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Determination method of sore breast pill for treating sore breast
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A determination method and a technique for breast sore, which are applied in the directions of pill delivery, measuring device, pharmaceutical formula, etc., can solve problems such as imperfect identification items and identification means content determination methods, and achieve the effect of improving quality control and improving product quality.
Active Publication Date: 2012-03-07
津药达仁堂集团股份有限公司乐仁堂制药厂
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[0014] But do not see yet with the prescription similar or identical with the Ministry of Health standard WS3-B-0569-91 Ruchuang pill disclosed above, the proportioning is different, the improved document of the product standard of effect similarity, but the Ministry of Health of prior art Ruchuang pill In the standard WS3-B-0569-91, there are still shortcomings such as identification items, identification methods, and content determination methods. For Chinese medicine to go to the world, it is necessary to improve and improve the quality standards of Chinese medicine
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[0045] Preparation of reference substance solution Take an appropriate amount of chlorogenic acid reference substance, weigh it accurately, add 50% methanol to make a solution containing 30 μg per 1 ml, and obtain it.
[0046] Preparation of the test solution Take 3g of this product, grind it finely, take 0.5g of sample powder, accurately weigh it, put it in a stoppered conical flask, accurately measure 50ml of 80% methanol, weigh it, heat and reflux for 30 minutes, put Cool, weigh, make up the lost weight with 80% methanol, filter, and obtain.
[0047] Determination method Precisely draw 5 μl each of the reference substance solution and the test solution, inject it into the liquid chromatograph, measure it, and obtain it. This product contains no less than 1.70mg of chlorogenic acid per gram.
[0048] Functions and indications: detoxification, detumescence, anti-inflammatory and pain relief. It is used for breast sores, carbuncles and swollen at the beginning, and the burni...
Embodiment 2
[0051] Example 2 Ruchuang Pill Quality Standard Drafting Description: The original quality standard of Ruchuang Pill did not have identification and content determination. The TLC identification of honeysuckle and forsythia and the content determination method of honeysuckle were researched and tested, and the results increased the content of honeysuckle and forsythia. TLC identification and determination of chlorogenic acid in honeysuckle.
[0056] Forsythia: National Institute for the Control of Pharmaceutical and Biological Products, batch number: 120908-200512
[0057] 1.2 Preparation of the test solution
[0058] Take 2g of this product powder, add 50ml of chloroform, heat to reflux for 1 hour, filter, discard the filtrate, evaporate the residue to dryness, add 50ml of et...
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Abstract
The invention belongs to the technical field of Chinese patent medicines, in particular to a quality control method of a sore breast pill for treating sore breast, which is prepared from traditional Chinese herbal medicines as raw materials. The method comprises the following steps of: with forsythia and chlorogenic acid as reference substances, identifying whether a sore breast pill prescriptioncontains forsythia and honeysuckle by using a TLC (Thin-Layer Chromatography); and with the chlorogenic acid as a reference substance, detecting the chlorogenic acid content in the sore breast pill prescription by using a high-efficiency liquid-phase chromatography method. The revised mass standard is perfect, improves the quality control of medicaments and is significant to the modernization andthe export of traditional Chinese medicines.
Description
technical field [0001] The invention belongs to the technical field of Chinese patent medicines, and relates to a method for measuring Ruchuang Pills for treating breast sores made from Chinese medicinal materials. Background technique [0002] Ruchuang Pill is a classic Chinese patent medicine. The Ministry of Health standard WS3-B-0569-91 records the prescription and quality standards: [0003] Prescription: Honeysuckle 250g Dandelion 250g Trichosanthum 150g [0004] Pangolin (made in vinegar) 100g Myrrh (made in vinegar) 100g Green skin (made in vinegar) 100g [0005] Forsythia 250g Angelica 200g Radix Paeoniae Rubra 150g [0006] Frankincense (made with vinegar) 100g Rehmannia glutinosa 100g Chuanxiong 100g [0007] Preparation method: Grind the above twelve flavors into fine powder, mix well, and sieve. Make pills with water and dry to get the final product. Inspection: It should comply with the relevant regulations under the pill item (Appendix 8...
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