| HS Code | 737628 |
| Product Name | Huangqin Jiedu Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Product Type | Veterinary grade active pharmaceutical ingredient (API) |
| Category | Traditional Chinese veterinary medicine extract |
| Physical Form | Fine dry powder |
| Color | Brownish-yellow to yellowish-brown |
| Odor | Slight characteristic herbal odor |
| Solubility | Partially soluble in water; soluble in dilute ethanol and alkaline solutions |
| Active Marker Compound | Baicalin and related flavonoids from Scutellaria baicalensis |
| Functional Indications | Antipyretic, antibacterial, antiviral, anti-inflammatory, detoxicating, and hepatoprotective actions for veterinary use |
| Applied Clinical Uses | Treatment of fever, infectious diseases, inflammatory conditions, respiratory infections, enteritis, and toxicosis in animals |
| Target Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Mechanism Of Action | Inhibits bacterial and viral replication, suppresses inflammation, reduces oxidative stress, and modulates immune response |
| Recommended Storage | Keep in airtight, moisture-proof container away from light and heat |
| Shelf Life | 24 months when stored under recommended conditions |
| Quality Compliance | Designed to meet veterinary grade API specifications for non-food-producing and food-producing animals as per applicable standards |
As an accredited Huangqin Jiedu Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.
| Packing | Packaging: Huangqin Jiedu Powder Veterinary Grade API available in 25 kg sealed drums with inner liner, ensuring stability. |
| Container Loading (20′ FCL) | Loading a 20′ FCL container with Huangqin Jiedu Powder veterinary-grade API, securely packed in sealed drums/cartons and palletized for safe transport. |
| Shipping | Huangqin Jiedu Powder Veterinary Grade API ships in sealed, moisture-proof drums or foil bags. Transport via dry, ventilated containers, avoiding direct sunlight and extreme temperatures. Dangerous goods documentation and safety data sheets are provided. Delivery options include air, sea, or courier, with full cold-chain protection if required. |
| Storage | Store Huangqin Jiedu Powder Veterinary Grade API in a tightly sealed, light-resistant container in a cool, dry, well-ventilated area. Avoid exposure to moisture, direct sunlight, and high temperatures. Keep away from incompatible substances and contaminants. Maintain room temperature, ideally below 25°C, with low humidity to preserve potency and stability. |
| Shelf Life | Shelf life is 24 months when stored in a cool, dry, well-ventilated area, protected from light and moisture. |
Among swine production lines where enterotoxigenic E. coli F4 (K88) pressure rises sharply during the first 7 days after weaning, the veterinary-grade Huangqin Jiedu Powder is most often routed into creep and starter feed as a top-dressed powder or oral drench rather than through steam-pelleted mash, because early application prioritizes rapid intake over finished-feed physical stability. Published field dossiers for Scutellaria baicalensis-containing oral powders in nursery pigs report administration ranges of 1.0–2.0 kg/t complete feed during the transition week, with 0.5–1.0 kg/t as the maintenance band during the following 10–14 days; the upper figure is normally reserved for high-stocking-density pens with confirmed E. coli or Clostridium perfringens type A co-detection. The powder is damp-mixed into a carrier of rice hull or maltodextrin in a ribbon blender operating at 15–20 rpm for 10–12 min until the coefficient of variation of baicalin by HPLC-UV at 280 nm falls below 5.0%. Screening through a 60-mesh stainless steel sieve before packaging limits particle-size segregation during bulk-bin discharge. Finished applications include 1 kg and 5 kg foil-lined pouches for on-farm top-dress use, 25 kg paper bags for feed-mill incorporation, and an oral paste/granule reconstituted at 0.2 g/kg body weight for veterinary-supervised intervention. Regulatory compliance for the finished feed requires the feed hygiene limits of GB 13078-2017, while the API itself is assessed against the relevant monograph of the Chinese Veterinary Pharmacopoeia (2020) for heavy metals, arsenic, loss on drying, and total aerobic count. Batch-to-batch variation in bulk density, typically 0.35–0.55 g/cm³ depending on spray-drying parameters, should be reported because it alters metering accuracy in volumetric feed augers by up to 8% compared with gravimetric dosing.
