特斯 HPLC（270 nm 定龙胆苦甙、同条件分 Swertiamarin/Sweroside/Amarogentin）+ LC-MS（ESI⁻ m/z 357.2）+ 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；干根来自东北关龙胆/西北秦艽/西南坚龙胆定点基地（部分 GAP 指导），长沙麓谷 B8 非种植产地（COA 注 "Origin: China / Processed in Changsha, Hunan"）。

产能与硬件：年处理龙胆/秦艽干根百吨级、大孔树脂富集苦甙段数十吨、龙胆标化粉（龙胆苦甙 5%–40% HPLC）数十吨、高纯单体 90%/95%/≥98% HPLC 数吨级、科研级 10 mg–1 g 分装；高纯供医药中间体/对照品、保肝利胆复方、NF-κB/Nrf2/CAR-PXR 科研底物。

体系认证：ISO 9001 / ISO 22000 / HALAL / KOSHER / cGMP-like；COA 多标记联检——龙胆苦甙 HPLC 270 nm（ChP 甲醇-水 30:70 或 C18 乙腈-0.1% 醋酸 9:91，龙胆苦甙 CRS 外标）+ 同条件 Swertiamarin/Sweroside/Amarogentin 分峰 + 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+日本肯定列表) + 溶剂残留（EtOH 痕/MeOH 痕/乙酸乙酯痕）+ 微生物 + 40℃/75%RH 6 月加速 + mp 191–193℃ + [α]ᴅ -196°～-210°。

### 专业生产工艺路线（双主轨：标化粉轨 + 高纯单体轨）

龙胆苦甙生产的专业性不在"提得出苦甙"，而在"护苷键（C-1 内酯+C-6 葡萄糖苷，>60℃ 长时或强酸强碱致水解/差向/褐变，全程≤60℃ 提、≤50℃ 减浓、≤40℃ 干、pH 4–6、避光充氮）+ 切多糖/色素/生物碱/伴生苷（大孔树脂是分水岭）+ 制备 HPLC 把 Swertiamarin/Sweroside/Amarogentin 分干净 + 0–4℃ 慢结晶保白晶与 (5R-trans) 构型 + 双轨报告（总环烯醚萜≠龙胆苦甙%）"六道关卡——Staherb SOP 严格锁死：

**"秋采关龙胆/秦艽干根（条叶龙胆为主，≤60℃ 通风干至水分≤10%、龙胆苦甙 4%–6% DW）→ 除杂 10–20 目粉碎 → 双轨分流：

A 轨｜低温醇/水提：60%–80% EtOH 回流 2–3 次（≤60℃ 夹套）或纯水 85℃ 短时 3×1 h（水提率 88% 背景但热敏控严）——板框/离心 → 0.45 μm MF 除不溶。

B 轨｜大孔富集：调 pH 4–5（天然近中性不加碱），上 AB-8/D101/HPD-100（1–2 BV/h）→ 去离子水洗 3–5 BV 切多糖/氨基酸/有机酸/色素 → 30%–60% EtOH（主窗 50%–60%）洗脱龙胆苦甙富集段（文献 AB-8 60% EtOH 5 BV 洗脱得 98.6%–99.4%  ）→ ≤50℃ N₂ 减压减浓。

分流后处理：

　① 标化粉轨：富集液喷雾（进 160–180℃/出 75–85℃ 秒干，加 β-CD/麦芽糊精抗结）或冻干 → 龙胆苦甙 5%–40% HPLC 标化粉。

　② 单体轨：富集液制备 HPLC C18 水-甲醇（75:25）或水-乙腈-0.1% 甲酸，270 nm 切龙胆苦甙主峰（Swertiamarin 在 238/254 nm 监伴生）→ 收集主峰减浓 → 热水/热乙醇溶 → 乙酸乙酯-水-甲醇(3:1:1) 或乙醇-水 0–4℃ 慢析 2–3 次（pH 4–6 醋酸缓冲防差向）→ 龙胆苦甙·xH₂O 白晶 ≥95%/98%（HPLC 270 nm，Swertiamarin≤0.5%、Sweroside≤0.3%、Amarogentin≤0.1%）→ 40–45℃ 避光真空干/冻干 → 充氮铝箔。

