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A Leonurus japonicus injection, its preparation method, and method for detecting total alkaloids

A technology of total alkaloids and detection methods, applied in the field of motherwort injection and its preparation, can solve the problems of low biological active ingredients, large dosage, cumbersome procedures, etc.

Active Publication Date: 2013-01-02
XIAN CHIHO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0017] Motherwort is a gynecological holy medicine with definite curative effect, and it is often used alone in clinical practice, such as motherwort ointment, motherwort granules, motherwort oral liquid, motherwort capsules, motherwort tablets, etc., but they are all general water extraction or water extraction and alcohol precipitation processes, and the preparations are not refined. And there are bitter taste, taking large amount, slow curative effect, unstable shortcoming; Existing motherwort injection is owing to volume is little, contains biological active ingredient low, so therapeutic effect is unsatisfactory; In addition, motherwort injection often needs to put Motherwort injection is diluted with glucose or sodium chloride injection, and then used by intravenous infusion. Due to the mixing of liquid before infusion, it has brought some disadvantages. Not only the procedures are cumbersome, but also it is easy to be polluted by the environment and equipment. Infusion reactions such as fever, nausea, chills, rapid or slow heartbeat, etc., may endanger the life of the patient in severe cases
[0018] In addition, the current detection of motherwort preparations is to detect a single component. For example, CN1973855A has involved the determination of stachydrine hydrochloride in motherwort injection by fingerprint method, but the main active ingredients of motherwort are leonurine and stachydrine. The determination of stachydrine hydrochloride in injections cannot fully reflect the precise content of active ingredients in crude drugs in injections

Method used

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  • A Leonurus japonicus injection, its preparation method, and method for detecting total alkaloids
  • A Leonurus japonicus injection, its preparation method, and method for detecting total alkaloids
  • A Leonurus japonicus injection, its preparation method, and method for detecting total alkaloids

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Experimental program
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Effect test

Embodiment 1

[0092] Embodiment 1: the preparation of large-capacity motherwort injection

[0093] a. Preparation and processing of motherwort extract: take 1kg of motherwort, add 10kg of water each time and decoct 3 times, combine the decoction, centrifuge for 30 minutes (1500 rpm), and take the supernatant for subsequent use;

[0094] b. Primary ultrafiltration: take the above supernatant and use a polyethersulfone membrane with a molecular cut-off of 10,000 Daltons to perform ultrafiltration at a pressure of 0.05 MPa, and the filtrate is for subsequent use;

[0095]c. Secondary ultrafiltration: Take the above filtrate, add appropriate amount of 1mol / L hydrochloric acid to adjust the pH value to 5.0, let it stand for 8 hours, and use a polyethersulfone membrane with a molecular cut-off of 3000 Daltons for ultrafiltration at a pressure of 0.2MPa. Ultrafiltrate standby;

[0096] d. Take the above-mentioned ultrafiltrate and add glucose to adjust isotonicity, then add water for injection ...

Embodiment 2

[0104] Embodiment 2: the preparation of large capacity motherwort injection

[0105] a. Preparation and processing of motherwort extract: take 1kg of motherwort, add 8kg of water each time, decoct 3 times, merge the decoction, centrifuge for 15 minutes (3000 rpm), and take the supernatant for subsequent use;

[0106] B, the first-stage ultrafiltration takes the above supernatant and uses a ceramic membrane with a molecular cut-off of 10,000 Daltons to perform ultrafiltration at a pressure of 0.1MPa, and the filtrate is for subsequent use;

[0107] c, secondary ultrafiltration to take the above-mentioned filtrate, add an appropriate amount of hydrochloric acid to adjust the pH value to 5.5, let stand for 10 hours, adopt a ceramic membrane with a molecular cut-off of 1000 Daltons to carry out ultrafiltration, the pressure is 0.1MPa, and the ultrafiltrate is for standby;

[0108] d. Take the above-mentioned ultrafiltrate and add sodium chloride to adjust isotonicity, then add w...

Embodiment 3

[0116] Embodiment 3: the preparation of large capacity motherwort injection

[0117] a. Preparation and processing of motherwort extract: take 1kg of motherwort, add 10kg of water each time, decoct twice, merge the decoction, centrifuge for 15 minutes (5000 rpm), and take the supernatant for subsequent use;

[0118] B, first-stage ultrafiltration: take the above-mentioned supernatant and adopt a cellulose acetate membrane with a molecular cut-off of 60,000 Daltons to carry out ultrafiltration at a pressure of 0.08 MPa, and the filtrate is for subsequent use;

[0119] c. Secondary ultrafiltration: Take the above filtrate, add appropriate amount of hydrochloric acid to adjust the pH value to 6.0, let it stand for 12 hours, and use a cellulose acetate membrane with a molecular cut-off of 10,000 Daltons for ultrafiltration at a pressure of 0.12 MPa. Liquid standby;

[0120] d. Take the above-mentioned ultrafiltrate and add calcium chloride to adjust isotonicity, then add water ...

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Abstract

The invention provides a Leonurus japonicus injection and its preparation method. The injection contains Leonurus japonicus ultrafiltrate, pharmaceutically acceptable compound for adjusting osmotic pressure, and optionally water for injection. The Leonurus japonicus injection provided by the invention is a large-volume injection, has high effective component content in crude drug and stable physicochemical properties, and can be directly used for intravenous injection. The invention also provides a method for detecting total alkaloids in Leonurus japonicus injection. The method can simultaneously detect leonurine and stachydrine hydrochloride in Leonurus japonicus injection to better reflect the content of total alkaloids in Leonurus japonicus injection.

Description

technical field [0001] The invention belongs to the technical field of pharmacy. Specifically, the present invention relates to a motherwort injection for intravenous infusion, a preparation method and a detection method thereof. Background technique [0002] Motherwort is the fresh or dry ground herb of Leonurus Japonicus Houtt., a plant of the Lamiaceae family. It was first recorded in "Shen Nong's Materia Medica", listed as top grade, and is a commonly used traditional Chinese medicine. Motherwort is pungent in taste, slightly bitter, and slightly cold in nature. Traditional medicine uses motherwort and its preparations to treat obstetrics and gynecology diseases. Physicians call motherwort a holy medicine for blood. [0003] The chemical constituents of motherwort mainly include: [0004] (1) Alkaloids: Motherwort contains total alkaloids, including Leonurine, Stachydrine, Leonurin and Leonurin; [0005] (2) Flavonoids: 5, 7, 3', 4', 5'-pentamethoxyflavone, wogonin, ...

Claims

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Application Information

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IPC IPC(8): A61K36/533A61K9/08G01N30/02A61P9/10A61P15/00
Inventor 胡小虎李文强
Owner XIAN CHIHO PHARMA
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