2. Standards issued by the Ministry of Traditional Chinese Medicine 2. 1 Pinyin name Kuiyangning Capsule
2.2 standard number WS3Bb008595
2.3 prescription indigo naturalis ivory crumb cocoon (charcoal) human nail (talcum hot) pearl layer powder bezoar borneol
2.4 Characteristics This product is a capsule, and its contents are gray powder blue; The air is cool and the taste is slightly bitter.
2.5 Mark (1) is 0. The content of this product is 1g, which is put in a test tube and ignited with a small fire to produce purple smoke.
(2) Take 65438 0 g of this product, put it in a test tube, and add 65438±0ml of dilute hydrochloric acid to generate bubbles.
(3) Take 65438 0 g of this product, add 65438±00ml of chloroform, shake well, soak for 24 hours, filter, and concentrate the filtrate to about 2 ml as the test solution. Indirubin and indigo are taken as reference substances, and chloroform is added to prepare a mixed solution containing 1ml as reference substance solution ①. Cholic acid and deoxycholic acid were used as reference substances, and chloroform was added to prepare a mixed solution containing 1ml as reference substance solution ②. According to the thin-layer chromatography test (page 57 of the appendix), absorb 65,438 00μ l of each of the above three solutions, respectively spot them on the same silica gel G thin-layer plate with sodium carboxymethyl cellulose as adhesive, and use ethyl n-hexane acetate and methanol glacial acetic acid (6:32: 1: 1) as developing agents, unfold, take out and dry. In the chromatogram of the test sample, spots with the same color appear at the position corresponding to the chromatogram ① of the control sample. Spray 10% anhydrous alcohol solution of phosphoric anhydride and bake at 105℃ for about 10 minute. In the chromatogram of the test sample, spots with the same color appear at the position corresponding to the chromatogram ② of the control sample.
2.6 The inspection shall comply with relevant regulations under Capsules (Appendix 65438+ Page 6).
2.7 Indications: clearing away heat and toxic materials, promoting granulation and relieving pain. It can be used for treating duodenal ulcer, gastric ulcer, erosive gastritis with stomach heat and liver depression.
2.8 Usage and dosage: Take 3 capsules orally every night before going to bed.
2.9 Pay attention not to eat or drink after taking the medicine. Avoid spicy food.
2. Each specification of10 contains 0. 3g。
2. 1 1 storage seal.
Drafted by Tianjin Institute for Drug Control
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