| HS Code | 392020 |
| Api Name | Baitouweng Oral Solution Veterinary Grade API |
| Source Plant | Pulsatilla chinensis (Baitouweng root) |
| Api Form | Concentrated oral solution suited for downstream formulation |
| Active Constituents | Anemoside B4, anemoside A3, pulchinenoside-related saponins |
| Pharmacological Actions | Anti-inflammatory, antibacterial, antipyretic, antidysenteric, immunomodulatory |
| Veterinary Indications | Bacterial enteritis, diarrhea, dysentery, bloody stools, and toxic-heat intestinal infections |
| Target Species | Poultry, swine, cattle, sheep, goats, and rabbits |
| Compatible Dosage Forms | Tablets, injections, capsules, powders, granules, premixes, and oral solutions |
| Solubility | Soluble in aqueous ethanol systems; miscible with water for liquid formulation |
| Stability | Stable under recommended sealed storage conditions; protect from light and moisture |
| Quality Grade | Veterinary-grade active pharmaceutical ingredient for animal drug manufacturing |
| Standard Reference | Conforms to veterinary pharmacopoeia requirements for botanical raw material extracts |
As an accredited Baitouweng Oral Solution 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 | Packaged in sealed, light-resistant containers with tamper-evident closures, ensuring stability and purity. Quantity: 1 kg per drum for veterinary pharmaceutical manufacturing. |
| Container Loading (20′ FCL) | One 20-foot FCL container securely loads Baitouweng Oral Solution veterinary-grade API, ensuring safe transport for pharmaceutical manufacturing. |
| Shipping | Baitouweng Oral Solution (Veterinary Grade API) is shipped in sealed, light-protected containers to preserve stability. Transport via temperature-controlled courier, avoiding extreme heat or freezing. Includes tamper-evident packaging, detailed SDS, and traceable documentation. Ensure dry, ventilated storage during transit to maintain purity and efficacy for downstream formulation. |
| Storage | Store in a cool, dry, well-ventilated area between 2–8°C or as specified. Keep container tightly sealed, protected from light and moisture. Avoid exposure to heat, strong oxidizers, and incompatible substances. Use clean, dry equipment to prevent contamination. Retain in original packaging until use. |
| Shelf Life | Shelf Life: 24 months from manufacture date in unopened, tightly sealed containers, stored below 25°C, protected from light and moisture. |
Wet granulation of the saponin-rich extract is avoided in production-scale tablet lines because the raw API foams under aqueous binder addition and the wet mass exhibits pronounced sticking to stainless steel surfaces. Dry granulation by roller compaction is the preferred route. The API is pre-blended with microcrystalline cellulose, anhydrous dibasic calcium phosphate, crospovidone, and colloidal silicon dioxide for 20 min in a 600 L bin blender at 15 rpm. The blend is compacted on a roller compactor fitted with a 0.8 mm knurled roll surface; roll pressure is qualified across 40 kN to 80 kN per supplier line, with target ribbon density between 1.15 g/cm³ and 1.35 g/cm³. Ribbons are milled through a 0.180 mm screen and re-blended with magnesium stearate at 0.5 wt% to 1.0 wt% for 5 min to avoid overlubrication. Tablets are compressed on a rotary tablet press with compression force from 8 kN to 15 kN, targeting hardness 70 N to 100 N and friability not more than 1.0% per USP <1216>. Disintegration is controlled to not more than 15 min in water at 37 °C per USP <701>, and content uniformity complies with USP <905> using 10 tablets. The core is film-coated with a hydroxypropyl methylcellulose system at 3.0% weight gain in a perforated pan at 4–8 rpm and inlet air 60 °C. The terminal product is an oral veterinary tablet for swine and calf dosing. Humidification of the dry granulation suite above 40% RH is controlled because the native extract reabsorbs ambient moisture and shifts ribbon density unpredictably.