Dissolution uniformity of baicalin-rich powder in poultry drinking water is governed less by primary particle size than by water pH, carbonate alkalinity, and free chlorine residual. In layer and broiler houses using in-line proportioners, a 1:50 stock solution is prepared at 12.5–25.0 g/L, corresponding to a final in-use concentration of 0.25–0.50 g/L over 5–7 consecutive days. Because the flavonoid fraction exhibits pH-dependent solubility, water with total alkalinity above 250 mg/L CaCO₃ should be pre-adjusted to pH 5.0–5.5 with food-grade citric acid; without pre-acidification, settling rates in static tanks can exceed 15% within 6 h. Chlorination at free chlorine levels above 2.0 mg/L may oxidize phenolic moieties in the extract, reducing HPLC-UV assay response at 280 nm; farms using municipal chlorinated water are advised to neutralize with sodium thiosulfate at 0.1–0.3 g/L before reconstitution, though published data for this specific formula under field chlorination is limited. Mixing is performed in a stainless steel tank with a high-shear disperser at 1,500 rpm for 10 min, followed by gentle recirculation pump delivery to nipple lines or bell drinkers at 0.5–1.0 bar line pressure. Final product types include 100 g and 500 g water-soluble powder sachets, 1 kg jars, and ready-to-use proportioner stock solutions packed in 5 L opaque HDPE containers. Regulatory compliance for medicated drinking water in export markets typically invokes Regulation (EU) 2019/6 for veterinary medicinal products, with stability testing conducted under VICH GL3 and analytical method validation under VICH GL1.
For toll mills producing medicated premixes under HACCP, the veterinary-grade powder is incorporated into a 1% intermediate premix at 50.0–100.0 kg/t carrier in a twin-shaft paddle mixer operating at 30–40 rpm for 8–10 min, with batch-to-batch carryover validated below 0.5% of the maximum active dose, to produce 25 kg paper bags for on-farm top-dress and bulk mill bins for finished feed manufacture under EU Regulation 2019/4 and GB 13078-2017 feed hygiene limits, with final products including 0.5%, 1.0%, and 2.0% premixes and 5 kg foil sachets for veterinary dispensing.
Steam-conditioned pellet lines operating at 75–85°C and 15–17% moisture for 30–60 s create measurable thermal and hydrolytic stress on the flavonoid glycoside fraction. Process validation batches frequently show baicalin assay retention between 90% and 97% after direct steam conditioning, while recovery can fall below 85% when mash residence time exceeds 90 s or when post-conditioner temperature exceeds 90°C under alkaline steam condensate; published data for this specific four-herb decoction powder is limited, so each mill is required to establish its own degradation curve. The recommended control sequence is HPLC-UV quantification at 280 nm on samples collected before the conditioner, after the die, and after the counterflow cooler, with acceptance criterion set at not less than 95% of label claim for baicalin. If the unprocessed API is assayed at ≥4.0% baicalin, the dry mix is metered at 1.0–1.2 kg/t complete feed; for lines where retention exceeds 80°C, a 2–5% overage is approved only when supported by three consecutive batch results under VICH GL3 stability protocols. Equipment selection matters: a short-retention paddle conditioner with a 1:6 length-to-diameter ratio causes less assay loss than a long-retention twin-shaft conditioner at 1:12 L/D, and a pellet die with a 40 mm die thickness and 6 mm hole diameter produces a lower frictional heat rise than 4 mm dies used for piglet starter crumbles. Final product forms include 3.0–4.0 mm pelleted broiler grower feed, 2.0–2.5 mm crumbled starter feed, and 1.5 mm micro-pellets for layer pullets, all packaged in 25 kg woven polypropylene bags with an inner PE liner to limit moisture uptake to ≤12%.
