| HS Code | 287073 |
| Product Name | Maxingshigan Granules Veterinary Grade API |
| Physical Form | Dry granules prepared from concentrated herbal extract |
| Suitable Dosage Forms | Tablets, Injections, Capsules, Powders, Granules, Premix, Solutions |
| Appearance | Brown to yellowish-brown granular powder |
| Solubility | Soluble in water with slight sediment |
| Active Ingredients | Ephedra, bitter apricot seed, gypsum, and licorice extracts |
| Assay | Contains specified marker compounds within 90%-110% of labeled claim |
| Purity Profile | Heavy metals ≤10 ppm; total microbial count ≤1000 CFU/g; absence of E. coli and Salmonella |
| Storage Condition | Sealed, cool, and dry place |
As an accredited Maxingshigan Granules 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 broiler and layer operations where drinking water delivery is the only practical route during acute respiratory outbreaks, Maxingshigan Granules Veterinary Grade API is converted into a water-soluble granule intermediate rather than being dispensed as unformulated herbal powder. The granulation formulation is typically loaded at 20–40% w/w API on a carrier of maltodextrin or lactose monohydrate, with polyvinylpyrrolidone K30 as binder at 2–5% w/w; the final drinking water solution is prepared at 1.0–2.0 g/L for poultry. Compliance against the Chinese Veterinary Pharmacopoeia 2020 Maxingshigan Granules monograph and EU GMP Part II for active substances used as starting materials is required; where the finished granule is marketed as a veterinary medicinal product inside the EU, the dossier obligations of Directive 2001/82/EC apply. Production on a high-shear granulator with product temperature kept below 70°C and subsequent fluid-bed drying at inlet air 60–70°C yields a final moisture content below 3.0%, a water activity below 0.6 measured by dew-point hygrometer, and a particle size D90 below 500 µm. Release testing includes dissolution in water at 25°C, with not less than 80% dissolved within 30 min. Packaged forms include 100 g, 500 g, and 1 kg foil-lined pouches, with 5 kg high-barrier bulk containers for larger farm dosing pumps.
Swine feed mill batches receiving Maxingshigan Granules Veterinary Grade API as a medicated premix require step-dilution blending rather than direct addition to the final feed, because the API often carries fine particle fractions below 200 µm that segregate in free-flowing meal. The intermediate premix is blended at 10–20% w/w API on a lactose or corn starch carrier, and the final feed inclusion is controlled at 2.0–5.0 kg/t complete feed depending on the target species body weight range and the regional formulation license. Compliance requires EU Regulation 2019/4 for medicated feed where applicable, feed safety management under ISO 22000 at the mill, and GMP+ FSA for cross-border feed material traceability. Process specifications on a twin-shaft ribbon mixer of 3,000 kg capacity include a mixing time of 15–20 min, a coefficient of variation below 5% determined by marker assay against an ephedrine hydrochloride reference standard, and carrier particle size D50 of 100–150 µm to minimize electrostatic adhesion. After blending, the premix is passed through a 1.0 mm vibratory screen and checked with metal detection set at 2.0 mm ferrous and 2.5 mm non-ferrous sensitivity before packing. Terminal finished products are 1 kg, 5 kg, and 25 kg multi-wall paper bags with polyethylene liners; the premix is subsequently mixed into pelleted or meal feed at the farm or feed mill. Because ephedrine-type alkaloid markers can volatilize under high-moisture thermal processing, pellet conditioner temperatures above 80°C require marker retention validation; published data for this specific configuration is limited, so manufacturing trials should establish loss limits before commercial batches.