| Component | Function | Range (wt%) | Control method |
|---|---|---|---|
| Baitouweng API standardized to pulsatilla saponins | Active | 20–40 | HPLC assay |
| Microcrystalline cellulose | Filler/dry binder | 30–50 | USP <905> |
| Anhydrous dibasic calcium phosphate | Filler | 15–25 | USP <905> |
| Crospovidone | Disintegrant | 3.0–5.0 | USP <701> |
| Colloidal silicon dioxide | Glidant/anti-caking | 0.5–2.0 | USP <786> |
| Magnesium stearate | Lubricant | 0.5–1.0 | USP <905> |
In medicated feed premix production, the API is adsorbed onto porous carriers to create a free-flowing intermediate. Rice husk, corn cob meal, calcium carbonate, and colloidal silica are common carrier systems. The carrier is pre-dried to water activity below 0.6 and particle size between 0.300 mm and 0.850 mm. The API is sprayed or tumbled into the carrier in a ribbon blender fitted with a spray bar at 15–20 rpm for 10–15 min. Blend uniformity is confirmed by taking 10 samples per ISO 6497 and accepting a coefficient of variation below 5.0%. Where carrier moisture exceeds 12%, capillary condensation inside the porous rice husk creates localized high-water zones that hydrolyse the ester-linked saponin and increase mold risk. Segregation also becomes non-linear because wet carrier particles bridge and then collapse during bin discharge. Colloidal silica at 0.5–2.0 wt% is required to reduce electrostatic adhesion and improve mass flow in silo hoppers. The terminal product is a concentrated medicated premix, typically incorporated into final feed at 1.0–10.0 kg/tonne depending on veterinary prescription and final feed formulation, though published data for this specific extract in different feed matrices is limited. Carryover control follows Regulation (EU) 2019/4, and validated cleaning sequences must demonstrate residues below the accepted carryover limit. Dedicated lines are preferred because lipophilic saponin residues adhere to stainless steel. Avoid direct combination with acidogenic mineral premixes containing high free acid because local pH below 3.0 at the particle surface accelerates aglycone cleavage.
Low-dose encapsulation of Baitouweng oral solution API requires particle-size reduction and moisture protection before filling. The dried extract is sieved through a 0.150 mm screen and pre-blended with lactose monohydrate and croscarmellose sodium in a 300 L V-blender at 25 rpm for 20 min. Magnesium stearate is added at 0.5 wt% and blended for a further 3–5 min. The blend is filled into size 0 or size 1 hydroxypropyl methylcellulose capsules on a dosator-type capsule filling machine at 10,000 capsules/h. Weight variation is maintained below 2.0% RSD, and content uniformity complies with USP <905> using 10 capsules. Because the API is hygroscopic, encapsulation suites are conditioned to 35–40% RH, and desiccant canisters are inserted into high-density polyethylene bottles. Dissolution is measured in 900 mL of water at 37 °C with paddle speed 50 rpm per USP <711>; the release specification is species-specific and is established through target animal dosage form qualification, with an aqueous medium reference point of not less than 70% at 45 min where specified. The terminal product is an oral capsule for companion animal or piglet administration. Collapse of the capsule fill occurs if the moisture sorption of the native extract exceeds 5.0% at the point of filling; this is mitigated by pre-drying in a vacuum tray dryer at 40 °C and 0.08 MPa until Karl Fischer moisture is below 4.0%. Batch-to-batch variation in extract density requires adjustment of dosator pin height rather than fill weight alone to maintain capsule compaction below 0.85 g/mL tapped density.Top-spray fluid-bed granulation converts the non-flowing native extract into water-dispersible granules for oral dosing via drinking water or drench. A 5% w/v polyvinylpyrrolidone binder solution is sprayed onto the fluidized powder. Inlet air temperature is held at 60–70 °C, product temperature at 35–45 °C, atomizing air at 2.0–3.0 bar, and spray rate is adjusted so that product moisture remains below 3.0% during the entire run. Saponin extracts have a narrow thermal window. Product temperature excursions above 50 °C cause particle surface tack and agglomerate collapse, while below 30 °C insufficient droplet drying leads to over-wetting and defluidization. The resulting granules are sieved to 0.250–0.850 mm using a vibratory sieve stack per USP <786>. Fines below 0.180 mm are recycled into the next batch at not more than 15% of total charge to preserve granule strength. The terminal product is a water-dispersible granule filled into foil laminate sachets at 3.0 g to 500 g depending on target species. Dissolution of the granule in water at 25 °C is tested by visual dispersion and HPLC recovery. Published data for this specific granule formulation is limited, so in-house qualification batches bracket binder viscosity from 5 mPa·s to 20 mPa·s. Avoid adding polysorbate-based surfactants above 0.2% because saponin co-micellization can reduce the available free active fraction.
When the native extract moisture exceeds 5.0%, low-dose powder blends for oral solution reconstitution exhibit caking, uneven color distribution, and significant assay variance. The API is pre-dried in a vacuum shelf dryer at 40 °C and 0.08 MPa until Karl Fischer moisture is below 4.0%, then milled through a 0.180 mm screen. Dried extract is blended with dextrose monohydrate, sodium chloride, and citric acid in a 500 L ribbon blender at 20 rpm for 15 min. Uniformity is confirmed by sampling 10 locations and accepting a coefficient of variation below 5.0% by HPLC assay. The terminal product is a powder for oral solution, filled into polyethylene terephthalate/aluminum/polyethylene foil pouches with a desiccant sachet. The finished pouch is sealed at 150 °C jaw temperature and 0.4 MPa seal pressure, with seal integrity tested under −80 kPa vacuum. In multi-dose farm packs, repeated opening without desiccant can raise headspace relative humidity above 60% and reinitiate clumping. The formulation therefore includes colloidal silicon dioxide at 1.0–2.0 wt% as a moisture-scavenging flow aid. Blend segregation during silo discharge is controlled by installing mass-flow hoppers with wall angles above 70°; funnel flow patterns produce fines-rich and coarse-rich zones that deviate from the target dose. This powder is not intended for dry administration. Reconstitution in potable water at 1:1000 (w/v) converts the mixture into a drinkable solution for poultry or swine within 5 min under gentle stirring.
