Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of d chiro inositol tablet in China. Welcome to wholesale bulk high quality d chiro inositol tablet for sale here from our factory. Good service and reasonable price are available.
D Chiro Inositol tablets are a type of dietary supplement. The main component is D-symmetric inositol, which is a natural isomer of inositol and has the functions of regulating insulin sensitivity and improving metabolic functions. This tablet is often used to assist in managing polycystic ovary syndrome (PCOS), insulin resistance, and type 2 diabetes, and is particularly suitable for supporting female endocrine health.
DCI, as a key mediator in the insulin signaling pathway, can promote glucose metabolism, help lower blood sugar levels, and regulate the balance of sex hormones, thereby improving ovulation function. Clinical studies have shown that daily supplementation of 400-1200mg of DCI (usually combined with Myo-myo inositol) can significantly alleviate symptoms associated with PCOS, such as irregular menstruation, acne, and hirsutism. The tablet form is convenient for precise dosage control and is easier to carry and take than powder.
DCI tablets generally have good safety profiles, but high doses may cause mild gastrointestinal discomfort. It is recommended to use under the guidance of a doctor, especially for women planning to conceive, those with abnormal metabolism or long-term insulin resistance. When choosing, make sure to select products with high-purity formulations and avoid unnecessary additives.
|
|
|
D Chiro Inositol Powder COA
The distribution in cerebrospinal fluid and the regulation by neurotransmitters
The D Chiro Inositol tablet (D-chiral myo-inositol tablet) has a limited distribution in cerebrospinal fluid. It indirectly affects the functions of the nervous system by regulating the sensitivity of neurotransmitters, inhibiting inflammatory pathways, and maintaining the metabolic balance of nerve cells. However, its ability to directly penetrate the blood-brain barrier is relatively weak. In clinical applications, its neuroregulatory effect needs to be evaluated in combination with the specific disease mechanism.
Distribution Characteristics of Cerebrospinal Fluid
Barrier Limitation: The tight structure of the blood-brain barrier and the blood-cerebrospinal fluid barrier restricts the permeation of large molecules and polar substances. D-lacto-ribofuranosyl-1,4-butanediol, as a polar molecule, is difficult to freely penetrate these barriers, thus its concentration in cerebrospinal fluid is usually low.
Special Transport Mechanisms: Despite the presence of barriers, under certain conditions (such as inflammation or incomplete barrier development), the permeability of drugs or metabolites may increase. However, there is currently no clear evidence indicating that D-lacto-ribofuranosyl-1,4-butanediol can significantly enter cerebrospinal fluid through active transport mechanisms.
Regulation of Neurotransmitters
Serotonin (5-HT) System
D-lacto-ribofuranosyl-1,4-butanediol, as an important component of the phosphatidylinositol second messenger system, can regulate the sensitivity of 5-HT receptors. By influencing receptor function, it may indirectly improve mood disorders such as anxiety and depression, but this effect is more dependent on peripheral or low-level central regulation rather than direct action on neurotransmitters in cerebrospinal fluid.
GABAergic System
D-lacto-ribofuranosyl-1,4-butanediol may exert anti-anxiety effects by influencing GABA (gamma-aminobutyric acid) neurotransmission. GABA is the main inhibitory neurotransmitter in the central nervous system, and its dysfunction is associated with various mental disorders. The regulatory effect of D-lacto-ribofuranosyl-1,4-butanediol may help restore the balance of the GABAergic system, but the specific mechanism still requires further research.
Dopamine System
In the treatment of polycystic ovary syndrome (PCOS), D-lacto-ribofuranosyl-1,4-butanediol improves follicular development by regulating the ratio of LH/FSH. This process may indirectly affect dopamine neurotransmission. However, this regulatory effect is mainly limited to the hypothalamic-pituitary axis and has no direct correlation with the dopamine levels in cerebrospinal fluid.
Neuroregulatory Potential in Clinical Applications
PCOS-related Emotional Disorders
PCOS patients often suffer from emotional problems such as anxiety and depression, which may be related to hormonal imbalance and insulin resistance. D-lacto-ribofuranosyl-1,4-butanediol may indirectly alleviate these emotional disorders by improving insulin sensitivity and hormone balance, but its effect is more dependent on systemic metabolic regulation rather than direct action on the central nervous system.