Formulators using 10 mm round flat-faced punches for large-animal tablets typically blend Maxingshigan Granules Veterinary Grade API at 30–60% w/w with microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. Tablet weight is set at 500 mg or 1,000 mg, giving an API load of 300–600 mg granular extract per unit. Compliance with the general tablet monograph of Chinese Veterinary Pharmacopoeia 2020 and in-process friability testing per USP <1216> is required for release. The dry blend is passed through a 0.85 mm mesh to de-lump the API before compression; if flowability measured by Carr index exceeds 30, wet granulation with 5% w/w polyvinylpyrrolidone K30 is substituted. Direct compression is feasible when the API’s moisture content is below 3.0% and the compression suite is maintained at 40–45% RH; otherwise the granulated extract becomes tacky on the die table. A rotary tablet press with forced feeder is operated at 20–40 rpm with pre-compression at 8–12 kN and main compression at 15–25 kN, targeting hardness 80–120 N, friability below 0.8%, and disintegration below 15 min in water at 37°C. Finished unit-dose presentations include 0.5 g and 1 g tablets in PVC/PVDC blister packs for oral dosing of cattle, horses, or pigs. Batch-to-batch variance in extract color and hygroscopicity requires that each API lot be tested for loss on drying before setting the final compression force.
Sterile filtration of Maxingshigan Granules Veterinary Grade API solutions containing unhydrolyzed polysaccharides and residual plant colloids introduces a narrower processing window than non-sterile oral liquids, because membrane loading capacity falls sharply if the solution is not pre-clarified. The injectable solution is prepared at 10–20% w/v extract solids in Water for Injection, adjusted to pH 5.5–7.0 with dilute hydrochloric acid or sodium hydroxide, and held under chilled conditions before filtration. Compliance is driven by EU GMP Annex 1 for sterile medicinal products, the bacterial endotoxin limits of USP <85>, the general injection monograph of Chinese Veterinary Pharmacopoeia 2020, and residual solvent controls under VICH GL18(R2). The production sequence uses 0.1% w/v activated carbon at 60°C for 30 min to remove pyrogens and pigments, followed by bioburden monitoring below 10 CFU/100 mL and sequential filtration through 0.45 µm and 0.22 µm polyethersulfone membranes before aseptic filling into amber borosilicate vials under nitrogen. Finished dosage forms are 10 mL, 20 mL, and 50 mL vials with bromobutyl rubber stoppers. Terminal steam sterilization at 121°C for 15 min may precipitate heat-sensitive polysaccharide components and should be evaluated lot by lot; because published data for this specific configuration is limited, aseptic filtration is preferred over terminal sterilization in most downstream transfer dossiers.
Aqueous oral drench systems with 20% (w/v) extract solids are formulated for pre-ruminant calves and lambs, where dose titration by body weight is required on individual animals. The formulation addition ratio is 200 g/L of Maxingshigan Granules Veterinary Grade API, dissolved or dispersed in purified water with a non-reducing sugar carrier such as sorbitol at 10–15% w/v to reduce metallic aftertaste. The general oral solution monograph of Chinese Veterinary Pharmacopoeia 2020 governs release, while antimicrobial effectiveness testing follows USP <51>. Production in a high-shear mixing vessel at 1,200–1,500 rpm ensures full hydration of the granulated extract; pH is adjusted with citric acid to 3.5–4.5, followed by pasteurization at 90–95°C for 30 min and hot-fill into high-density polyethylene bottles. Filled bottles are induction-sealed and torque-tested at 1.5–2.0 N·m for cap integrity. Packaged configurations are 100 mL, 250 mL, and 1 L HDPE dosing bottles fitted with graduated polypropylene measuring cups. The lower pH boundary is critical because prolonged exposure below 3.5 can hydrolyze glycosidic components, whereas pH above 4.5 increases the risk of yeast and mold proliferation in sugar-containing drenches.
