| HS Code | 541811 |
| Product Name | Chuangan Kushen Powder Veterinary Grade API |
| Api Substance | Sophora flavescens (Kushen) extract |
| Active Constituents | Matrine and oxymatrine |
| Grade | Veterinary grade API |
| Physical Form | Fine, free-flowing powder |
| Solubility | Soluble in water and partially soluble in ethanol |
| Dosage Form Compatibility | Tablets, injections, capsules, powders, granules, premix, solutions |
As an accredited Chuangan Kushen 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 | Chuangan Kushen Powder veterinary API is supplied in double-laminated aluminum foil bags inside fiber drums, 25 kg net per drum. |
| Container Loading (20′ FCL) | 20′ FCL loaded with 20 pallets of drummed powder, weight optimized, safely secured, sealed for export delivery. |
| Shipping | Shipped in sealed, moisture-proof drums with hazard-compliant labeling. Transport via cold-chain or temperature-controlled logistics to preserve potency. Strict handling protocols for veterinary API safety. Customs documentation and material safety data sheets included. Delivery worldwide with tracking, ensuring compliance with international pharmaceutical shipping regulations. |
| Storage | Store in a cool, dry, well-ventilated area, tightly sealed in its original container. Protect from moisture, direct sunlight, and high temperatures. Avoid contact with strong oxidizers or acids. Keep away from food, feed, and reach of children. Use under appropriate ventilation and follow handling precautions. |
| Shelf Life | Shelf life: 24 months when stored in a cool, dry, sealed container, protected from light and moisture. |
Dry blending of the veterinary-grade extract into water-soluble oral powders for swine and poultry is constrained by the hygroscopic behavior of the alkaloid fraction rather than by chemical potency alone. The API received in fiber drums typically ranges from 0.35 g/cm³ to 0.55 g/cm³ bulk density, and when the warehouse dewpoint rises above 12 °C, the powder begins to form soft agglomerates that survive a 600 µm sweep. In a 600 L double-ribbon mixer running at 22–25 rpm, the API is first pre-blended 1:5 with spray-dried lactose monohydrate, then extended to the full batch; without this staged dilution, near-sieve fractions of the extract can stratify during discharge and produce sachet content uniformity outside RSD ≤ 5.0%. The formulation addition ratio for the finished powder is set at 10.0–25.0% w/w API, with anhydrous sodium sulfate or colloidal silicon dioxide at 0.5–1.5% w/w as a moisture scavenger, and the total water content is controlled by USP <921> Karl Fischer titration at a release limit of ≤ 3.0%. Downstream, the blend is discharged through a vibratory sifter fitted with a 0.8 mm mesh, conveyed by vacuum to a volumetric sachet filler, and sealed in LDPE/aluminum-foil laminate pouches at 140–150 °C sealing-bar temperature. The terminal finished product is a 100 g or 500 g water-soluble powder for proportional drinking-water medication; in-use solutions are evaluated for turbidity below 10 NTU and pH at 6.0–7.5 before connection to a metering pump. Industry compliance for this format draws on USP <811> powder fineness, USP <731> loss on drying, and VICH GL18 residual solvent limits for veterinary APIs.