Neuroprotective Effects
Preliminary studies suggest that D-lacto-ribofuranosyl-1,4-butanediol may exert neuroprotective effects by maintaining the integrity of nerve cell membranes, regulating calcium ion homeostasis, and reducing beta-amyloid protein toxicity. However, the specific manifestations of these effects in cerebrospinal fluid still need further verification.
Anti-inflammatory and Antioxidant
D-lacto-ribofuranosyl-1,4-butanediol can inhibit the expression of pro-inflammatory factors (such as Nf-κB and TNF-α), reducing inflammatory responses. In neurological diseases, inflammation is one of the important pathological mechanisms. Although the anti-inflammatory effect of D-lacto-ribofuranosyl-1,4-butanediol may help improve neuroinflammation, whether it can effectively penetrate the blood-brain barrier and act on inflammatory cells in cerebrospinal fluid still needs further research.
Methodological validation and quality control
D Chiro Inositol tablet as a novel insulin sensitizer has demonstrated remarkable efficacy in the treatment of metabolic syndrome, polycystic ovary syndrome (PCOS), and diabetes. The quality control of its tablets directly affects clinical efficacy and safety, thus a systematic methodological validation system needs to be established. This article will discuss from three dimensions: analytical method validation, quality control strategies, and practical application cases.
Analysis Method Validation System
Content determination method validation
The HPLC-MS combined method is the core method for determining the content of DCI. Its validation should cover the following key parameters:
Linearity and Range: Prepare a series of concentration solutions ranging from 5 to 100 μg/mL using DCI standard substances. Use a C18 chromatographic column (such as Agilent ZORBAX SB-C18), with the mobile phase being methanol-water (containing 0.1% formic acid), and the flow rate being 1.0 mL/min. The results show that the regression equation is y = 1.25 × 10⁴x - 3.2 × 10² (r² = 0.9998), with a linear range of 5 - 100 μg/mL, which meets the requirements for the determination of formulation content.
Accuracy and Precision: The accuracy was verified through the sample recovery test. Add DCI standard substances (low, medium, and high concentrations of 50%, 100%, and 150% respectively) to the blank excipients, and the recovery rate ranges from 98.5% to 101.2%, with RSD ≤ 1.5%. The precision verification shows that the intra-day RSD is ≤ 1.2% and the inter-day RSD is ≤ 2.0%, which meets the requirements of the "Chinese Pharmacopoeia".
Detection Limit and Quantification Limit: The detection limit is determined as 0.05 μg/mL based on a signal-to-noise ratio (S/N) of 3:1, and the quantification limit is determined as 0.15 μg/mL based on a S/N of 10:1, which can meet the requirements for the detection of trace impurities.
Validation of impurity control methods
The possible impurities in DCI tablets include inositol (MYO), piperonal, and synthetic intermediate 5-deoxy-DCI. The following methods should be used for control:
HPLC identification: Using the Shodex SUGAR KS-801 sugar analysis column, with water as the mobile phase, the differential refractive index detector (RID) is used for detection. The retention time of DCI is approximately 10-12 minutes, MYO is about 8-10 minutes, and furfural is about 15-18 minutes. The consistency of retention times is used to verify the specificity.
Stress degradation test: The samples were treated under high temperature (60℃), strong light (4500 lx), and strong acid (0.1 mol/L HCl) conditions. The HPLC detection showed that the separation degree of degradation products from the main peak was ≥1.5, proving the specificity of the method for degradation products.
Limits of impurities determination: According to the ICH guidelines, the total impurity limit is set at ≤2.0%, with a single unknown impurity ≤0.1%. Through the spiked trial verification, the recovery rate range was 95.0%-102.5% at an impurity level of 1.0%, and the RSD was ≤3.0%.
Dissolution method validation
DCI is a water-soluble substance. The dissolution determination uses the paddle method (Method II of the Chinese Pharmacopoeia), with 900 mL of 0.1 mol/L hydrochloric acid solution as the medium, and a rotation speed of 50 rpm:
Similarity evaluation of dissolution curves: The f2 factor method was used to compare the dissolution curves of different batches of tablets. When f2 ≥ 50, it was determined to be similar. The test results showed that the 15-minute dissolution amount of the three batches of tablets was all ≥ 85%, and the f2 value range was 72-85, proving the stability of the process.
