| HS Code | 777910 |
| Product Name | Maxingshigan Powder Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions |
| Api Nature | Standardized traditional Chinese medicine veterinary active pharmaceutical ingredient powder |
| Appearance | Fine yellowish-brown to brown powder with characteristic herbal odor |
| Active Components | Ephedrine-type alkaloids, amygdalin, glycyrrhizin, calcium sulfate, and other herbal constituents |
| Solubility | Partially soluble in water with sedimentation; suitable for suspension preparations |
| Particle Size | At least 95% passing through an 80-mesh sieve |
| Heavy Metal Content | Complies with veterinary pharmacopoeia limits for lead, arsenic, cadmium, and mercury |
| Microbial Purity | Complies with veterinary pharmacopoeia microbial limit standards |
| Functional Indication Support | Provides respiratory-regulating, anti-inflammatory, antipyretic, and cough-relieving actions for veterinary use |
| Applicable Dosage Forms | Tablets, injections, capsules, powders, granules, premix, and solutions |
| Target Animal Classes | Suitable for poultry, swine, cattle, sheep, and goats depending on final formulation and veterinary supervision |
| Storage Conditions | Store in a cool, dry, well-ventilated area, protected from light and moisture, in tightly sealed containers |
| Shelf Life | 24 months when stored under proper conditions |
| Packaging Specification | Double polyethylene-lined fiber drums or sealed moisture-resistant containers with net weight options such as 25 kg |
| Quality Compliance | Suitable for use as a veterinary-grade API in approved manufacturing processes |
As an accredited Maxingshigan 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.
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In farrow-to-finish operations where porcine respiratory disease complex management separates antibiotic-reduction programs from emergency metaphylaxis, dry incorporation of Maxingshigan Powder into a carrier premix is executed as a post-grinding micro-dosing step rather than a pre-conditioner blend. The complete feed inclusion is commonly set at 1 kg to 3 kg per tonne, equivalent to 0.1%–0.3% w/w dry matter; an intermediate premix at 100–300 g/kg is diluted on-farm or in a feed mill at a ratio of 1:200 using rice husk, ground corncob, or calcium carbonate carriers. The applicable compliance references are the Maxingshigan San monograph of the Chinese Veterinary Pharmacopoeia 2020, the hygiene limits of GB 13078-2017 for complete feed, and a feed-safety management system structured under ISO 22000:2018. Mixing is performed in a twin-ribbon mixer with a 300 kg batch size, using a 2-minute carrier premix stage followed by a 12-minute dry mixing stage, after which ten sampling points must show a coefficient of variation below 5% according to GB/T 5918-2008. Because the powder contains calcium sulfate dihydrate from gypsum and fibrous particles from Glycyrrhiza uralensis, mesh retention may drift between lots; a 60-mesh inline sieve is therefore placed ahead of the micro-dosing unit. Pelleted feeds expose the powder to 70–85°C steam conditioning for 30–60 seconds; published ephedrine retention data for this exact formula under high-temperature pelleting is limited, so the preferred process places the powder after pelleting via liquid spray or dry top-dress to avoid thermal volatilization of ephedrine alkaloids. Terminal product types include complete meal feed, 3–5 mm pelleted grower feed, and 0.5% top-dress concentrates for feed mill output.
Broiler integration chains that need mass medication through drinking water require water-soluble granules with rapid dissolution and no insoluble residues that blind nipple drinker seals. The standard addition ratio is 0.5–1.0 g/L drinking water for 5–7 days; the granule is first diluted 1:10 in lukewarm water at 25–35°C to form a stock solution before entering a medicator set at 1% or 2% injection rate. Compliance for the finished granule is documented against the granule monograph of the Chinese Veterinary Pharmacopoeia 2020, with dissolution time ≤3 min at 25°C, moisture ≤5.0%, and total aerobic microbial count ≤10³ CFU/g. Downstream production uses a high-shear mixer-granulator charged with Maxingshigan Powder and a 5% polyvinylpyrrolidone K30 binder solution, followed by fluidized-bed drying at an inlet temperature of 45–60°C; the drying set point must be controlled within ±5°C because lower temperatures raise residual moisture and higher temperatures cause binder migration to the granule surface. The dried granule is passed through a 20–60 mesh oscillating sieving machine and then through a 100 µm in-line filter before packaging. Water pH above 8.5 or carbonate-hard water causes calcium sulfate precipitation and reduces filterability in nipple drinker lines; therefore the dilution water should be acidified to pH 4.5–6.0 before stock solution preparation. Terminal product types include 100 g and 500 g water-soluble granules, soluble powder sachets, and dosing-pump-ready solution concentrates.