Sterilization options for a parenteral grade prepared from Kushen extract are determined by the ratio of matrine to oxymatrine and by the oxygen permeability of the primary container. The extraction lot assay for total alkaloid, calculated as matrine by HPLC-UV at 220 nm, may vary between 90.0% and 105.0% of label claim; when the oxymatrine fraction is high, unbuffered aqueous solutions exhibit pH drift from 5.5 to 6.3 during nitrogen stripping, which changes ionization and can alter the retention behavior of related alkaloids in stability-indicating methods. Production-scale heat sterilization is therefore limited by the need to hold the solution at pH 5.5–6.0 with 0.2 M citrate buffer; aseptic filtration through a 0.22 µm PVDF membrane is preferred when terminal 121 °C exposure would generate assay loss exceeding the registered acceptance range. Where a terminal moist-heat cycle is required by the destination monograph, a reduced cycle at 116 °C for 20 min is evaluated with headspace oxygen below 2.0%, because published data for oxymatrine-rich veterinary injections remain limited and batch-specific thermal-degradation screening is mandatory. The formulation addition ratio is 1.0–5.0% w/v total alkaloid, with sodium chloride 0.85% w/v for isotonicity, citrate buffer 0.2–0.5% w/v, and benzyl alcohol ≤ 1.0% w/v only for multi-dose presentations. Filling runs use 10 mL, 20 mL, and 50 mL amber Type II glass vials with chlorobutyl stoppers on a 300 vials/min line, with in-process sterility assurance following EU GMP Annex 1 and compendial requirements for injections under USP <1>. The terminal product is a sterile injectable solution for veterinary use, released after container-closure integrity testing, endotoxin control, and residual solvent testing under VICH GL18.
In feed-mill premix lines, the extract must remain suspended in a carrier system that is often 1.5–2.0 times denser than the API. Horizontal paddle mixers with 1000 kg capacity are typically run at 25–30 rpm for 12–15 min after the final dilution; at shorter mixing times, samples drawn from the dead zone behind the discharge gate have shown alkaloid assay values below 85% of target even when the main blend passes. The addition ratio in the concentrated premix is 2.0–10.0% w/w of the veterinary-grade powder, prepared by stepwise dilution against calcium carbonate or wheat middlings; a finished complete-feed dosage of 0.5–2.0 kg/tonne corresponds to 0.05–0.20% w/w in the final ration and is metered through a loss-in-weight screw feeder with an accuracy of ±2.0% at 500 kg/h. The downstream process includes dust extraction, air classification of the carrier, and final packaging into 20 kg paper/PE valve bags; all sampling follows ISO 6497, and homogeneity is assessed by high-performance liquid chromatography across 10 sampling points with a release criterion of 90.0–110.0% of declared content. Compliance is framed under Regulation (EU) 2019/4 for medicated feed where the finished product is registered as a veterinary medicinal premix, including validated carryover limits in the production line; the operator must also apply VICH GL18 for any solvent residues introduced by extraction. The terminal product is a medicated premix for incorporation in complete feed or home-mixed rations, not a directly administered dosage form.
Wet granulation of the API into oral granules for piglets and calves addresses the poor flow and segregation tendency of the dry extract. The formulation addition ratio is 20.0–40.0% w/w API, 45.0–70.0% w/w lactose monohydrate, 3.0–5.0% w/w povidone K30 as binder, 2.0–3.0% w/w crospovidone as disintegrant, and 0.5–1.0% w/w talc. The binder is prepared as an aqueous solution and added at 8.0–10.0% of the dry powder weight in a high-shear granulator operating at an impeller speed of 150 rpm and chopper speed of 1800 rpm; the wet mass is screened through a 1.5 mm mesh and transferred to a fluid-bed dryer with inlet air at 55–65 °C and product temperature held between 38 °C and 42 °C. Drying is terminated when loss on drying reaches 2.5–3.5%; overdrying below 2.0% increases granule friability and produces a dusty fraction that compromises dosing-spoon accuracy. The dried granules are milled and sieved to 500–1000 µm, then filled into 100 g high-density polyethylene jars with a silica gel desiccant sachet. Release testing includes USP <905> uniformity of dosage units, USP <711> dissolution using 0.1 M hydrochloric acid at 37 °C, and USP <921> water determination. The terminal finished product is an oral granule for direct administration or mixing into small quantities of liquid feed.