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Baitouweng Oral Solution Veterinary Grade API is a clarified multi-herb liquid extract supplied as an active pharmaceutical ingredient for finished veterinary dosage forms: oral solutions, premixes, powders, granules, tablets, capsules, and injectable intermediates after additional purification. The extract is prepared from Pulsatilla chinensis Bunge, Coptis chinensis Franch., Phellodendron chinense C.K.Schneid., and Fraxinus rhynchophylla Hance by aqueous-ethanolic extraction, vacuum concentration, and centrifugal clarification. The product retains triterpene saponins, protoberberine alkaloids, coumarins, and water-soluble polysaccharides; it is not reduced to a single-marker berberine isolate. The retained saponin and polysaccharide fractions control adsorption onto dry premix carriers and act as binding aids during wet granulation, which is an operational distinction from purified alkaloid streams.
Two standard commercial model designations are BTO-20 and BTO-35. BTO-20 is a lower total-solids concentrate for direct dilution in oral solutions and for low-viscosity granulation; BTO-35 is a higher total-solids concentrate for premix and powder lines where solvent input must be limited. The liquid is supplied preservative-free unless a preservative-compatibility variant is declared, because added preservatives such as benzyl alcohol, sorbic acid, or parabens can alter tablet hardness, feed-dilution stability, and preservative efficacy-test performance in the final product.
| Attribute | Measurement principle | BTO-20 limit | BTO-35 limit |
|---|---|---|---|
| Appearance | Visual inspection against white background | Dark amber to brown clear-to-slightly opalescent liquid | Dark brown viscous liquid |
| Total solids | Oven drying at 105 °C to constant mass | 18.0–22.0% w/v | 33.0–37.0% w/v |
| pH | Potentiometric at 25 °C | 4.5–6.0 | 4.5–6.0 |
| Relative density | Oscillating U-tube at 20 °C | 1.04–1.10 | 1.10–1.16 |
| Berberine hydrochloride | HPLC-UV, C18 column, 346 nm, reference-standard assay | ≥ 0.80 mg/mL | ≥ 1.40 mg/mL |
| Viscosity | Brookfield LVDV, spindle SC4-18, 60 min-1, 25 °C | 30–80 mPa·s | 50–150 mPa·s |
| Microbial enumeration | Ph. Eur. 5.1.4 | TAMC ≤ 103 CFU/mL, TYMC ≤ 102 CFU/mL | Same as BTO-20 |
The limits in Table 1 are manufacturer-defined release criteria, not harmonized compendial requirements. No single international monograph covers this exact multi-herb veterinary API; therefore, a lot-specific certificate of analysis should also include residual solvent by headspace gas chromatography, pesticide residues according to Ph. Eur. 2.8.13, and arsenic or heavy metals where required by the destination market. The extract-control strategy follows the principles of USP <565> Botanical Extracts and Ph. Eur. 5.1.4 for microbiological quality. Extract ratios should be expressed as dry extract equivalent, not raw herb equivalent, because water-ethanolic extraction increases alkaloid recovery but may reduce extraction of highly polar polysaccharides. Batch-to-batch viscosity variation is a recognised botanical API issue; the stated viscosity limits are necessary to prevent fixed pump and spray-nozzle settings from becoming unstable across lots.
Crude Pulsatilla chinensis root powder is not standardized by marker content or viscosity; its alkaloid and saponin levels vary with growing region, drying temperature, and comminution. The API is released with a dual control: quantitative HPLC of berberine hydrochloride for Coptis chinensis and Phellodendron chinense contributions, plus TLC identity for anemoside B4 and aesculin to confirm Pulsatilla chinensis and Fraxinus rhynchophylla respectively. Single-marker control would allow a subpotent Pulsatilla fraction to pass if the alkaloid contribution from Coptis and Phellodendron remained in range. The saponin fraction affects foaming, wetting, and precipitation in final solutions; therefore, its retention is an intended specification choice rather than a by-product.