Before encapsulation, the granulated Maxingshigan Granules Veterinary Grade API is dry-milled and screened to a particle size range of 350–800 µm, because larger particles cause low fill weight uniformity in automated capsule filling equipment. Canine and feline respiratory dosage forms use the API at 300–400 mg per size 1 hard capsule, with the remaining 100–200 mg of fill consisting of lactose monohydrate and microcrystalline cellulose; total fill weight is maintained at 450–550 mg. Compression of the dry blend through a roller compactor at 20–30 kN roll force brings bulk density to 0.55–0.65 g/mL, preventing volumetric fill variation above ±5% during continuous encapsulation. The general capsule monograph of Chinese Veterinary Pharmacopoeia 2020 and weight variation testing per USP <1217> are the main release standards. Encapsulation is carried out at 25°C and 45% RH using a continuous capsule filling machine with dosing chamber vacuum; pre-drying of the granulated API at 60°C for 4 h is required when ambient relative humidity exceeds 60%. Final capsule presentations include 0.3 g and 0.5 g hard gelatin or hydroxypropyl methylcellulose capsules, packed in PVC/PVDC blister strips containing a silica gel desiccant pouch. Substitution of gelatin with hydroxypropyl methylcellulose is recommended for export markets with tropical storage conditions, because the API’s residual hygroscopicity can soften gelatin shells at dew points above 28°C.
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Maxingshigan Granules Veterinary Grade API for Tablets / Injections / Capsules / Powders / Granules / Premix / Solutions is a standardized, granulated dry extract intermediate derived from the fixed combination of Ephedrae Herba, Armeniacae Semen Amarum, Gypsum Fibrosum, and Glycyrrhizae Radix et Rhizoma. The product is released under the model code MXSG-VG-100 for standard oral and premix applications, with a low-endotoxin subset designated MXSG-VG-100I for parenteral compounding. It is not a simple pulverized herb blend; the granulated matrix is manufactured by aqueous-alcoholic extraction, concentration, and fluid-bed granulation to achieve a defined marker profile. The free-flowing granule has a bulk density of 0.45–0.65 g/mL, a tapped density of 0.55–0.78 g/mL, and a particle size distribution in which ≥90% passes 850 µm and ≤30% passes 150 µm as measured by USP <786>. The release marker content is 4.5–6.5 mg/g combined ephedrine hydrochloride and pseudoephedrine hydrochloride, 2.0–3.5 mg/g amygdalin, and 3.0–5.0 mg/g glycyrrhizic acid on an as-is basis. The veterinary-grade designation imposes additional controls for Salmonella, Escherichia coli, heavy metals, and bacterial endotoxins that are not uniformly applied to non-pharmaceutical botanical powders. The standard granule is suitable for subsequent manufacture of tablets, hard gelatin capsules, oral powders, reconstitutable granules, medicated premixes, oral solutions, and, in the low-endotoxin subset, injectable solutions after aseptic filtration.
The release specification matrix for MXSG-VG-100 covers the following pharmacopoeial and ISO-derived criteria.
| Parameter | Acceptance criterion | Reference method |
| Identification | Positive TLC for ephedrine, pseudoephedrine and amygdalin; HPLC retention times agree with reference standards | CPV 2020 |
| Loss on drying | ≤5.0% w/w | USP <731> |
| Bulk density | 0.45–0.65 g/mL | USP <616> Method I |
| Tapped density | 0.55–0.78 g/mL | USP <616> Method I |
| Particle size distribution | ≥90% through 850 µm; ≤30% through 150 µm | USP <786> |
| pH of 10 g/L dispersion | 4.0–6.5 | USP <791> |
| Heavy metals | ≤20 ppm total; ≤2 ppm As; ≤1 ppm Cd; ≤5 ppm Pb | USP <233> |
| Aerobic microbial count | ≤10³ CFU/g | USP <61> |
| Yeast and mould count | ≤10² CFU/g | USP <61> |
| Escherichia coli | Absent in 1 g | USP <62> |
| Salmonella | Absent in 10 g | USP <62> |
| Bacterial endotoxins, injection subset | ≤0.25 EU/mg | USP <85> |
| Residual ethanol | ≤500 ppm | USP <467> |
Batch production uses vacuum concentration at ≤70 °C to avoid marker degradation and is followed by fluid-bed spray granulation onto a pharmaceutical-grade carrier consisting of maltodextrin and 1.0% w/w colloidal silicon dioxide. The resulting granules have an intra-granular porosity sufficient to yield a Hausner ratio of 1.15–1.25 and a water activity of 0.35–0.45. These values are relevant for transfer and storage because a water activity above 0.60 accelerates microbial proliferation and causes extract-derived fructose and sucrose components to soften the granule surface. Multi-marker standardization is performed by high-performance liquid chromatography on blended liquid extract before granulation, and again on the finished granule after drying. Acceptance windows are deliberately wider than single-marker botanical extracts because Ephedrae Herba contributes both ephedrine and pseudoephedrine, while bitter apricot seed contributes the cyanogenic glycoside amygdalin. The ratio of ephedrine hydrochloride to pseudoephedrine hydrochloride is monitored at 1.0–2.5:1; a ratio outside this range indicates preferential extraction or storage degradation rather than a simple assay shift. Residual water is controlled to ≤5.0% w/w because higher moisture increases tablet sticking and reduces the flowability of premix blends.