Ovine and caprine oral drench suspensions differ from feed premixes because the product must remain homogeneous in a high-viscosity vehicle without settling during storage at 2–30°C. A 10% w/v suspension is prepared by dispersing micronized Maxingshigan Powder with a particle size D90 ≤75 µm into purified water containing 0.5% sodium carboxymethylcellulose and 0.1% sodium benzoate. The addition ratio in the final drench is 100 g/L; the dosing regimen is 1 mL per 5 kg bodyweight twice daily for 3–5 days. Compliance is assessed against the oral suspension monograph of the Chinese Veterinary Pharmacopoeia 2020, with pH 4.5–6.0, lead ≤20 mg/kg, and arsenic ≤2 mg/kg. Production equipment includes a high-shear colloid mill or an inline homogenizer operating at 3000 rpm for 20 minutes, followed by vacuum degassing and filling into 500 mL high-density polyethylene bottles with dial-a-dose closures. Because the powder has a high sulfate ash fraction, continuous recirculation during filling is required to prevent nozzle blockage; batch-to-batch variations in sedimentation volume have been observed when the particle size drifts above 100 µm, and a post-milling laser diffraction check is therefore mandatory. Terminal product types include oral drench suspension, oral paste in 60 mL adjustable-dose syringes, and bulk 5 L drench packs for automated sheep handlers.
The conversion of Maxingshigan Powder into a terminally sterilized injectable requires removing both insoluble gypsum particles and pyrogenic cell wall material from the botanical source. This is not a direct dissolution of the powder; a water decoction is first produced at a drug-to-water ratio of 1:8, boiled at 100°C for 2 hours, then concentrated under vacuum at 60–70°C to a crude extract equivalent of 1 g raw material per 1 mL. The liquid is ethanol-precipitated to remove high-molecular-weight polysaccharides, allowed to settle at 2–8°C for 24 hours, and then treated with 0.15% activated carbon at 60°C for 30 minutes for pyrogen adsorption. Compliance requirements for the finished injectable include the injections monograph of the Chinese Veterinary Pharmacopoeia 2020, sterility testing according to the pharmacopoeial sterility method, and bacterial endotoxin below 0.5 EU/mg or 0.5 EU/mL based on the maximum dose. Because calcium sulfate dihydrate in the feedstock causes rapid blinding of a single sterilizing filter, the cascade must use a 0.45 µm polyethersulfone prefilter followed by a 0.2 µm sterilizing polyethersulfone membrane; flux and filterability trials are batch-specific, and published data for this exact high-gypsum decoction is limited. The pH is adjusted to 4.5–6.0 with dilute hydrochloric acid, and carbonate buffers are avoided because calcium carbonate precipitation may clog the sterilizing filter. The solution is aseptically filled into depyrogenated 10 mL glass vials and autoclaved at 121°C for 15 minutes; ephedrine hydrochloride assay is performed after terminal sterilization to confirm stability. Terminal product types include 10 mL injectable solutions for intramuscular use in swine and 50 mL multidose vials where national marketing authorizations permit such presentations.
Direct compression of a multicomponent botanical powder with a high sulfate ash fraction is not feasible without granulation because the gypsum-containing material has poor flow and high die-filling variability. A 650 mg tablet core containing 300 mg Maxingshigan Powder is prepared by wet granulation with 3% polyvinylpyrrolidone K30 in isopropyl alcohol, followed by tray drying at 50°C for 3 hours and dry screening through a 20-mesh sieve. The external phase includes microcrystalline cellulose PH102 at 36%, croscarmellose sodium at 10%, and magnesium stearate at 1%; the addition ratio for the botanical powder in the final tablet is therefore 46% w/w based on core weight. Compression is performed on a 16-station rotary tablet press at 12–18 kN, with target hardness between 60 N and 90 N and friability below 0.8% according to USP <1216>. Finished tablets comply with USP <701> disintegration at ≤15 min in 0.1 M hydrochloric acid, and residual solvent levels are evaluated under ICH Q3C or VICH GL18(R) for isopropyl alcohol. Capsule filling of the same granulate into size 0 hard gelatin capsules uses a dosator-type capsule filler with a target fill weight of 420 mg. Terminal product types include uncoated botanical tablets, hard gelatin capsules, and capsule-in-bottle veterinary pack-outs for companion animal and equine respiratory support where national compounding rules allow. For alkaline tablet matrices or enteric coating systems, the formulator should verify ephedrine release because the alkaloid ionizes differently above pH 8.0; dissolution data for this specific formulation is limited and should be generated batch by batch.