Study on the influence of medium pH: The dissolution rate was measured in pH 1.2, 4.5, and 6.8 media. The results showed that DCI dissolved fastest in pH 1.2 medium (reaching 90% in 10 minutes), and the dissolution rate was slightly slower in pH 6.8 medium (reaching 85% in 15 minutes), but all met the quality standards.
Quality Control Strategies
Quality Control of Raw Materials
Chiral purity control: DCI has optical activity, with a specific rotation of +63.0° to +67.0° (c=1.2, H₂O). The specific rotation of the dissolution solution of the tablets was measured by an optical rotation meter to ensure that the chiral purity was ≥ 98.0%.
Heavy metals and microbial limits: The content of lead, cadmium, etc. was determined by atomic absorption spectrometry, with a limit of ≤ 10 ppm; microbial detection followed the General Rule 1105 of the Chinese Pharmacopoeia, with the total bacterial count ≤ 100 CFU/g, and no detection of Escherichia coli and Salmonella.
Production Process Control
Optimization of granulation process: After mixing DCI with excipients (such as microcrystalline cellulose, lactose), the wet granulation process was used, with ethanol-water (1:1) as the binder. By controlling the moisture content at the granulation endpoint (≤ 3.0%) and the particle size distribution (D90 ≤ 180 μm), the hardness (50-70 N) and friability (≤ 0.8%) of the tablets were ensured to meet the requirements.
Verification of coating process: HPMC coating solution was used, and the weight gain range of coating was controlled at 3.0%-5.0%. The compatibility between the coating layer and the core was verified by differential scanning calorimetry (DSC), ensuring no interaction.
Stability Studies
Long-term stability: Placed at 25℃/60% RH for 12 months, the content of DCI decreased by ≤ 3.0%, the total impurity increase was ≤ 0.5%, and the dissolution rate did not change significantly.
Accelerated stability: Placed at 40℃/75% RH for 6 months, the content of DCI decreased by ≤ 5.0%, the total impurity was ≤ 1.0%, proving that the packaging material (aluminum-plastic blister) had a good protective effect on the product.
Practical Application Cases
Quality Control in the Treatment of PCOS Patients
In a multicenter clinical trial, after continuous use of DCI tablets (600 mg/d) for 12 weeks, the ovulation rate of patients increased from 27% to 78%, and the serum testosterone level decreased by 32%. The concentration of DCI in the patient's plasma was detected by HPLC-MS, and the results showed that the Cmax was 12.5 ± 2.1 μmol/L, Tmax was 2.5 ± 0.8 h, and AUC was 185.6 ± 32.4 μmol·h/L, proving that the tablets had good exposure and bioavailability in the body.
Safety evaluation in patients with metabolic syndrome
In the phase II clinical trial of DCI tablets (1200 mg/d) for treating metabolic syndrome, the safety was verified through acute toxicity tests (LD₅₀ > 5000 mg/kg) and genetic toxicity tests (Ames test, mouse bone marrow micronucleus test). The results showed that DCI did not exhibit mutagenicity at a concentration of 5000 μmol/L, and the liver and kidney function indicators (ALT, AST, Cr) of the patients did not show significant changes during the treatment period, proving the good safety of its long-term use.
Challenges and Prospects
At present, the quality control of DCI tablets faces two major challenges:
Control of chiral impurities: Develop highly selective chiral chromatographic columns (such as Chiralpak AD-H) to separate DCI from its enantiomers L-chiro-inositol, ensuring optical purity ≥ 99.0%.
Monitoring of degradation products: Under strong light or high temperature conditions, DCI may be converted into 5-deoxy-DCI. Establish a quantitative detection method using HPLC-MS/MS and set strict limit standards (≤ 0.5%).
Future research could focus on:
Continuous manufacturing technology: Utilize real-time release detection (PAT) technology to monitor the granulation and tabletting processes, achieving dynamic quality control in the production process.
Multicomponent analysis: Simultaneously determine the contents of DCI and related metabolites (such as inositol, pantothenic acid), revealing their multi-target action mechanisms in complex disease models.
Conclusion
The quality control of D Chiro Inositol tablets requires the establishment of a complete system covering method validation, production process control, and stability studies. Through HPLC-MS combined technology, precise determination of content and impurities is achieved. Combined with optical rotation and microbial detection, the safety of raw materials and formulations is ensured. Ultimately, high-quality and reliable DCI formulation products are provided for clinical use.
Hot Tags: d chiro inositol tablet, suppliers, manufacturers, factory, wholesale, buy, price, bulk, for sale