The granulation carrier is added at 10–20% w/w relative to dry extract solids and consists of maltodextrin DE 10–15 with 1.0% w/w colloidal silicon dioxide. This carrier level prevents over-granulation in the fluid bed and gives a compressibility index of 8–15% under USP <1174>. Without the carrier, the dried extract forms a hygroscopic glass that agglomerates in storage and cannot be metered accurately into tableting or capsule filling equipment. The granulated material is screened through a 1.0 mm perforated screen before final blending to remove oversized fused granules; oversized material above 5.0% w/w indicates fluid-bed channeling and must be reworked.
Direct compression of MXSG-VG-100 is constrained by hygroscopicity and by the elastic recovery of extract granules under compaction. When uncompressed granules are exposed to 60% RH at 25 °C, moisture uptake exceeds 3.0% within 4 h in open trays; rotary tablet presses without feed-frame humidity control show sticking at compression forces above 12 kN. Wet granulation in a high-shear mixer granulator with impeller speed 300–500 rpm and chopper speed 1,500–2,000 rpm for 3–5 min is preferred for tablets. The granulation liquid is 50% ethanol containing 2.0–5.0% w/w polyvinylpyrrolidone K30. Extra-granular disintegrant 1.0–2.0% w/w croscarmellose sodium and lubricant 0.5–1.0% w/w magnesium stearate are added after dry sizing. Tablets compressed to hardness 60–90 N on a 9 mm standard concave punch disintegrate in ≤15 min in 900 mL water at 37 °C under USP <701>. Content uniformity passes USP <905> only when mixer torque rheometry shows a granulation endpoint steady-state torque of 0.8–1.4 N·m and final blend RSD is below 2.0%.
Encapsulation on intermittent-motion tamping-pin capsule fillers is more sensitive to granule friability than tablet compression. When friability exceeds 0.8% w/w after 15 min in a stirred friability tester, fine particles migrate toward the hopper periphery and fill weight RSD rises above 2.5%. Addition of 0.25% w/w colloidal silicon dioxide before final blending reduces static charge and improves flow; increasing colloidal silica above 0.5% w/w delays aqueous disintegration because the hydrophobic surface layer impedes wetting. For size 0 hard gelatin capsules, a fill weight of 350–420 mg is common, but the fill mass must be adjusted to the marker assay because the API is standardized on a per-gram basis, not on unit dose. The granulated form also permits direct filling into sachets as a final oral granule product after dry flavor masking with 0.2–0.5% w/w sucralose or equivalent bitter-blocking excipient; residual bitterness from ephedrine alkaloids remains the main organoleptic constraint at levels above 6.5 mg/g ephedrine equivalents.