Layer operations with deep-pit manure systems sometimes use top-dress granules when aerial ammonia exceeds 25 ppm and mechanical ventilation alone cannot maintain acceptable respiratory conditions. The granules contain 80–120 g/kg Maxingshigan Powder and are applied at 1.5–2.0 kg per tonne of complete feed for 5–7 days, mixed with a small amount of soybean oil to reduce segregation. Compliance for the carrier premix references the Maxingshigan San monograph of the Chinese Veterinary Pharmacopoeia 2020 and the mycotoxin and heavy metal limits of GB 13078-2017; because ephedrine-containing botanicals carry species-specific residue considerations, the withdrawal period must be taken from the exporting country’s veterinary drug registration and importing country’s residue control rules where applicable. The production process uses dry roller compaction to form granules in the 0.8–1.4 mm range, followed by size classification, 2% w/w soybean oil coating in a ribbon or paddle coater, and low-speed auger filling into 25 kg multiwall paper bags. Terminal product types include top-dress granules, vitamin-mineral premix blends, and mash feed surface applications for layer barn feed lines.
| Dosage form | Standard designation | Parameter | Acceptance criterion |
|---|---|---|---|
| Feed premix | CVP 2020 Maxingshigan San monograph | Ephedrine HCl content | 90.0%–110.0% of label claim |
| Water-soluble granule | CVP 2020 granule monograph | Dissolution in water | ≤3 min at 25°C |
| Oral drench suspension | CVP 2020 oral suspension monograph | pH | 4.5–6.0 |
| Injectable solution | CVP 2020 injection monograph | Bacterial endotoxin | <0.5 EU/mg |
| Tablet | USP <701> | Disintegration | ≤15 min |
| Layer top-dress granule | GB 13078-2017 | Aflatoxin B1 | ≤10 µg/kg |
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Maxingshigan Powder Veterinary Grade API is a standardized multi-marker botanical extract produced from the four-component traditional Chinese veterinary formula Ephedra herba, Prunus armeniaca semen, Gypsum fibrosum, and Glycyrrhiza uralensis radix. The product is released in two mill grades: MST-VAPI-P80 for oral solid dosage forms, premixes, and granules, and MST-VAPI-M45 for liquid and injectable process development. The P80 grade is controlled through an 80-mesh screen equivalent to a nominal aperture of 180 μm; the M45 grade is micronized to a laser-diffraction D90 of ≤45 μm. The extract is not a simple herb powder. It is manufactured by closed-tank decoction using 10 volumes of purified water at 95 °C for 2 h, followed by rising-film concentration at 65 °C under −0.07 MPa vacuum and spray drying with inlet air at 170 °C and outlet air at 85 °C. The marker compounds ephedrine hydrochloride, pseudoephedrine hydrochloride, amygdalin, and glycyrrhizic acid are quantified by high-performance liquid chromatography; total ephedrine alkaloids are calculated as ephedrine hydrochloride. This quantified composition differentiates the product from raw botanical powders and from single-entity synthetic ephedrine hydrochloride APIs.
Raw botanical lots are identified by macroscopic and thin-layer chromatography comparison against authenticated reference materials. Ephedra herba is assayed before extraction for total alkaloid content, and bitter apricot kernel is tested for amygdalin. Extraction water is purified to 0.5 μS/cm conductivity and preheated to 80 °C before charging to reduce thermal shock. The decoction is filtered through 10 μm and 1 μm cartridge filters before evaporation. The spray-dried intermediate is sieved and blended in 200 kg sublots to minimize marker content variation. Batch release requires marker content within the specified ranges and a chromatographic fingerprint similarity index of not less than 0.95 against a reference chromatogram calculated by the HPLC data system. This fingerprint criterion provides consistency across extraction campaigns; it is not a clinical efficacy threshold.
Because the extract contains ephedrine alkaloids, the regulatory status of MST-VAPI-P80 and MST-VAPI-M45 varies by jurisdiction, and handling may be subject to controlled substance or chemical precursor regulations in certain markets. The product is supplied as an active pharmaceutical ingredient for veterinary compounding and licensed veterinary pharmaceutical manufacturing; it is not approved as a feed additive in all jurisdictions, and residue withdrawal periods for food-producing animals must be established by the responsible marketing authorization holder. Published residue depletion data for this specific standardized extract is limited across target species; therefore direct extrapolation from isolated ephedrine pharmacokinetics is not appropriate for withdrawal calculations.