Compression of the extract into veterinary tablets or large-animal boluses cannot follow direct-compression routes when the active fraction exceeds 25.0% w/w because the alkaloid-rich granules exhibit low plastic deformation and edge capping appears at upper punch forces above 15 kN. A wet-granulated formulation containing 25.0–35.0% w/w API, 20.0–30.0% w/w microcrystalline cellulose, 20.0–30.0% w/w lactose monohydrate, 2.0–4.0% w/w croscarmellose sodium, and 0.5–1.0% w/w magnesium stearate is compressed on a 16-station rotary press with pre-compression at 3–5 kN and main compression at 12–18 kN. Tablet hardness is held between 60 N and 90 N for 0.3 g and 0.5 g tablets, while 3.0 g boluses require 120–180 N to avoid fracture during automatic coating transfer. The process includes forced feeder speed adjustment to avoid segregation of the fines fraction, and friability must remain below 1.0% after 100 rotations according to Ph. Eur. 2.9.7. Aqueous film coating with hypromellose is applied to a 8.0–10.0% weight gain in a perforated pan at 50–55 °C inlet air; the terminal product is a film-coated tablet or veterinary bolus in 10-unit or 50-unit aluminum blister packs. Batch release includes USP <905> uniformity of dosage units, USP <711> dissolution at 50 rpm paddle speed, and USP <921> water determination. Where the destination market requires a pharmacopoeial monograph, the dissolution acceptance criterion is derived from the registered specification, not from human pharmaceutical defaults.
During continuous filling of the hygroscopic extract into hard capsules for companion-animal or small-ruminant dosing, moisture transfer between the fill material and the capsule shell controls line speed. The formulation addition ratio is 45.0–60.0% w/w API, 20.0–35.0% w/w microcrystalline cellulose, 5.0–10.0% w/w pregelatinized starch, 2.0% w/w croscarmellose sodium, and 0.5% w/w magnesium stearate; the blend is milled through a 0.6 mm screen immediately before filling. The encapsulation suite is maintained at 20–25 °C and 30–35% RH, and the hopper mill air is dewpoint-controlled to below 4 °C to keep the powder moisture load under 4.0%. A dosing-disk machine operating at 60,000 capsules/h is used for size 2 or size 3 capsules; fill weight is checked every 15 min, and the line is stopped if compression of the powder slug exceeds the target thickness by more than 5.0% because such drift correlates with splitting after blister storage. Hypromellose shells are preferred over gelatin when the destination label must avoid animal-derived excipients, but hypromellose shells transfer moisture more slowly and require lower initial fill moisture. The terminal product is a hard capsule containing 250–500 mg of blend, packaged in 60-count or 100-count PVC/PVDC-aluminum blister cards. Release testing follows USP <905> for content uniformity, USP <711> for dissolution, and USP <921> for water content; the capsule shell itself is verified against USP <61> and USP <62> for microbial limits.
Formulated as an oral drench solution for sheep and goats, the API is dissolved in a co-solvent system that maintains clarity across a storage range of 4–30 °C without the viscosity rise that would clog a 10 mL automatic drench gun. The addition ratio is 1.0–4.0% w/v total alkaloid, with propylene glycol 10.0–20.0% v/v, sorbitol solution 20.0–30.0% v/v, potassium sorbate 0.10–0.20% w/v, and pH adjusted to 5.5–6.5 with citric acid. The manufacturing sequence uses a jacketed mixing vessel at 25–30 °C, with the API pre-dissolved in purified water for 20–30 min before the sorbitol phase is added; a high-shear recirculation loop is avoided because cavitation can generate foam and reduce fill accuracy. The solution is filtered through a 10 µm clarifying cartridge and filled into 1 L high-density polyethylene bottles or 20 L jerrycans, with headspace nitrogen where the packaging is oxygen-permeable. Terminal product testing includes USP <791> pH, USP <911> viscosity, and Ph. Eur. 5.1.4 microbial quality for non-sterile oral liquids. The finished oral solution is intended for direct drench administration; in-use pumps must be calibrated against the specific gravity of the final liquid, not against water, because the sorbitol fraction raises density by 0.03–0.05 g/cm³.
