As a new-type foreign trade service provider driven by both technology transformation and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply raw materials of Pueraria Mirifica extract from multiple well-known original manufacturers.
As a technology R&D-oriented foreign trade enterprise, HiSiaddi has repeatedly proposed formula optimization schemes and application improvement suggestions for Pueraria Mirifica extract products through technological transformation cooperation with manufacturers and precise market insight. Below is a case of HiSiaddi’s consulting service on Pueraria Mirifica extract formula optimization.
If you require more formula optimization consulting services, please contact HiSiaddi customer service.
The purchaser is SanaHerb AG based in Geneva, Switzerland, a mid-to-high-end functional pharmaceutical enterprise in Switzerland with core product lines of Pueraria soft capsules and botanical anti-aging oral liquids. Its full product range is sold in premium Swiss organic chain pharmacies, private anti-aging clinics and boutique supermarkets in Liechtenstein. Raw materials comply with EU EC396 covering 226 pesticide residue items, USP Pharmacopoeia, LFGB food raw material standards and cGMP formulation production specifications. The enterprise previously sourced Pueraria Mirifica extract from France for a long time, but launched a localized China procurement project amid rising raw material prices and unstable supply, with an annual total procurement volume of 15.3 tons and two mandatory customized indicators: pharmaceutical-grade extract with total isoflavones ≥40% and puerarin ≥22% (free of starch and dextrin additives); cold-water instant powder for oral liquids that remains free of precipitation and stratification after 90 days of storage at 4°C.
The client independently contacted three domestic plant extract manufacturers for sampling and trial production. After raw materials entered its Swiss GMP production line, multiple production and formula failures occurred consecutively, delaying the new product launch by 72 days with combined losses of 27,200 Swiss Francs from sample wastage and production line shutdowns. Original manufacturers could only produce standard domestic crude powder and lacked capabilities to resolve derivative technical problems on the formulation end, prompting the client to entrust HiSiaddi’s technical team with full-dimensional troubleshooting and rectification.
Suppliers scattered sourced high-quality 3-year wild Pueraria from Hubei, fast-growing starch Pueraria from Guangxi and residual inferior Pueraria tubers from Jiangxi for mixed feeding. High-quality Pueraria contains intrinsic total isoflavone levels above 7.5%, while fast-growing starch Pueraria only holds around 3.7%. Feeding ratios were adjusted arbitrarily based on costs, resulting in finished total isoflavones fluctuating between 33% and 42% with puerarin generally below 20%, failing to hit the 22% customization minimum threshold. HPLC detection showed messy impurity miscellaneous peaks, preventing the pharmaceutical plant from fixing feeding conversion coefficients and triggering unstable active ingredient content in mass-produced capsules, with partial batches seized during sampling inspections by Swiss drug regulatory authorities. Pueraria harvested by individual farmers carried soil pesticides and heavy metals, pushing multiple indicators close to EU limit thresholds.
Puerarin exhibits prominent thermosensitivity and oxidizes and decomposes above 60°C. Original manufacturers adopted 78°C high-temperature ethanol reflux extraction, leading to over 30% puerarin loss from prolonged high-temperature extraction. Even with high-quality raw materials, indicators struggled to meet standards. Open extraction equipment lacked solvent recovery systems, resulting in finished ethanol residue exceeding 6000 ppm, far above the client’s internal control limit of ≤2800 ppm. After soft capsule filling, gelatin shells absorbed moisture, softened and leaked, pushing the rejection rate as high as 26.5%.
Manufacturers uniformly produced identical crude powder via spray drying without customized powder modification for capsules and oral liquids:
1. Capsule powder featured uneven particle size with a repose angle over 47%, electrostatic caking of powder materials, frequent clogging of automatic filling machines and maximum single capsule filling error of 7.6%;
2. Poor water solubility of crude powder for oral liquids led to cloudy solutions after feeding, with brown flocculent precipitates forming after one week of low-temperature storage, damaging the beverage colloidal system and failing to meet long-term storage requirements.
The client’s formula mixes vitamin C and citric acid to produce oral liquids. Crude extracts retained large volumes of native starch, botanical colloids and trace heavy metal impurities. Metal ions catalyzed vitamin C oxidation, turning liquid products from light yellow to dark brown after 45 days of room-temperature storage, failing to meet the EU 24-month shelf-life standard. Multiple adjustments to auxiliary material ratios by the pharmaceutical plant could not fundamentally improve the issue.