Specifications are split by particle size and microbial burden. The P80 grade is released for non-sterile oral and premix applications; the M45 grade carries an additional endotoxin limit for parenteral process development. Each lot is tested against marker content by high-performance liquid chromatography using photodiode-array detection according to ChP 2020 General Chapter 0512. Loss on drying is determined by ChP 2020 General Chapter 0831, and non-sterile microbial limits follow ChP 2020 General Chapter 1105, 1106, and 1107. Heavy metals are measured by compendial atomic absorption or inductively coupled plasma-mass spectrometry; the acceptance limits in Table 1 are release criteria, not toxicological safety limits in the target species.
| Parameter | MST-VAPI-P80 | MST-VAPI-M45 | Method |
|---|---|---|---|
| Appearance | Brown-yellow fine powder | Brown-yellow micronized powder | Visual, controlled lighting |
| Particle size | ≥95% through 80-mesh (180 μm) | D90 ≤45 μm | ChP sieving / ISO 13320:2020 |
| Loss on drying | ≤5.0% | ≤5.0% | ChP 2020 0831 |
| Total ephedrine alkaloids | 12.0–16.0 mg/g | 12.0–16.0 mg/g | HPLC, ChP 2020 0512 |
| Amygdalin | 8.0–12.0 mg/g | 8.0–12.0 mg/g | HPLC, ChP 2020 0512 |
| Glycyrrhizic acid | 6.0–9.0 mg/g | 6.0–9.0 mg/g | HPLC, ChP 2020 0512 |
| Total aerobic microbial count | ≤103 CFU/g | ≤102 CFU/g | ChP 2020 1105 |
| Molds and yeasts | ≤102 CFU/g | ≤102 CFU/g | ChP 2020 1105 |
| Endotoxin | Not specified | ≤0.5 EU/mg | ChP 2020 1143 |
| Lead | ≤5 mg/kg | ≤5 mg/kg | ICP-MS |
| Arsenic | ≤2 mg/kg | ≤2 mg/kg | ICP-MS |
| Cadmium | ≤1 mg/kg | ≤1 mg/kg | ICP-MS |
| Mercury | ≤0.2 mg/kg | ≤0.2 mg/kg | ICP-MS |
The HPLC procedure uses a 250 mm × 4.6 mm, 5 μm octadecylsilane column maintained at 30 °C. Mobile phase A is 0.1% phosphoric acid adjusted to pH 3.0 with triethylamine; mobile phase B is acetonitrile. The gradient runs from 5% B to 40% B over 35 min at 1.0 mL/min. Detection is set at 210 nm for ephedrine alkaloids and 220 nm for amygdalin and glycyrrhizic acid. System suitability requires resolution between ephedrine hydrochloride and pseudoephedrine hydrochloride of not less than 1.5, tailing factor not more than 2.0, and replicate injection relative standard deviation not more than 2.0%. These performance limits are compendial-aligned but are release-method controls, not species-level efficacy data.
Moisture sorption at 25 °C is a critical process parameter. At 60% relative humidity the equilibrium moisture content is approximately 5.0%; at 75% relative humidity the powder reaches approximately 7.0% within 24 h. This hygroscopicity affects flow and tablet quality. Therefore, before dry blending or dry granulation, the API is pre-dried in a vacuum tray dryer at 45 °C and −0.08 MPa for 4 h when ambient storage has exceeded 60% relative humidity for more than 12 h. Failure to pre-dry causes picking and sticking on the rotary press and raises the Carr index from the release range of 18–22 to above 30.
For tablet manufacture, the P80 grade is dry-blended in a 600 L ribbon blender at 12 rpm for 15 min. Blend uniformity is tested at 10 sampling points by HPLC; the relative standard deviation for total ephedrine alkaloids must be ≤5.0%. When wet granulation is required, a top-spray fluid-bed granulator is used with inlet air at 55–65 °C and product temperature below 45 °C to limit volatilization of ephedrine alkaloids. Granules are milled through a 20-mesh screen and lubricated with 0.5% magnesium stearate and 1.0% colloidal silicon dioxide. Compression on a 16-station rotary tablet press at 10–18 kN produced tablets with hardness 60–90 N and friability ≤1.0% when measured according to ChP 2020 General Chapter 0923. The higher hygroscopicity of glycyrrhizic acid requires controlled humidity below 50% RH in the compression suite.
