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The Preparation of and Clinical Observation on Stomakulm


 

Composition and Preparation
The oral Stomakulm is made up of Rhizoma Coptidis, Radix Paeoniae Alba, Radix Sanguisorbae, Rhizoma Bletillae and Endothelium Corneum Gigeriae Galli. It is extracted and prepared by scientific methods. All the Chinese medicines in the prescription are included in the first part of the Pharmacopoeia of the People’s Republic of China 1995. They have the heat-clearing and detoxicating effects and no toxicity. The preparing technology: Rhizoma Coptidis and Radix Paeoniae Alba are extracted by water and made as liquid extract. The others are made as power. Then mix them together and make them as pills. One pill is 0. 6g. The best extracting condition is chosen by orthogonel assay test: After making Rhizoma Coptidis and Radix Paeoniae Alba into power, first add 7 times of water and boil for half an hour, then add 5 times of water and boil for an hour again, mix the two portions of the boiling extracting fluids, concentrate and dry by vacuum, obtain an extract at last. The quality standard: In the qualitative analysis, it is affirmed that there are Radix Sanguisorbae, Rhizoma Bletillae and Endothelium Corneum Gigeriae Galli by power microscopic distinction and Rhizoma Coptidis, Radix Paeoniae Alba by the thin layer chromatograph. In the quantitative analysis Berberine hydrochloride is detected by thin layer scanning. Its content is stipulated to be over 0.3 % (g/g). The other items have been checked according to the requirements of the Pharmacopoeia. Because the pill's samples under the indoor temperature have been observed for two year and each requirement accords with the quality standard, it is stable during the store period. The storage time is two years.

Functions and indications
It clears away heat from the stomach, benefits the liver and alleviates pain. Indications: peptic ulcer caused by the stagnation and heat of the liver Qi and stomach Qi, epigastralgia, abdominal distention, bitter taste in mouth, yellow tongue fur, wiry pulse etc. Administration and dosage: swallow. The usual dosage is 6 pi1ls a time, four times a day for 42 days. Packing: It is packed in p1astic bottle. Each big box has16 units. One unit contains 12 bottles and there are 90 pills in a bottle. Storage: keep tightly closed and protect from heat and dampness.

Experiment Research
1. Anima1 experiment: the pill has:
1). The marked protecting action on animal models with stress ulcer and gastric ulcer induced by reserpine; 2). The action of improving ulcer healing on the animal model with gastric ulcer induced by acetic acid; 3). The inhibiting action on gastric acid secretion; and 4). The obvious remission action on mice abdominal pain by glacial acetic acid injection; and 5) The obvious inhibiting action on clinical helicobacter strain.

2.  Long-term toxicity test in animal: 2 groups of rats were infused 6.8g/kg, 13.5g/kg and 21g/kg raw medicine respectively for 90 days. Comparing with the control group: the appearance, body weight, organ index, hemogram, functions of the liver and the stomach and the pathologic findings in tissues of seven organs showed no significant differences. Large dosage in the long-term toxic experiment is 27g/ka, which is l00 times of clinical-dosage in adult. It proves the oral pill is safe.

Clinical researches
This prescription is an experimental one. It is the clinical experiences based on 800 cases. In an observation of 30 patients with peptic ulcer of stagnation and heat of liver and stomach, the marked effective rate was 70%, ulcer healing rate76.7%. It inhibits the epigastric cavity pain in 5.4 days (mean time) without side effects.

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Jing ICP Record No.08105532-2