Teriparatide 10mg/vial Increasing Bone Density And Promoting Bone Health

Teriparatide 10mg/bottle core introduction

Pharmaceutical-grade peptide formulations | Parathyroid hormone (1-34) fragments made in China 10mg/vial

CAS : 52232-67-4

Molecular formula : C₁₈₁H₂₉₁N₅₅O₅₁S₂

Molecular weight : 4117.8 g/mol

Purity : ≥99% (HPLC detection)

Appearance : White lyophilized powder

Storage : Refrigerate at 2-8℃, protected from light. Use immediately after reconstitution.

Core advantages and functions

Teriparatide is a recombinant human parathyroid hormone (1-34) active fragment and the first bone formation promoter to be approved by the FDA . By specifically activating the parathyroid hormone receptors on osteoblasts, it promotes bone formation, increases bone density, and improves bone microstructure, and has important clinical value and scientific research significance in the treatment of osteoporosis, fracture healing, and bone regeneration .

✅Pharmacological mechanism :

Bone formation promotion : Stimulates osteoblast proliferation and differentiation, and promotes bone matrix formation.

Bone resorption regulation : Intermittent administration can promote bone formation and inhibit bone resorption.

Fracture healing : Accelerates the fracture healing process and improves callus quality.

Bone density enhancement : Significantly improves bone density in the lumbar spine and hip.

Improved bone quality : Improved trabecular structure and connectivity

✅Quality advantages of Chinese manufacturers :

Production process : The E. coli recombinant expression system is used, and the fermentation process is stable.

Purification process : Three-stage purification: ion exchange + hydrophobic chromatography + reversed-phase HPLC

Quality control : Complies with ICH Q6B guidelines, purity ≥99%.

Activity validation : Dual validation using in vitro osteoblast model + in vivo osteoporosis model

Aseptic assurance : Terminal sterilization filtration and freeze-drying process ensure stability.

Documentation system : Complete DMF documents, supporting international registration applications.

✅Product Features :

Highly active : Possesses complete PTH (1-34) bioactivity

Good stability : The freeze-dried formulation has a stability of up to 24 months.

High safety : strict control over host protein and DNA residues

Bioequivalence : Having the same amino acid sequence and spatial structure as the original drug.

Usage and Storage Guide

1. Reconstitution and preparation :

Special solvent :

It is recommended to use physiological saline containing 0.1% BSA.

In vitro study: serum-free α-MEM medium

Intracorporeal injection: physiological saline containing 0.1% BSA

Standard configuration :

Inject 2 mL of solvent into the 10 mg vial and gently swirl to dissolve.

A stock solution of 5 mg/mL (approximately 1.2 mM) was obtained .

Gradually dilute to the working concentration using the appropriate solvent.

Dissolution control :

Dissolving time: Gently rotate for 5-10 minutes at room temperature.

Observation criteria: The solution should be clear and transparent, free of particulate matter.

Avoid the following procedures: violent shaking, ultrasonic treatment, and heating to dissolve.

pH range: The pH after preparation should be 5.0-7.0.

2. Storage conditions :

Unopened :

Store at 2-8℃ for 24 months .

Store frozen at -20℃ for 36 months .

Avoid repeated freeze-thaw cycles

Reconstituted :

Stock solution: Refrigerate at 2-8℃ and use within 24 hours .

Working solution: It is recommended to prepare and use immediately ; store at 4°C for no more than 8 hours.

Do not freeze reconstituted solutions.

Transportation conditions :

Cold chain transportation (2-8℃)

Uses professional temperature-controlled packaging

Equipped with temperature recording device

Stability parameters :

Temperature sensitive: Degradation accelerates at temperatures above 25℃

Photosensitized: Sensitive to ultraviolet light, requires storage away from light.