For parenteral presentations, direct reconstitution of untreated dry powder in normal saline is insufficient because residual endotoxins, water-insoluble particulates, and non-ionized flavonoids produce a cloudy, precipitation-prone solution. Converters preparing a sterile injectable must first dissolve the extract in water-for-injection at 60–70°C under a nitrogen blanket, then adjust to pH 6.5–7.5 with phosphate buffer, and pass the cooled liquor through a 0.45 μm polyethersulfone membrane followed by a 0.22 μm sterilizing-grade membrane; if the crude API is used, tangential-flow ultrafiltration with a 10 kDa molecular weight cut-off is applied to reduce endotoxin load to ≤0.5 EU/mg before final formulation. The final parenteral solution is commonly standardized to 5–10 mg/mL baicalin and filled into 10 mL or 20 mL Type II glass vials under Grade A laminar flow, with terminal sterilization withheld when color darkening exceeds 10% absorbance at 420 nm; aseptic filtration is preferred. Regulatory compliance for this dosage form falls under EudraLex Volume 4 Annex 1 for sterile manufacture, the Chinese Veterinary Pharmacopoeia (2020) general chapters on sterility and bacterial endotoxins, and VICH GL1 for analytical method validation; injectable presentations are not automatically authorized from the API and require a separate marketing authorization in each target territory. Finished product types include intramuscular and subcutaneous solutions for cattle, swine, and equine veterinary use under prescription, with published data for this specific configuration limited to single-batch pilot reports.
Extrusion processing changes the thermal history of the API far more than pelleting: a twin-screw extruder operating at barrel temperatures of 110–125°C and specific mechanical energy input of 250–300 Wh/kg may degrade oxygen-sensitive polyphenols within 10–20 s of residence time, especially when moisture is high and die pressure fluctuates between 25–35 bar. For this reason, aquaculture feed manufacturers do not add the API into the pre-extrusion mash. Instead, the powder is suspended in fish oil or lecithin and applied post-extrusion in a vacuum coater at 0.5–1.5 kg/t finished feed, with vacuum level −0.6 to −0.8 bar and jacket temperature 35–45°C; this keeps baicalin assay retention above 95% in the coated pellet. The target inclusion range for warm-water omnivorous species is 1.0–2.0 kg/t grow-out feed, adjusted downward to 0.5 kg/t when the formula already contains high levels of free fatty acids that accelerate oxidative rancidity. Compliance for such feed depends on the marketing status: as a veterinary medicinal product, medicated feed rules under Regulation (EU) 2019/4 apply; as a feed material or additive, dioxin, heavy metal, and pesticide limits under Directive 2002/32/EC and national aquafeed codes must be met, while finished feed safety follows HACCP protocols based on ISO 22000. Final product types include 2–3 mm sinking pellets for carp, 3–4 mm slow-sinking pellets for tilapia, and 1.5 mm micro-pellets for juvenile shrimp, packed in 25 kg moisture-barrier sacks.
In ruminant oral drench and pre-ruminant liquid presentations, high-shear homogenization is avoided because excessive foam generation and entrained air destabilize the suspension and complicate metering through drench syringes. A low-shear impeller mixer operating at 60–120 rpm for 20–30 min is used to disperse the API in a vehicle of propylene glycol, glycerin, and purified water at 20–25°C, with final solids content maintained at 10–15% w/v for syringeability. The addition ratio for calf oral solutions is typically 0.5–1.0 g/kg body weight administered once daily for 3–5 days under veterinary oversight, while adult bovine drench concentrates are prepared at 50 mg/mL baicalin and diluted 1:5 with drinking water at the point of administration. Polyethylene terephthalate or HDPE opaque bottles of 500 mL and 1 L are used because the flavonoid fraction is sensitive to UVA; amber glass is substituted where long-term stability beyond 18 months is claimed. Compliance is verified under VICH GL3 stability testing and the Chinese Veterinary Pharmacopoeia (2020) monograph for oral liquid preparations, while residue control for food-producing bovines requires withdrawal-period studies under Regulation (EU) 2019/6 or the corresponding national veterinary drug regulator; published baicalin residue depletion data in bovine milk is limited, so dairy use should be restricted to labeled veterinary authorization. Final forms include calf drench bottles with graduated caps, 20 L returnable bulk containers for feedlot water medication, and 5 L concentrate jugs for dilution through automated proportioner units.
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Huangqin Jiedu Powder Veterinary Grade API is a spray-dried aqueous decoction powder prepared from Scutellaria baicalensis Georgi root, Coptis chinensis Franch. rhizome, Phellodendron amurense Rupr. bark, and Gardenia jasminoides Ellis fruit. Three release models are assigned: HQJDP-VAPI-100 for powders, granules, and feed premix; HQJDP-VAPI-200 for tablet and capsule applications requiring reduced particle geometry; and HQJDP-VAPI-SI for injectable solutions under aseptic or terminal-sterilization processes. The API is standardised by HPLC to not less than 15.0% baicalin, 5.0% berberine hydrochloride, and 2.0% geniposide on a dry basis. The oral powder models are not sterile and are unsuitable for parenteral administration unless the injection-grade model is used. The material is a veterinary starting material, not a finished dose form, and its use in tablets, injections, capsules, powders, granules, premix, and solutions requires downstream process validation in the intended manufacturing line.