Injectable use is limited to the low-endotoxin subset MXSG-VG-100I with bacterial endotoxin release limit ≤0.25 EU/mg under USP <85>. Dissolution of the granulated API for parenteral compounding is followed by staged filtration through 0.45 µm and 0.22 µm polyethersulfone membranes at ≤0.5 bar differential pressure. Herbal polysaccharides and glycopeptides can foul membrane filters; filter capacity must be determined by a prefilter challenge test because published data for this specific fixed-combination injection is limited. Terminal steam sterilisation is not recommended: forced degradation studies show ephedrine hydrochloride loss above 2.0% after 121 °C for 15 min at pH 5.0, and the process darkens the solution. Aseptic filtration followed by fill-finish is the only viable route for injectable solutions. The reconstituted solution must meet USP <788> particulate limits of not more than 6,000 particles per container at ≥10 µm and 600 particles per container at ≥25 µm. Benzyl alcohol preservative levels above 2.0% v/v are incompatible at pH below 4.0 because glycyrrhizic acid precipitates and turbidity exceeds 10 NTU. The practical pH window for injectable compounding is 4.5–6.0 buffered with citrate or phosphate; outside this window, amygdalin hydrolysis accelerates.
For medicated premix manufacture, MXSG-VG-100 is incorporated into corncob or calcium carbonate carriers at 2–10% w/w blend ratio. Ribbon blender mixing at 20–25 rpm for 10–15 min achieves a marker coefficient of variation below 5.0% when the API is added to the moving carrier rather than pre-loaded at the mixer base. Farm storage in polyethylene-lined paper bags at 25 °C/60% RH for 12 months retains marker content above 95% of the initial HPLC assay. Storage above 40 °C or direct ultraviolet exposure for 72 h drifts the ephedrine/pseudoephedrine ratio and darkens the granule surface; the product should not be stored in unlined metal bins or with oxidizing disinfectants.
For oral solutions, the granules are dispersed at 10 g/L in purified water. The resulting dispersion has pH 4.0–6.5 and settles within 30 min without continuous agitation; a suspending vehicle containing 0.5% w/w sodium carboxymethylcellulose and 0.1% w/w sodium citrate buffer is recommended for drench administration. The finished solution should be used within 24 h at 2–8 °C; longer hold times increase both microbial growth and marker degradation. The granulated API wets faster than spray-dried powder, with a wetting time of 45–90 s in a modified disintegration basket test. In hard water above 300 mg/L CaCO₃ equivalents, gypsum-derived calcium can reduce dispersibility; a chelating agent such as disodium EDTA at 0.05–0.1% is then required.
The granulated veterinary API differs from unprocessed pulverized Maxingshigan herb powder and from concentrated liquid extract in processing, microbiological, and standardization characteristics. Dust generation during enclosed transfer is ≤0.8 mg/m³ for the granulated API, compared with 8–15 mg/m³ for pulverized herb powder under the same transfer conditions. Total aerobic count is reduced by approximately 2–3 log10 CFU/g relative to raw powder. Marker content is fixed at 4.5–6.5 mg/g ephedrine alkaloids instead of varying with plant source, harvest season, and milling fraction. Flow function measured by USP <1174> is improved from poor to fair. Reconstitution in water is faster, and the granulated form can be used across the listed dosage forms; raw powder is generally limited to non-aseptic oral powders and traditional decoctions. Concentrated liquid extracts retain higher water activity and require ethanol or preservative systems, limiting their utility in solid dosage form manufacture. The granulated API is therefore specified for regulated veterinary drug manufacturing rather than direct unprocessed feed application.
| Property | MXSG-VG-100 granulated API | Pulverized raw herb powder | Concentrated liquid extract |
| Marker ephedrine content | 4.5–6.5 mg/g | 1.5–8.0 mg/g variable | 20–40 mg/mL batch-adjusted |
| Bulk density / solution density | 0.45–0.65 g/mL | 0.25–0.45 g/mL | 1.05–1.20 g/mL |
| Water activity | 0.35–0.45 | 0.60–0.85 | 0.90–0.95 |
| Aerobic microbial count | ≤10³ CFU/g | 10⁵–10⁷ CFU/g | ≤10² CFU/mL |
| Endotoxin control | ≤0.25–0.50 EU/mg | Not routinely controlled | ≤0.50 EU/mL |
| Residual ethanol | ≤500 ppm | Not applicable | 20–35% v/v |
| Dosage-form compatibility | Tablets, capsules, oral powders, granules, premixes, solutions, injectable subset | Non-aseptic powders and decoctions | Oral liquids and injectable liquids after ethanol removal |