Crude drying processes left finished product moisture content above 1.4%. Switzerland maintains storage humidity above 50% year-round, causing raw materials to absorb moisture and cake within two to three days after unpacking, blocking sieve screens and adhering to capsule pressing molds during feeding, increasing manual crushing costs and continuously elevating product defect rates.
HiSiaddi set up a task force consisting of plant extract engineers, dietary formulation consultants and third-party testing specialists. It designated GAP planting bases in Enshi, Hubei and compliant refining manufacturers, conducting step-by-step optimization from raw material source to terminal application with repeated verification across three phases: sample testing, pilot production and mass production.
HiSiaddi conducted on-site contracts with three standardized planting cooperatives in Enshi, restricting harvesting to 3-year wild-domesticated Pueraria collected in autumn and winter, with manual sorting to remove rotten tubers and fast-growing starch Pueraria. Each batch of raw materials came with field pesticide application ledgers and origin certificates. Intrinsic flavonoid content of raw materials was tested prior to factory admission, with entire batches rejected if intrinsic levels fell below 7%, completely eliminating mixing of miscellaneous raw materials and stabilizing the innate baseline of active ingredients.
The high-temperature reflux process was abandoned in favor of a 42°C normal-temperature percolation, gradient ethanol extraction, negative-pressure low-temperature concentration and dual-stage resin impurity removal process operated under fully closed and light-shielded conditions, cutting puerarin degradation loss to within 5%. Resins deeply removed starch and colloidal impurities, stabilizing finished total isoflavones at 40.1%–40.8% and puerarin at 22.2%–22.8%. Supporting closed rectification equipment controlled ethanol residue within 2700 ppm, resolving capsule shell leakage issues.
1. Pharmaceutical capsule powder: Low-temperature vacuum drying + nitrogen-sealed air jet milling optimized the repose angle to 33°±2°, delivering excellent powder fluidity with no additional anti-caking auxiliary materials, compatible with automatic capsule filling.
2. Water-soluble powder for oral liquids: Low-temperature β-cyclodextrin filler-free inclusion modification without maltodextrin or starch additives, enabling instant full dissolution in cold water with no precipitation after 90 days of storage at 4°C.
On the raw material side, resin refining removed heavy metals and oxidation-promoting impurities. On the formula side, HiSiaddi coordinated the Swiss R&D team to adjust feeding logic: Pueraria Mirifica extract, vitamin C and fruit acids were separately pre-mixed and fed in batches to reduce metal ion-catalyzed oxidation. No browning or turbidity appeared after 90-day accelerated retention testing.
Finished products underwent segmented vacuum dehydration to lock moisture content at ≤0.5%. HiSiaddi compiled English storage specifications requiring constant warehouse temperature of 22°C and humidity ≤40%, with raw materials packed in nitrogen-filled vacuum small bags to be unpacked on demand, avoiding moisture absorption and caking in high-humidity environments.
Multiple rounds of cross-border sample delivery passed full testing by Swiss third-party laboratories and pilot production in the client’s workshop. The first batch of 4.5 tons of goods was shipped from Shanghai to Geneva, clearing Swiss customs in one inspection. After production launch, capsule filling error was controlled within ±1.8% and rejection rate dropped to 1.1%, while all batches of oral liquids remained stable without precipitation during storage. The new product launch delayed by 72 days successfully rolled out across all premium retail channels in Switzerland. The client signed an annual framework procurement contract for 15.3 tons: 8.9 tons of refined capsule powder and 6.4 tons of water-soluble powder for oral liquids, split into 11 monthly batches throughout the year. The client later added customized procurement of high-end anti-aging skincare-grade Pueraria Mirifica extract, with HiSiaddi fully tracking all technical coordination and sample testing. Compared with raw materials imported from France, comprehensive procurement costs fell by 30.2%, and ocean transit time was shortened from 76 days to 21 days.
Most domestic plant extract manufacturers excel in crude mass production yet lack formulation supporting R&D and powder modification capabilities, with limited familiarity with EU Pharmacopoeia standards and overseas production operating conditions. Mid-to-high-end Swiss pharmaceutical enterprises specialize in terminal formula development but lack insight into chaotic domestic raw material producing areas and uneven factory processes, making independent procurement prone to mass production accidents. Acting as a technical service provider, HiSiaddi built a full chain covering raw material control, process improvement and formula adaptation, bridging technical information gaps between China and overseas and empowering domestic Pueraria Mirifica extract to stably enter the high-end Swiss pharmaceutical raw material supply chain.
If you require more formula optimization consulting services, please contact HiSiaddi customer service.
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