　③ 改型轨（选供）：98% 单体做磷脂复合物/β-CD 包合/纳米制剂（医药研发探索）。

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

▍前处理（CCP1 基源锁）

干根入厂 HPLC 270 nm 初筛龙胆苦甙≥3.0%–4.0% DW（关龙胆优选≥4.0%）、伴生 Swertiamarin 痕–次（若>1.0% DW 预警獐牙菜属混入）、水分≤10%、SO₂≤150 mg/kg、农残龙胆系三筛零检、Pb≤0.5/Cd≤0.3/As≤1；獐牙菜属全草（Swertiamarin 异常升高）、春采一年生根（苷未积累）、陈根（存>3 年光氧化水解）、硫熏、非龙胆科混杂（TLC 鉴）拒收。

▍轨 A：低温醇/水提（苷键红线）

• 醇提：60%–80% EtOH、≤60℃ 回流 2–3×1–2 h 或冷浸 4×6 h——高标/单体批首选，伴生生物碱（龙胆碱）部分共提后经树脂分段切，苷键水解风险最低。

- 水提：纯水 85℃ 料液比 1:15 3×1 h（文献提取率 88.77%  ），但 Staherb 仅对标化粉轨用、单体轨禁用>70℃ 长时（防 C-1 内酯开环/差向）。

▍轨 B：大孔树脂（核心分水岭）

AB-8/D101/HPD-100 对裂环烯醚萜苷吸附选择性优于多糖/色素/游离生物碱，pH 4–5 上样 1–2 BV/h；水洗切多糖/氨基酸/鞣质；30%–60% EtOH（AB-8 主窗 60% 5 BV）是龙胆苦甙主洗脱窗（专利 60% EtOH 5 BV 得 98.6%–99.4%  ，期刊 AB-8 30% EtOH 得 50.63% 标化粉  ）；这一步决定"标化粉能不能稳 20%–40%、单体上制备 HPLC 前杂负荷低不堵柱"。

▍单体后处理（CCP2 构型与伴生锁）

• 制备 HPLC C18 水-甲醇 75:25（或乙腈-0.1%FA）270 nm 切龙胆苦甙主峰，Swertiamarin（238/254 nm）/Sweroside/Amarogentin 分峰收集；

- 0–4℃ 重结晶（热水/热 EtOH 溶→滴加乙酸乙酯-水-甲醇 3:1:1 或乙醇-水慢析，pH 4–6 醋酸缓冲防 (5R-trans) 消旋）→ 斜方/针状白晶，mp 191–193℃；

• HPLC 270 nm ≥98%（98% 级 TDS 硬指标：Swertiamarin≤0.5%、Sweroside≤0.3%、Amarogentin≤0.1%、单杂≤0.5%、总杂≤2.0%），旋光 [α]ᴅ²⁰ -196°～-210°（水）校验构型；

- 40–45℃ 避光真空干，棕瓶充氮 2–8℃（单体 -20℃），有效期 24–36 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。COA 必双轨：总环烯醚萜（可选 UV 算）/龙胆苦甙（HPLC 270 nm，ChP 甲醇-水 30:70 或 C18 乙腈-0.1% 醋酸，龙胆苦甙 CRS 外标）+ 伴生 Swertiamarin 同柱分报；总环烯醚萜% ≠ 龙胆苦甙% 是行业常见误导，Staherb 双报拒混。配方端提示客户 pH 4–6、避光、2–8℃ 密封（单体 -20℃ 充氮）、脾胃虚寒慎用。