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Chuangan Kushen Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a dried, milled extract of Sophora flavescens Aiton root standardised for the quinolizidine alkaloids matrine and oxymatrine. The trade designation represents a veterinary active pharmaceutical ingredient rather than a finished dose form; no additional model suffix is published in the regulatory records available for this designation. The material is multi-component by design, containing co-extracted flavonoids, saponins, and polysaccharides that influence moisture uptake, powder flow, chromatographic response, and membrane filter loading. Downstream use spans tablet compression, injectable reconstitution, capsule filling, powder blending, granulation, medicated premix dilution, and solution compounding. Each route imposes distinct specifications for particle-size distribution, microbial burden, endotoxin content, and residual solvent profile. Numerical acceptance limits are batch-specific and must be verified against the manufacturer’s certificate of analysis and the receiving jurisdiction’s veterinary drug approval conditions.
The chief analytical and processing difference lies in the non-alkaloid matrix. A synthetic matrine or oxymatrine reference substance can be assayed as a single peak with high specificity at 210 nm; the botanical powder produces multiple overlapping UV-active peaks that require a C18 reversed-phase separation with a phosphate/acetonitrile gradient. In solid-dose manufacturing, the presence of hygroscopic oligosaccharides broadens the glass transition of the dried extract and reduces the humidity tolerance of the powder. This creates a narrower processing window than that of crystalline synthetic APIs. In liquid formulations, plant polysaccharides and residual proteins increase the viscosity of the reconstituted solution and reduce the throughput of sterilising-grade membrane filters. The powder also carries batch-to-batch variability in minor co-extractives that do not appear as a single marker peak but may affect excipient compatibility. Acceptance criteria must therefore address both marker alkaloid content and the broader extract fingerprint rather than a single chemical titre.
The exact solvent history is not stated in the public trade designation; different extraction routes produce different alkaloid ratios. Ethanol-water extraction tends to preserve the natural oxymatrine-to-matrine ratio, whereas acid-water extraction may alter alkaloid salts and minor co-extractive composition. The concentrated liquor may be spray-dried onto a carrier or dried as a neat extract and milled. Spray-dried powder typically has a more spherical particle geometry and better flow than vacuum-dried slab extract, but it may also have a lower bulk density that complicates die fill. The drying method therefore affects downstream tablet weight variation and capsule fill capacity even when the total alkaloid assay is unchanged.
Direct compression of the as-supplied powder is generally constrained by poor flow and high hygroscopicity. Formulators typically pretreat the API by dry roller compaction or wet granulation before tablet compression. The powder is screened through a stainless-steel sieve with a nominal aperture of 18-mesh or 20-mesh after milling to remove agglomerates. In high-shear granulator processing, the extract is dry-blended with microcrystalline cellulose and a disintegrant, then wet-massed with a binder solution. Drying is continued until the loss-on-drying endpoint in the master batch record is reached; residual moisture above approximately 5% by weight can increase sticking on rotary tablet presses and promote weight variability in dosator-type capsule fillers. For capsules, preblending with 0.5–1.0% colloidal silicon dioxide is often used to improve flow, but the exact level is determined by Carr index and Hausner ratio testing under the target humidity conditions.
For tablet and capsule manufacture, four physical properties control die filling and content uniformity: particle-size distribution, moisture content, bulk density, and flow function. Laser diffraction testing under USP <429> is used to generate D10, D50, and D90 values; the acceptance range is dosage-route dependent and must appear on the CoA. A narrow distribution with low fines reduces segregation in low-dose tablet blends, while a controlled fraction below 75 μm may be required for dissolution and content uniformity in capsules. Milling through a hammermill or conical screen mill generates heat; water-jacketed mills are specified when the extract approaches its glass transition temperature. For granular and premix products, the API is often first dissolved or slurried in water, sprayed onto a feed-grade carrier in a fluidised-bed granulator, and dried to a final moisture specification.
On rotary tablet presses, the powder may exhibit lamination and capping when the extract is too dry or too fine. This arises from the low plastic deformation capacity of the dried plant matrix. A granulation step is therefore preferred over direct compression. The granule is compacted to a target hardness and friability that is characterised for each formulation, not copied from a synthetic API formulation. Tooling with concave or standard concave punches is often used; punch sticking is controlled by lubrication with magnesium stearate, but excess lubricant can delay tablet disintegration and alkaloid dissolution.