The distinction from a single-alkaloid extract is equally important. A berberine hydrochloride stream lacks the native polysaccharide-saponin matrix and cannot reproduce the adsorption, granulation, and solution stability behaviour of the full extract. The oral-solution API therefore occupies an intermediate position: more standardized than crude botanicals, more complex than purified alkaloids, and requiring stricter processing controls than either.
For production-scale fluid-bed granulation lines, BTO-20 or BTO-35 is pre-warmed to 35 °C before spraying onto corncob meal, maltodextrin DE 10–15, or precipitated silica. Atomization air is typically 1.0–1.5 bar, and product temperature is maintained between 38 °C and 45 °C. If product temperature exceeds 45 °C, surface tacking causes defluidization and filter-bag blinding. If spray rate is too low, the saponin fraction may create foam, reducing nozzle performance. Lot viscosity above 150 mPa·s at 25 °C reduces peristaltic pump accuracy and should be compensated by dilution with 10–15% v/v deionized water rather than by increasing pump speed alone. For premix manufacture, diluted API is adsorbed at a liquid-to-carrier ratio of 8–12% v/v to limit moist clumping. Final blend uniformity is verified by HPLC assay of berberine hydrochloride at 10 sampling points; a commonly used acceptance criterion is RSD ≤ 5.0% for the active marker. Published data for this specific herbal extract configuration is limited, so these process windows are operational ranges rather than compendial limits.
Spray-dried intermediates for powders and hard capsules are prepared from BTO-20 or BTO-35 with maltodextrin DE 10–15 as carrier. Inlet temperature is 160–180 °C and outlet temperature is 75–85 °C; lower outlet temperatures produce residual moisture above 5.0% w/w, causing caking in low-density polyethylene liners. The dried intermediate is milled to D90 ≤ 250 μm by laser diffraction according to ISO 13320:2020, then blended with 0.5–1.0% w/w colloidal silicon dioxide to reduce segregation during capsule filling. Hard capsule filling is more tolerant than tablet compression because the dried extract intermediate has moderate hygroscopicity; however, storage at RH > 60% for more than 24 h increases moisture uptake and cap splitting.
Liquid BTO-20 can be used as a partial or sole granulating fluid in high-shear tablet manufacture, but the polysaccharide fraction increases wet-mass viscosity disproportionately above 20% w/v addition. In a vertical granulator with impeller speed 300 min-1 and chopper speed 1,500 min-1, the endpoint is more reproducibly controlled by torque rise of 0.5–1.0 N·m above dry-mix baseline than by fixed time. After drying at inlet 60 °C to moisture ≤ 4.0% w/w, the granules are milled and blended at ≤ 40% RH. No pre-drying of the input liquid is required for high-shear wet granulation, but direct compression of the liquid API is not technically feasible without the spray-dried intermediate described above. Tablet cores containing this API should be coated with a moisture-protective film if bulk storage exceeds 30 days at RH > 50%.
The traditional veterinary application of the four-herb combination is supportive management of damp-heat diarrhoea in swine and poultry. This API is not presented as a substitute for antimicrobial therapy in severe bacterial enteritis, and registration-specific indications must be confirmed in the target market. The formulator must reconcile the botanical origin of the API with target-species tolerability and withdrawal-period requirements, because residual solvent, toxic metal, and pesticide data all feed into the veterinary drug submission file.
The oral-solution API is not a sterile injectable grade. Direct use in parenteral preparations is outside specification because the liquid contains endotoxin background, polysaccharide-tannin aggregates, and filter-blinding particulates. Injectable development requires dilution and cold precipitation at 4–8 °C for 12–24 h, centrifugation, filtration through 0.45 μm and 0.22 μm membranes, and depyrogenation by tangential-flow filtration using a 10 kDa regenerated cellulose membrane. Final endotoxin content must be justified by dose and route under Ph. Eur. 2.6.14; sterility is confirmed by Ph. Eur. 2.6.1. The presence of saponins may cause haemolysis in parenteral use, so injectable formulations based on this API should include a saponin-removal or selective-extraction step rather than relying on filtration alone.
For oral solutions, BTO-20 is diluted with purified water at ratios typically between 1:10 v/v and 1:50 v/v, depending on the registered dose and target species. The pH is adjusted to 4.0–5.0 with citric acid monohydrate or sodium citrate. At pH ≥ 7.5, berberine-type alkaloids precipitate, producing turbidity and assay loss. Hard water with calcium plus magnesium above 200 mg/L should be replaced with deionized water or chelated to avoid polyphenol-metal complexes. Packaging must be light-protected HDPE or amber glass because the coumarin fraction is photolabile. Headspace oxygen should be minimized with inert-gas blanketing in bulk storage. The product is for veterinary use only and is not approved for human use.