The release specification is aligned with the Chinese Veterinary Pharmacopoeia 2020 Edition monograph for Huangqin Jiedu San where applicable, with chromatographic assay performed under ChP 2020 General Chapter 0512. Identification of the four botanical inputs is confirmed by thin-layer chromatography against reference materials for Scutellaria baicalensis, Coptis chinensis, Phellodendron amurense, and Gardenia jasminoides. Loss on drying is determined at 105 °C for 5 h according to ChP 2020 General Chapter 0832. The powder is assayed for baicalin, berberine hydrochloride, and geniposide; the marker window is deliberately wider than a single-herb extract because the four-herb decoction matrix contains additional flavone iridoid and berberine-type alkaloids that influence chromatographic integration.
| Parameter | HQJDP-VAPI-100 |
HQJDP-VAPI-200 |
HQJDP-VAPI-SI |
Method reference |
|---|---|---|---|---|
| Appearance | Yellowish-brown to brown powder, characteristic bitter taste | Visual / TLC identification | ||
| Baicalin content, dried basis | ≥ 15.0% | ChP 2020 General Chapter 0512 | ||
| Berberine hydrochloride content | ≥ 5.0% | ChP 2020 General Chapter 0512 | ||
| Geniposide content | ≥ 2.0% | ChP 2020 General Chapter 0512 | ||
| Loss on drying | ≤ 5.0% | ChP 2020 General Chapter 0832 | ||
| Sulphated ash | ≤ 8.0% | ChP 2020 General Chapter 2302 | ||
| Particle size | ≥ 95% pass 80-mesh, D90 ≤ 180 μm | ≥ 95% pass 200-mesh, D90 ≤ 75 μm | D90 ≤ 45 μm | ChP 2020 General Chapter 0982 |
| Bulk density | 0.35–0.55 g/mL | USP <616> | ||
| Total aerobic microbial count | ≤ 1000 CFU/g | ≤ 1000 CFU/g | ≤ 100 CFU/g | ChP 2020 General Chapter 1105 |
| Total yeast and mould count | ≤ 100 CFU/g | ≤ 100 CFU/g | ≤ 10 CFU/g | ChP 2020 General Chapter 1105 |
| Bacterial endotoxins | Not specified | Not specified | ≤ 0.50 EU/mg | ChP 2020 General Chapter 1143 |
| Heavy metals | Pb ≤ 5 ppm, As ≤ 2 ppm, Cd ≤ 1 ppm, Hg ≤ 0.2 ppm | ChP 2020 General Chapter 2321 | ||
| Aflatoxin B1 | ≤ 5 μg/kg | ISO 16050:2003 | ||
Tablet and capsule manufacture with HQJDP-VAPI-200 requires granulation if the Hausner ratio exceeds 1.40. In a 5 kg top-spray fluid-bed granulation trial, the API was preblended with microcrystalline cellulose 102 and croscarmellose sodium 4.0% w/w; a binder solution of PVP K-30 at 5.0% w/w solids in 60% v/v ethanol was added at 3.0% w/w of API to control fine-particle elutriation. Compression on a 10-station rotary tablet press using 10 mm round tooling at 8–12 kN produced tablets with hardness 70–90 N and friability ≤ 0.8% after 24 h equilibration. When relative humidity exceeded 60% RH, the powder showed caking and star-wheel jams in an automatic capsule filler; packaging in aluminium-aluminium blister packs was therefore required rather than PVC/PVDC blisters.
Bulk density of spray-dried lots ranges from 0.35 g/mL to 0.55 g/mL. The powder is hygroscopic and is handled below 60% RH; open storage above 65% RH for 4 h increases loss on drying by 1.0–1.5% and causes sieve blinding on 80-mesh screens. Granulation is performed in a top-spray fluid-bed dryer at inlet-air temperature 60–65 °C; discharge is triggered at product temperature 40 °C and outlet-air relative humidity below 15%. For feed premix, the API is first diluted 1:5 w/w with precipitated silica or calcium carbonate to suppress electrostatic adhesion, then blended in a ribbed piston mixer at 25 rpm for 10 min. Premix homogeneity acceptance is set at relative standard deviation ≤ 5.0% for baicalin content across 10 sampling points.