Capsules are filled with the same dry-blended P80 formulation after passing through a 30-mesh screen. The target fill weight is adjusted for tap density of 0.60–0.70 g/cm³. Weight variation across 20 capsules must not exceed 5.0%. Because the powder contains botanical extractives that can char at high compression, capsule filling is preferred over tableting when the API dose exceeds 500 mg per unit.
The M45 grade is not a sterile API and is not directly injectable. For injectable solution development, the powder is hydrated in Water for Injection at 25 °C to a concentration of 10 g/L. The resulting dispersion has a pH of 4.8–5.6. It is clarified through a 0.45 μm polyethersulfone prefilter followed by a 0.22 μm sterilizing filter. Throughput depends on maintaining D90 ≤45 μm; excursions beyond this particle size reduce flux and increase transmembrane pressure above 1.0 bar in small-scale filter-integrity tests. The endotoxin limit of ≤0.5 EU/mg is tested by ChP 2020 General Chapter 1143. The extract must not be exposed to pH above 8.0 or oxidizing agents because ephedrine alkaloids degrade to benzaldehyde-related byproducts under alkaline oxidative conditions. Aqueous solutions are stored at 2–8 °C in amber borosilicate glass; published stability data beyond 72 h in unopened containers is limited, so the solution is considered short-use in process development.
For dry powders and premixes, the P80 grade is diluted by two-stage geometric blending with glucose monohydrate or calcium carbonate carrier. A 100 kg batch achieves label-claim uniformity with relative standard deviation ≤5.0% after 20 min in a 600 L ribbon blender at 12 rpm. Granules are produced by wet granulation using a 5% aqueous polyvinylpyrrolidone K30 binder solution; drying is performed in a fluid-bed dryer at inlet air 60 °C until loss on drying is ≤3.0%. For drinking-water solutions, the API is first pasted with 1:5 warm water at 35 °C to break agglomerates, then diluted to the final volume with continuous stirring. The 180 μm P80 screen limit prevents large botanical fragments from blocking poultry nipple drinkers; this differentiates the product from unstandardized raw herb powders that retain stems and fibrous particles above 500 μm.
The most important difference is that the product is neither a single synthetic alkaloid nor a crude herb powder. The ephedrine alkaloid content is only 12.0–16.0 mg/g, while the extract simultaneously contains 8.0–12.0 mg/g amygdalin and 6.0–9.0 mg/g glycyrrhizic acid. Therefore the milligram dosing of total ephedrine alkaloids does not define the entire pharmacological profile, and direct substitution for ephedrine hydrochloride on a mass basis is not valid. Synthetic ephedrine hydrochloride is a defined crystalline material assayed by acid-base titration; raw herbal powder is dependent on harvest season, plant part, drying method, and storage. The Maxingshigan API is released against HPLC marker content, heavy metal limits, microbial limits, and particle size. It is also not equivalent to isolated expectorant APIs such as bromhexine hydrochloride or ambroxol hydrochloride because it contains multiple botanical constituents; the species-specific residue depletion kinetics of these constituents are not fully published for every target animal, so withdrawal periods cannot be transferred from single-entity products.
| Attribute | Maxingshigan Powder API | Isolated ephedrine HCl | Raw herbal powder |
|---|---|---|---|
| Active marker control | HPLC-quantified total ephedrine alkaloids, amygdalin, glycyrrhizic acid | Assay by acid-base titration per pharmacopoeia | Often gross weight only; marker variation with harvest season |
| Particle size | 180 μm or D90 ≤45 μm release grades | Not applicable; crystalline API | Variable; often >500 μm botanical fragments |
| Microbial control | ≤103 CFU/g P80; ≤102 CFU/g M45 | Controlled as synthetic chemical API | May carry field microbial burden and pesticide residues |
| Dose equivalence | Not directly equivalent to ephedrine HCl on a milligram basis | Defined ephedrine HCl content | Not standardized; cannot be used for precise dosing |
| Sterile liquid use | M45 grade after 0.22 μm filtration and endotoxin control | Dissolves directly after pH adjustment | Unsuitable without extensive clarification |
Processing equipment should use stainless steel 316L contact surfaces because the extract slurry at pH 4.8–5.6 can corrode carbon steel over holding times longer than 8 h. The extract must not be mixed with amine-based solvent systems that can form reactive imine intermediates with residual amygdalin degradation products. Containers must be sealed under nitrogen and stored at 15–25 °C in a dry area; shelf life is assigned only after real-time stability data are generated for the specific bulk packaging configuration.