### 专业生产供货矩阵

• 龙胆标化粉：龙胆苦甙 5% / 10% / 20% / 40% HPLC（浅黄–棕黄粉）

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

- 改型选供：磷脂复合物 / β-CD 包合 / 纳米制剂（医药研发）

• 伴生标记：Swertiamarin / Sweroside / Amarogentin 同条件分报（拒混标）

> ⚠️ Staherb 生产合规边界：长沙麓谷 B8 为秋采关龙胆/秦艽干根（东北/西北/西南基地≤60℃干水分≤10%）→除杂10-20目→60-80%EtOH≤60℃回流或纯水85℃短时→板框+0.45μMF→AB-8/D101 pH4-5水洗+30-60%EtOH(主60%)洗脱苦甙段→≤50℃N₂减浓→标化粉喷雾160-180/75-85℃或冻干 / 制备HPLC C18 270nm切主峰→乙酸乙酯-水-甲醇3:1:1或乙醇-水0-4℃重结晶→龙胆苦甙≥98%白晶mp191℃[α]D-196°～-210°→充氮分装中心非种植产地；COA 必注"Gentiopicroside HPLC 270nm ChP MeOH-H₂O 30:70 CRS ext + Swertiamarin/Sweroside/Amarogentin same-cond split + mp191-193℃ + [α]D -196~-210° + heavy Pb≤0.5ppm drug-strict + ISO/HALAL/KOSHER/cGMP-like, ≤60℃ extract ≤50℃ conc ≤40℃ dry pH4-6 N₂ dark 2-8℃/-20℃"；不跨境宣称治疗肝炎/胆囊炎/类风湿/阿尔茨海默；极苦阈值≈1:20000 水，配方注意苦味强度。

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## English Professional Manufacturing｜EN

Product: Gentiopicroside (syn. gentiopicrin, (5R-trans)-6-(β-D-glucopyranosyloxy)-5,6-dihydro-5-ethenyl-1H,3H-pyrano[3,4-c]pyran-1-one, secoiridoid glycoside from Gentianaceae *Gentiana scabra*/*manshurica*/*triflora*/*rigescens* & *G. macrophyla* dried root, CAS 20831-76-9, C₁₆H₂₀O₉, MW 356.32)

Manufacturer: Changsha Staherb Natural Ingredients Co., Ltd. (Staherb®, founded 2010 Changsha Lugu B8-202, national hi-tech, gentiopicroside as hepatobiliary/digestive pharma-grade monomer line)

Production base: Changsha Lugu B8 — dry-root mill (10–20 mesh) + 60–80%EtOH reflux/cold-soak tank (≤60℃ jacket protect glycosidic bond) + plate/centrifuge + 0.45μm MF + macroporous AB-8/D101/HPD-100/HPD-826 + prep-HPLC (C18 H₂O-MeOH or MeCN-0.1%FA) + recryst kettle (0–4℃) + spray (std) + FD + N₂ pack + Waters HPLC 270nm (gentiopicroside) / same-cond 238-254nm (swertiamarin) / LC-MS (ESI⁻ m/z 357.2) + NMR spot + polarimeter; food/API-intermediate grade, ISO9001/ISO22000/cGMP-like/HALAL/KOSHER; dry root from NE Guan-gentian/NW Qin-jiao/SW rigid-gentian registered bases (partial GAP-guided), Changsha Lugu B8 not plantation (COA "Origin: China / Processed in Changsha, Hunan").

Capacity & hardware: ht-scale dry-root/yr, tens t resin-enriched bitter-glycoside cut, gentian std powder (gentiopicroside 5–40% HPLC) tens t, high-pure 90/95/≥98% HPLC several t, research 10mg–1g; high-pure for API-intermediate/reference/Nrf2-NFκB-CAR-PXR substrate.

