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Pulse-activating preparation for injection and preparation method thereof

A technology for injection and pulse regeneration, which is applied in the field of preparation of injection preparations made from natural medicine extracts of traditional Chinese medicines, can solve problems such as difficulty in large-scale production, undisclosed extraction and purification methods, affecting product quality and clinical efficacy, etc.

Active Publication Date: 2011-04-20
江苏苏中药业集团生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Clinical reactions, a small number of traditional Chinese medicine injections have problems such as unstable quality and allergic reactions. This is because the injections are generally obtained after extraction, simple refining, liquid filling, sealing and sterilization. Chinese herbal extracts contain a large number of impurities such as tannin Acids, pigments, bacterial heat sources, etc. are the key issues restricting the improvement of the quality and stability of traditional Chinese medicines, which directly affect the quality and clinical efficacy of products.
Many inventors and pharmaceutical companies have done a lot of research work, such as patent application number 200510047834.9, which discloses a large-capacity injection of Shengmai and its preparation method. Effective extraction and purification methods are not disclosed in this method, so it is difficult to guarantee Product quality, and it is difficult to achieve in large-scale production; the patent application number is 200810101610.5, which discloses a Sanwei Shengmai injection and its preparation method. Although ultrafiltration technology is used in this method, the key control of ultrafiltration technology is not proposed It is difficult to operate in large-scale production, and macroporous resin adsorption technology is applied in the extraction of red ginseng. Although macroporous resin is an effective purification method for enriching active ingredients and removing impurities, its porogens and degradation products Toxic, on November 28, 2000, the National Center for Drug Evaluation held a "Macroporous Adsorption Resin Separation and Purification Technology Symposium", the meeting pointed out that Chinese medicine injections should be used with caution when using macroporous resins for purification, and sufficient evidence needs to be provided. Therefore, this method is operable in the laboratory, but it is rarely used in the actual large-scale industrial production of injections.

Method used

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0167] Raw material medicinal material proportioning weight part of the present invention is:

[0168] Red Ginseng 100g, Ophiopogon japonicus 312g, Schisandra 156g

[0169] The proportioning weight part of auxiliary material of the present invention is:

[0170] Sodium chloride 390g, mannitol 390g

[0171] 1) Preparation of red ginseng extract

[0172] With 95% ethanol, the red ginseng was refluxed and extracted 5 times, each time for 2 hours, filtered, the combined filtrate reclaimed the ethanol to the utmost, adjusted the pH value to 7.0, added purified water to adjust the amount of medicinal solution so that the amount of crude drug per ml was 1.5g, and Stand at -1°C-4°C for 12-48 hours, filter until clear, and adjust the pH value to 7.0 to obtain red ginseng extract A; (red ginseng extract A is prepared with ginsenoside Rg 1 2.5mg / ml in total, 1.3mg / ml in ginsenoside Re)

[0173] 2) Preparation of Ophiopogon japonicus extract

[0174] Decoct Ophiopogon japonicus with wa...

Embodiment 2

[0183] Raw material medicinal material proportioning weight part of the present invention is:

[0184] Red Ginseng 80g, Ophiopogon japonicus 250g, Schisandra 80g

[0185] The proportioning weight part of auxiliary material of the present invention is:

[0186] Sodium chloride 420g, lactose 420g

[0187] 1) Preparation of red ginseng extract

[0188] With 85% ethanol, the red ginseng was refluxed and extracted 4 times, each time for 1 hour, filtered, the combined filtrate recovered the ethanol to the utmost, adjusted the pH value to 6.0, added purified water to adjust the amount of medicinal solution so that the amount of crude drug per ml was 0.5g, and Stand at -1°C-4°C for 12-48 hours, filter until clear, and adjust the pH value to 6.0 to obtain red ginseng extract A; (red ginseng extract A is prepared with ginsenoside Rg 1 1.25mg / ml in total, 0.65mg / ml in ginsenoside Re)

[0189] 2) Preparation of Ophiopogon japonicus extract

[0190] Decoct Ophiopogon japonicus with wa...

Embodiment 3

[0199] Raw material medicinal material proportioning weight part of the present invention is:

[0200] Red Ginseng 150g, Ophiopogon japonicus 320g, Schisandra 160g

[0201] The proportioning weight part of auxiliary material of the present invention is:

[0202] Sodium chloride 440g, sucrose 440g

[0203] 1) Preparation of red ginseng extract

[0204] Red ginseng was extracted with 90% ethanol by reflux for 5 times, each time for 1 hour, filtered, and the filtrate was combined to recover the ethanol until it was exhausted, and the pH value was adjusted to 6.5. Stand at 1°C-4°C for 12-48 hours, filter until clear, and adjust the pH value to 6.5 to obtain red ginseng extract A; (red ginseng extract A is made of ginsenoside Rg 1 2.55mg / ml in total, 1.35mg / ml in ginsenoside Re)

[0205] 2) Preparation of Ophiopogon japonicus extract

[0206] Decoct Ophiopogon japonicus with water for 3 times, the first and second times are 1 hour respectively, and the third time is 30 minutes...

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Abstract

The invention relates to a pulse-activating preparation for injection and a preparation method thereof. The pulse-activating preparation contains red ginseng, ophiopogon root and Chinese magnoliavine fruit and is mainly used for treating deficiency of both qi and yin, cardiopalmus caused by feeble pulse, breath shortage, cold limbs, sweating, feeble and impalpable pulse, myocardial infraction, cardiogenic shock and infectious shock. The invention has more stable preparation quality and simple and convenient preparation processes, is safe and reliable, and provides the reasonable and realisticpreparation method for large-scale production of Chinese injection preparation.

Description

technical field [0001] The technology of the invention belongs to the field of traditional Chinese medicine pharmacy, and in particular relates to a preparation method for making injection preparations from natural medicine extracts of traditional Chinese medicines. Background technique [0002] Shengmaisan prescription (ginseng, Ophiopogon japonicus, Schisandra chinensis) is derived from "Internal and Internal Injury Debate Theory of Stomach Qi Injury due to Heatstroke in Juan". Traditional Chinese medicine Shengmaisan is used for critically ill patients, which is beneficial to Qi solidification and strengthens the heart. The clinical application effect is better. [0003] Shengmai Injection is an intravenous injection made according to the traditional ancient prescription Shengmai Powder through formulation reformation. It has the effect of replenishing qi and nourishing yin, recovering pulse and solidifying the pulse. It is used for palpitations, shortness of breath, col...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K36/8968A61P9/10A61P7/08A61P9/00A61P9/06A61P9/04A61P7/02A61P31/12A61P35/00
Inventor 唐仁茂徐柏颐闵文林周九兰戴德玲
Owner 江苏苏中药业集团生物制药有限公司
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