Drinking-water stock solutions are prepared at 5 g/L and buffered to pH 6.0–6.5. At pH 4.0 or below, baicalin degradation accelerates; at pH 8.0 or above, berberine precipitates as the free base. The stock solution is used within 6 h unless a stabilised vehicle with a registered preservative is employed. Published long-term stability data for this drinking-water preparation in target species is limited, so the marketing authorisation holder must establish the in-use shelf life under intended farm water conditions.
For species-specific dose calculation, the API use rate is derived from the marker assay rather than direct transfer of traditional unprocessed powder doses. A baicalin target of 20 mg/kg body weight requires 133 mg/kg of API at the 15.0% baicalin release limit. For complete feed, this corresponds to 0.5–2.0 kg/tonne in most monogastric formulations, but the final inclusion rate is adjusted by the responsible veterinarian after verifying the actual marker content of the batch and the target species’ feed intake.
HQJDP-VAPI-SI is produced from a deproteinized and decolorized aqueous decoction and is spray-dried under controlled bioburden. For injectable solution compounding, the powder is reconstituted in water for injection at 0.10–0.20 g/mL, adjusted to pH 5.5–6.5, and filtered through a 0.22 μm polyethersulfone membrane. Terminal sterilization at 121 °C for 15 min is acceptable only when heat-stability data confirm geniposide loss ≤ 5.0% and pH drift ≤ 0.2 units. Bacterial endotoxins are controlled to ≤ 0.50 EU/mg by ChP 2020 General Chapter 1143, and pre-filtration bioburden is held to ≤ 10 CFU/100 mL. The injection-grade powder is not suitable for lipid emulsion injections because residual polyphenols and amphiphilic constituents may alter interfacial tension and destabilize lecithin-stabilised emulsions. Published data for depot or sustained-release injectable configurations of this four-herb powder is limited.
Compared with a high-purity Scutellaria baicalensis extract standardised to 85.0% baicalin, the four-herb API contains a broader marker set but lower single-marker content. To deliver 10 mg/kg body weight berberine, the API quantity required is 200 mg/kg at the 5.0% berberine hydrochloride release limit, whereas purified berberine chloride requires 10.3 mg/kg. The API is not interchangeable with synthetic antipyretics or antimicrobials such as flunixin meglumine, doxycycline hyclate, or sulfamethazine. No MIC-based breakpoints have been established for the multi-marker herbal powder against veterinary bacterial pathogens. Combination with ionophore coccidiostats, bentonite-based mycotoxin binders, or macrolide premixes requires compatibility screening because berberine may bind to clay surfaces or precipitate with tannin-rich extracts.
| Comparator | Marker standardisation | Typical dosage-form fit | Elemental and microbial control |
|---|---|---|---|
| Huangqin Jiedu Powder Veterinary Grade API | Baicalin ≥ 15.0%, berberine HCl ≥ 5.0%, geniposide ≥ 2.0% | Tablets, capsules, granules, premix, oral solutions, injections with SI model |
Pb ≤ 5 ppm, As ≤ 2 ppm, Cd ≤ 1 ppm, Hg ≤ 0.2 ppm, TAMC ≤ 1000 CFU/g |
| Single-herb Scutellaria baicalensis extract | Baicalin ≥ 85.0% | Capsules, granules, liquid concentrates | Supplier-dependent unless pharmacopoeial grade is specified |
| Purified berberine chloride | Berberine ≥ 97.0% | Injectables, soluble powders, oral solutions | Pharmacopoeial limits apply |
| Unstandardised raw Huangqin Jiedu powder | Not controlled | Traditional oral powder only | Often not controlled or batch-variable |
The API should be stored in sealed aluminium-laminated bags at 25 °C or below and 60% RH or below. Real-time stability is assessed at 25 °C/60% RH for 24 months, with accelerated stress at 40 °C/75% RH for 6 months. A compatibility screen is required before blending with bentonite, montmorillonite, or chitosan-based binders used in mycotoxin-binder premixes because adsorption may reduce marker recovery. Combination with high-molecular-weight polyphenols in aqueous solution is also not recommended due to potential insoluble complex formation with berberine.