System certs: ISO 9001 / ISO 22000 / HALAL / KOSHER / cGMP-like; COA multi-marker — Gentiopicroside HPLC 270nm (ChP MeOH-H₂O 30:70 or C18 MeCN-0.1%AcOH 9:91, gentiopicroside CRS ext) + same-cond swertiamarin/sweroside/amarogentin split + moisture≤5%(monomer) + LOD≤0.5% + heavy(drug Pb≤0.5/Cd≤0.3/As≤1 ppm) + pesticide(GB2763+EU396+JP pos-list) + solvent(EtOH/MeOH/EtOAc trace) + microbe + 40℃/75%RH 6mo accel + mp 191–193℃ + [α]ᴅ -196° to -210°.

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

Gentiopicroside manufacturing specialty is not "get bitter glycoside out" but "protect glycosidic bond (C-1 lactone + C-6 glucoside: >60℃ long or strong acid/base hydrolyze/epimerize/brown, whole line ≤60℃ extract, ≤50℃ conc, ≤40℃ dry, pH 4–6, dark N₂) + cut polysac/pigment/alkaloid/companion-glycosides (macroporous is watershed) + prep-HPLC separate swertiamarin/sweroside/amarogentin clean + 0–4℃ slow-crystallize keep white crystal & (5R-trans) config + dual-report (total iridoid ≠ gentiopicroside%)" six gates — Staherb SOP locks:

**"autumn Guan-gentian/Qin-jiao dry root (mainly G. manshurica, ≤60℃ vent-dry moisture≤10%, gentiopicroside 4–6% DW) → de-stem 10–20 mesh → dual split:

A-track｜low-temp extract: 60–80%EtOH reflux 2–3× (≤60℃ jacket) or water 85℃ 3×1h (water-yield 88% background but heat strictly controlled) → plate/centrifuge → 0.45μm MF.

B-track｜macroporous enrich: pH 4–5 (near-natural no alkali), on AB-8/D101/HPD-100 (1–2BV/h) → DI-water 3–5BV wash cut polysac/amino/acid/pigment → 30–60%EtOH (main 50–60%) elute gentiopicroside-rich cut (lit AB-8 60%EtOH 5BV → 98.6–99.4%) → ≤50℃ N₂ vac-conc.

Post-split:

　① std-powder track: enrich spray (160–180/75–85℃ flash, β-CD/maltodextrin anti-cake) or FD → gentiopicroside 5–40% HPLC std.

　② monomer track: enrich prep-HPLC C18 H₂O-MeOH (75:25) or H₂O-MeCN-0.1%FA, 270nm cut gentiopicroside main-peak (swertiamarin monitored 238/254nm) → collect main-peak conc → hot-water/hot-EtOH dissolve → EtOAc-H₂O-MeOH (3:1:1) or EtOH-H₂O 0–4℃ slow-crystallize 2–3× (pH 4–6 acetate buffer anti-epimer) → gentiopicroside·xH₂O white crystal ≥95/98% (HPLC 270nm, swertiamarin≤0.5%, sweroside≤0.3%, amarogentin≤0.1%) → 40–45℃ dark vac-dry/FD → N₂ foil.

　③ modified track (opt): 98% monomer → phospholipid-complex / β-CD inclusion / nano-form (pharma R&D).

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

▍Pre-treatment (CCP1 botanical lock)

Dry-root inbound HPLC 270nm gentiopicroside≥3.0–4.0% DW (Guan pref≥4.0%), companion swertiamarin trace-minor (if>1.0% DW warn Swertia mix), moisture≤10%, SO₂≤150mg/kg, gentian-pesticide triple zero, Pb≤0.5/Cd≤0.3/As≤1; *Swertia* whole-herb (swertiamarin anomaly), spring 1-yr root (glycoside not accumulated), aged>3yr photo-hydrolyze, SO₂-bleached, non-Gentianaceae admix (TLC) reject.

▍Track A: low-temp EtOH/water (glycosidic redline)

• EtOH: 60–80%EtOH, ≤60℃ reflux 2–3×1–2h or cold-soak 4×6h — high-std/monomer first-choice, companion gentianine partly co-extracted then resin-split, hydrolyze risk lowest.