For capsule filling, dosator-type machines require uniform powder plug formation; poor flow and high cohesion result in weight variability. Auger-type fillers are more tolerant of poor-flowing botanical powders but may generate more dust, which requires local exhaust ventilation and respiratory protection for operators. The powder is milled to a particle size compatible with the target capsule shell size; size 0 and size 1 shells are common for veterinary formulations, but the fill volume is determined by bulk density rather than shell capacity alone.
Premix blending follows a two-step geometric dilution sequence. A concentrated API premix is first prepared at a high ratio in a ribbon mixer or horizontal paddle mixer operated at low shear to avoid alkaloid degradation from frictional heating. The concentrated premix is then let down into a feed carrier such as ground maize, lactose, or calcium carbonate. Sampling for active content uniformity is performed at multiple points using a stratified thief sampler; the extracted sample is assayed by HPLC rather than UV to avoid interference from carrier pigments. If the coefficient of variation exceeds the batch record limit, the mixing time is not simply extended, because prolonged agitation can increase electrostatic charges and cause fines to segregate. The fault is instead investigated for particle-size mismatch, excessive moisture in the carrier, or inadequate cleaning of the mixer surfaces.
Parenteral preparations require the dry API to be reconstituted in Water for Injection or a buffered co-solvent system at a controlled temperature and pH. The extraction matrix influences filter capacity; co-extracted polysaccharides and denatured protein fractions can foul membranes and reduce flux. A two-stage filtration train is therefore specified in most pilot-scale protocols, beginning with a depth filter or a 0.45 μm polypropylene prefilter and proceeding to a sterile-grade 0.22 μm polyethersulfone membrane. Endotoxin control is assessed by Limulus amebocyte lysate testing according to USP <85> or the corresponding CP 2020 bacterial endotoxin chapter, with the limit calculated from the maximum intended dose per kilogram for the target species. The alkaloid salts are more soluble in acidic media; precipitation risk increases above pH 7.0. Terminal steam sterilisation may degrade heat-sensitive alkaloid components, so aseptic filtration is commonly used for injectable forms. The final solution is protected from light and oxidative headspace if forced-degradation studies confirm alkaloid oxidation.
The choice of membrane polymer is process-critical. Polyethersulfone and nylon are used for aqueous alkaloid solutions; cellulose acetate membranes may bind phenolic co-extractives and reduce alkaloid recovery. If the solution contains organic co-solvents such as propylene glycol or ethanol, membrane compatibility is verified by a filter validation study under worst-case process conditions including pressure, temperature, and duration. Bubble point and pressure hold tests are recorded before and after filtration. The filtered solution is filled under nitrogen overlay if oxygen sensitivity is confirmed in forced degradation studies.
The active marker specification is expressed as total matrine and oxymatrine or as the individual alkaloid ratio, depending on the purchaser’s regulatory filing. HPLC with a C18 column and detection at 210 nm is the primary assay because UV spectrophotometry cannot resolve the co-extractive baseline. Contaminant control follows both the plant monograph and residual solvent requirements. The table below lists the typical quality-control matrix for this type of dried botanical extract; numerical limits are batch-specific and must be obtained from the manufacturer’s CoA rather than assumed from a general monograph.
