Quality Control

Sennosides as calcium salts are assayed as Total hydroxyanthracene glucosides estimated as Sennoside B. As per BP, E (1%,1cm) value of 240 or 200 for color development at 515nm and 500nm respectively) is used. USP employs spectroflurometric method necessitating the use of standard every time. There is an increased tendency nowadays to use HPLC method declaring Sennosides A + B. A rapid and useful method based on the BP is popularly used all over the world.



Manufacture of Calcium Sennosides

A.Short description of process :

Senna leaves are tested before and after grinding for Sennosides contents and are extracted with methanol. The above methanolic extracts are collected and Calcium sennosides are separated by addition of Calcium Salt solution. The precipitated Calcium sennosides are centrifuged and washed with methanol & dried under vacuum. The dried Calcium sennosides are ground, tested and packed.

B.Process Control Test :

The following control parameters are monitored during manufacture :

• PH of Aqueous Suspension
• Heavy Metals
• Residue on Igination
• L.O.D
• Assay

Constipation

Types of Constipation

Constipation can be broadly classified into two types:

a) Casual or temporary: Can be caused by indigestion, overeating, contaminated food or bacterial infection.

b) Chronic or habitual: Occurs largely in the elderly usually due to the loss of Tonality in the sphincter muscles. It is also presented by persons sufering from piles or haemorrhoidal tissues.

Oral laxatives medicines taken by mouth to encourage bowel movements to relieve constipation. Most laxatives (except saline laxatives) may also be used to provide relief:

• During pregnancy.
• For a few days after giving birth.
• During preparation for examination or surgery.
• For constipation of bedfast patients.
• For constipation caused by other medicines.
• Following surgery when straining should be avoided.
• Following a period of poor eating habits or a lack of physical exercise in order to develop normal bowel function (bulk-forming laxatives only).
• For some medical conditions that may be made worse by straining, for example:
  

  Heart disease Hemorrhoids Hernia (rupture) High blood pressure (hypertension) History of stroke

Different types of oral laxatives

Bulk-formers : Bulk-forming laxatives are not digested but absorb liquid in the intestines and swell to form a soft, bulky stool. The bowel is then stimulated normally by the presence of the bulky mass. Some bulk-forming laxatives, like psyllium and polycarbophil, may be prescribed by your doctor to treat diarrhea.

Hyperosmotics : Hyperosmotic laxatives encourage bowel movements by drawing water into the bowel from surrounding body tissues. This provides a soft stool mass and increased bowel action. There are three types of hyperosmotic laxatives taken by mouth-the saline, the lactulose, and the polymer types.

• The saline type is often called "salts.'' They are used for rapid emptying of the lower intestine and bowel. They are not used for long-term or repeated correction of constipation.
• The lactulose type is a special sugar-like laxative that works the same way as the saline type. However, it produces results much more slowly and is often used for long-term treatment of chronic constipation.
• The polymer type is a polyglycol (polyethylene glycol), a large molecule that causes water to be retained in the stool; this will soften the stool and increase the number of bowel movements. It is used for short periods of time to treat constipation.

Lubricants : Lubricant laxatives, such as mineral oil, taken by mouth encourage bowel movements by coating the bowel and the stool mass with a waterproof film. This keeps moisture in the stool. The stool remains soft and its passage is made easier.

Stimulants : Stimulant laxatives, also known as contact laxatives, encourage bowel movements by acting on the intestinal wall. They increase the muscle contractions that move along the stool mass. Stimulant laxatives are a popular type of laxative for self-treatment. However, they also are more likely to cause side effects. They are synthetics like Bisacodyl as well as natural products like senna, cascara sagrada, cassia fistula, etc. Phenolphthalein is known to cause severe side effects and is banned in several countries.

Stool softeners (emollients) : Stool softeners encourage bowel movements by helping liquids mix into the stool and prevent dry, hard stool masses. This type of laxative has been said not to cause a bowel movement but instead allows the patient to have a bowel movement without straining.

Combinations : There are many products that you can buy for constipation that contain more than one type of laxative.

Saline laxatives : Have more limited uses and may be used to provide rapid results :

• During preparation for examination or surgery.
• For elimination of food or drugs from the body in cases of poisoning or overdose.
• For simple constipation that happens on occasion (although another type of laxative may be preferred).
• In supplying a fresh stool sample for diagnosis.

The use of laxatives may create other problems if these conditions are present :

• Diabetes mellitus (sugar diabetes)
• Heart disease
• High blood pressure
• Kidney disease
• Swallowing difficulty

Dosing

There are a large number of laxative products on the market. The dose of laxatives will be different for different products. The number of capsules or tablets or teaspoonfuls of crystals, gel, granules, liquid, or powder that you use; the number of caramels or wafers that you eat; or the number of pieces of gum that you chew depends on the strength of the medicine. Follow your doctor's orders if this medicine was prescribed, or follow the directions on the box if you are buying this medicine without a prescription .

Storage

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule, tablet, granules, or powder form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed.
• Be sure that any discarded medicine is out of the reach of children.