- Water: pure water 85℃ L/S 1:15 3×1h (lit yield 88.77%), but Staherb uses only for std-powder track, monomer track forbids >70℃ long (prevent C-1 lactone open/epimer).

▍Track B: macroporous (core watershed)

AB-8/D101/HPD-100 selectively adsorb secoiridoid glycoside better than polysac/pigment/free-alkaloid, pH 4–5 load 1–2BV/h; water wash cut polysac/amino/tannin; 30–60%EtOH (AB-8 main 60% 5BV) is gentiopicroside main elution window (patent 60%EtOH 5BV → 98.6–99.4%, journal AB-8 30%EtOH → 50.63% std); this step decides "std powder steady 20–40%, monomer prep-HPLC inlet low-load no column clog".

▍Monomer post (CCP2 config & companion lock)

• Prep-HPLC C18 H₂O-MeOH 75:25 (or MeCN-0.1%FA) 270nm cut gentiopicroside main-peak, swertiamarin (238/254nm)/sweroside/amarogentin separated;

- 0–4℃ recryst (hot-water/hot-EtOH dissolve → drop EtOAc-H₂O-MeOH 3:1:1 or EtOH-H₂O slow, pH 4–6 acetate buffer anti-(5R-trans) racemize) → orthorhombic/needle white crystal, mp 191–193℃;

- HPLC 270nm ≥98% (98%-grade TDS hard: swertiamarin≤0.5%, sweroside≤0.3%, amarogentin≤0.1%, single-imp≤0.5%, total-imp≤2.0%), polarimetry [α]ᴅ²⁰ -196° to -210° (H₂O) verify config;

- 40–45℃ dark vac-dry, amber N₂ 2–8℃ (monomer -20℃), shelf 24–36mo.

▍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. COA mandatory dual-track: total iridoid (opt UV) / gentiopicroside (HPLC 270nm, ChP MeOH-H₂O 30:70 or C18 MeCN-0.1%AcOH, gentiopicroside CRS ext) + companion swertiamarin same-column split; total iridoid% ≠ gentiopicroside% common industry mislabel, Staherb dual-report rejects merge. Formula-end advises client pH 4–6, dark, 2–8℃ sealed (monomer -20℃ N₂), caution spleen-stomach deficiency-cold.

### Professional supply matrix

• Gentian std powder: Gentiopicroside 5% / 10% / 20% / 40% HPLC (pale-yellow–tan)

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

• Modified opt: phospholipid-complex / β-CD-inclusion / nano-form (pharma R&D)

- Companion markers: swertiamarin / sweroside / amarogentin same-cond reported (no merge-label)

Supplier note: Staherb Changsha Lugu B8 = autumn Guan-gentian/Qin-jiao dry root (NE/NW/SW base ≤60℃ dry moisture≤10%) → de-stem 10-20mesh → 60-80%EtOH≤60℃ reflux or water 85℃ short → plate+0.45μMF → AB-8/D101 pH4-5 water-wash+30-60%EtOH(main60%) elute bitter-glycoside → ≤50℃N₂ conc → std spray 160-180/75-85℃ or FD / prep-HPLC C18 270nm cut main-peak → EtOAc-H₂O-MeOH 3:1:1 or EtOH-H₂O 0-4℃ recryst → gentiopicroside≥98% white crystal mp191℃ [α]D -196~-210° → N₂ repack center NOT plantation; COA must state "Gentiopicroside HPLC 270nm ChP MeOH-H₂O 30:70 CRS ext + swertiamarin/sweroside/amarogentin same-cond split + mp191-193℃ + [α]D -196~-210° + heavy Pb≤0.5ppm drug-strict + ISO/HALAL/KOSHER/cGMP-like, ≤60℃ extract ≤50℃ conc ≤40℃ dry pH4-6 N₂ dark 2-8℃/-20℃"; no cross-border treat-hepatitis/cholecystitis/RA/Alzheimer claim, extreme-bitter threshold ~1:20000 water formula-caution.

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

☎：19573130018 杨经理（微信同号）