Oxidation sensitive: Avoid contact with oxidants

Optimal pH: 5.0-7.0

3. Research and application plan :

In vitro cell experiments :

Cell model :

Human osteoblasts (hFOB, SaOS-2)

Mouse osteoblasts (MC3T3-E1)

Human mesenchymal stem cells

Osteosarcoma cells (MG-63)

Concentration gradient :

Low concentration: 0.1-1 nM

Medium concentration: 1-10 nM

High concentration: 10-100 nM

Processing time :

Short-term stimulus: 5-60 minutes (signaling pathway)

Intermediate treatment: 6-48 hours (gene expression)

Long-term induction: 3-21 days (differentiation and mineralization)

Evaluation indicators :

Cell proliferation: CCK-8, BrdU

Alkaline phosphatase (ALP) activity

Formation of mineralized nodules (Alizarin Red S staining)

Osteogenic gene expression: Runx2, OSX, OCN

Animal in vivo studies :

Disease model :

Ovarian removal (OVX) rat osteoporosis model

Age-related osteoporosis mouse model

Glucocorticoid-induced osteoporosis model

Fracture healing model (femoral/tibial defect)

Dosage regimen :

Subcutaneous injection: 20-40 μg/kg , once daily.

Intraperitoneal injection: 20-40 μg/kg , once daily.

Local injection: Inject at the fracture site, 5-10 μg/site

Dosage cycle :

Prophylactic administration: Begin immediately after model establishment and continue for 8-12 weeks.

Therapeutic administration: Begin 4 weeks after model establishment and continue for 4-8 weeks.

Intermittent administration: simulating clinical practice, once daily.

Evaluation method :

Bone mineral density testing: DXA, μCT

Bone biomechanics: Three-point bending and compression tests

Histological morphology: HE staining, Goldner staining

Serum biomarkers: PINP, CTX-1

Mechanism of action study :

Signaling pathways: PKA, PKC, Wnt/β-catenin

Gene expression: microarray analysis, RNA-seq

Proteomics: Expression of Osteogenesis-Related Proteins

Metabolomics: Analysis of Bone Metabolites

4. Experimental design optimization :

Dosage selection :

Low dose: 20 μg/kg/day

Medium dose: 40 μg/kg/day

High dose: 80 μg/kg/day

Control group setup :

Sham surgery group

Model control group (OVX + Vehicle)

Positive control group: Alendronate sodium (3 mg/kg/week)

Sampling time point :

4 weeks after administration: Early effects

8 weeks after administration: Mid-term effect

12 weeks after administration: Long-term effects

Sample processing :

Serum: Detection of bone turnover markers

Bone tissue: fixed with 4% paraformaldehyde (histological analysis)

Bone tissue: preserved at -80℃ (molecular biology)

Urine: Collect urine over 24 hours

Why choose Teriparatide made in China?

Technical advantages :

Mature recombinant expression and purification processes

Complete quality research system

Strict process control and release standards

A complete document system supporting Sino-US dual reporting

Quality Guarantee :

Purity ≥ 99% (HPLC)

Host protein residue <10 ppm

Host DNA residue <10 pg/mg

Endotoxin <1 EU/mg

The peptide diagram is consistent with the original drug.

Biological activity ≥ 90% of the original drug

Cost advantage :

Large-scale production reduces costs by 30-50%.

Compared to imported products, they have a clear price advantage.

Custom specifications and packaging are supported.

Provide technology transfer and process support

Service Support :

Professional technical support team

Provide detailed technical documents

Assist in experimental design

Comprehensive after-sales service system

Research and application directions

Osteoporosis research :

Pathogenesis of osteoporosis

Bone metabolism regulation mechanism

Bone quality assessment methods

Exploring combination therapy regimens

Bone regeneration research :

Molecular mechanisms of fracture healing

Bone tissue engineering construction

Bone defect repair strategies

Functionalization of biomaterials

Drug development :

Screening of novel bone formation promoters

Optimization of drug delivery systems (transdermal, oral)

Pharmacokinetic/Pharmacodynamic Studies

Preclinical safety evaluation

Basic research :

osteoblast differentiation mechanism

Bone metabolism signaling pathway

Aging and bone loss

Mechanical stress and bone formation

Summarize

Teriparatide (PTH 1-34) is currently the only marketed bone formation promoter , possessing irreplaceable value in osteoporosis treatment and bone regeneration research. Chinese manufacturers, through advanced recombinant expression technology, a rigorous quality control system, and comprehensive research data , provide global researchers with high-quality, highly active, and highly stable research-grade products , supporting the entire research chain from basic research to preclinical development.

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