Efficacy and function of pharmaceutical grade pentoxaverine citrate chemical raw materials

Efficacy and function of pharmaceutical grade pentoxaverine citrate chemical raw materials acid salt
.

Calculated by dry product, the content of C20H31NO3•C6H8O7 shall not be less than 98.
5%
.

【Properties】This product is white or off-white crystalline or granular powder; odorless
.

Pentoverine citrate is readily soluble in water, soluble in ethanol, and almost insoluble in acetonitrile
.

Take this product for melting point, put it into a melting point measuring capillary, melt and seal it under reduced pressure, and measure it according to the law (General Rule 0612).
The melting point is 88-93 °C
.

[Identification] (1) Take about 20 mg of this product, dissolve it in 2 ml of water, add 4 drops of dilute hydrochloric acid and a few drops of ferrous potassium test solution, which will produce yellow White crystals precipitated
.

(2) Take about 20mg of this product, add 10ml of water to dissolve, add 2 drops of dilute hydrochloric acid and a few drops of potassium dichromate test solution, which will form a yellow precipitate
.

(3) The infrared absorption spectrum of this product should be consistent with the control spectrum (spectrum set 267)
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(4) This product shows the identification reaction of citrate (general rule 0301)
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【Check】Clarity of solution Take 0.
50g of this product, add 5ml of water, shake to dissolve, and compare with No.
3 turbidity standard solution (general rule 0902 first method), it should not be more concentrated
.

Relevant substances are determined according to high performance liquid chromatography (General Rule 0512)
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Take about 50mg of this product from the test solution, put it in a 50ml volumetric flask, add mobile phase to dissolve and dilute to the mark, shake well
.

Control solution Precisely measure 1ml of the test solution, put it in a 100ml volumetric flask, dilute to the mark with mobile phase, and shake well
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Chromatographic conditions: Use octadecylsilane-bonded silica gel as filler; use water (take 10ml of triethylamine, dilute to 1000ml with water, adjust pH to 3.
0 with phosphoric acid)-methanol (45:55) as mobile phase; detect wavelength 215nm; injection volume 20μl
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The applicability of the system requires that the number of theoretical plates shall not be less than 2000 calculated according to the penttoverine peak, and the separation degree between the penttoverine peak and the adjacent impurity peaks should meet the requirements
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Determination method Precisely measure the test solution and the control solution, inject them into a liquid chromatograph, and record the chromatogram to 3 times the retention time of the main component peak
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If there are impurity peaks in the chromatogram of the test solution, the area of ​​a single impurity peak shall not be greater than 0.
2 times (0.
2%) of the main peak area of ​​the control solution, and the sum of the peak areas of each impurity shall not be greater than the main peak area (1.
0%) of the control solution
.

Loss on drying Take this product, put it in a phosphorus pentoxide desiccator, and dry it under reduced pressure at 60 °C to constant weight, and the weight loss should not exceed 1.
0% (General Rule 0831)
.

Take 1.
0g of this product for the residue on ignition and inspect it according to the law (General Rule 0841), and the remaining residue should not exceed 0.
1%
.

Heavy metals and residues left under the item of residue on ignition shall be inspected according to law (the second method of General Rule 0821), and the content of heavy metals shall not exceed 15 parts per million
.

[Determination of content] Take about 0.
4g of this product, accurately weigh it, add 10ml of glacial acetic acid to dissolve, add 1 drop of crystal violet indicator solution, and titrate with perchloric acid titration solution (0.
1mol/L) until the solution turns blue, and then add 1 drop of crystal violet indicator solution.
The titration results were corrected with a blank test
.

Each 1ml of perchloric acid titration solution (0.
1mol/L) is equivalent to 52.
56mg of C20H31NO3•C6H8O7
.

[category] antitussives
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【Storage】Sealed and stored in a dry place
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[Preparation] (1) Pentoxyverine Citrate Tablets (2) Pentoxyverine Citrate Dropping Pills API The efficacy and effect of Pentoxyverine Citrate 25kg/barrel are as follows: Which? The finished pentoverine citrate tablets made from pentoxaverine citrate are western medicines.
Its main effect is to relieve cough and asthma, and it also has the effect of relieving the pain and discomfort of the chest and throat caused by dry cough
.

Mainly used for bronchitis, pneumonia, bronchial asthma and other respiratory diseases; if cough and sputum volume are large, the use of this drug should be avoided
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【Pharmacological action】This product has central and peripheral antitussive effect, and its antitussive effect is about 1/3 of that of codaiine
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In addition to a direct inhibitory effect on the respiratory center of the medulla oblongata, it also has a mild atropine-like effect
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It can relax spasmodic bronchial smooth muscle and reduce airway resistance
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[Precautions] 1.
This medicine is only a symptomatic treatment medicine.
If the symptoms do not improve significantly after 7 days of application, you should seek medical attention immediately
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2 Do not drive machines, vehicles, boats, engage in high-altitude operations, mechanical operations and operate precision instruments during the period of taking the medicine
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3 Pregnant and lactating women should use it under the guidance of a physician
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4.
Use with caution in patients with glaucoma and heart failure
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5.
This product has no expectorant effect, and patients with excessive phlegm should use it under the guidance of a physician
.

6.
Those who are allergic to this product are prohibited, and those with allergies should use it with caution
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7.
It is forbidden to use this product when its properties change.
8.
Please keep this product out of the reach of children
.