| Test parameter | Reference method | Dosage-route relevance |
|---|---|---|
| Identification of matrine and oxymatrine | TLC and HPLC against reference standard; CP 2020 Sophora flavescens monograph | All routes |
| Assay of total matrine and oxymatrine | HPLC-UV, C18 column, detection 210 nm | All routes |
| Loss on drying | USP <731> | Stability, powder flow, capsule fill |
| Total ash and acid-insoluble ash | CP 2020, USP <561> | Purity, extraction efficiency |
| Heavy metals Pb, As, Cd, Hg | ICP-MS or AAS; USP <730>, CP 2020 | Safety, premix, long-term feeding |
| Residual solvents | GC headspace per VICH GL18 / ICH Q3C | All routes, especially injections |
| Microbial limits | USP <61> and USP <62> or CP 2020 microbial chapters | Non-sterile oral and premix |
| Bacterial endotoxins | Limulus amebocyte lysate, USP <85> | Injections, solutions |
| Particle-size distribution | Laser diffraction, USP <429> | Tablets, capsules, granules, premixes |
For parenteral-grade material, bacterial endotoxin and bioburden are usually more stringent than for oral or premix grade. The CoA may distinguish an oral-grade powder from a parenteral-grade powder only by the endotoxin test and microbial limits; the chemical marker content may be identical. Purchasers should not substitute one grade for another without confirming all route-specific criteria. Residual solvents are of particular concern because extraction processes may use ethanol, methanol, or acetone at different stages. Headspace gas chromatography under VICH GL18 is used to quantify Class 1 and Class 2 solvents; Class 1 solvents are expected to be absent or below the method detection limit unless a specific regulatory justification exists.
The extract occupies an intermediate position between purified alkaloid fractions and unprocessed ground root. Against a purified matrine or oxymatrine salt, the powder offers a broader co-extractive profile but requires stricter moisture control, more complex analytical release, and higher filter loading. Against crude root powder, it provides controlled marker content, reduced microbial burden, and finer particle-size distribution suitable for pharmaceutical processing. The table below summarises the operational distinctions that affect route selection.
| Attribute | Chuangan Kushen Powder | Purified matrine / oxymatrine | Crude root powder |
|---|---|---|---|
| Composition | Standardised extract with co-extracted flavonoids, saponins, polysaccharides | Single chemical entity | Unprocessed plant matrix |
| Assay specificity | HPLC required; matrix peaks interfere with UV | HPLC or UV with high specificity | Variable; interference significant |
| Moisture handling | Hygroscopic; caking risk above 60% RH | Low hygroscopicity, crystalline | High hygroscopicity and biological burden |
| Particle size | Milled and sieved, CoA-specified | Controlled by crystallisation or micronisation | Uncontrolled, coarse |
| Microbial control | Tested per USP <61> and USP <62> or CP 2020 | Typically low bioburden | Requires treatment if used directly |
| Formulation routes | Tablets, injections, capsules, powders, granules, premix, solutions | Injectable or oral after dilution | Limited; mainly traditional powder or decoction |
The choice between the extract and a purified alkaloid also affects pharmacovigilance and residue depletion data. The extract may contain minor alkaloids and flavonoids with their own metabolic profiles; residue markers are selected on the basis of the administered product, not only matrine. For target-species dosing, the dosage of the extract is usually expressed as total matrine equivalents per kilogram body weight, but the actual administered mass is higher because of co-extractives. This distinction is critical for injectable formulations where the total dissolved solids affect osmolality and injection-site tolerability.
HPLC method validation for this type of product must demonstrate resolution of matrine and oxymatrine from adjacent matrix peaks, linearity over the expected assay range, and specificity against forced-degradation samples. The extraction solvent and sonication time influence alkaloid recovery from the dried powder; methanol-water or acidified water are common extraction media. Incomplete extraction can produce an apparent low assay, while excessive heat during sample preparation can convert oxymatrine to matrine or degrade the analytes.
Operational boundaries for storage and compounding must be respected. The powder is stored in a sealed container with desiccant at not more than 25°C and protected from light unless the CoA indicates otherwise. Exposure to relative humidity above 60% may cause agglomeration and is limited to short intervals during dispensing. Mixtures with strong oxidising agents may degrade the alkaloid fraction; combinations with tannin-rich plant extracts can form insoluble complexes and require evaluation before compounding. The material is not interchangeable with a pure matrine standard on a weight-to-weight basis unless the total alkaloid titre is recalculated. In parenteral compounding, the non-sterile supply is not suitable for direct injection without further sterilising-grade filtration or terminal sterilisation. Published stability data for this specific trade designation are limited; batch-specific real-time data from the manufacturer or a designated contract laboratory govern shelf-life and re-test dating.
